Food for human consumption: Food labeling healthy'' definition; partial stay extension,
[Federal Register: March 16, 1999 (Volume 64, Number 50)]
[Rules and Regulations]
[Page 12886-12887]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16mr99-4]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[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.
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
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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. 99-6300Filed3-15-99; 8:45 am]
BILLING CODE 4160-01-F
