[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]
[[Page 12886]]
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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
