FDA Notification for Permissible Structure/Function Claims for Dietary Supplements

by Babener & Associates
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MLM Distributors and MLM companies often ask about the notification requirements for permissible structure/function claims for dietary supplements, under FDA rules of DSHEA (Dietary Supplement Health Education Act). Here is summary, directly from the FDA, which may prove helpful:

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MLM Distributors and MLM companies often ask about the notification requirements for permissible structure/function claims for dietary supplements, under FDA rules of DSHEA (Dietary Supplement Health Education Act).

PART 101 — FOOD LABELING

Subpart F–Specific Requirements for Descriptive Claims That Are Neither Nutrient Content Claims nor Health Claims

Sec. 101.93 Certain types of statements for dietary supplements.

(a)(1) No later than 30 days after the first marketing of a dietary supplement that bears one of the statements listed in section 403(r)(6) or the Federal Food, Drug, and Cosmetic Act, the manufacturer, packer, or distributor of the dietary supplement shall notify the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, that it has included such a statement on the label or in the labeling of its product. An original and two copies of this notification shall be submitted.

(2) The notification shall include the following:

(i) The name and address of the manufacturer, packer, or distributor of the dietary supplement that bears the statement;

(ii) The text of the statement that is being made;

(iii) The name of the dietary ingredient or supplement that is the subject of the statement, if not provided in the text of the statement; and

(iv) The name of the dietary supplement (including brand name), if not provided in response to paragraph (a)(2)(iii) on whose label, or in whose labeling, the statement appears.

(3) The notice shall be signed by a responsible individual or the person who can certify the accuracy of the information presented and contained in the notice. The individual shall certify that the information contained in the notice is complete and accurate, and that the notifying firm has substantiation that the statement is truthful and not misleading.

(b)Disclaimer. The requirements in this section apply to the label or labeling of dietary supplements where the dietary supplement bears a statement that is provided for by section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the act), and the manufacturer, packer, or distributor wishes to take advantage of the exemption to section 201(g)(1)(C) of the act that is provided by compliance with section 403(r)(6) of the act.

(c)Text for disclaimer.

(1) Where there is one statement, the disclaimer shall be placed in accordance with paragraph (d) of this section and shall state:

This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

(2) Where there is more than one such statement on the label or in the labeling, each statement shall bear the disclaimer in accordance with paragraph (c)(1) of this section, or a plural disclaimer may be placed in accordance with paragraph (d) of this section and shall state:

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

(d)Placement. The disclaimer shall be placed adjacent to the statement with no intervening material or linked to the statement with a symbol (e.g., an asterisk) at the end of each such statement that refers to the same symbol placed adjacent to the disclaimer specified in paragraphs (c)(1) or (c)(2) of this section. On product labels and in labeling (e.g., pamphlets, catalogs), the disclaimer shall appear on each panel or page where there such is a statement. The disclaimer shall be set off in a box where it is not adjacent to the statement in question.

(e)Typesize. The disclaimer in paragraph (c) of this section shall appear in boldface type in letters of a typesize no smaller than one-sixteenth inch.

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This article is also available online at: http://mlmlegal.com/MLMBlog/?p=408

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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