[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