65 FR 205 pgs. 63256-63257 - Statements Made for Dietary Supplements Concerning the Effect of theProduct on the Structure or Function of the Body; Availability of CitizenPetitions for Comment
Type: NOTICEVolume: 65Number: 205Pages: 63256 - 63257
Docket number: [Docket No. 98N 0044]
FR document: [FR Doc. 00-27083 Filed 10-20-00; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N 0044]
Statements Made for Dietary Supplements Concerning the Effect of theProduct on the Structure or Function of the Body; Availability of CitizenPetitions for Comment
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing theavailability for comment of three petitions submitted by Hyman PhelpsMcNamara (HPM), the American Herbal Products Association (AHPA), andjointly by the Council for Responsible Nutrition (CRN) and the ConsumerHealthcare Products Association (CHPA). The petitions requested, amongother things, that dietary supplements be permitted to make claims abouteffects on the structure or function of the body that are derived fromnutritive value without being subject to the disclaimer and notificationrequirements 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 ManagementBranch (HFA 305), Food and Drug Administration, 5630 Fishers Lane, rm.1061, Rockville, MD 20852. Electronic comments may be submitted via theInternet atwww.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm or viae-mail: fdadockets@oc.fda.gov. All comments should be identified with thedocket number found in brackets in the heading of this document. Thepetitions are available for review at the Dockets Management Branch(address above) or electronically on the agency's website athttp//www.fda.gov/ohrms/dockets/dockets.htm. You may also request copiesof the petitions from the Dockets Management Branch.
FOR FURTHER INFORMATION CONTACT:
Rhonda Rhoda Kane, Office ofNutritional Products, Labeling, and Dietary Supplements, Center for FoodSafety and Applied Nutrition (HFS 821), Food and Drug Administration, 200 CSt. SW., Washington, DC 20204, 202-205-4168.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 6, 2000 (65 FR 1000), in thepreamble to its final rule entitled "Regulations on Statements Made forDietary Supplements Concerning the Effect of the Product on the Structureor Function of the Body," FDA stated that dietary supplements bearingstructure/function claims must comply with the notice, disclaimer, andother 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 dietarysupplements. The other possible source of authority to makestructure/function claims on dietary supplements is section 201(g)(1)(C) ofthe act, which provides that "articles (other than food) intended toaffect the structure or any function of the body of man or other animals"are drugs. Under this provision, foods may make claims to affect thestructure or function of the body without being regulated as drugs. By itsterms, however, section 201(g)(1)(C) of the act exempts a dietarysupplement that bears a structure/function claim from drug regulation onlyif it is also a food. The last sentence of section 201(ff) of the actprovides, "Except for purposes of section 201(g), a dietary supplementshall be deemed to be a food within the meaning of this Act." The clearimport of this language is that dietary supplements are not foods undersection 201(g) of the act and therefore cannot qualify for the "(otherthan food)" exception to the drug definition in section 201(g)(1)(C). Asa result, dietary supplements that use structure/function claims may do soonly under section 403(r)(6) of the act and are therefore subject to thedisclaimer, notification, and other requirements in that section and inFDA's implementing regulation.
65 FR 1000 at 1033.
The preamble acknowledged that this conclusion reverses a positionstated in the Federal Register of September 23, 1997 (62 FR 49859),in the final rule entitled "Food Labeling; Requirements for NutrientContent Claims, Health Claims, and Statements of Nutritional Support forDietary Supplements." The preamble to that rule stated that a dietarysupplement could bear a structure/function claim under the "(other thanfood)" 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 plainlanguage of section 201(ff) of the act.
II. The Citizen Petitions
On February 4, 2000, HPM filed a petition requesting, among otherthings, that the agency reconsider and revoke its "pronouncement" in theJanuary 6, 2000, final rule that all structure/function claims in thelabeling of dietary supplements must use the section 403(r)(6) of the actdisclaimer and notification procedures. The petition further requests thatFDA reinstate its previous position that a structure/function claim in thelabeling of a dietary supplement product need not comply with thedisclaimer and notification requirements if the claim is truthful,nonmisleading, and derived from nutritive value.
Citing United States v. Ten Cartons * * * Ener-B VitaminB 12 , 72 F.3d 285, 287 (2d Cir. 1995), HPM argues that section201(g)(1)(C) of the act must be applied without reference to section201(ff) of the act. In sum, HPM states that the effect of section 201(ff)of the act "is merely that a dietary supplement will not "automaticallyqualify as food."' HPM further argues that whether or not a particulardietary supplement qualifies as food is determined by Nutrilab, Inc .v. Schweiker , 713 F.2d 335 (7th Cir. 1983). That case held that aproduct is a food if it is used primarily for "taste, aroma or nutritivevalue." Nutrilab , 713 F.2d at 338. For example, the petition argues that calcium would qualify as a food since it is an essential mineralnutrient.
HPM articulates several other grounds for the action requested in thepetition. HPM also argues that the requirements of section 403(r)(6) ofthe act apply only to structure/function claims that fall within thehealth claims definition 21 CFR 101.14(a)(1). Moreover, HPM argues thatFDA's change in interpretation is not entitled to deference because it wasissued more than 5 years after the Dietary Supplement Health and EducationAct (DSHEA) was passed and, therefore, is not a "contemporaneousconstruction" of the statute. The petition also asserts that Congressintended DSHEA to reduce FDA requirements for dietary supplements. HPMbelieves that FDA's new position is inconsistent with congressional intentsince it imposes regulatory burdens that did not exist before DSHEA.Finally, the petition also raises an administrative law argument that FDA'sreversal is effectively a substantive rule that must comply with the noticeand comment rulemaking procedures of the Administrative Procedure Act in 5U.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. Thesepetitions made arguments similar to those made by the HPM petition.
III. Questions
The agency is interested in receiving comments on all three petitions.Moreover, there are several specific questions on which FDA would likecomment.
1. The outcome of a reversal of FDA's position would be that dietarysupplements that qualify for the "(other than food)" exception would nothave to accompany the structure/function claim with a disclaimer whiledietary supplements that do not qualify would. Would consumer confusionresult from this outcome?
2. The outcome of maintaining the current position would be thatdietary supplements making a structure/function claim would have to bear adisclaimer while conventional foods making the same claim would not. Is itbetter to have an inconsistency between dietary supplements andconventional 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 dietarysupplements, but not others. Therefore, the agency would not be aware ofall the structure/function claims in the marketplace, including some thatmight be in fact disease claims rather than legitimate structure/functionclaims. To determine whether a dietary supplement could legitimately beara structure/function claim without a disclaimer, FDA would have toinvestigate whether the claim was based on the nutritive value of thesupplement. 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 viae-mail: fdadockets@oc.fda.gov. Groups or organizations must submit twocopies of any comments. Individuals may submit one copy of their comments.Identify your written comments by placing the docket number at the top ofyour 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 inbrackets in the heading of this document. The petition and receivedcomments may be seen in the Dockets Management Branch between 9 a.m. and 4p.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