Definition of Dietary Supplement
A dietary supplement:
- is intended to supplement the diet;
- bears or contains:
- a vitamin;
- a mineral;
- an herb or other botanical;
- an amino acid;
- a dietary substance to supplement the diet by increasing total dietary intake; and/or
- a concentrate, metabolite, constituent, extract, or combination of any of the above;
- is intended for ingestion as a tablet, capsule, powder, softgel, gelcap, or liquid;
- is not represented as a conventional food or as the sole item of a meal or of the diet; and
- is labeled as a dietary supplement;
- can be an approved new drug or biologic that was marketed as a dietary supplement or a food prior to approval, unless FDA by regulation finds the product to be unsafe as a dietary supplement; but
- cannot be an approved new drug or biologic (or a new drug or biologic under an IND for which clinical investigations have been instituted and publicized) that was not previously marketed as a dietary supplement or a food, unless FDA issues regulations finding its use as a dietary supplement to be lawful.
Safety of Dietary Supplements
- A dietary supplement is adulterated if:
- it presents a significant or unreasonable risk of illness or injury under labeled conditions of use, or under ordinary conditions of use if none are recommended in the labeling;
- it contains a dietary ingredient not marketed in the United States before October 15, 1994 for which there is inadequate information to provide a reasonable assurance of no significant or unreasonable risk of illness or injury;
- the Secretary of HHS declares it to pose an imminent hazard to public health or safety (promptly followed by a formal rulemaking to affirm or withdraw the declaration); or
- it bears or contains any “poisonous or deleterious substance which may render it injurious to health” under labeled conditions of use.
- The government bears the burden of proof in any action against a dietary supplement on the ground that it is adulterated.
- FDA must give a potential defendant at least 10 days notice and an opportunity to respond before asking a U.S. Attorney to undertake a civil proceeding on the ground that a dietary supplement presents a significant or unreasonable risk of illness or injury under labeled conditions of use.
“Labeling” Exemption
- A publication (including an article, book chapter, or official abstract of a peer-reviewed scientific publication) that is reprinted in its entirety will not be “labeling” when used in connection with the sale of a dietary supplement to consumers as long as it:
- is not false or misleading;
- does not promote a particular manufacturer or brand;
- is displayed so as to present a balanced view of the relevant scientific information;
- is physically separate from the dietary supplement to which it relates; and
- does not have any other information appended to it.
Claims
- A statement that:
- claims a benefit related to a “classical nutrient deficiency disease” and discloses the prevalence of such disease in the United States;
- describes the role of a nutrient or dietary ingredient “intended to affect the structure or function in humans;”
- characterizes the “documented mechanism” by which such nutrient or dietary ingredient acts to maintain such structure or function; or
- describes “general well-being” from consumption of a nutrient or dietary ingredient,
may be made for a dietary supplement if:
- the manufacturer of the supplement “has substantiation that such statement is truthful and not misleading;” and
- the statement contains, “prominently displayed and in boldface type,” the words: “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.”
- None of the above statements may claim to diagnose, mitigate, treat, cure, or prevent a specific disease.
- A manufacturer who proposes to make one of the above statements in the labeling of a dietary supplement must notify FDA that the statement is being made within 30 days after the first marketing of the dietary supplement with that statement.
- A dietary supplement for which one of the above statements is made is not a drug under the “structure or function” test of section 201(g) of the Act solely because its labeling contains such a claim.
Dietary Supplement Labeling
The label or labeling of a dietary supplement must:
- list the name and quantity of each vitamin, mineral, herb or botanical, amino acid, dietary substance, or concentrate, metabolite, constituent, extract, or combination of any of these, including an identification of any part of the plant from which an herb or botanical is derived; and
- identify the product by the term “dietary supplement”; and
The supplement itself:
- must conform to the specifications of any official compendium to which it is claimed to conform; or
- if not covered by an official compendium, must have the identity and strength it is claimed to have, or meet the quality, purity, or compositional specifications it is claimed to meet.
- Dietary supplement labeling is to comply with nutrition labeling requirements “in a manner which is appropriate for the product” as specified in FDA regulations, which must provide that:
- the supplement’s nutrition information must first list those ingredients that are present “in a significant amount” and for which FDA has established an RDI or DRV;
- the list of ingredients must include the quantity of each such ingredient per serving; and
- the list of ingredients may include the source of an ingredient.
- A dietary supplement is not to be deemed misbranded solely because its labeling contains directions or warnings.
- The DSHEA labeling rules may be followed as of the date of enactment of DSHEA (10/25/94), and must be followed after December 31, 1996.
New Dietary Ingredients
A dietary supplement containing an ingredient not marketed in the United States before October 15, 1994 is adulterated unless:
- it contains only ingredients that have been present in the food supply as an article used for food in a form that has not been chemically altered, or
- there is evidence establishing that the supplement, when used as directed, will “reasonably by expected to be safe,” and the manufacturer, as least 75 days before marketing the product, provides FDA with information on the basis of which the manufacturer has concluded that the dietary supplement will reasonably be expected to be safe.
GMPs
- FDA may issue regulations establishing GMP requirements for dietary supplements.
- Those regulations must be “modeled after” current GMP regulations for food and “may not impose standards for which there is no current and generally available analytical methodology.”
- Dietary supplements “prepared, packed, or held” under conditions that do not meet such GMP regulations will be adulterated.
New Government Bodies
- A new independent executive branch agency called the Commission on Dietary Supplement Labels is established.
- This Commission is to conduct a study on, and provide recommendations for, regulating label claims for dietary supplements.
- A final report including those recommendations is to be completed by October 25, 1996.
- Within 90 days of completion of that report, FDA is to publish a notice of the Commission’s recommendations for changes in relevant FDA regulations, together with a notice of proposed rulemaking on such changes.
- That rulemaking must be completed no later than two years after the completion of the Commission’s report. If it is not, the existing FDA regulations on health claims for dietary supplements will go out of effect.
- In addition, a new Office of Dietary Supplements is established within NIH, with the function of coordinating research and advising senior health officials on dietary supplement issues.