[Federal Register Volume 59, Number 2 (Tuesday, January 4, 1994)]
[Rules and Regulations]
[Pages 350-354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 93-31812]
[[Page Unknown]]
[Federal Register: January 4, 1994]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Parts 20 and 101
Food Labeling; General Requirements; Final Rules and Proposed Rule
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 93N-0478]
RIN O905-ADO8 and O905-AB68
Dietary Supplements; Establishment of Date of Application
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is publishing this
final rule to establish July 1, 1995, as the date on which it will
apply the mandatory nutrition labeling and nutrient content claims
provisions of the Federal Food, Drug, and Cosmetic Act (the act) to
dietary supplements of vitamins, minerals, herbs, and other similar
nutritional substances (hereinafter referred to as dietary
supplements). This action is in accordance with the Dietary Supplement
Act of 1992 (the DS act) and the Nutrition Labeling and Education Act
of 1990 (the 1990 amendments), which allows the Secretary of Health and
Human Services (the Secretary) (and, by delegation, FDA) to delay, for
up to 1 year, the date on which FDA applies those provisions to foods
(including dietary supplements) if the agency finds that compliance
with them would cause ``undue economic hardship.''
EFFECTIVE DATE: July 1, 1995.
FOR FURTHER INFORMATION CONTACT: Laina M. Bush, Center for Food Safety
and Applied Nutrition (HFS-726), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-205-5271.
SUPPLEMENTARY INFORMATION:
I. Background
On November 8, 1990, President Bush signed into law the 1990
amendments (Pub. L. 101-535). This statute adds to the Federal Food,
Drug, and Cosmetic Act (the act) among other sections, section 403(q)
(21 U.S.C. 343(q)), which makes nutrition labeling mandatory for most
foods, and section 403(r)(2) (21 U.S.C. 343(r)(2)), which gives FDA
authority to define nutrient content claims.
In accordance with the 1990 amendments, FDA published proposed
rules on November 27, 1991 (56 FR 60366 et seq.), and final rules on
January 6, 1993 (58 FR 2066 et seq.) implementing, among other things,
the sections of the act on mandatory nutrition labeling and nutrient
content claims, among other things, for foods in conventional food
form. Because of the DS act, the final regulations did not include
provisions on the nutrition labeling of, or nutrient content claims
for, dietary supplements.
The DS act (Pub. L. 102-571) was signed into law on October 6,
1992. In section 202(a)(1), the DS act established a moratorium until
December 15, 1993, on the implementation of the 1990 amendments with
respect to dietary supplements that are not in the form of conventional
food. Section 202(a)(2) of the DS act required the Secretary (and, by
delegation, FDA) to issue new proposed regulations that are applicable
to dietary supplements no later than June 15, 1993, and final
regulations by December 31, 1993. On June 18, 1993, FDA issued proposed
regulations in response to this provision of the DS act (58 FR 33700 et
seq.). Elsewhere in this issue of the Federal Register, FDA is issuing
the final rules.
Under section 10(a)(1)(A) and (B) of the 1990 amendments (21 U.S.C.
343 note), section 403(q) and (r)(2) of the act are effective 6 months
after the promulgation of final regulations or after the date that
proposed regulations are considered to be final regulations. Thus,
because the final regulations on the nutrition labeling of, and
nutrient content claims for, dietary supplements are being issued on
January 4, 1994, section 403(q) and 403(r)(2) will be effective with
respect to dietary supplements July 5, 1994. However, section
10(a)(3)(B) of the 1990 amendments provides that if the Secretary and,
by delegation, FDA `` * * * finds that compliance with sections
403(q) and 403(r)(2) of such Act would cause an undue economic
hardship, the Secretary may delay the application of such sections for
no more than one year.''
FDA found such ``undue economic hardship'' existed for the
conventional food industry in a final rule published on January 6, 1993
(58 FR 2070), entitled ``Food Labeling: Establishment of Date of
Application'' (hereinafter called the date of application final rule).
In that document, FDA delayed the application of section 403(q) and
(r)(2) for 1 year, until May 8, 1994.
In the proposed rules on nutrition labeling (58 FR 33715 at 33725)
and nutrient content claims (58 FR 33731 at 33748) for dietary
supplements, FDA asked for comment on whether a similar delay in
application of section 403(q) and (r)(2) would be appropriate for
dietary supplements. The agency gave interested persons until August
17, 1993, to comment on whether the 6-month proposed compliance date
would cause ``undue economic hardship.'' FDA received approximately
2,000 letters of which approximately one-third contain one or more
comments concerning either the date of application or other economic
issues from consumers, consumer advocacy organizations, health care
professionals, professional societies, universities, manufacturers,
distributors, retailers, trade associations, and State governments. A
discussion of the agency's decision, and a summary of the comments,
concerning the delay of the date of application and other economic
issues and the agency responses follow.
II. Undue Economic Hardship
A. Comments
Several comments requested that FDA extend the date that the
nutrition labeling and nutrient content claim provisions of the act
will be applied to dietary supplements. Most comments requested an
additional year, for a total compliance period of 18 months. One
comment proposed a delay of at least 9 months. The comments reported
many examples of the difficulties in meeting a 6-month compliance
period. Several comments stated that the amount of time needed to
redesign labels would far exceed the resources available. One comment
reported that the insufficient time allowed to revise labels would
result in some products being removed from the market temporarily while
new labels are being prepared. An additional comment requested the
extension because of the difficulties in the logistics of revising
existing labels, printing, packaging, and exhausting existing label
supplies with a short compliance period.
Other comments that requested a delay cited the savings that could
be gained with insignificant loss of benefits. One comment reported
that inventory disposal could be reduced by 85 percent with an 18-month
compliance period. Another comment stated that FDA's cost estimate of
$20 million represents 1 percent of industry sales but a much larger
percentage of industry profits. The comment explained that extending
the compliance period would reduce the costs of compliance and,
therefore, minimize any reduction in profits.
One comment requested a delay because there will be additional
costs for compliance with the upcoming United States Pharmacopoeia
(USP) standards. The comment stated that resources could be better
spent if these compliance efforts were completed concurrently rather
than consecutively.
One comment requested a delay because of the overlap with the final
months of the extended period that was allowed for foods in
conventional food form. The comment reported that many conventional
food manufacturers and their label suppliers are rushing to produce
final labels for such foods. The comment said that supplement
manufacturers will not be able to secure revised labels for their
products from label manufacturers in time to meet a 6-month deadline
because of the competition for label manufacturers' resources.
The agency agrees that it will be difficult for dietary supplement
manufacturers to comply within 6 months, especially in light of the
fact that label suppliers are currently stressed with label orders from
manufacturers of food in conventional food form who are attempting to
meet the May 1994 deadline for complying with the 1990 amendments. The
agency also agrees that an extension of the date of application would
result in significant savings for the industry. Administrative costs,
printing costs, and label inventory disposal costs are all dependent on
the length of the compliance period. The agency has determined that the
costs of the regulations could be reduced with an extension.
The agency made a determination in the date of application final
rule that the 1990 amendments will result in an undue economic hardship
on manufacturers of food products in conventional food form (58 FR 2070
at 2075). The agency notes that the costs of compliance for
manufacturers of foods in conventional food form represent less than 1
percent of sales. The costs of compliance with a 6-month compliance
period for dietary supplements is approximately 2 percent of sales.
Therefore, if the agency does not extend the date of application for
dietary supplement manufacturers, that segment of the food industry
will be asked to bear higher relative costs than the agency determined
were reasonable for foods in conventional food form.
For all these reasons, the agency determines that the
congressionally mandated date of application will result in an undue
economic hardship for dietary supplement manufacturers.
B. The Agency's Determination of a Date of Application of Section
403(q) and (r)(2) of the Act as Applied to Dietary Supplements
The agency has determined that undue economic hardship will result
if the dietary supplement industry is required to comply with section
403(q) and (r) of the act within 6 months. As will be shown in the
following discussion on the economic impact, a 6-month delay (total of
12 months to comply) in the application of section 403(q) and (r)(2) to
dietary supplements would result in over 40 percent savings of
compliance cost, and a 12-month delay (total of 18 months to comply)
would result in over 50 percent savings. Given the large disparity in
costs of compliance for manufacturers of dietary supplements if they
are required to comply in 6 months, as compared to those that are being
borne by manufacturers of food in conventional form, FDA finds that it
should tailor the delay to reduce the costs for dietary supplement
manufacturers and thus to minimize the disparity. Therefore, the agency
concludes that it is appropriate to delay the application date for
dietary supplements for 12 months, as it did for foods in conventional
food form. Thus, the agency intends to apply section 403(q) and (r)(2)
to foods labeled after July 1, 1995. The agency fully expects that some
dietary supplement firms will be able to comply before this date once
the pressure on printing labels for foods in conventional food form is
eased after May 8, 1994. Therefore, consumers can expect to begin
enjoying the health benefits of the label changes prior to July 1,
1995.
III. Economic Impact
Some comments agreed with the agency's estimates of the costs of
relabeling. Many comments were directed at issues covered by the
advance notice of proposed rulemaking (ANPRM), which addressed the safe
use of dietary supplements (58 FR 33690, June 18, 1993). Several
comments stated that the three proposals that the agency issued (there
was a proposed rule on health claims (58 FR 33700 in addition to the
proposals on nutrition labeling and nutrient content claims)) and the
ANPRM should be considered one proposal. These comments stated that the
economic impact of the four documents would exceed $100 million and
would be considered a major rule under Executive Order 12291.
The agency disagrees. Executive Order 12291 did not apply to
advance notices. Therefore, no analysis of that document was required
by that Executive Order. (FDA has not taken any action with respect to
the ANPRM that would make it subject to Executive Order 12866). The
three proposals are concerned with the labeling of dietary supplements,
while the ANPRM is concerned with other issues. Thus, the costs and
benefits associated with regulatory alternatives described in the ANPRM
can be separated from those resulting from the three proposals on
labeling actions. The agency has evaluated the labeling actions
together, however, because it is not possible to separate the impacts
of the various labeling actions. Finally, FDA is taking no further
action with respect to the ANPRM at this time.
A. Scope
1. Several comments objected to the agency's estimate of the number
of products that will be affected by the nutrition labeling and
nutrient content claims rulemakings. Two comments stated that there are
25,000 products that are potentially affected by the rules, rather than
the agency's estimate of 5,000 products. Another comment stated that
there are approximately 25,000 herbal products alone that would be
required to be tested and relabeled. Another comment objected to the
agency's estimate because the agency failed to include amino acids,
herbal products, and other dietary supplements that have no
recognizable food function.
In its analysis of the proposals, FDA stated that there could be as
many as 25,000 products that could be considered to be dietary
supplements. The agency reduced that number to 5,000, an estimate of
the number of vitamin and mineral supplement products, because: (1)
Many products that contain herbs or other similar nutritional
substances would not be subject to the nutrition label requirements
because they do not contain the nutrients that must be declared, and
(2) some products marketed as dietary supplements would be unaffected
by the 1990 amendments because they bear drug claims that make them
subject to the drug provisions of the act. For these reasons, it is
clear that not all 25,000 products would be required to be tested or
relabeled in response to the regulations implementing the 1990
amendments.
However, FDA is convinced by the comments that some herbal products
and other dietary supplements might need to be tested and relabeled as
a result of these regulations. FDA is unable to determine exactly how
many of those products would be covered by the food provisions of the
act rather than by the drug provisions. Therefore, the agency's final
analysis of the rules is based on a range of products between 5,000 and
25,000.
2. Several comments objected to the agency's estimate that
approximately 150 firms will be affected by the regulations. Some
comments stated that approximately 500 firms would be affected by the
proposed rules if made final. Another comment stated that 250 herb
manufacturers and 150 manufacturers of dietary supplements of vitamins
and minerals would be affected. Another comment objected to the
agency's source for the number of firms. The comment explained that
Dunn and Bradstreet's Electronic Yellow Pages is primarily a listing
for public companies, and the majority of supplement manufacturers are
privately-held corporations. The comment suggested that conservative
estimates suggest that there are a minimum of 150 herb companies alone.
The agency has confirmed that the Electronic Yellow Pages covers
both public and private organizations of all types and sizes. The
agency admits that the Electronic Yellow Pages is not a perfect source
for the number of firms, but FDA believes that it is not entirely
inadequate. The major difference between the agency's estimate and
those of the comments is the inclusion or exclusion of manufacturers
herbal products and products containing other similar nutritional
substances. As stated in the response to the previous comment, the
agency has determined that at least some of these types of dietary
supplement products may be subject to the nutrition labeling
provisions. However, because many of these products do not contain
significant amounts of nutrients, many manufacturers will not be faced
with the necessity of relabeling their products. For these reasons, the
agency believes that its estimate of the number of firms may be low,
but that to include all herbal products manufacturers and manufacturers
of other similar nutritional substances would inflate the estimate.
However, the agency has no basis on which to arrive at the actual
number of firms. Therefore, in its final analysis, the agency is
estimating the total number of firms affected to be between 150 and
300.
B. Costs
3. Several comments disagreed with the agency's estimate of
administrative costs. The comments stated that actual administrative
expenses would be at least $1,000 per label. Administrative expenses,
according to the comments, are associated with the creation or
redesign, proofreading, legal review, pricing, bid review, and
retraining of customer service and sales staff. One comment estimates
that administrative costs to one firm would be 80 to 120 hours of
executive time, or approximately $2,500 to $3,750.
FDA recognizes that the factors that determine administrative costs
are very complicated. The agency's estimates of administrative costs
are based on a compliance cost model for food labeling created for FDA
by Research Triangle Institute (RTI) (Ref. 1). According to RTI, many
firms estimate that administrative effort would be twice as high for a
6-month compliance period as for a 12-month compliance period. In the
dietary supplement proposals, FDA estimated that for a 6-month
compliance period, manufacturers of dietary supplements will incur
administrative costs of $850 per firm. The range of administrative cost
estimates submitted in the comments was broad and there were no
identifiable patterns to the estimates given. Although FDA acknowledges
that its assumptions may have resulted in underestimates, the comments
did not provide enough detailed information to permit FDA to evaluate
the administrative cost estimates that they submitted. Therefore, the
agency is not altering its original estimates based on these comments.
The agency has determined that total administrative costs for a 6-
month compliance period are between $130,000 and $250,000, depending on
the exact number of firms affected by the regulations. As determined by
the contractor's study (Ref. 1), administrative costs are lower with
longer compliance periods. A 1-year compliance period results in
administrative costs of between $65,000 and $125,000. An 18-month
compliance period results in administrative costs of between $50,000
and $94,000.
4. One comment stated that the requirement that herbal dietary
supplements be required to bear nutrition labeling would mandate that
all herbal products be assayed for their nutrient content. The comment
further explained that testing for 12 nutrients would cost $588 per
product for a total of $15 million for 25,000 products.
The agency agrees that to the extent that herbal product
manufacturers will provide nutrition labeling, herbal products will
need to be assayed for their nutrient content. The agency notes,
however, that many herbs do not contain significant amounts of the
nutrients that must be listed in the nutrition label, and that this
fact is determinable from reference works without testing. Thus, these
herbs will not need to be tested. Many comments admitted that, in
general, herbal products do not contain significant amounts of
nutrients and are not consumed for their nutrient content. However,
some herbal products and combination products will require nutrient
testing.
In the proposals, the agency assumed that dietary supplements of
vitamins and minerals will not undergo any additional testing as a
result of the nutrition labeling requirements. Comments did not object
to this assumption.Therefore, in its final analysis, the agency is
estimating that as many as 20,000 products may undergo testing once
every 5 years for a total discounted analytical cost over the next 20
years of $33 million (7 percent discount rate).
5. One comment agreed, and several comments disagreed, with the
agency's estimate of label printing and redesign costs. The comments
that disagreed stated that printing and redesign costs would be at
least $800 to $1,200 per label. One comment stated that the cost of
redesigning and printing each label would be 2 hours of desktop
redesign, $20 for linotronic service, and $600 for new plates, for a
total of $750 per label.
One comment objected to FDA's assumption that label revisions for
supplements are less comprehensive than revisions for foods in
conventional food form. The comment states that incorporating the
``Nutrition Facts'' section plus the ingredient list will necessitate
complete redistribution of information on many labels.
In the analysis of the proposed rules, the agency estimated that,
for a 6-month compliance period, printing and redesign costs would be
approximately $1,000 per label. The comments do not suggest that the
agency's estimate is incorrect. Therefore, the agency's final analysis
of printing costs is based on a per label cost of $1,000 for each of
between 15,000 and 75,000 labels, or between $15 million and $75
million. According to the RTI study, the length of the compliance
period determines a firm's ability to combine planned label changes
with mandated changes. Therefore, incremental labeling and redesign
activities are less costly with lengthier compliance periods. If the
agency extended the compliance period by only 6 months, printing and
redesign costs would be between $7.5 million and $37.5 million. The 1-
year extension that the agency is providing will reduce printing and
redesign costs to between $6 million and $28 million.
6. Several comments provided data on label inventories that would
be subject to disposal. These comments stated that a 4- to 6-month
supply of product labels is common, resulting in $3.4 million to $5.1
million of label inventory that will be discarded. Another comment
suggested that its dietary supplement label and box inventory disposal
costs would be $325,000 with a 6-month compliance period, $200,000 with
a 1-year compliance period, and $50,000 with an 18-month compliance
period. One comment estimated the cost of discarding noncompliant
labels would be approximately $30,000 for one firm.
The estimates provided by the comments are in line with the
agency's preliminary estimate of label inventory disposal costs.
Therefore, the agency is not changing its estimate based on the
comments. The cost of label inventory disposal for a 6-month compliance
period is between $5 million and $25 million, depending on the number
of products affected. According to the RTI study and comments,
lengthier compliance periods allow firms to use up more existing label
supplies, thus reducing inventory disposal costs. According to data
submitted in response to the Regulatory Impact Analysis document that
was published in the Federal Register of November 27, 1991 (56 FR
60366), and adjusted to reflect the range of products affected, if the
agency had extended the compliance period for an additional 6 months,
inventory disposal costs would be between $3 million and $13 million.
The 18-month compliance period that the agency is providing will result
in costs of between $2 million and $9 million.
7. Several comments disagreed with the agency's estimate of the
cost of inventory disposal. The comments argued that firms would
dispose of finished product in addition to labels. The comments stated
that typical product costs for dietary supplements would result in an
inventory value for the disposal of 5,000 products of between $48
million and $73 million. One firm estimated its own cost of discarding
noncompliant inventory would be approximately 30 percent of finished
goods inventory, or about $45,000.
Because these proposals cover only the labeling of dietary
supplements, the agency does not agree that there would be any reason
for firms to dispose of any product inventory. Nor did the comments
provide an explanation as to why it would be necessary to do so.
Moreover, any product packaged and labeled in accordance with law
before the date that FDA begins to apply the section 403(q) and (r) of
the act will not need to be relabeled. Therefore, the agency is not
changing its estimate based on this comment.
8. Several comments argued that the agency failed to consider the
cost of discarding and redesigning catalogs, product literature, and
advertising. The comments suggested that these costs would be at least
$40,000 per firm, or $20 million for all firms.
The comments did not provide an explanation as to why it would be
necessary to discard and redesign catalogs and product literature. The
agency does agree that, to the extent that these materials are
labeling, they must comply with the nutrient content and health claims
provisions of the act.
However, the agency believes that many of the claims made in these
types of materials are drug claims or structure-function claims, not
health claims, and therefore are not subject to these rules. The
comments did not present evidence to support a different finding.
Consequently, the agency has no basis on which to conclude that
extensive catalog and product literature redesign will be required by
these final rules. Therefore, the agency is not changing its estimate
based on these comments.
9. Several comments argued that the agency failed to consider the
cost of relabeling of product returned from the retailer. The comments
stated that it is common practice in the supplement industry to accept
returns from retailers in the event of a label change. Industry firms
would be faced with a number of products returned from retailers
unwilling to carry products with older labels. The comments estimated
the cost of processing returns, disposing of product, and applying for
full credit at $48 million.
Any product labeled before the applicability date will not need to
comply with the new nutrition labeling and nutrient content claim
provisions. Therefore, no product that is labeled in accordance with
law before July 1, 1995, need be returned, relabeled, or destroyed as a
result of these new provisions. However, FDA agrees that to the extent
that product is returned, the cost of disposing of product returned
from retailers because of ``old'' labeling should be considered a cost
of these regulations. However, the agency is unpersuaded of the
magnitude of the cost and is unsure of the extent to which ``old''
product will be returned. The comments provided insufficient
information with which the agency could estimate these costs.
Therefore, the agency is not changing its estimates based on this
comment.
10. Several comments expressed concern that the rules may cause the
loss of many thousands of jobs, the closing of many firms, and the loss
of products from the marketplace. According to one comment, the
proposed rules would cause the loss of more than $10 million in sales
and as many as 100 jobs in one company. Another comment stated a belief
that 2 million Americans will lose their jobs as a result of the
regulations. The comments did not provide any specific information as
to how the regulations would cause the loss of jobs and products.
The agency agrees that the inability to make certain nutrient
content or health claims may reduce the marketability of certain
products and perhaps lead to a company's decision to remove a product
from the marketplace. However, these rules affect only labeling; they
do not require any supplement to be removed from the market. Moreover,
the agency does not believe that many products are currently making
health claims, as distinguished from drug claims or structure-function
claims. Therefore, the agency has no basis to find that these
regulations will cause the problems described in these comments. The
agency believes that there is every reason to expect that the continued
marketing of the vast majority of dietary supplement products will be
unaffected by these regulations.
11. In the analysis of the proposed rules, the agency recognized
that the rules could have an adverse impact on small businesses. Most
of the costs associated with labeling regulations are fixed costs,
which are typically more burdensome for small firms than for large
firms because of the smaller sales base on which to spread costs.
One comment stated that the small business exemption was inadequate
because small firms would not be able to avoid complying with the
regulations because of competitive pressure. Another comment stated
that the proposals would be catastrophic to small business owners and
workers.
FDA notes that the Nutrition Labeling and Education Act Amendments
of 1993, which were enacted on August 13, 1993, provide relief for
small businesses from the requirements of section 403(q) of the act.
The agency believes that the new exemption for small businesses will
significantly mitigate any negative impact on small firms.
12. One comment stated that the proposed rule regarding health
claims will cause pain, suffering, and death that would not occur were
labeling and advertising allowed to include health claims. The comment
was unspecific as to why these results would occur.
If the absence of health claims causes pain, suffering, or death,
these regulations provide any party with a vehicle for submitting data
to support a particular health claim for agency review. Therefore, the
agency does not agree with this comment.
C. Benefits
13. One comment stated that the regulations will provide benefits
by preventing consumers from wasting money on unnecessary and
ineffective dietary supplements. Another comment stated that if someone
wanted to waste a little money taking too many vitamins or supplements
in the hope of avoiding serious illness and the need for harsh drugs,
they should be allowed to do so.
Because there are sources other than labeling that provide
information about the potential uses of dietary supplements, the agency
believes that limiting the use of claims on labels or labeling will be
of limited effect in preventing consumers from purchasing supplements
that they erroneously believe will prevent serious illness. However,
these regulations will ensure that the labels of dietary supplements
will provide full nutrition labeling to help consumers to maintain
healthy dietary practices, and they will help to ensure that any
nutrient content or health claims made in the labeling of these
products are scientifically valid, truthful, and not misleading. For
these reasons, these regulations will provide a significant benefit.
14. Some comments stated that the cost of providing nutrition
information on the labels of dietary supplements of herbs would greatly
outweigh any clear public benefit. The comments explained that herbs do
not contain significant amounts of the core nutrients and are not
normally consumed for their nutritional value. Therefore, the value to
consumers of including nutrition labeling on herb products is
insignificant.
The agency agrees with this comment. However, the agency notes that
those products that do not contain significant amounts of the 14
mandatory nutrients will generally not be required to bear nutrition
labeling. Therefore, although there will be no clear public benefit,
there will also be no cost.
D. Summary of the Economic Impact
FDA has examined the economic implications of the final rules
amending on nutrition labeling, nutrient content claims, and health
claims for dietary supplements as required by Executive Order 12866 and
the Regulatory Flexibility Act (Pub. L. 96-354). Executive Order 12866
directs agencies to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety effects; distributive
impacts; and equity). The Regulatory Flexibility Act requires analyzing
options for regulatory relief for small businesses. FDA finds that
these final rules on dietary supplements, taken together, are not
significant as defined by Executive Order 12866. In accordance with the
Regulatory Flexibility Act, the agency certifies that the final rules
will not have a significant impact on a substantial number of small
businesses.
The agency has reviewed the comments and has determined that the
costs of compliance associated with the 18-month compliance period
provided by the agency include administrative costs of between $50,000
and $100,000, analytical costs of between $0 and $33 million, printing
and redesign costs of between $6 and $28 million, and label inventory
disposal costs of between $2 and $9 million. Total discounted costs of
the final regulations, taken together are between $8 and $60 million (7
percent discount rate). If the agency did not extend the application of
the rules, total discounted costs would be between $20 and $133 million
for a 6-month compliance period, or between $11 and $84 million for a
1-year compliance period.
IV. 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 impact on the human environment. Therefore, neither an
environmental impact statement is required.
V. Reference
The following reference has been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. RTI, ``Compliance Costs of Food Labeling Regulations,'' FDA
Contract No. 223-87-2097, Project Officer--Richard A. Williams, Jr.,
Research Triangle Park, NC, December 1990.
VI. Conclusion
For the reasons stated above, FDA hereby establishes July 1, 1995,
as the date on which it will apply the mandatory nutrition labeling and
nutrient content claims provisions of the act to dietary supplements.
Dated: December 23, 1993.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 93-31812 Filed 12-29-93; 8:45 am]
BILLING CODE 4160-01-F
