[Federal Register Volume 64, Number 50 (Tuesday, March 16, 1999)]
[Rules and Regulations]
[Pages 12886-12887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6300]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. 96P-0500 and 91N-384H]
RIN 0910-AA19


Food Labeling; Nutrient Content Claims, Definition of Term: 
Healthy; Extension of Partial Stay

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; extension of partial stay.

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SUMMARY: The Food and Drug Administration (FDA) is extending until 
January 1, 2003, the 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 March 16, 1999; 21 CFR 101.65(d)(2)(ii)(C), 
(d)(3)(ii)(C), and (d)(4)(ii)(B) are stayed until January 1, 2003. 
Written comments by April 15, 1999.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Ellen M. Anderson, Center for Food 
Safety and Applied Nutrition (HFS-165), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5662.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 10, 1994 (59 
FR 24232), FDA published a final rule to define the term ``healthy'' 
under section 403(r) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 343(r)). The final rule set up criteria for foods and for meals 
and main dishes to be able to use the nutrient content claim 
``healthy.'' Among other things, it defined two separate timeframes in 
which different criteria for sodium content would be effective (i.e., 
before January 1, 1998, and after January 1, 1998) and specified the 
criteria for a food to qualify to be labeled with either the term 
``healthy'' or another related term.
    Among other things, before January 1, 1998, under 
Sec. 101.65(d)(2)(ii)(A), (d)(2)(ii)(B), (d)(3)(ii)(A), and 
(d)(3)(ii)(B), for a food to qualify to bear the term ``healthy'' or a 
derivative of that term, the food could contain no more than 480 
milligrams (mg) of sodium (first-tier sodium level): (1) Per reference 
amount customarily consumed (RACC) per eating occasion; (2) per serving 
size listed on the product label; and (3) per 50 grams (g) for products 
with small RACC's (i.e., less than 30 g or less than 2 tablespoons). 
After January 1, 1998 (Sec. 101.65(d)(2)(ii)(C) and (d)(3)(ii)(C)), the 
food could contain no more than 360 mg of sodium (second-tier sodium 
level) per RACC, per labeled serving size, and per 50 g for products 
with small RACC's. Under Sec. 101.65(d)(4)(ii), main dish and meal 
products, to qualify to bear this or a related term, could 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 ConAgra, Inc., a petition 
requesting that the agency amend Sec. 101.65(d) 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.'' As an 
alternative, 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.
    In the Federal Register of April 1, 1997 (62 FR 15390), in response 
to this petition, FDA announced a stay until January 1, 2000, of the 
provisions in Sec. 101.65(d)(2)(ii)(C) and (d)(4)(ii)(B). This stay was 
intended: (1) To allow time for FDA to reevaluate the standard, 
including the data contained in the petition and any additional data 
that the agency might receive; (2) to conduct any necessary rulemaking; 
and (3) to allow time for industry to respond to the rule or to any 
change in the rule that may result from the agency's reevaluation.
    In the Federal Register of December 30, 1997 (62 FR 67771), FDA 
published an advanced notice of proposed rulemaking (ANPRM) announcing 
that it was considering whether to initiate rulemaking to reevaluate 
and possibly amend the nutrient content regulations pertaining to use 
of the term ``healthy.'' Among other things, FDA requested information 
on the current status of ``healthy'' labeling and on the impact of 
permitting the second-tier, more-restrictive sodium levels to become 
effective. The agency also asked that persons who support changing the 
definition should address what the new definition should require to 
ensure that the term can appear on a significant number of foods but is 
not so broadly defined as to lose its value in highlighting foods that 
are useful in constructing a diet consistent with dietary guidelines. 
The agency asked that those who support keeping the existing 
definition, including the second-tier sodium levels, should provide 
data showing that the second-tier sodium levels are not so restrictive 
as to effectively prevent use of the term.
    FDA received 22 responses to the ANPRM. The comments responding to 
the ANPRM presented strong and opposing views on whether FDA should let 
the second-tier sodium levels take effect. They also contained a 
significant amount of data relating to use of the term ``healthy.''
    FDA has reviewed the comments and also made an independent 
assessment of the number of foods labeled as ``healthy.'' Based on the 
information available, the agency tentatively concludes that, in some 
cases, the second-tier sodium levels may be overly restrictive, thereby 
eliminating a term that may potentially assist consumers in maintaining 
a healthy diet. The agency needs time to reevaluate the definition of 
the term ``healthy'' to consider options that preserve the public 
health intent while permitting manufacturers to use this term on foods 
that are consistent with dietary guidelines.
    FDA has not completed its reevaluation in the time allowed by the 
April 1, 1997, partial stay due to: (1) Limited agency resources; (2) 
other agency priorities; and (3) the need to investigate independently 
the validity of the strong, opposing positions expressed in the 
comments. Because FDA needs additional time to consider whether 
proposing a change in the definition is necessary, the agency is 
extending the partial stay until January 1, 2003.
    Under 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 the partial stay 
(62 FR 15390) and the ANPRM (62 FR 67771), 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 
labeling if they have not already done so for those products that do 
not currently comply with the requirement that must be met after 
January 1, 2000, for a product to bear

[[Page 12887]]

the claim. FDA needs time to consider the supporting and opposing 
positions and to conduct any necessary rulemaking on the issues raised. 
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'' (Sec. 101.65).
    Therefore, while the agency resolves these issues, FDA is staying 
until January 1, 2003, the provisions in Sec. 101.65(d)(2)(ii)(C) for 
foods and in Sec. 101.65(d)(4)(ii)(B) for meals and main dishes. The 
agency also is staying the provisions in Sec. 101.65(d)(3)(ii)(C) for 
raw, single-ingredient seafood or game meat, a citation that was 
inadvertently omitted in the initial stay. This action is being taken 
to: (1) Allow FDA time to reevaluate the information that supports and 
opposes the petition, (2) conduct any necessary rulemaking on the 
sodium limits for the term ``healthy,'' and (3) provide time for 
companies to respond to any changes that may result from agency 
rulemaking.
    Interested persons may 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.
    Interested persons may, on or before April 15, 1999, 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 the authority of 15 U.S.C. 1453, 
1454, 1455, and 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), (d)(3)(ii)(C), and (d)(4)(ii)(B) are stayed until 
January 1, 2003.

    Dated: March 8, 1999.
 William K. Hubbard,
 Acting Deputy Commissioner for Policy.
[FR Doc. 99-6300 Filed 3-15-99; 8:45 am]
BILLING CODE 4160-01-F