[Federal Register Volume 67, Number 89 (Wednesday, May 8, 2002)]
[Rules and Regulations]
[Pages 30795-30796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-11378]



[[Page 30795]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 91N-384H and 96P-0500]
RIN 0910-AA19


Food Labeling; Nutrient Content Claims, Definition of Sodium 
Levels for the 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, 2006, the partial stay of certain provisions of the nutrient 
content claim regulations pertaining to the use of the term 
``healthy.'' This action is being taken to allow the agency to conduct 
rulemaking to consider amending the sodium content requirements for 
foods labeled ``healthy.'' A stay also will provide industry time to 
implement any changes resulting from the rulemaking.

DATES: Effective May 8, 2002, 21 CFR 101.65(d)(2)(ii)(C), 
(d)(3)(ii)(C), and (d)(4)(ii)(B) are stayed until January 1, 2006. 
Submit written or electronic comments by June 7, 2002.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20857. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Ellen M. Anderson, Food and Drug 
Administration, Center for Food Safety and Applied Nutrition (HFS-822), 
Harvey W. Wiley Federal Bldg., 5100 Paint Branch Pkwy., College Park, 
MD 20740-3835, 301-436-1798.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 10, 1994 (59 
FR 24232), FDA published a final rule defining 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 individual foods and 
for meal and main dish products to be able to use the nutrient content 
claim ``healthy.'' Among other things, the final rule defined 
sequential timeframes (before January 1, 1998, and after January 1, 
1998) in which different criteria for sodium content would be effective 
for foods labeled ``healthy'' or bearing another related term.
    The final rule provided that before January 1, 1998, individual 
foods (including raw, single-ingredient seafood or game meat) could be 
labeled as ``healthy'' only if they contained no more than 480 
milligrams (mg) of sodium: (1) Per reference amount customarily 
consumed per eating occasion (reference amount); (2) per serving size 
listed on the product label; and (3) per 50 grams (g) for products with 
small reference amounts (i.e., less than or equal to 30 g or less than 
or equal to 2 tablespoons) (Sec. 101.65(d)(2)(ii)(A) through 
(d)(2)(ii)(B) and (d)(3)(ii)(A) through (d)(3)(ii)(B)). Meal and main 
dish products could be labeled as ``healthy'' only if they contained no 
more than 600 mg of sodium per reference amount 
(Sec. 101.65(d)(4)(ii)(A)). After January 1, 1998, however, the sodium 
criteria for ``healthy'' foods were to become more stringent. For 
individual foods, the limit to qualify for a ``healthy'' claim was to 
become 360 mg sodium: (1) Per reference amount; (2) per serving size 
listed on the product label; and (3) per 50 g for products with small 
reference amounts (Sec. 101.65(d)(2)(ii)(C)(1) through (d)(2)(ii)(C)(2) 
and (d)(3)(ii)(C)(1) through (d)(3)(ii)(C)(2)). For meal and main dish 
products, the limit was to become 480 mg of sodium per reference amount 
(Sec. 101.65(d)(4)(ii)(B)). In the remainder of this document, the 
original, higher sodium levels will be referred to as the ``first-tier 
sodium levels''; the lower levels that were to go into effect on 
January 1, 1998, will be referred to as the ``second-tier sodium 
levels.''
    On December 13, 1996, FDA received a petition from ConAgra, Inc. 
(the petitioner), 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 January 1, 1998, 
effective date for the second-tier sodium levels be delayed until such 
time as food technology ``catches up'' with FDA's goal to reduce the 
sodium content of foods, and there is a better understanding of the 
relationship between sodium and hypertension.
    FDA responded to ConAgra's petition by announcing a stay of the 
second-tier sodium levels until January 1, 2000 (62 FR 15390, April 1, 
1997). This stay was intended to allow time for FDA to: (1) Reevaluate 
the second-tier sodium levels based on data contained in the petition 
and any additional data that the agency might receive; (2) conduct any 
necessary rulemaking; and (3) give industry an opportunity 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 advance notice of proposed rulemaking (ANPRM) announcing 
that it was considering whether to initiate rulemaking to reevaluate 
and possibly amend the nutrient content claim regulations pertaining to 
use of the term ``healthy.'' In the ANPRM, FDA requested comments on 
whether it should propose to amend the definition of the term 
``healthy'' relative to sodium requirements. Persons who supported 
changing the ``healthy'' definition were asked to address what the new 
definition should require to ensure that the term could appear on a 
significant number of foods, without being so broadly defined as to 
lose its value in highlighting foods that are useful in constructing a 
diet consistent with dietary guidelines. Those who supported allowing 
the second-tier sodium levels to take effect were asked to provide data 
to demonstrate that those levels were not so restrictive as to 
effectively prevent use of the term (62 FR 67771 at 67772).
    FDA received 22 responses to the ANPRM. The comments presented a 
variety of views on whether FDA should allow the second-tier sodium 
levels to take effect. They also contained a significant amount of data 
relating to the use of the term ``healthy'' in the marketplace.
    In the Federal Register of March 16, 1999 (64 FR 12886), FDA 
further extended the stay of the second-tier sodium requirement for 
individual foods (Sec. 101.65(d)(2)(ii)(C)), for meal and main dish 
products (Sec. 101.65(d)(4)(ii)(B)), and for raw, single-ingredient 
seafood or game meat (Sec. 101.65(d)(3)(ii)(C)) until January 1, 2003.
    FDA has decided that it is appropriate to further stay the second-
tier sodium provisions of the final rule for the term ``healthy'' until 
January 1, 2006. Agency regulations at 21 CFR 10.35(a) provide that the 
Commissioner of Food and Drugs may at any time stay the effective date 
of an action. The agency finds that a further extension of the stay of 
the second-tier sodium provisions is in the public interest.
    To the extent that 5 U.S.C. 553 applies to this action, it is 
exempt from notice and comment because it constitutes a rule of 
procedure under 5 U.S.C. 553(b)(3)(A). Alternatively, the agency's 
implementation of this action without opportunity for public comment,

[[Page 30796]]

effective immediately upon publication today in the Federal Register, 
is based on the good cause exceptions in 5 U.S.C. 553(b)(3)(B), (d)(3), 
and 21 CFR 10.40(e)(1). Under these provisions, FDA may issue a 
regulation without notice and comment when the agency determines that 
such procedures are impracticable, unnecessary, or contrary to the 
public interest. Seeking public comment before implementing this stay 
would be contrary to the public interest.
    The current, second-tier sodium provisions are scheduled to take 
effect on January 1, 2003. To comply with this effective date, 
manufacturers would have to reformulate and/or relabel their products 
within a short timeframe, a process that could involve significant 
expense. As FDA is currently preparing to issue a proposed rule 
concerning ``healthy'' sodium levels, it would be contrary to the 
public interest to require manufacturers to comply with the second-tier 
sodium levels, even as the agency considers whether alternative levels 
may be more appropriate. Accordingly, a further stay of the second-tier 
sodium levels is warranted. This stay will give the agency time to 
issue its proposed rule, consider comments, and complete the 
rulemaking. The stay also will allow time for manufacturers to make 
changes necessitated by the rulemaking (e.g., reformulating or 
relabeling products and using up old label stock). Finally, the January 
1, 2006, effective date should coincide with the uniform compliance 
dates for food labeling regulations. The next uniform compliance date 
is scheduled for January 1, 2004, and FDA typically sets these dates to 
occur every 2 years (see 65 FR 69666).
    Although FDA has determined that it is in the public interest to 
issue this rule without prior public comment, interested persons are 
invited to submit comments on whether this extension of the stay of the 
second-tier sodium levels should be modified or revoked (see 21 CFR 
10.40(e)(1)). 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.
    FDA encourages manufacturers who can meet the second-tier sodium 
levels for particular foods and still produce an acceptable product to 
do so, even as the agency proceeds with rulemaking.
    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, 2006.

    Dated: April 29, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-11378 Filed 5-7-02; 8:45 am]
BILLING CODE 4160-01-S