[Federal Register Volume 60, Number 27 (Thursday, February 9, 1995)]
[Rules and Regulations]
[Pages 7710-7712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3294]
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[[Page 7711]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 95N-0025]
Food Labeling; General Requirements for Nutrition Labeling of
Dietary Supplements; General Requirements for Nutrient Content Claims
for Dietary Supplements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of intent.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that,
given the need to modify its regulations on nutrition labeling and
nutrient content claims for dietary supplements to respond to the 1994
Dietary Supplement Health and Education Act (the 1994 DSHEA), it does
not intend to enforce those regulations until after December 31, 1996.
FDA is issuing this notice of intent in response to inquiries from the
dietary supplement industry.
FOR FURTHER INFORMATION CONTACT: Virginia L. Wilkening, 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:
I. Background
The Nutrition Labeling and Education Act (the 1990 amendments) was
enacted on November 8, 1990. This law amended the Federal Food, Drug,
and Cosmetic Act (the act) to require that virtually all foods,
including conventional foods and dietary supplements, bear nutrition
labeling (section 403(q) of the act (21 U.S.C. 343(q)), and that if
they bear claims about the level of nutrients that they contain, those
claims be made in accordance with definitions adopted by FDA (see
section 403(r) of the act). The 1990 amendments required that FDA issue
proposed rules implementing these provisions within 12 months from the
date of their enactment and final rules within 24 months (sections 2(b)
and 3(b) of the 1990 amendments). The final rules were to be effective
6 months after they were issued, although FDA was authorized to delay
application of the rules for up to 1 year if it found that compliance
with the nutrition labeling and nutrient content claim provisions would
cause undue economic hardship (section 10(a) of the 1990 amendments).
FDA issued proposed rules on November 27, 1991 (see 56 FR 60366 and
60421). On October 29, 1992, however, shortly before the final rules
were to be issued, the Dietary Supplement Act of 1992 (the 1992 DS act)
(Title II of Pub. L. 102-571) was enacted. This law took dietary
supplements out of the rulemaking schedule that had been established
under the 1990 amendments. It provided that FDA issue new proposals on
the nutrition labeling of, and nutrient content claims for, dietary
supplements by June 15, 1993, and that the agency issue final rules by
December 31, 1993. However, the provisions of the 1990 amendments that
made the final rules effective 6 months after issuance, and that gave
FDA discretion to delay their applicability for 1 year, continued to
apply to dietary supplements.
Consistent with the 1990 amendments and the 1992 DS act, on June
18, 1993 (58 FR 33715 and 33731), FDA issued proposed rules on the
nutrition labeling and nutrient content claims for dietary supplements.
On January 4, 1994 (59 FR 354 and 378), FDA issued the final rules. As
stated above, under the 1990 amendments, these final rules were to be
effective 6 months from December 31, 1993, or on July 1, 1994. However,
in conjunction with the publication of the final rules, FDA made a
finding that requiring compliance by that date would cause dietary
supplement manufacturers undue economic hardship (59 FR 350, January 4,
1994). Therefore, FDA stated that these manufacturers need not comply
with the final rules on nutrition labeling and nutrient content claims
until July 1, 1995.
Having completed these rulemakings, FDA anticipated that dietary
supplement firms would begin taking steps to come into compliance with
the new rules, and dietary supplement manufacturers have apparently
done so. For example, in 1994, a number of dietary supplement trade
associations held conferences about the new rules, and FDA received
inquiries from a number of firms about what steps are required.
In October 1994, however, a significant ambiguity was introduced
into the regulation of the labeling of dietary supplements. At that
time, the 1994 DSHEA (Pub. L. 103-417) was enacted. This new law
amended both the nutrition labeling and nutrient content claim
provisions of the act (see sections 7(b) and (c) of the 1994 DSHEA). It
made limited changes in how nutrition information is to be presented in
the labeling of dietary supplements, although it made implementation of
these changes subject to regulations adopted by the Secretary of Health
and Human Services (and, by delegation, FDA) (section 403(q)(5)(F) of
the act). It also limited in one respect the nutrient content claims
for dietary supplements that must be defined by regulation by FDA
(section 403(r)(2)(F) of the act).
With respect to the effective date of these amendments and to the
other labeling provisions enacted as part of the new law, the 1994
DSHEA stated that dietary supplements may be labeled in accordance with
its provisions after its date of enactment, and that they must be
labeled in compliance with its provisions after December 31, 1996
(section 7(e) of the 1994 DSHEA). The new law was silent, however, with
respect to its effect on the July 1, 1995, applicability date
established under the 1990 amendments and the 1992 DS act for FDA's
regulations on the nutrition labeling and nutrient content claim
requirements for dietary supplements.
II. Statement
In the wake of the new law, FDA has received inquiries from the
dietary supplement industry about how the agency intends to enforce the
law. One trade association wrote that its members are making efforts to
comply with the July 1, 1995, effective date established under the 1990
amendments and the 1992 DS act, but that, as a practical matter, that
effective date should not be enforced to allow the process of
implementing the 1994 DSHEA to proceed in a reasonable fashion. The
trade association cautioned that if FDA did not follow such a course,
companies would be put in the untenable position of needing to relabel
in July 1995, only to relabel again by the end of 1996 (Ref. 1).
FDA believes that it is appropriate, in response to these
inquiries, to issue a statement on how it intends to enforce its
nutrition labeling and nutrient content claim regulations with respect
to dietary supplements in light of the passage of the 1994 DSHEA (Ref.
2). In formulating this statement, FDA has carefully considered
Congress' goals in passing the 1994 DSHEA and the 1990 amendments, as
well as the needs of the companies that are required to label their
products in accordance with the act and of consumers to whom the
information in question is to be provided.
In the 1990 amendments, Congress required that food labels bear
information that will help consumers to maintain healthy dietary
practices and established timeframes for the implementation of the
legislation to [[Page 7712]] ensure that it would be given effect
without undue delay. In the 1994 DSHEA, Congress, while embracing most
of what FDA has done under the 1990 amendments with respect to dietary
supplements, sought to provide for the inclusion of additional
information on the nutrition label and to provide additional
flexibility in how that information is presented. The dietary
supplement industry is left facing an applicability date for FDA's
nutrition labeling and nutrient content claim regulations for dietary
supplements of July 1, 1995, without complete guidance on how the
nutrition label is ultimately to be presented on these products. As for
consumers, they are currently provided with nutrition information on
many, but by no means all, dietary supplements, but that information is
not being presented in a form that is consistent with the ``Nutrition
Facts'' panel that appears on conventional foods.
Having considered these factors, FDA advises that, while the
nutrition labeling and nutrient content claim regulations implementing
the 1990 amendments for dietary supplements will go into effect on July
1, 1995, it does not intend to enforce those regulations until it has
modified them to reflect the 1994 DSHEA, and until after dietary
supplement manufacturers are required to label their products in
accordance with the 1994 DSHEA; that is, not until after December 31,
1996.
FDA considers this course of action appropriate for several
reasons. First, FDA recognizes the merit in the dietary supplement
industry's argument that it should not be required to relabel its
products until it has a full understanding of what its alternatives and
obligations are. Enforcing the nutrition labeling and nutrient content
claims regulations on July 1, 1995, would require dietary supplement
manufacturers to choose between relabeling their products twice, the
first time to come into compliance and the second to take advantage of
the flexibility provided by the new law, or foregoing that flexibility.
To force dietary supplement manufacturers to make such a choice would
be a result that the agency does not believe Congress contemplated or
would have intended in enacting the 1994 DSHEA.
The 1994 DSHEA provides for flexibility in the dietary ingredients
that can be included in the ``Nutrition Facts'' box and in the
presentation of ingredient information. FDA, pursuant to the 1994
DSHEA, is at work on regulations that define this flexibility. FDA
agrees that industry should have an opportunity to take advantage of
this flexibility without being forced to relabel twice to do so. FDA
acknowledges that it will not be possible for the agency to have its
regulations in place, nor for the industry to have adequate time to
design its labeling in accordance with these regulations, by July of
this year. Thus, the interests of industry and the policies embodied in
the 1994 DSHEA will be advanced if FDA declines to enforce the
nutrition labeling and nutrient content claim regulations that apply to
dietary supplements until after December 31, 1996, when they will be
fully modified to reflect the 1994 DSHEA.
While the purposes of the 1990 amendments will not be as clearly
advanced by such a course of action, they will also not be contravened.
Implementation of the 1994 DSHEA will move FDA forward toward its goal
of full implementation of the 1990 amendments. Moreover, while Congress
sought to rule out undue delay in implementation of the 1990
amendments, a delay caused by implementation of another law enacted by
Congress can hardly be considered ``undue.''
Finally, it is true that consumers face an additional delay before
dietary supplements bear nutrition information that is as consistent as
possible, both in content and presentation, with that on other foods,
and until there is full compliance by dietary supplements with the
nutrient content claim provisions of the act. These facts are
mitigated, however, by the fact that there is information listing
nutrients and their levels on many dietary supplements, and that many
dietary supplements do not bear nutrient content claims.
Thus, having fully considered these factors, the agency advises
that it does not intend to enforce the nutrition labeling and nutrient
content claims regulations that apply to dietary supplements until
after December 31, 1996. The agency is at work developing a proposal
that implements the labeling provisions of the 1994 DSHEA and expects
to publish it in the near future.
III. References
The following references have been placed on display in the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Cordaro, John, President, Council for Responsible Nutrition,
letter to David A. Kessler, Commissioner, FDA, December 7, 1994.
2. Shank, Fred, R., Director, Center for Food Safety and Applied
Nutrition, FDA, letter to John B. Cordaro, President, Council for
Responsible Nutrition, January 30, 1995.
Dated: February 6, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-3294 Filed 2-8-95; 8:45 am]
BILLING CODE 4160-01-F