[Federal Register Volume 62, Number 62 (Tuesday, April 1, 1997)]
[Rules and Regulations]
[Pages 15390-15391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8127]
[[Page 15390]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 101
[Docket Nos. 96P-0500 and 91N-384H]
RIN 0910-AA19
Food Labeling: Nutrient Content Claims, Definition of Term:
Healthy
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; partial stay.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a partial
stay of certain provisions of the nutrient content claim regulations
pertaining to the use of the term ``healthy.'' This action is in
response to a citizen's petition from ConAgra, Inc. (the petitioner),
to amend the definition of this term.
DATES: Effective April 1, 1997 21 CFR 101.65(d)(2)(ii)(C) and
(d)(4)(ii)(B) are stayed until January 1, 2000. Written comments by May
1, 1997.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Joyce J. Saltsman, Center for Food
Safety and Applied Nutrition (HFS-165), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5483.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 10, 1994 (59
FR 24232 at 24249), FDA published a final rule to establish a
definition of the term ``healthy'' under section 403(r) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)). Under
Sec. 101.65(d)(2)(ii) (21 CFR 101.65(d)(2)(ii)), for a food to qualify
to use the term ``healthy,'' or a derivative of that term, on its label
or in its labeling, the food must contain no more than 480 milligrams
(mg) of sodium per reference amount customarily consumed (RACC) before
January 1, 1998 (Sec. 101.65(d)(2)(ii)(A) and (d)(2)(ii)(B)), and no
more than 360 mg of sodium per RACC after January 1, 1998
(Sec. 101.65(d)(2)(ii)(C)). Under Sec. 101.65(d)(4)(ii), main dish and
meal products, to qualify to bear this term, must contain no more than
600 mg of sodium per RACC before January 1, 1998
(Sec. 101.65(d)(4)(ii)(A)), and no more than 480 mg of sodium per RACC
after January 1, 1998 (Sec. 101.65(d)(4)(ii)(B)).
On December 13, 1996, FDA received from the petitioner, ConAgra,
Inc., 888 17th Street, suite 300, NW., Washington, DC 20006, a petition
requesting that Sec. 101.65(d) be amended to ``eliminate the sliding
scale sodium requirement for foods labeled `healthy' by eliminating the
entire second tier levels of 360 mg sodium for individual foods and 480
mg sodium for meals and main dishes.'' Alternatively, the petitioner
requested that the effective date of January 1, 1998, in
Sec. 101.65(d)(2) through (d)(4), be delayed until such time as food
technology ``catches up'' with FDA's goals to reduce the sodium content
of foods, and there is a better understanding of the relationship
between sodium and hypertension.
The petitioner cited as grounds for its requests: (1) A lack of
scientific basis supporting the Daily Reference Value for sodium and
the allowable levels of sodium in Sec. 101.65(d); (2) a lack of
consumer acceptance of products containing low sodium levels; (3) a
lack of acceptable sodium substitutes and the difficulties in
manufacturing whole lines of food products at low sodium levels; and
(4) FDA's failure to provide notice and comment on the ``second tier''
sodium levels in the healthy definition, to follow directives of the
Nutrition Labeling and Education Act of 1990 (the 1990 amendments), and
to consider all the science, stating that recent studies indicate a
concern if too little sodium is consumed (Docket 96P-0500, CP1, p. 3).
While FDA finds little merit in the first and last of these grounds,
the middle two raise questions that merit further consideration.
Relative to the efforts of industry to lower the sodium level in
foods, the petitioner stated that the technology does not yet exist to
manufacture certain low fat products at the ``healthy'' definition
levels of sodium that will be required in 1998 and still provide foods
that will be acceptable to consumers. The petitioner submitted the
results of a consumer survey that examined consumer acceptance of
several products with different sodium levels. While the survey found
reductions in consumer acceptance at levels of 480 mg sodium compared
to higher sodium levels, much greater, i.e., statistically significant,
drops occurred at levels of 360 mg sodium per serving. As stated by the
petitioner:
If the sodium is so low in a product as to render the product
tasteless or even bad tasting, consumers will not eat the product or
will reach for the table salt. This is counter-productive to the
intent of the 1990 amendments and will not result in the goal
Congress envisioned; i.e., to improve the eating habits of the
American public, but instead could result in even more salt intake--
not less.
Docket 96P-0500, CP1, p. 28
The petitioner also delineated several technological concerns with
lowering sodium levels in foods related to the functional role of salt,
such as impacts on the microbial stability of perishable products,
changes in product texture and in water binding capacities, and effects
on flavor characteristics of other ingredients and on total electrolyte
levels that play a critical role in product safety.
Important issues have been raised in this petition regarding the
technological feasibility of further reductions in the sodium levels in
certain foods that currently meet FDA's definition of ``healthy'' and
regarding the palatability of such foods after the sodium has been
reduced. The agency recognizes that the food industry has made a
significant effort over the past few years to lower both the fat and
sodium levels in food products while maintaining taste and texture
attributes that are acceptable to consumers. The agency continues to
believe, however, that the scientific evidence indicates further
reductions in fat and sodium intakes will result in meaningful public
health gains.
FDA has defined the term ``healthy'' to serve as a means to help
consumers identify food products that will help them meet dietary
guidelines for a healthy diet. Consumers appreciate the significance of
this term, and thus many make purchasing decisions based on its
presence on a food label. Because of this fact, manufacturers have an
incentive to produce foods that qualify to bear this term. If the
petitioner is correct that the technology does not yet exist that will
permit manufactures to produce certain types of low fat foods that will
contain the lower levels of sodium required by January 1, 1998, and
still be acceptable to consumers, then the possibility exists that
``healthy'' will disappear from the market for such foods. If this
situation comes to pass, FDA will have squandered a significant
opportunity. Therefore, the agency finds that, before the new sodium
levels for ``healthy'' go into effect, it needs to explore whether it
has created an unattainable standard for many types of foods.
Under the provisions of Sec. 10.35(a) and (d)(1), the Commissioner
of Food and Drugs (the Commissioner) may at any time stay or extend the
effective date of a pending action if the Commissioner determines that
it is in the public interest to do so. As discussed previously in this
document, the petition has raised significant issues that have public
health implications. FDA also recognizes, as mentioned in the petition,
that manufacturers must begin very soon to revise the formulations and
the labeling, if they have not already done so, for those products that
do not currently comply with the requirements that must be met after
January 1, 1998, for a product to bear the claim ``healthy.'' Time is
[[Page 15391]]
needed for the agency to complete its review of the issues raised by
the petition. Additionally, FDA believes that it should seek comment on
these issues from other interested persons. Given these factors, the
agency is persuaded that it is in the public interest to stay the
provisions for the lower standards for sodium in the definition of
``healthy'' in Sec. 101.65 while the agency endeavors to resolve the
issues raised by the petition.
Therefore, the agency is staying the provisions for further
reducing the sodium level in foods labeled as ``healthy'' until January
1, 2000, to allow time for FDA to reevaluate the standard, including
the data contained in the petition and any additional data that the
agency may receive, to conduct any necessary notice-and-comment
rulemaking, and for industry to respond to the rule or to any change in
the rule that may result from the agency's reevaluation.
To assist the agency in its reevaluation, FDA intends to issue an
advance notice of proposed rulemaking (ANPR) in the near future to ask
for comments on the petition as well as for additional data regarding
the technological feasibility of reducing the sodium content of
individual foods to 360 mg per RACC and of meals and main dishes to 480
mg sodium per RACC. The agency will also be seeking comments on other
approaches to reduce the amount of sodium in foods labeled ``healthy.''
It is important that consumers seeking to eat a health-promoting diet
have food choices that enable them to further reduce the amount of
sodium in their diet. Interested persons need not wait for the
publication of the ANPR but should feel free to review the petition and
to submit to the agency any information or views they have on consumer
acceptance of foods with low sodium levels and on the lack of
acceptable sodium substitutes and the difficulties in manufacturing
lines of food products with low sodium levels.
Accordingly, FDA is announcing a stay of the provisions in
Sec. 101.65(d)(2)(ii)(C) and (d)(4)(ii)(B) until January 1, 2000.
Interested persons may also submit comments regarding the
appropriateness of the basis of this stay. In doing so, however, FDA
encourages manufacturers who can meet the lower sodium levels for
particular foods and still produce an acceptable product to do so even
as the agency reevaluates the issues discussed previously in this
document.
Interested persons may, on or before May 1, 1997 submit to the
Dockets Management Branch (address above) written comments regarding
this document. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
This document is issued under sections 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).
For the reasons set forth in the preamble, 21 CFR
101.65(d)(2)(ii)(C) and (d)(4)(ii)(B) are stayed until January 1, 2000.
Dated: March 26, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-8127 Filed 3-31-97; 8:45 am]
BILLING CODE 4160-01-F
