FDA disclaimer for dietary supplements

A dietary supplement needs the FDA disclaimer when its label or labeling carries a statement made under FD&C Act section 403(r)(6), such as a structure/function claim, and the firm wants to rely on 403(r)(6) to keep that statement from making the product a drug under section 201(g)(1)(C) ^[1]. The rule is 21 CFR 101.93.

What triggers it

• Under 101.93(f), labels and labeling may describe how a nutrient or dietary ingredient is intended to affect the structure or function of the body in humans, or the documented mechanism by which it maintains that structure or function. This is allowed only if the statement is not a disease claim and the product meets paragraphs (a) to (e), which include the disclaimer ^[2].
• The disclaimer does not cover a disease claim. If a supplement's labeling makes a disease claim, the product "will be subject to regulation as a drug" unless the claim is an authorized health claim the product qualifies for ^[2].
• A statement is a disease claim if it says, openly or by implication, that the product does any of the following:
  • affects a specific disease, or its characteristic signs or symptoms ^[3][4]
  • substitutes for a disease therapy ^[5]
  • "augments a particular therapy or drug action" ^[6]
• The product name, pictures or symbols can also make a claim a disease claim ^[7][8].
• Classical nutrient deficiency diseases (for example scurvy, pellagra) are outside the disease-claim definition ^[9][10].

Required wording (101.93(c))

• One statement: "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." ^[11]
• More than one statement: each statement carries the single disclaimer, or you can use one plural version: "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." ^[12]

Placement and type size (101.93(d) and (e))

• The disclaimer "shall be placed" right next to the statement with nothing in between, or linked to it by a symbol (for example an asterisk) at the end of each statement.
• It "shall appear on each panel or page" where such a statement appears, on labels and in labeling such as pamphlets and catalogs.
• When it is not next to the statement, it "shall be set off in a box" ^[13].
• It must be in boldface type no smaller than one-sixteenth inch ^[14].

Notifying FDA (101.93(a))

• The manufacturer, packer or distributor "shall notify" FDA's Office of Dietary Supplement Programs no later than 30 days after the product bearing the statement is first marketed. The notice goes as an original plus two copies ^[15].
• It must give the firm's name and address, the text of the statement, the ingredient or supplement the statement is about, and the product's name including brand ^{[16][17][18][19]}.
• A responsible individual must sign it and certify that the firm has substantiation that the statement is truthful and not misleading ^[20].

Approach: I searched the current eCFR text of 21 CFR Part 101, section 101.93. I couldn't open the statute itself (21 U.S.C. 343(r)(6) on the US Code site), so its full list of claim types that need the disclaimer is not quoted here.