[Federal Register Volume 65, Number 205 (Monday, October 23, 2000)]
[Notices]
[Pages 63256-63257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-27083]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N 0044]


Statements Made for Dietary Supplements Concerning the Effect of 
the Product on the Structure or Function of the Body; Availability of 
Citizen Petitions for Comment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for comment of three petitions submitted by Hyman Phelps & 
McNamara (HP&M), the American Herbal Products Association (AHPA), and 
jointly by the Council for Responsible Nutrition (CRN) and the Consumer 
Healthcare Products Association (CHPA). The petitions requested, among 
other things, that dietary supplements be permitted to make claims 
about effects on the structure or function of the body that are derived 
from nutritive value without being subject to the disclaimer and 
notification requirements of the Federal Food, Drug, and Cosmetic Act 
(the act).

DATES: Submit written comments on the petitions by December 22, 2000.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Electronic comments may be submitted via the 
Internet at www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm or via e-mail: <a href="/cdn-cgi/l/email-protection#d0b6b4b1b4bfb3bbb5a4a390bfb3feb6b4b1feb7bfa6"><span class="__cf_email__" data-cfemail="d6b0b2b7b2b9b5bdb3a2a596b9b5f8b0b2b7f8b1b9a0">[email protected]</span></a>. All comments 
should be identified with the docket number found in brackets in the 
heading of this document. The petitions are available for review at the 
Dockets Management Branch (address above) or electronically on the 
agency's website at http//www.fda.gov/ohrms/dockets/dockets.htm. You 
may also request copies of the petitions from the Dockets Management 
Branch.

FOR FURTHER INFORMATION CONTACT: Rhonda Rhoda Kane, Office of 
Nutritional Products, Labeling, and Dietary Supplements, Center for 
Food Safety and Applied Nutrition (HFS 821), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, 202-205-4168.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 6, 2000 (65 FR 1000), in the 
preamble to its final rule entitled ``Regulations on Statements Made 
for Dietary Supplements Concerning the Effect of the Product on the 
Structure or Function of the Body,'' FDA stated that dietary 
supplements bearing structure/function claims must comply with the 
notice, disclaimer, and other requirements of section 403(r)(6) of the 
act (21 U.S.C. 343(r)(6)). More specifically, the agency stated:
    Section 403(r)(6) of the act, by its terms, applies to dietary 
supplements. The other possible source of authority to make structure/
function claims on dietary supplements is section 201(g)(1)(C) of the 
act, which provides that ``articles (other than food) intended to 
affect the structure or any function of the body of man or other 
animals'' are drugs. Under this provision, foods may make claims to 
affect the structure or function of the body without being regulated as 
drugs. By its terms, however, section 201(g)(1)(C) of the act exempts a 
dietary supplement that bears a structure/function claim from drug 
regulation only if it is also a food. The last sentence of section 
201(ff) of the act provides, ``Except for purposes of section 201(g), a 
dietary supplement shall be deemed to be a food within the meaning of 
this Act.'' The clear import of this language is that dietary 
supplements are not foods under section 201(g) of the act and therefore 
cannot qualify for the ``(other than food)'' exception to the drug 
definition in section 201(g)(1)(C). As a result, dietary supplements 
that use structure/function claims may do so only under section 
403(r)(6) of the act and are therefore subject to the disclaimer, 
notification, and other requirements in that section and in FDA's 
implementing regulation.
65 FR 1000 at 1033.
    The preamble acknowledged that this conclusion reverses a position 
stated in the Federal Register of September 23, 1997 (62 FR 49859), in 
the final rule entitled ``Food Labeling; Requirements for Nutrient 
Content Claims, Health Claims, and Statements of Nutritional Support 
for Dietary Supplements.'' The preamble to that rule stated that a 
dietary supplement could bear a structure/function claim under the 
``(other than food)'' exception to the drug definition in section 
201(g)(1)(C) of the act (21 U.S.C. 321(g)(1)(C)), provided that the 
claim was truthful, nonmisleading, and derived from nutritive value 
(see 62 FR 49859 at 49860, 49863, and 49864). The reversal was based on 
reconsideration of the plain language of section 201(ff) of the act.

II. The Citizen Petitions

    On February 4, 2000, HP&M filed a petition requesting, among other 
things, that the agency reconsider and revoke its ``pronouncement'' in 
the January 6, 2000, final rule that all structure/function claims in 
the labeling of dietary supplements must use the section 403(r)(6) of 
the act disclaimer and notification procedures. The petition further 
requests that FDA reinstate its previous position that a structure/
function claim in the labeling of a dietary supplement product need not 
comply with the disclaimer and notification requirements if the claim 
is truthful, nonmisleading, and derived from nutritive value.
    Citing United States v. Ten Cartons * * *Ener-B Vitamin B 12, 72 
F.3d 285, 287 (2d Cir. 1995), HP&M argues that section 201(g)(1)(C) of 
the act must be applied without reference to section 201(ff) of the 
act. In sum, HP&M states that the effect of section 201(ff) of the act 
``is merely that a dietary supplement will not ``automatically qualify 
as food.''' HP&M further argues that whether or not a particular 
dietary supplement qualifies as food is determined by Nutrilab, Inc. v. 
Schweiker, 713 F.2d 335 (7th Cir. 1983). That case held that a product 
is a food if it is used primarily for ``taste, aroma or nutritive 
value.'' Nutrilab, 713 F.2d at 338. For example, the petition argues

[[Page 63257]]

that calcium would qualify as a food since it is an essential mineral 
nutrient.
    HP&M articulates several other grounds for the action requested in 
the petition. HP&M also argues that the requirements of section 
403(r)(6) of the act apply only to structure/function claims that fall 
within the health claims definition 21 CFR 101.14(a)(1). Moreover, HP&M 
argues that FDA's change in interpretation is not entitled to deference 
because it was issued more than 5 years after the Dietary Supplement 
Health and Education Act (DSHEA) was passed and, therefore, is not a 
``contemporaneous construction'' of the statute. The petition also 
asserts that Congress intended DSHEA to reduce FDA requirements for 
dietary supplements. HP&M believes that FDA's new position is 
inconsistent with congressional intent since it imposes regulatory 
burdens that did not exist before DSHEA. Finally, the petition also 
raises an administrative law argument that FDA's reversal is 
effectively a substantive rule that must comply with the notice and 
comment rulemaking procedures of the Administrative Procedure Act in 5 
U.S.C. 553.
    Petitions filed by AHPA and jointly by CRN and CHPA on February 7, 
2000, also requested a reversal of FDA's position on this issue. These 
petitions made arguments similar to those made by the HP&M petition.

III. Questions

    The agency is interested in receiving comments on all three 
petitions. Moreover, there are several specific questions on which FDA 
would like comment.
    1. The outcome of a reversal of FDA's position would be that 
dietary supplements that qualify for the ``(other than food)'' 
exception would not have to accompany the structure/function claim with 
a disclaimer while dietary supplements that do not qualify would. Would 
consumer confusion result from this outcome?
    2. The outcome of maintaining the current position would be that 
dietary supplements making a structure/function claim would have to 
bear a disclaimer while conventional foods making the same claim would 
not. Is it better to have an inconsistency between dietary supplements 
and conventional foods or between dietary supplements that qualify for 
the ``(other than food)'' exception and dietary supplements that do 
not?
    3. If FDA were to reverse its position as requested by the 
petitions, the agency would be notified of some structure/function 
claims for dietary supplements, but not others. Therefore, the agency 
would not be aware of all the structure/function claims in the 
marketplace, including some that might be in fact disease claims rather 
than legitimate structure/function claims. To determine whether a 
dietary supplement could legitimately bear a structure/function claim 
without a disclaimer, FDA would have to investigate whether the claim 
was based on the nutritive value of the supplement. What would be the 
impact of this situation on enforcement?

IV. Comments

    You may submit to the Dockets Management Branch (address above) 
written or electronic comments by December 22, 2000. Electronic 
comments may be submitted via the Internet to: www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm or via e-mail: 
<a href="/cdn-cgi/l/email-protection#ea8c8e8b8e8589818f9e99aa8589c48c8e8bc48d859c"><span class="__cf_email__" data-cfemail="dabcbebbbeb5b9b1bfaea99ab5b9f4bcbebbf4bdb5ac">[email protected]</span></a>. Groups or organizations must submit two copies 
of any comments. Individuals may submit one copy of their comments. 
Identify your written comments by placing the docket number at the top 
of your comment(s). If you base your comments on scientific evidence or 
data, please submit copies of the specific information along with your 
comments. Any comments submitted will be filed under the docket number 
identified in brackets in the heading of this document. The petition 
and received comments may be seen in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 13, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-27083 Filed 10-20-00; 8:45 am]
BILLING CODE 4160-01-F


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