[Federal Register Volume 61, Number 150 (Friday, August 2, 1996)]
[Rules and Regulations]
[Pages 40320-40332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19645]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 101
[Docket No. 93N-0153]
RIN 0910-AA19
Food Labeling; Nutrient Content Claims and Health Claims;
Restaurant Foods
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its food
labeling regulations to remove the provisions that exempt restaurant
menus from the requirements for how nutrient content claims and health
claims are to be made and from the requirements for the provision of
nutrition information with respect to the nutrients that are the basis
for the claim, when claims are made. Because a significant number of
meals are consumed outside of the home, the extension of these
requirements to menus will help to increase the awareness of the
American consumer to the relationships between diet and health. FDA is
issuing this final rule at this time in response to a decision by the
United States District Court for the District of Columbia.
DATES: This regulation is effective May 2, 1997. Written comments on
the information collection requirements should be submitted by October
1, 1996.
ADDRESSES: Submit written comments on the information collection
requirements to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All
comments should be identified with the docket number found in brackets
in the heading of this document. Persons who believe it would be useful
for the agency to hold a public meeting on what is required by this
rule should also send their letters to the Dockets Management Branch.
FOR FURTHER INFORMATION CONTACT: Michelle A. Smith, Center for Food
Safety and Applied Nutrition (HFS-158), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5099.
SUPPLEMENTARY INFORMATION:
I. Background
A. Requirements for Nutrition Labeling and Nutrient Content Claims and
Health Claims
The Nutrition Labeling and Education Act of 1990 (the 1990
amendments) and the final regulations that implement the 1990
amendments (58 FR 2066, January 6, 1993, as modified at 58 FR 44020,
August 18, 1993) provide for a number of fundamental changes in how
food is labeled, including mandatory nutrition labeling on most foods,
uniform definitions for terms that characterize the level of nutrients
in a food, and the use of claims about the relationship between
nutrients and diseases or health-related conditions. These changes
apply to virtually all foods in the food supply, including foods sold
in restaurants.
The provision on nutrition labeling that was added to the Federal
Food, Drug, and Cosmetic Act (the act) by the 1990 amendments, section
403(q) (21 U.S.C. 343(q)), includes an exemption for foods that are
served or sold in restaurants or other establishments in which food is
served for immediate human consumption (section 403(q)(5)(A)(i)). This
exemption, however, is contingent on there being no claims or other
nutrition information on the label or labeling, or in the advertising,
for the food. The use of nutrient content claims, health claims, or
other nutrition information on the label or labeling of a food sold in
a restaurant or other establishment in which food is served for
immediate consumption will subject that food to the nutrition labeling
provisions of the act (see sections 403 (q) and (r) of the act and
Sec. 101.9 (j)(2)(i) through (j)(2)(iii) (21 CFR 101.9 (j)(2)(i)
through (j)(2)(iii))). Consistent with these provisions, in this
discussion the term ``restaurant foods'' refers to foods served in
restaurants and in other establishments in which food that is ready for
human consumption is sold (e.g., institutional food service,
delicatessens, catering) or sold only in such establishments. Firms
selling such foods will be referred to as ``restaurants,'' and
responsible individuals in these firms will be referred to as
``restaurateurs.''
In the January 6, 1993, final rules on nutrient content claims and
health claims (entitled ``Food Labeling: Nutrient Content Claims,
General Principles, Petitions, Definitions of Terms; Definitions of
Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol
Content of Food'' (58 FR 2302); and ``Food Labeling; General
Requirements for Health Claims for Food'' (58 FR 2478), respectively
(hereinafter referred to as the ``nutrient content claims final rule''
and the ``health claims final rule,'' and collectively, as the ``claims
final rules'')), the agency concluded that if claims on restaurant
foods are to be useful to consumers, they must be valid. Thus, FDA
stated that the same standards will apply to restaurant foods as to
other foods with respect to basic definitions for nutrient content
claims. FDA also stated that when a restaurant makes explicit or
implied reference to a food or substance in food, and directly or
indirectly links that substance to an effect on a disease or health-
related condition (i.e., when both basic elements of a health claim are
present), the restaurant must comply with the health claims regime (58
FR 2478 at 2516). At the same time, FDA acknowledged that how a
restaurant demonstrates compliance with these requirements is a
difficult matter. FDA pointed out, in the claims final rules (58 FR
2302 at 2386 and 58 FR 2478 at 2515), that it is not obligated under
the act to regulate claims on restaurant foods in a manner identical to
that in which it regulates claims on packaged foods. In the nutrient
content claims final rule (58 FR 2302), the agency amended Sec. 101.10
Nutrition labeling of restaurant foods (21 CFR 101.10) to provide
flexibility for restaurants in determining compliance with FDA's
requirements for the claims regime and in providing nutrition labeling
for foods that bear a claim.
Consequently, although restaurant food must comply with the same
standards as other foods to bear a claim, the way in which a restaurant
determines the nutrient content of a food or meal, and the way in which
nutrition information is communicated to consumers, may be different
for restaurant foods than for foods from other sources. For example,
Sec. 101.10 provides that nutrient levels in restaurant foods may be
determined through the use of nutrient data bases, cookbooks, or other
reasonable bases that provide assurance that the food or meal meets the
nutrient requirements for the claim. For compliance purposes,
[[Page 40321]]
a restaurant is required to provide information on its reasonable basis
for making a claim. Further, restaurants making a claim are required to
provide consumers, upon request, with nutrition information on the
nutrient that is the subject of the claim. However, Sec. 101.10
provides that nutrition labeling may be presented in various forms,
including those provided in Sec. 101.45 (21 CFR 101.45) for raw fruit,
vegetables, and fish, or by other reasonable means.
Thus, although FDA encourages restaurants to provide full nutrition
information according to Sec. 101.9 whenever possible, the agency has
determined that information on the nutrient amounts that are the bases
for claims (e.g., if the claim is a ``low fat'' claim, the nutrition
information must only state that ``this meal provides less than 10
grams of fat'') may, in a restaurant setting, serve as the functional
equivalent of complete nutrition information as described in
Sec. 101.9. Further, this information may be provided by reasonable
means, e.g., in a flier, brochure, poster, notebook, or orally. FDA
concluded that these flexibilities (e.g., the ``reasonable basis''
criterion) would help to ensure that a restaurateur is provided with a
readily achievable way to make claims for his or her food, while the
consumer is provided with a reasonable assurance that the claim is
valid (58 FR 2302 at 2387 and 58 FR 2478 at 2516).
The claims final rule contained two additional provisions. First,
Sec. 101.13(q)(5) (21 CFR 101.13(q)(5)) exempts nutrient content claims
made on menus from the requirement that such claims comply with the
requirements and definitions governing nutrient content claims. There
is a similar provision with respect to health claims made on restaurant
menus in Secs. 101.10 and 101.14 with respect to nutrition labeling
requirements for a restaurant food that makes a nutrient content claim
or a health claim. The agency's decision to exempt restaurant menus
from the requirements for nutrient content claims and health claims was
based, in part, on the frequency with which menus change (sometimes
daily) (58 FR 2302 at 2388 and 58 FR 2478 at 2517).
Second, because of concerns about the demands that the new labeling
requirements would impose on small restaurants, FDA decided to use its
enforcement discretion to delay for 1 year the effective date of its
regulations governing the use of claims by these firms. The agency
defined ``small restaurants'' as ``restaurant firms consisting of 10 or
fewer establishments'' (58 FR 2302 at 2388 and 58 FR 2478 at 2517).
Consequently, FDA provided that its requirements for health claims and
nutrient content claims on restaurant labeling (except menus) would be
effective on May 8, 1993, and May 8, 1994, respectively, for other than
small restaurants (i.e., restaurant firms with more than 10
establishments), and on May 8, 1994, and May 8, 1995, for small
restaurants.
FDA concluded that these additional measures of flexibility would
help to ensure that restaurants, especially small restaurants, would
not be deterred by the 1990 amendments from providing useful nutrition-
related information to their customers. It is the latter two decisions
that FDA decided to reconsider.
B. Decision to Reconsider
Among the final rules that FDA issued in the Federal Register of
January 6, 1993, was one entitled ``Food Labeling Regulations
Implementing the Nutrition Labeling and Education Act of 1990;
Opportunity for Comments'' (58 FR 2066) (hereinafter referred to as the
``implementation final rule''). Among other things, the implementation
final rule provided 30 days for the submission of comments on technical
issues, such as inconsistencies or unintended consequences of specific
provisions not raised in earlier comments. Two comments received during
the technical comment period criticized the menu exemption and
questioned its legality under both the 1990 amendments and the
Administrative Procedure Act (the APA). One comment received during the
technical comment period maintained that the effort required for small
restaurants to comply with the new labeling requirements is no
different from that required by medium and large restaurants. Another
comment argued that delaying the effective dates for small restaurants
is not consistent with the 1990 amendments.
After careful consideration of the comments and further study of
the administrative record, the agency decided to reconsider these
provisions. Based on its reconsideration, in the Federal Register of
June 15, 1993 (58 FR 33055), FDA proposed to remove the exemption for
menus from the coverage of the claims provisions. In this proposed rule
(hereinafter referred to as the June 15, 1993, proposed rule), FDA
tentatively concluded that the menu exemption is not consistent with
the act or with the statutory charge provided by the 1990 amendments.
FDA stated that it was concerned that health claims and nutrient
content claims in menus will be of little utility if they fail to
comply with the standards in the claims regulations, which are designed
to ensure the validity of these claims. Further, FDA stated that the
menu exemption could create a situation in which confusion about the
valid information provided by authorized claims in non-menu labeling
would result from the use of unauthorized claims in menus. FDA
emphasized that (except for the deletion of the menu exemption) the
proposed amendments do not alter the substance or status of the current
regulations governing the use of nutrient content claims and health
claims in restaurants (58 FR 33055 at 33057). Finally, the agency noted
that it is virtually impossible to distinguish menus from other types
of restaurant labeling, such as signs, placards, and other point of
purchase information, that are covered by the claims final rules.
FDA also tentatively concluded that, in establishing dates of
applicability for its requirements, it had no reasonable basis for
differentiating among restaurants based on size. Consequently, the
agency proposed to remove the provisions that delayed by 1 year the
effective dates for compliance for small restaurants. However, because
the agency was unable to publish a final rule before the May 8, 1994,
and May 8, 1995, compliance dates for non-menu labeling, this aspect of
the proposal, i.e., to shorten the delay in effective dates for small
restaurant firms, is moot. Therefore, FDA is withdrawing that aspect of
its June 15, 1993, proposed rule.
In deciding whether to publish a final rule, several concerns were
raised for the agency's consideration. These concerns involved
evaluation of the extent to which the nutrient content claims and
health claims that were being made on restaurant menus failed to meet
FDA's definitions, and of whether consumers were experiencing confusion
or were concerned about variations between the labeling of restaurant
and packaged foods. Concerns were also raised about whether both
nutrient content claims and health claims needed to be covered, about
whether the regulations would cause restaurants to stop making claims
and/or the associated foods, and about what the effect of the
regulations would be on small restaurants.
Before the agency had fully resolved these issues, other events
intervened. As noted in the June 15, 1993, proposed rule, FDA had been
sued by two public interest groups and two individuals on the grounds
that the menu exemption violates the 1990 amendments and the
Administrative Procedure Act (Public
[[Page 40322]]
Citizen, Inc., et al. v. Shalala, Civil Action No. 93 0509 (D.D.C.)).
On June 28, 1996, the court declared that the parts of the regulations
that exempted restaurant menus from the nutrient content claim and
health claim provisions of the 1990 amendments are contrary to the
statute and ordered FDA to amend its regulations to include menus.
Therefore, FDA is issuing this final rule. However, as explained below,
in doing so, the agency remains committed to ensuring that the changes
made by this final rule do not adversely affect either small
restaurants or the flow of information from restaurant menus to
consumers.
II. Comments
The agency received 37 letters, each containing 1 or more comments
on its June 15, 1993, proposed rule, from consumers and consumer
groups, restaurateurs, trade associations, registered dieticians,
academia, and State officials. Some letters supported the proposal to
delete the exemption for restaurant menus, stating, for example, that
exempting restaurant menus that make claims from the new labeling
requirements would undermine the ability of consumers to make improved
dietary choices. Conversely, other letters opposed applying the new
labeling requirements to restaurant menus, stating that the
requirements are burdensome and not appropriate for a restaurant
situation. Many of these comments, however, expressed confusion as to
how the agency would implement its requirements with respect to
restaurant foods.
In response to the latter comments, FDA prepared a guidance
document on the labeling of restaurant foods. The agency announced in
the Federal Register of September 19, 1995 (60 FR 48516), the
availability of the guidance document. The agency also published, as an
appendix to that notice of availability, answers to some of the most
frequently asked questions. The guidance document, entitled ``Food
Labeling: Questions and Answers, Volume II; A Guide for Restaurants and
Other Retail Establishments,'' explains how FDA will implement its
requirements for restaurant labeling that bears a health claim or
characterizes the level of a nutrient in a food.
Several comments addressed issues that are outside the scope of
this rulemaking, such as modifying the criteria for nutrient content
and health claims set out in the claims final rules. These comments are
not responded to in this document. A summary of the comments that did
address the proposal, and the agency's responses, follow.
A. Menu Exemption
1. A number of comments supported the proposal, stating that FDA is
legally bound to include menus under the 1990 amendments. Comments
stated that restaurant menus are labeling under the act and appropriate
case law and, as such, are covered by the 1990 amendments. Comments
further stated that Congress neither provided for nor intended an
exemption for menus, and, therefore, FDA cannot grant one.
Other comments cited the importance of restaurant foods in the
American diet, stating that applying the requirements of the 1990
amendments to menus would play a critical role in the ability of
consumers to make healthy dietary choices. Comments maintained that
menus are the primary means by which a consumer discovers information
about the foods available in a restaurant. Thus, these comments argued,
the new labeling requirements should apply to all types of restaurant
labeling, including menus. As evidence of the need to apply the new
requirements to restaurant menus, several comments submitted menus
that, in their opinion, bear claims that do not comply with FDA's
requirements.
Conversely, a number of comments maintained that many restaurateurs
currently offer ``healthier'' menu items and promote the nutritional
quality of these foods to consumers in a variety of ways that are
truthful and not misleading. These comments maintained that applying
the requirements of the 1990 amendments to restaurant menus is
redundant and unnecessary because restaurant menus are already covered
by section 403(a) of the act. Several comments stated that menus are
also regulated by States and, because they are considered to be
advertising, by the Federal Trade Commission (FTC).
FDA agrees that many restaurants currently provide consumers with
useful information in a way that is not inconsistent with FDA's new
requirements. Nonetheless, FDA concludes, based at least in part on the
act, that it is necessary to make the proposed changes. Thus, the
agency disagrees with the comments that state that applying the
requirements of the 1990 amendments to restaurant menus is redundant
and unnecessary.
As stated in the nutrient content claims final rule (58 FR 2302 at
2388), before the 1990 amendments, when restaurants provided nutrition
information they were subject to Sec. 101.10, FDA's pre-1990 amendment
nutrition labeling regulation. FDA enforcement of that regulation was
virtually nonexistent, however. Further, while section 403(a) of the
act prohibits labeling that is ``false or misleading in any
particular,'' section 403(r) provides for requirements with respect to
claims that are in addition to those established in section 403(a) of
the act. FDA's statutory charge under the 1990 amendments is to ensure
that nutrient content claims and health claims made for food accurately
characterize the food and are scientifically valid. Finally, although
FTC has jurisdiction over national advertising, restaurant menus are
more akin to labeling than advertising in their use and function. Thus,
they are appropriately included within the regulatory scheme designed
for food labeling.
FDA notes that restaurant foods are an important part of the food
supply. As stated in the nutrient content claims final rule (58 FR 2302
at 2387), as much as 30 percent of the American diet is composed of
foods prepared in food service operations. The agency agrees with
comments that menus are a primary source of information for consumers
making purchase decisions in a restaurant or other establishment where
food is sold for immediate consumption.
In the claims final rules, the agency justified the menu exemption
on the grounds that it will help ensure that restaurants are not
deterred by the requirements of the 1990 amendments from providing
useful nutrition-related information. FDA also noted that fast food
chains and other restaurants frequently use non-menu media, such as
posters and placards, to convey nutrition information to consumers, and
stated that it would focus its efforts on these media. However, FDA
notes that menus are used to present information about the choices
available in a restaurant or other establishment in which food is
served for immediate consumption. Consequently, FDA concludes that
menus that bear a nutrient content claim, health claim, or other
nutrition information have a significant bearing on the ability of
consumers to select foods that are useful in maintaining healthy
dietary practices. Therefore, FDA finds that claims on restaurant menus
should be subject to the same standards as claims on other food labels
and in labeling.
FDA finds that, if it were to maintain the exemption for restaurant
menus, it would have no specific criteria for determining whether a
nutrient content claim made in a menu appropriately describes the food,
or for determining whether a health claim is scientifically valid.
Consequently, there would be no assurance that claims made in
[[Page 40323]]
restaurant menus are consistent with claims on other restaurant
labeling or on the labeling of other foods, or that such claims would
help consumers select foods that are useful in maintaining healthy
dietary practices.
On further review of the legislative history, FDA noted that
section 405 of the act (21 U.S.C. 345), which authorizes exemptions to
the act, was amended by the 1990 amendments to state: ``This section
does not apply to the labeling requirements of section 403(q) and
403(r).'' Because the menu exemption is an exemption from section
403(r) of the act, FDA tentatively concluded that it is barred by
section 405 of the act.
FDA also noted that section 403(r)(5)(B) of the act limits the
extent to which the nutrient content claims and health claims
provisions of the act apply to restaurants by, e.g., exempting
restaurant foods from certain disclosure statements that apply to
claims on packaged food labels. In its discussion of whether Congress
intended to apply the 1990 amendments to restaurant menus (58 FR 33055
at 33056), the agency cited a sponsors' report explaining this section.
That report stated that restaurants that use nutrient content claims in
connection with the sale of a food must comply with regulations issued
by the Secretary of Health and Human Services under section
403(r)(2)(A)(I). In that report, the sponsors specifically gave the
example of the use of the word ``light'' or ``low'' on a menu as the
type of labeling that must comply with FDA's requirements (136
Congressional Record H5841 (July 30, 1990)). This part of the bill was
passed by the Senate unchanged. Thus, FDA concludes that the menu
exemption is not consistent with the congressional intent in adopting
the 1990 amendments, and that there is no basis for exempting menus
from the coverage of section 403(r) of the act. (See also Public
Citizen v. Shalala, supra.)
2. A number of comments stated that consumers' need for useful
nutrition information outweighs any burden that the requirements might
place on restaurants making claims on their menus. One comment stated
that it did not believe that the new requirements would be burdensome
for restaurants because, according to the comment, a ``good''
restaurant ordinarily keeps track of ingredient quantities to evaluate
food preparation costs. Several comments stated that ample resources
exist to aid restaurants in developing menu items that comply with
FDA's requirements. They noted that applying the new requirements to
menus would not interfere with a restaurant's ability to provide
dietary guidance on a menu, e.g., to identify those foods with a
nutrient content such that the food could be helpful to consumers in
achieving a diet consistent with the dietary guidelines of a
professional health organization.
A number of comments stated that it is important that claims be
used in a consistent manner across the food industry. One comment
argued that exempting menus from the nutrient content claims and health
claims provisions would create an uneven playing field between
restaurateurs and food processors. Another comment maintained that the
need for a single rule for the use of claims is further evidenced by
FTC's decision to adopt FDA's definitions for nutrient content claims.
Conversely, a number of comments stated that the menu exemption
provides critical flexibility to the restaurant industry. Comments
cited numerous differences between restaurant foods and standardized,
processed foods, including: Ingredient supply sources, methods of
preparation, and marketing. One comment stated that many food service
operations find the new regulations to be burdensome and poorly suited
to the food service industry. Another comment argued that the nutrition
labeling regulations would impose a greater burden on restaurants than
on food manufacturers because restaurants may change their menus more
than once a day, for example, between lunch and dinner. Several
comments stated that revoking the menu exemption would create a barrier
to the dissemination of beneficial information to the consumer, would
increase the cost of creating and promoting nutritionally improved
foods, and would ultimately limit the number of nutritionally improved
foods in restaurants.
In response to comments that compliance with the requirements of
the 1990 amendments will be burdensome, FDA notes that these rules
place no affirmative requirements on restaurants that do not make
claims. In other words, a restaurant would be in complete compliance
with the new regulations if it simply refrained from making a nutrient
content claim or a health claim. However, FDA does not believe such a
situation would be the most desirable outcome.
As stated in the nutrient content claims final rule (58 FR 2302),
two of the goals of the 1990 amendments are to provide for information
that can assist consumers in maintaining healthy dietary practices and
to encourage product innovation through the development and marketing
of improved foods. FDA has concluded that, for information to be useful
to consumers, nutrient content and health claims must be valid. At the
same time, the agency has recognized that there are sources of
variation unique to restaurant foods (e.g., methods of preparation).
Consequently, to ensure that the new requirements do not place an
unreasonable burden on restaurants, FDA has included a number of
provisions to provide flexibility in how these requirements can be met
in a restaurant situation. For example, as stated above,
Secs. 101.13(q)(5)(ii) and 101.14(d)(2)(vii)(B) provide that a
restaurant may make a nutrient content claim or a health claim for a
food as long as it has a ``reasonable basis'' for believing that the
food contains the requisite level of the nutrient in question (58 FR
2302 at 2387 and 58 FR 2478 at 2516). The ``reasonable basis''
criterion provides that nutrient content levels may be determined by
use of nutrient data bases, cookbooks, analyses, or other sources that
provide reasonable assurance that the food meets the criteria for a
claim.
FDA also notes that restaurants may develop and market menu items
that help consumers to achieve certain dietary goals without subjecting
the food to the requirements of the 1990 amendments. For example,
restaurants may offer alternative selections whose value in a diet that
conforms to dietary guidelines may be recognized by consumers without
elaboration, e.g., raw vegetables, steamed vegetables, pasta with a
tomato based sauce instead of a cream sauce, a grain dish, or a fresh
fruit plate. Optional preparation or serving methods may be highlighted
on menus by statements such as ``may be prepared with half the oil on
request,'' ``smaller portions,'' or ``dressings and sauces available on
the side.''
Further, foods that meet the dietary guidelines of a recognized
dietary authority or health professional organization may be
highlighted without subjecting the food to the nutrient content claims
regime, provided the statement that a food meets dietary guidelines
does not go on to characterize the level of a nutrient in the food
(Sec. 101.13(q)(5)(iii)). For example, a restaurateur may signal to
consumers by the use of a term or symbol that a meal is formulated in
complete accordance with the Dietary Guidelines for Americans (e.g.,
moderate calories, less than 30 percent of calories from fat, less than
10 percent of calories from saturated fat, emphasis on vegetables,
fruits, and grain products,
[[Page 40324]]
and moderate use of sugars and sodium). Likewise, dietary guidance
that, within the context of the labeling, does not meet the definition
of a health claim, i.e., does not include both the food or substance
element and the disease-related element (e.g., ``eating five fruits and
vegetables a day is an important part of a healthy diet''), would be
considered dietary guidance and not a health claim subject to section
403(r) of the act (Sec. 101.14(a)(1)). FDA advises that foods bearing
statements outside the coverage of section 403(r) of the act are still
subject to section 403(a) of the act, which requires that the label be
truthful and not misleading, and to section 201(n) of the act which
describes the circumstances in which labeling is misleading.
The agency acknowledges that a significant effort will be required
on the part of some restaurants to examine their meals and menus to
ensure that they are in compliance with the new regulations. However,
many of the comments that argued that the requirements for nutrient
content claims and health claims would be burdensome for restaurants
consistently evidenced a significant misunderstanding of the relevant
provisions, such as the application of ``reference amounts customarily
consumed'' and the need for a ``reference food'' when making some types
of claims. For example, several comments seemed to believe that
restaurants would be forced to alter their portion sizes to be
identical to the established reference amounts. Another comment
expressed the belief that restaurants would be required to declare the
serving size of its food as the same as the reference amount, even if
the amount served differed from the reference amount. A number of
comments expressed concern that restaurateurs would be required to
develop recipes for, analyze, and market, a reference food for every
food that bears a claim. Several comments maintained that there is not
enough room on menus to provide the nutrition information that they
assumed FDA would require.
The agency advises that there is no basis for the concerns
expressed by these comments. In a January 6, 1993, final rule, entitled
``Food Labeling; Serving Sizes'' (58 FR 2229) (hereinafter referred to
as the ``serving size final rule''), FDA defined reference amounts, and
the serving sizes derived from them, on the basis of the amount of food
customarily consumed per eating occasion (reference amount customarily
consumed or ``reference amount'') in order to facilitate comparison of
the nutrient content of similar foods. FDA established reference
amounts for 139 food product categories (Sec. 101.12 (21 CFR 101.12)).
The agency provided that, in order to make certain nutrient content
claims or health claims, a food must meet the criteria for the claim
based on the amount of the particular nutrient present in the reference
amount of the food. For example, the reference amount for all soups is
245 grams (g) based on a serving size of 1 cup. However, restaurants
may offer soup in more than one portion size, e.g., by the cup and by
the bowl. In order to bear a ``low fat'' claim a cup of soup may
contain up to 3 g of fat per reference amount (245 g). If this same
soup is served to customers in a bowl that contains 367 g of soup (367
g serving/245 g per reference amount for all soups = 1.5), it may
contain up to 4.5 g of fat (3 g of fat per reference amount x 1.5 = 4.5
g of fat) and still be labeled ``low fat.''
Criteria for claims on meals and main dishes (as defined in
Sec. 101.13(l) and (m)) are generally based on the level of a nutrient
in 100 g of the food. For example, a ``low fat'' meal weighing 333 g
can contain up to 10 g of fat (333 g serving /100 g = 3.3; 3 g of fat
per 100 g of food x 3.3 = 10 g of fat). Again, a restaurant serving a
larger portion of a meal or main dish item is not at a disadvantage
compared to other food sources when making a ``low fat'' claim. FDA
advises, however, that some claims, e.g., ``free'' claims and
cholesterol claims, have additional criteria based on the labeled or
actual serving size. The criteria for specific nutrient content and
health claims are set out in part 101 (21 CFR part 101).
FDA advises that it is not necessary for restaurants to produce and
market a reference food in order to sell a food that bears a claim.
Reference foods are necessary only for comparative nutrient content
claims, i.e., claims about the level of a nutrient in one food compared
to another, such as ``reduced sodium'' or ``less fat.'' Provisions for
the use of data bases and other means to determine nutrient values for
an appropriate reference food are set out in Sec. 101.13(j)(1)(ii). FDA
also advises that, while restaurants are required to provide nutrition
information on request for foods that make a claim, FDA is providing
considerable flexibility in Sec. 101.10 as to the type of nutrition
information that must be provided and on how this information can be
provided. For example, in a restaurant situation, nutrition information
may be presented in various forms, including those provided in
Sec. 101.45 and by other reasonable means (e.g., using posters, fliers,
brochures, notebooks, or communicated orally by restaurant staff). In
sum, FDA notes that the types of misconceptions presented by these
comments have resulted in a perception of burdens that do not in fact
exist.
Given the flexible provisions, such as the ``reasonable basis''
criterion that the agency set out in the claims final rules, FDA
concludes that most restaurants that wish to make claims will be able
to do so. Further, as stated in several comments, many resources,
including Federal, State, and local governments; professional health
organizations; and dietary professionals, are available to aid
restaurants in their efforts to comply with FDA's requirements.
Moreover, as stated above, FDA has made available the labeling guidance
document to assist restaurants and other retail establishments in
developing or revising their labeling to comply with the new
requirements.
Although these resources will likely be sufficient to meet the
needs of restaurateurs for information, FDA is willing, if necessary,
to take other steps to help restaurants, particularly small
restaurants, to understand and respond to the requirements established
in this final rule. The agency requests that restaurateurs contact the
agency (see address above) if they believe that it would be useful to
have a national meeting or regional meetings to discuss what is
required for health or nutrient content claims made on menus to comply
with FDA's regulations. If the agency receives a sufficient expression
of interest, it will hold such a meeting or meetings. If it decides to
hold a meeting, FDA will provide ample notice of the time and place in
the Federal Register.
While FDA acknowledges that some restaurants may discontinue
offering improved food selections because menus have to comply with the
requirements for claims, the agency concludes that most restaurants
will continue to work to develop improved foods about which they can
make claims. Consumer interest in improved food choices provides a
continuing incentive for such efforts. The number of menus that
currently bear claims and other nutrition information evidences the
impact of consumer demand. FDA intends to work, as described above, to
help restaurants to minimize the number of claims that are removed and
to monitor the extent of this effect.
3. One comment argued that the First Amendment to the Constitution
protects menus through its guarantee of freedom of the press. Another
comment stated that FDA is not authorized to regulate restaurant foods
under the Tenth
[[Page 40325]]
Amendment, as this power is not one provided for in Article I, Section
8, of the Constitution.
The agency disagrees. FDA's authority to regulate the content of
the labels and labeling of food in interstate commerce has been broadly
upheld against First Amendment and other constitutional challenges. The
agency's authority to regulate food labeling, including the labeling of
restaurant foods, is discussed at length in the claims final rules (58
FR 2302 at 2392 and 58 FR 2478 at 2524), which are incorporated herein
by reference. The comments did not provide any information, or make any
arguments, that the agency has not previously considered and found to
be without merit.
4. Several comments maintained that FDA cannot legally justify
reversing its policy with respect to restaurant menus. These comments
maintained that FDA has received no new information or facts since the
claims final rules on which to base its reconsideration. They further
maintained that the proposal to delete the menu exemption without, in
the comments' opinion, adequately explaining the departure from the
past norm constitutes arbitrary and capricious rulemaking and is a
violation of the APA.
FDA disagrees with these comments. An agency may always change its
mind and alter its policies. Conference of State Bank Examiners v.
Office of Thrift Supervision, 792 F. Supp. 837, 845 (D.D.C. 1992).
While the burden is on the agency to justify the change from the status
quo, that justification need not consist of an affirmative
demonstration that the status quo is wrong. It may also consist of a
demonstration that there is no cause to believe that the status quo is
right, so that the existing rule has no rational basis to support it.
Center for Auto Safety v. Peck, 751 F.2d 1336, 1349 (D.C. Cir. 1985).
Concern about whether a rational basis existed for the agency's
rule is exactly what motivated FDA. In its June 15, 1993, proposed
rule, the agency pointed out that, in confronting the issue of what
defines a menu in the wake of the publication of the January 6, 1993,
final rules, it found that it was virtually impossible to distinguish
menus from other types of restaurant labeling, such as signs, placards,
and other types of point of purchase information that are covered under
the agency's rules (58 FR 33055 at 33056). Thus, the agency had ample
basis to be concerned about the distinction that it had drawn in the
final rules. This concern was underscored by technical comments that
the agency received on the menu exemption (id). The conclusion that the
agency has reached based on its consideration of the comments that it
received on the June 15, 1993, proposed rule is that there is, in fact,
no rational basis for distinguishing menus from other types of
restaurant labeling, and, therefore, FDA is revoking the provisions
that established that distinction.
5. One comment objected to what it perceived as the agency's
inability to define menus in the June 15, 1993, proposed rule. The
comment maintained that this problem was not a reasonable basis for
deleting the menu exemption. The comment argued that, at the least, FDA
should issue an advanced notice of proposed rulemaking on this issue.
FDA believes that the comment misinterpreted the agency's statement
in the June 15, 1993, proposed rule (58 FR 33055 at 33056), about
distinguishing between menus and other restaurant labeling. FDA did not
say that it could not define menus, but rather, that the agency found
that it is virtually impossible to distinguish menus from other types
of restaurant labeling, such as signs, placards, and other point of
purchase information, that the agency said in the claims final rules
would be covered.
The agency notes that if its problem were one of defining ``menu,''
it has numerous sources to which it could turn. Webster's II New
Riverside University Dictionary defines ``menu'' as ``A list of the
food and drink available or to be served for a meal.'' Comments
received during the 30-day technical comment period to the claims final
rules provided additional guidance, stating that a menu ``includes any
medium available to consumers in a restaurant that can be consulted in
making a purchasing decision in terms of food selection or price.'' One
comment stated that ``A broad range of formats are used to convey
selection and price information on which consumers rely. These formats
are all properly ``menus'.''
However, the problem that the agency stated that it was having in
June of 1993 was one of drawing a rational distinction that would
justify its treatment of menus on the one hand and of other types of
restaurant labeling on the other. Such a distinction is particularly
difficult to draw given that some of the same types of restaurant media
that FDA said were covered in the claims final rules, e.g., signs,
posters, and placards, are used, like menus, to convey purchase
information to consumers. Both menus and non-menu media may be used to
provide restaurant patrons with information about the foods available
in a restaurant.
Accordingly, for the foregoing reasons, FDA is amending its food
labeling regulations by removing the provisions of the regulations that
exempt nutrient content claims and health claims made on restaurant
menus from the coverage of these regulations. Specifically, FDA is
amending the regulations by removing: (1) From Sec. 101.10, pertaining
to nutrition labeling of restaurant foods, the language that reads ``*
* * (except on menus)''; (2) from Sec. 101.13(q)(5), pertaining to
nutrient content claims on restaurant foods, the language that reads
``* * * (except on menus)''; and (3) from Sec. 101.14(d)(2)(vii)(B),
pertaining to health claims on restaurant foods, the language that
reads ``* * * (except if the claim is made on a menu).'' Thus, the
requirements of FDA's food labeling regulations will be applied to all
forms of restaurant labeling, including menus, signs, posters, or
placards, that bear a nutrient content claim, health claim, or
otherwise characterize the level of a nutrient in a food.
6. One comment suggested that FDA specify that the term ``menu''
applies to all types of menus, including wallboards, take- out menus,
and menus delivered to the table.
FDA advises that, in the claims final rules, it differentiated
between menus and non-menu media by describing those media that it did
not consider to be menus, e.g., posters, signs, and placards. However,
as discussed in response to the preceding comment, the agency has
determined that it is virtually impossible to distinguish between menus
and other media that are used to convey purchase information to
consumers. Therefore, FDA is amending its food labeling regulations by
removing the provisions that exempt menus from the coverage of these
regulations. Because the requirements will be applied to all forms of
restaurant labeling that bear a claim, the issue of distinguishing
between menus and non-menu labeling is rendered moot.
B. Modification of Effective Date
The claims final rules provided that regulations governing the use
of health claims in restaurant labeling (other than menus) would become
effective on May 8, 1993, except for small restaurant firms consisting
of 10 or fewer establishments for which these provisions were to become
effective 1 year later, i.e., May 8, 1994. With respect to the use of
nutrient content claims and other nutrition information in restaurant
labeling (except for menus), FDA's requirements were to
[[Page 40326]]
become effective on May 8, 1994, for medium and large restaurant firms
and on May 8, 1995, for small firms.
In the claims final rules, FDA stated that it recognized that a
significant effort would be necessary on the part of restaurants to
show that they have a reasonable basis to believe that their food
complies with FDA's regulations for the use of nutrient content claims
and health claims. At that time, the agency believed that it would be
especially difficult for small restaurants to become familiar with
Federal requirements and to determine how to apply these requirements
to their individual food selection and preparation methods in a short
time. Consequently, FDA had decided that small restaurants should be
given the additional time (i.e., 1 year) to come into compliance.
During the technical comment period, FDA received information that
convinced the agency that it was appropriate to reconsider its decision
to delay the effective date of the claims requirements for small
restaurants. Thus, in its June 15, 1993, proposed rule (58 FR 33055 at
33057), FDA proposed to modify the delay in the effective dates for
small restaurant firms. However, based in part on numerous demands
associated with implementing the 1990 amendments and the agency's
limited resources, this speed-up did not happen. FDA's efforts to move
up those dates have effectively been rendered moot by the agency's
inability to issue a final rule. Consequently, the following comments
are now only relevant as they apply to restaurant menus.
1. Delay for Small Restaurants
7. One comment argued that compliance would be more difficult for
small firms compared to large restaurant chains because of limited
resources. The comment did not, however, provide any information that
the agency had not previously considered. Another comment maintained
that an extension for small restaurants is justified by the ``lack of
real harm'' to the public from such a delay.
Conversely, the majority of letters that addressed the proposed
modification in effective dates supported the agency's proposal to
establish uniform effective dates for all restaurants. These comments
maintained that there is no appropriate basis for differentiating among
restaurants based on size when establishing a date by which each must
comply with FDA's requirements. Thus, the comments stated, the agency
should enforce its labeling requirements for large and small
restaurants, at the same time. However, the comments contained numerous
and varied suggestions as to when the new effective dates should be.
Having considered the comments, FDA concludes that, although there
are some areas where small restaurants may be at a disadvantage
compared to large restaurants, e.g., the cost of a one-time menu change
relative to more limited resources, in most respects, the distinction
between small restaurants and larger restaurants is not as great as the
agency had believed when it issued the January 6, 1993, final rules.
For example, not all restaurant firms with greater than 10
establishments are familiar with the new requirements or have
established nutrition support personnel. Further, in establishing the
requirements for restaurant labeling in the claims final rules, the
agency worked with restaurant industry representatives to make its
requirements feasible for both large and small restaurants. FDA advises
that the flexibility built into these requirements, e.g., the
``reasonable basis'' criterion, provides a wide range of options for
how a restaurant may determine the nutrient content of its food, and
how it communicates this information to consumers. FDA finds that this
flexible approach will allow most restaurants, including small
restaurants, to choose options that fit their own needs and resources.
Thus, FDA finds nothing in the comments that would provide a basis for
differentiating among restaurants based on size when establishing a
date by which restaurants must comply with these requirements.
2. Establishment of Effective Date for Menus
FDA is removing the exemption for menus that it adopted
inappropriately. While, in light of overwhelming support from comments
and in the absence of any new information to the contrary, FDA has
concluded that the same date of applicability should apply to menus in
all restaurants, regardless of size, the agency wants to be sure that
the effect of its decision is not punitive for restaurants. FDA finds
that it has flexibility in setting the date by which menus must comply
with its requirements for claims. Thus, the agency is using that
discretion in setting the date by which menus must comply with the
rules on the use of claims. The issue that FDA has considered is what
effective date will provide all restaurants with a reasonable amount of
time to make any necessary changes in their menus while providing
consumers with useful information as quickly as possible.
8. A few comments stated that restaurant menus should comply with
FDA's requirements by the same date as labeling on foods from other
sources, i.e., May 8, 1994. These comments stated that to delay the
effective date for compliance by restaurant menus beyond May 8, 1994,
would create an uneven playing field between restaurants and food
processors. The comments further argued that any extension for
restaurants beyond May 8, 1994, would violate the mandatory effective
dates provided by the 1990 amendments. Another comment also tied the
effective date for restaurant labeling with the date of applicability
for other foods, except that it suggested that restaurants should have
an additional 4 months after the May 8, 1994, deadline (i.e., until
September 8, 1994) to bring their menus into compliance.
FDA does not agree that it must establish the same effective dates
for restaurant menus as for other food labeling. As stated above, FDA
must act in an equitable manner in removing the exemption for
restaurant menus. Although the agency continues to strive for
consistency within the framework of the 1990 amendments, this
rulemaking to amend certain provisions of the January 6, 1993, final
regulations cannot reasonably impose the same deadlines that the agency
imposed in the final regulations implementing the 1990 amendments that
it promulgated over 40 months ago. Further, the date of publication of
this final rule obviously makes an effective date of May 8, 1994, moot.
9. One comment suggested that compliance with FDA's requirements
begin 1 year from the date of the last menu printing. In support of its
suggestion, the comment stated that many restaurants change their menus
yearly, and that it would be costly for restaurants to change menus in
midyear to comply with the new regulations. The comment did not,
however, provide data on the number of restaurants that will need to
make changes in their menus or on the number of restaurants that do not
normally change their menus more than once a year.
FDA notes that restaurants vary widely in the frequency with which
they print new menus. Comments to the June 15, 1993, proposed rule,
stated that menus may be printed infrequently, annually, daily, or even
for each meal. Given the wide variance in practices within the
industry, the agency finds that establishing a compliance date that is
based on a date that is a given period of time from the last menu
printing would be impractical from an enforcement standpoint. It would
be extremely difficult to ensure compliance with an application date
that varies
[[Page 40327]]
from one establishment to another. In such a situation, compliance
checks would require not merely looking at the labeling but also
determining the date on which labels had last been revised.
Further, establishing an application date that, as it is phased in,
affects only some establishments, is inconsistent with the
establishment of a single effective date for labels on foods from other
sources. As stated in the August 18, 1993, technical amendments (58 FR
44033 at 44035), the nutrition labeling requirements apply to food
labeled after May 8, 1994. The agency stated that the term ``labeled''
means the date that the label is affixed to the food. FDA notes that
each time a menu is used in a restaurant to convey purchase information
about a food served in the restaurant, such use is analogous to
affixing a label to a packaged food. Thus, establishing a specific date
of applicability for restaurant menus, such that the date applies to
the date that any menu is used as labeling in any restaurant, would be
consistent with the treatment of labels on foods from other sources.
Finally, confusion could result from a situation in which, for
example, two neighboring restaurants use identical claims on identical
menus, one restaurant that makes claims would use terms in a manner
that complies with FDA's requirements, while the restaurant that
printed its menus less than a year earlier would not. Moreover, a
restaurant that has not changed its menu in some time because of
limited resources could be forced to change its menu sooner than a
larger restaurant that had recently printed new menus. Such an outcome
would make no sense.
FDA concludes that it is more appropriate to establish an effective
date for applying its requirements to menus based on a given amount of
time following the date on which this final rule publishes rather than
an arbitrary date, such as the date of the last menu change, that may
vary between restaurants. This approach will ensure that all
restaurants will have a specified amount of time to change menus to
comply with any applicable requirements, and that the amount of time
will be based on an accommodation of both consumer and industry needs,
rather than an arbitrary date that will vary between restaurants.
10. A number of comments agreed with FDA's proposal that the
modified effective dates for restaurant menu labeling should allow
restaurants to achieve compliance within an amount of time similar to
the time that other food producers have had, and that the effective
dates should be uniform for all restaurants, regardless of size. These
comments stated that all restaurants should be required to comply with
health claims regulations 4 months after publication of a final rule
and with nutrient content claims regulations 1 year after publication,
as proposed. One comment stated that the date of applicability for
requirements for menus bearing nutrient content claims should be based
on the same amount of time that packaged foods had, i.e., 16 months
after publication of the January 6, 1993, final rules.
Alternatively, several comments maintained that compliance with the
nutrient content claims regulations would be no more difficult than
compliance with the requirements for the use of health claims, and
that, consequently, restaurant menus should be required to comply with
both regulations at the same time. Comments were divided, however, as
to whether the single effective date for both nutrient content claims
and health claims should be 4 months or 12 months after the date of
publication of a final rule.
FDA has carefully considered how much time should be given for
restaurant menus to be brought into compliance with the nutrient
content claim and health claim labeling requirements. FDA's
consideration has been guided by section 10 of the 1990 amendments.
That provision made the nutrient content claim and health claim
provisions effective 6 months after enactment but gave FDA the
authority to delay application of the nutrient content claim
requirements for up to 1 year if it found that compliance with those
requirements would cause undue economic hardship (section 10(a)) of the
1990 amendments). FDA took advantage of the latter provision. FDA notes
that a number of the factors that influenced the agency's decision to
delay the application of the nutrient content claims requirements in
the January 6, 1993, final rule do not have equal application with
respect to this rulemaking.
One factor that influenced FDA's decision to delay the
applicability date was the amount of effort that would be necessary to
learn about how to come into compliance with the new rules (56 FR 60856
at 60862, November 27, 1991). The agency notes that, since publication
of the January 6, 1993, final rules, FDA and other organizations have
been active in disseminating information about the new food labeling
requirements. Because access to information about these requirements,
and the number of resources available to facilitate compliance with
these requirements, have grown, the effort required on the part of a
restaurateur who is not familiar with the requirements to obtain
information about them has been reduced compared to that which was
required for makers of other types of food. Moreover, the effort
required for compliance by restaurateurs is even further reduced by the
flexible provisions that FDA has established specifically for
restaurant situations, e.g., providing the ``reasonable basis''
criterion for nutrient content determinations.
A second factor that influenced FDA's decision was the amount of
time needed to come into compliance with the labeling requirements (56
FR 60856 at 60862). The type of labeling used in restaurants reduces
the amount of time, compared to other food sources, that is reasonably
necessary to achieve compliance. For example, for packaged foods that
bear nutrient content claims, manufacturers needed time to use up
preexisting labels to reduce the cost of complying with the new
requirements. Conversely, menu inventory is generally not affected by a
food purchase. Further, many restaurants use menus that may be revised,
printed, and copied in-house, thereby avoiding the queue at printers
that affected many food manufacturers. Therefore, providing time for
bringing menus into compliance will not have the same effects on the
costs of a restaurateur that it had on the costs of the manufacturer.
Consequently, FDA concludes that significant circumstances that
justified a1-year delay in the applicability of the nutrient content
claims provisions for packaged foods do not apply to restaurant foods.
Moreover, in the June 15, 1993, proposed rule (58 FR 33055 at
33058), FDA cited an informal survey by the National Restaurant
Association indicating that up to 89 percent of all printed menus
include at least one claim. Based on information in the survey, FDA had
assumed that more restaurants were making nutrient content claims than
health claims, and that, consequently, a larger effort would be
required on the part of restaurants to ensure compliance with
requirements for nutrient content claims compared to health claims. The
agency tentatively concluded that a date of applicability of 4 months
after the publication of a final rule would be sufficient to ensure
compliance with the requirements for health claims.
FDA continues to believe that few if any restaurant menus bear
express health claims, such as ``a diet low in sodium may contribute to
a reduced risk of high blood pressure, a disease associated with many
factors,'' on their
[[Page 40328]]
menus. However, a number of comments to the June 15, 1993, proposed
rule provided examples of menus that bear terms and symbols (e.g.,
heart symbols and terms such as ``heart healthy'') in a manner that
makes them implied health claims under the act. Based on this
information, and on information gleaned by FDA from informal inquiries
from the industry (Ref. 1), FDA concludes that the number of
restaurants making health claims is greater than it had previously
assumed.
Furthermore, because of the flexible provisions that FDA has
established for restaurant foods, it may be easier for a restaurant to
establish that a food qualifies to bear a nutrient content claim (e.g.,
that a ``low fat'' food contains no more than 3 g of fat per reference
amount) than that it qualifies to bear a health claim (i.e., that, in
addition to the criterion for the nutrient in the claim, the food
contains less than the disqualifying levels for fat, saturated fat,
sodium, and cholesterol, and 10 percent or more of the Reference Daily
Intake or Daily Reference Value for vitamin A, vitamin C, iron,
calcium, protein, or fiber per reference amount prior to nutrient
addition). The agency concludes that the effort required on the part of
restaurants that want to make health claims in their menus (e.g., to
obtain, read, and understand FDA's regulations; to develop a
``reasonable basis'' for making claims; to generate nutrition
information for consumers; and, in some cases, to modify a food or its
labeling) will be as great, if not greater, than that required of
restaurants making nutrient content claims.
The agency notes that, in establishing a specific effective date,
its goal is to ensure that consumers have access to useful nutrition-
related information as quickly as possible while providing
restaurateurs with sufficient time to make necessary changes. FDA does
not believe that all restaurant menus could be reasonably expected to
comply with the health claims requirements within the proposed 4-month
timeframe. While many restaurants have already begun actions to come
into compliance, especially larger restaurants that make claims on non-
menu labeling, some restaurants that use only menus to convey purchase
information may not be familiar with the requirements or know how to
obtain the necessary information to determine whether their menus are
in compliance. FDA further notes that an effective date for its
requirements for restaurant menus that bear nutrient content claims of
4 months after the publication of this final rule, as suggested by some
comments, would provide restaurant foods significantly less time than
had been afforded foods from other sources. Thus, a compliance period
of 4 months after publication would place restaurants offering improved
foods and promoting these foods on their menus at a disadvantage
compared to other food manufacturers.
Conversely, FDA concludes that it is not necessary for restaurant
menus to have the same amount of time that other food labeling
producers were given. Based in part on the amount of time that
information on the criteria that will be applied to menus has been
available (i.e., since January 6, 1993), and on the flexible rules it
has adopted for restaurants, FDA concludes that a compliance period of
12 or 16 months is longer than is necessary for menus, and that such a
time period would unduly delay consumer access to useful information.
After considering the foregoing, FDA has decided to establish a
single date of applicability for both the nutrient content claim and
health claim requirements for menus and to establish that date as May
2, 1997. This date will provide restaurateurs with 9 months to bring
their menus into compliance. FDA has decided to provide 9 months based
on the following three factors: First, 6 months is the amount of time
that Congress provided for compliance with these provisions in the
absence of undue economic hardship (section 10 of the 1990 amendments).
Second, FDA finds that, based on the economic impact analysis in this
rulemaking, unlike for non-restaurant foods, economic hardship does not
exist. Consequently, the agency has no basis for providing an
additional year for compliance by restaurant menus. Third, in Pub. L.
103-261, Congress provided non-restaurant food manufacturers with an
additional 3 months to achieve compliance with the new labeling rules.
Consequently, FDA finds that establishing May 2, 1997 as the effective
date for the amendments that it is making to Secs. 101.10,
101.13(q)(5), and 101.14(d)(2)(vii)(B) and (d)(3), and, thus, as the
date that menus must be in compliance, is consistent with the treatment
of non-restaurant foods. FDA believes that establishing a single date
will benefit both consumers and industry. FDA notes that the different
effective dates for nutrient content claims and for health claims in
non-menu labeling in small restaurants and in larger restaurants have
created a great deal of confusion about what requirements are effective
at a given time. The agency concludes that establishing different dates
for the use of health claims and of nutrient content claims in menus
would only further compound this confusion. FDA finds that, in light of
the confusion expressed by comments and in informal communications with
the agency (Ref. 1), establishing a uniform date for all types of
claims on menus makes the most sense. The agency further finds that a
single effective date for menus will prevent the consumer confusion
that could result from a restaurant using a menu that bears some types
of claims that are consistent with the new requirements and other
claims that are not. In addition, a single effective date for all menu
claims will aid compliance by giving restaurants a single date by which
to make necessary changes, regardless of the kind of statement (e.g.,
nutrient content claim, health claim, third party endorsement, or
dietary guidance) used to present nutrient information to consumers.
Thus, a single date will avoid the need to change menus twice within
the compliance period. The agency concludes that, for efficient
enforcement of the act, establishing a single effective date for both
nutrient content claims and health claims on menus is desirable and
appropriate.
Moreover, given the amount of time that FDA's labeling rules have
been in place, an effective date of May 2, 1997, will provide ample
time for restaurants to bring their menus into compliance without
unduly delaying consumer access to useful nutrition-related
information. An effective date of May 2, 1997, will also provide time
for FDA and other regulatory officials to work with restaurants,
consumers, dietitians, health professional organizations, and other
interested parties to ensure that the agency's regulations are
adequately implemented with respect to restaurant menus.
Thus, the deletion of the phrase ``(except for menus)'' that
exempted menus from nutrient content claim requirements in Secs. 101.10
and 101.13(q)(5) will be effective on May 2, 1997. Likewise, the
deletion of the phrase ``(except on menus)'' that exempted menus from
health claim requirements in Sec. 101.10 and the phrase ``(except if
the claim is made on a menu)'' in Sec. 101.14(d)(2)(vii)(B) will also
be effective on that date.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(11) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
[[Page 40329]]
IV. Analysis of Impacts
FDA has examined the economic implications of the final rule as
required by Executive Order 12866 and the Regulatory Flexibility Act (5
U.S.C. 601-612). Executive Order 12866 directs agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select the regulatory approach that
maximizes net benefits (including potential economic, environmental,
public health and safety effects; distributive impacts; and equity). If
a rule has a significant economic impact on a substantial number of
small entities, the Regulatory Flexibility Act requires agencies to
analyze regulatory options that would minimize the significant economic
impact of that rule on those small entities. FDA finds that this final
rule is a significant rule as defined by Executive Order 12866, and
finds under the Regulatory Flexibility Act, that the final rule will
not have a significant economic impact on a substantial number of small
entities.
A. Background
In the Federal Register of January 6, 1993 (58 FR 2927), FDA
published a final regulatory impact analysis (RIA) of the final rules
implementing the 1990 amendments (hereinafter referred to as the
January 6, 1993, RIA). In that document (58 FR 2927 at 2934), FDA
presented costs of compliance with the 1990 amendments for food service
establishments. Although the agency did not include menus in its
regulatory coverage of the nutrient content claims and health claims
final rules, it assumed that restaurants would alter their menus to
comply with the agency's definitions because of the possibility of
enforcement by the States. Consequently, FDA included the cost of
altering menus in its assessment.
In the June 15, 1993, proposed rule, FDA proposed to remove the
provisions that exempt restaurant menus from the requirements for how
nutrient content claims and health claims are to be made. Because the
agency originally assumed that restaurants would alter their menus in
order to comply with the regulations so as to avoid State enforcement,
FDA assumed that the proposed action to include menus in the agency's
regulatory coverage would not result in any significant increase in
costs to food service establishments beyond that estimated in the
January 6, 1993, RIA.
B. Costs of the Final Regulation
The following estimates are based on both quantitative and
anecdotal information provided in the comments. However, FDA has
previously stated that it lacks in-depth data on a number of issues
related to the food service industry (56 FR 60537 at 60554, November
27, 1991). Therefore, while these estimates represent the best
information available to the agency, FDA acknowledges that there is
uncertainty in these estimates.
In the January 6, 1993 (58 FR 2927 at 2934), RIA, FDA estimated
that 75 percent of restaurants, including all small restaurants, would
normally alter menus before the applicable compliance date for nutrient
content claims and health claims on non-menu labeling (based on a 16-
month compliance period). The agency also assumed that, in revising
their menus, most restaurants would make changes to comply with the
regulations so as to avoid enforcement by the States. Consequently, FDA
estimated that only 14,500 commercial establishments would incur costs
attributable to the nutrient content claims and health claims final
rules. In the June 15, 1993, proposed rule, FDA repeated the
assumptions stated in the January 6, 1993, RIA, i.e., that most
restaurants would alter their menus in order to comply with the
regulations.
FDA received very few comments regarding its economic analysis of
the June 15, 1993, proposed rule. However, a few comments indicated
that the agency's assumption that most restaurants would alter menus to
comply with the agency's requirements because of the possibility of
enforcement by the States was not correct. FDA has anecdotal
information indicating that at least some restaurants have not yet
altered menus to comply with the claims requirements and would,
therefore, bear some cost of the agency's action to remove the
exemption for menus. However, the comments did not provide information
regarding the proportion of the industry that has not yet altered its
menus.
FDA notes that the costs of revising menus to comply with the new
requirements are one-time costs only. However, costs of ensuring that
claims are made on a reasonable basis and are in conformance with FDA
rules, and costs of maintaining that information and presenting it to
consumers on demand, are on-going costs, changing with new claims only
in the former case. FDA does not have information with which to
estimate these costs. However, those firms that would normally redesign
their menus within the compliance period will not incur costs
attributable to FDA's regulations. In the analysis of the proposed
rule, FDA estimated that 75 percent of all menus would normally be
revised during the compliance period ending in May 1994.
FDA received comments regarding the frequency of menu changes.
Comments varied in their estimates of the frequency of menu redesign,
ranging from several times a day to once a year. FDA concludes that,
taken as a whole, these comments do not significantly alter its
original assumptions about the rates at which restaurants alter menus,
that is, that an average of 5 percent of all restaurants would normally
alter their menus in a month and, thus, 45 percent of all restaurants
would normally alter their menus during a 9-month compliance period.
In previous analyses, FDA noted that, because it is requiring only
a reasonable basis to support claims in restaurant labeling, no
analytical testing is necessary. FDA has described a number of methods
by which a restaurant may determine the nutrient content of a food that
are less costly than chemical analyses. For example, a claim may be
based on nutrient data published in FDA's regulations for the voluntary
nutrition labeling of fresh fruits, vegetables, and fish. A claim may
also be based on nutrient data provided in USDA's Handbook 8,
information in a cookbook, or an analysis using a reliable database.
However, the cost of determining whether or not a reasonable basis
exists to support a claim is not zero. Estimates of the cost of these
sources range from $10 to $175 per claim (Ref. 2).
FDA now assumes that approximately 50 percent of the industry has
already redesigned menus to comply with the nutrient content and health
claims regulations. This rulemaking provides 9 months for menus to come
into compliance with the claims requirements. FDA assumes that
approximately 45 percent of restaurants will normally alter their menus
during this compliance period; those restaurants can incorporate the
requirements of this regulation into their normally scheduled menu
revisions and, thus, will incur no regulatory costs associated with
menu changes.
According to the National Restaurant Association, there are
approximately 262,000 commercial establishments and 36,000 institutions
with a combined total of approximately 460,000 printed menus. Based on
a review of menus entered in the National Restaurant Association's
annual menu contest, the association estimated that 89 percent of all
printed menus include at least one nutrient content or health claim.
Although FDA has not challenged this
[[Page 40330]]
number, it has no basis on which to determine whether this number
fairly represents the situation in restaurants. Nonetheless, FDA is
using the 89 percent survey result as an upper-bound estimate of the
likelihood of typical menus bearing claims. The association also
indicated that at least 18 percent of the printed menus that it
reviewed would require more complex changes, such as the revision of an
entire section or symbol program (e.g., programs using a heart logo).
Based on the association's estimates and on the agency's revised
estimate of the number of menus that have already been changed to
comply with the nutrient content and health claims requirements, FDA
estimates that approximately 90,000 individual menus
[460,000 x (.89-.18) x (1-.45) x (1-.50)] would require simple changes
valued at $500 per menu, or $45 million. In addition, approximately
23,000 menus [406,000 x .18 x (1-.45) x (1-.50)] would require more
complex changes valued at $1,700 per menu, or $39 million. The cost of
establishing a reasonable basis to support a claim ranges between $10
and $175 per claim for each of the 113,000 menus, or a total cost of
between $1 and $20 million. FDA estimates that the total cost of
compliance for food service establishments would be between $85 million
and $104 million if none of the restaurants currently making claims on
menus have a reasonable basis to support their claims. However, because
significant time has elapsed since publication of the nutrient content
and health claims final rules, it is likely that at least one-third of
restaurants have a reasonable basis for believing that their foods meet
the nutrient requirements for the claims that they are making.
Therefore, the total costs of compliance are estimated to be between
$57 million and $69 million. However, if as many as 90 percent of
restaurants have a reasonable basis to support claims currently being
made, the regulations will result in costs of between $8.5 million and
$10 million.
C. Benefits
Requiring that health claims and nutrient content claims on menus
be consistent with FDA's definitions and with these types of claims
made on packaged foods will provide consumers with consistent,
reasonably based signals from restaurant menus with regard to health
claims and nutrient content claims that they can use to achieve dietary
goals. It is possible that information that is now on menus that
complies with FDA's requirements and that would aid consumers in
meeting dietary goals may be removed if a restaurateur believes that
the burden of proof to support a claim is too costly. However, FDA
believes that in many circumstances this will not be the case, because
the minimum amount of effort that a restaurant would have to go through
to validate a claim is not overly burdensome.
D. Regulatory Flexibility
FDA has examined the economic implications of the final rule as
required by the Regulatory Flexibility Act
(5 U.S.C. 601-612).
In this final rule FDA defines small commercial food service
establishments consistent with the Small Business Administration's
(SBA's) definitions (13 CFR part 121) as firms with $5 million or less
in total annual revenue. In addition, small institutional food service
establishments defined as those with less than $15 million in sales.
FDA estimates that approximately 66 percent of all of the firms
affected by this rule are small by SBA's definitions. Using that
figure, FDA estimates that there are approximately 173,000 commercial
food establishments and 24,000 institutional food establishments that
may be defined as small under these definitions. Using the same
assumptions as in the previous analysis, i.e., that 89 percent of all
printed menus contain at least one nutrient content or health claim,
then there are approximately 175,000 small establishments with 270,000
menus that contain claims. Using the same assumptions as above ((1) 50
percent have already revised their menus, (2) 55 percent of the
remaining establishments would not normally revise their menus within
the compliance period for this rule, and (3) 18 percent of these latter
establishments will have to make complex changes), approximately 9,700
small establishments will potentially have one-time costs of $1,700 to
make complex changes to each menu. In addition, approximately 38,000
small establishments will potentially have one-time costs of $500 to
make simple revisions to each menu.
In addition, firms will have initial and recurring costs of
ensuring that health claims and nutrient content claims are supported
by a reasonable basis and are in conformance with FDA's definitions of
terms. For each claim, a firm must establish via books, databases, or
by some reasonable means that the claim falls within FDA's definition.
The supporting information must be kept as long as the claim appears on
the menu and must be presented to customers on demand. Thus, as menu
items and claims change, the cost of establishing a reasonable basis is
incurred.
FDA has no data on how often firms change claims or how often
restaurant customers will ask to see the nutrition information for
foods that bear these claims. However, as stated earlier, cost
estimates of establishing a reasonable basis for a claim run between
$10 and $175 per claim. Assuming one future claim change or addition
per menu per year and an average of 1.5 menus per firm, costs to
determine a reasonable basis per firm will be between $15 and $260 per
year. As stated earlier, for existing claims, many firms already have
or would be likely to have established a reasonable basis for such
claims, and this analysis will continue to presume that at least one
third to as much as 90 percent of all firms would do so. Thus, average
total cost per small firm may range from as high as $2,135 to as low as
$765 in the first year for those who have menus with claims and between
$15 and $260 per firm for each subsequent year. Firms that neither have
claims nor would be expected to have them on their menus in the future
will not incur cost.
It is important to note that this rule provides flexibility for
restaurateurs in how they determine the nutrient content of a food and
in how they communicate this information to consumers, as described
above in the preamble. That is, for enforcement purposes, restaurateurs
need only show that they have a reasonable basis for the claim and that
the method of preparation does not violate the basis for the claim.
Therefore, the costs of this regulation for small businesses have been
minimized. Accordingly, under the Regulatory Flexibility Act, 5 U.S.C.
605(b) the Secretary certifies that this final rule will not have a
significant economic impact on a substantial number of small entities.
E. Summary
FDA has examined the impact of the final rule in accordance with
Executive Order 12866 and has determined that, while it is a
significant rule, it is not an economically significant rule. The rule
will result in total costs to restaurants of between $8.5 million and
$69 million, depending on the number of restaurants that can provide a
reasonable basis to support the claims currently in use.
FDA has also examined the impact of the final rule on small
entities in accordance with the Regulatory Flexibility Act and has
determined that it will not result in a significant burden on a
substantial number of small entities.
[[Page 40331]]
V. Paperwork Reduction Act
This final rule contains information collection requirements that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
title, description, and respondent description of the collection of
information are shown below with an estimate of the annual
recordkeeping burden. Included in the estimate is the time for
reviewing instructions, gathering necessary information, maintaining
records of that information, and making that information available upon
request.
Title: Food Labeling: Nutrient Content Claims and Health Claims;
Restaurant Foods.
Description: This regulation removes the provisions that exempt
restaurant menus from the requirements for how nutrient content claims
and health claims are to be made and from therequirements for the
provision of nutrition information with respect to the nutrients that
are the basis of the claim, when claims are made. Once it becomes
effective, Secs. 101.13(q)(5) and 101.14(d)(2)(vii)(B) will require
that nutrient content claims and health claims appearing on menus
comply with FDA's regulations for nutrient content claims in
Sec. 101.13 and subpart D of part 101 of this chapter and for health
claims in Sec. 101.14 and subpart E of part 101. Restaurants using
nutrient content claims or health claims on menus will be required by
Sec. 101.10 to provide nutrition information for the food that bears
the claim. Information on the nutrient that is the basis of the claim
may serve as the functional equivalent of complete nutrition
information as described in Sec. 101.9.
Because of the flexibility provided for restaurants in determining
the nutrient content of a food (they need only have a reasonable basis
that provides assurance that the food meets the requirements for the
claim) and in how this information may be communicated to consumers, a
wide range of options is available to restaurants in meeting the
information collection requirements imposed by this rule. For example,
a restaurant may choose to run a full nutrient profile analysis on a
group of items listed under a heading of ``low fat'' on its menu.
alternatively, it may chood to offer an item purchases from a
commercial manufacturer where the item is appropriately labeled by the
manufacturer as ``low fat.'' In such a case, the restaurant requirement
for the provision of nutrituin information with respect to the
nutrients that are the basis of the claim, when claims are made. Once
it becomes effective, Sec. Sec. 101.13(q)(5) and 101.14(d)(2)(vii)(B)
will require that nutrient content claims and health claims appearing
on menus comply with FDA's regulations for nutrient content claims in
Sec. 101.13 and subpart D of part 101 of this chapter and for health
claims in Sec. 101.14 and subpart E of part 101. Restaurants using
nutrient content claims or health claims on menus will be required by
Sec. 101.10 to provide nutrition information for the food that bears
the claim. Information on the nutrient that is the basis of the claim
may serve as the functional equivalent of complete nutrition
information as described in Sec. 101.9.
Because of the flexibility provided for restaurants in determining
the nutrient content of a food (they need only have a reasonable basis
that provides assurance that the food meets the requirements for the
claim) and in how this information may be communicated to consumers, a
wide range of options is available to restaurants in meeting the
information collection requirements imposed by this rule. For example,
a restaurant may choose to run a full nutrient profile analysis on a
group of items listed under a heading of ``low fat'' on its menu.
Alternatively, it may choose to offer an item purchased from a
commercial manufacturer where the item is appropriately labeled by the
manufacturer as ``low fat.'' In such a case, the restaurant would not
have to collect any additional information. All a restaurant must do to
satisfy the nutrition information requirement in Sec. 101.10 is provide
information to demonstrate that the food meets the requirements for any
nutrient content claim or health claim being made about the food. The
agency expects that restaurants will choose the least burdensome option
that complies with Sec. 101.10. Thus, FDA concludes that the
information collection requirements in this final rule will create a
minimal burden for restaurants.
Description of Respondents: Businesses or other for profit
organizations.
Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Annual Total
21 CFR No. of frequency of annual Hours per Total hours
recordkeepers recordkeeping records recordkeeping
----------------------------------------------------------------------------------------------------------------
Secs. 101.10, 101.13(q)(5), and 101.14
(d)(2)(vii)(B) and (d)(3)............... 265,000 1.5 397,500 1 397,500
----------------------------------------------------------------------------------------------------------------
Note: There are no operation and maintenance costs or capital costs associated with this information collection.
Although the June 15, 1993, proposed rule provided a 60-day comment
period, and this final rule incorporates the comments received, FDA is
providing an additional opportunity for public comment under the
Paperwork Reduction Act of 1995, which applies to this final rule but
which was enacted after the expiration of the comment period for the
June 15, 1993, proposal. FDA invites comments on: (1) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information will have practical utility; (2) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (3) ways to enhance the quality, utility, and clarity of
the information to be collected; and (4) ways to minimize the burden of
the collection of information on those who are to respond, including
through the use of automated collection techniques or other forms of
information technology, when appropriate. Individuals and organizations
may submit comments on the information collection requirements by
October 1, 1996. Comments should be directed to the Dockets Management
Branch (address above).
At the close of the 60-day comment period, FDA will review the
comments received, make revisions as necessary to the information
collection requirements, and submit the requirements to OMB for review
and approval. FDA will publish a notice in the Federal Register when
the information collection requirements are submitted to OMB, and an
opportunity for public comment to OMB will be provided at that time.
Additional time will be allotted for public comment to OMB. Prior to
the effective date of this final rule, FDA will publish a notice in the
Federal Register of OMB's decision to approve, modify, or
[[Page 40332]]
disapprove the information collection requirements. An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.
VI. References
The following references have been placed on display in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Smith, M.A., communications regarding labeling of restaurant
foods that bear a claim or other nutrition information, memorandum
to file, November 9, 1994.
2. Bush, L.M., communication regarding the cost of establishing
a reasonable basis for a claim, memorandum of telephone
conversation, September 14, 1994.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
101 is amended as follows:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342,
343, 348, 371).
2. Section 101.10 is revised to read as follows:
Sec. 101.10 Nutrition labeling of restaurant foods.
Nutrition labeling in accordance with Sec. 101.9 shall be provided
upon request for any restaurant food or meal for which a nutrient
content claim (as defined in Sec. 101.13 or in subpart D of this part)
or a health claim (as defined in Sec. 101.14 and permitted by a
regulation in subpart E of this part) is made, except that information
on the nutrient amounts that are the basis for the claim (e.g., ``low
fat, this meal provides less than 10 grams of fat'') may serve as the
functional equivalent of complete nutrition information as described in
Sec. 101.9. Nutrient levels may be determined by nutrient data bases,
cookbooks, or analyses or by other reasonable bases that provide
assurance that the food or meal meets the nutrient requirements for the
claim. Presentation of nutrition labeling may be in various forms,
including those provided in Sec. 101.45 and other reasonable means.
3. Section 101.13 is amended by revising the introductory text of
paragraph (q)(5) to read as follows:
Sec. 101.13 Nutrient content claims--general principles.
* * * * *
(q) * * *
(5) A nutrient content claim used on food that is served in
restaurants or other establishments in which food is served for
immediate human consumption or which is sold for sale or use in such
establishments shall comply with the requirements of this section and
the appropriate definition in subpart D of this part, except that:
* * * * *
4. Section 101.14 is amended by revising paragraphs (d)(2)(vii)(B)
and (d)(3), introductory text, and adding paragraph (d)(3)(i) to read
as follows:
Sec. 101.14 Health claims; general requirements.
* * * * *
(d) * * *
(2) * * *
(vii) * * *
(B) Where the food that bears the claim is sold in a restaurant or
in other establishments in which food that is ready for immediate human
consumption is sold, the food can meet the requirements of paragraphs
(d)(2)(vi) or (d)(2)(vii) of this section if the firm that sells the
food has a reasonable basis on which to believe that the food that
bears the claim meets the requirements of paragraphs (d)(2)(vi) or
(d)(2)(vii) of this section and provides that basis upon request.
* * * * *
(3) Nutrition labeling shall be provided in the label or labeling
of any food for which a health claim is made in accordance with
Sec. 101.9; for restaurant foods, in accordance with Sec. 101.10; or
for dietary supplements of vitamins or minerals, in accordance with
Sec. 101.36. The requirements of this paragraph are effective as of May
8, 1993, except:
(i) For menus, for which the requirements of paragraph (d)(3) of
this section will be effective May 2, 1997.
* * * * *
Dated: July 25, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 96-19645 Filed 7-30-96; 12:21 pm]
BILLING CODE 4160-01-U
