Supplements and the FDA

Congress defined the term “dietary supplement” in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of “foods,” not drugs, and requires that every supplement be labeled a dietary supplement.

What is a “new dietary ingredient” in a dietary supplement?

The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined both of the terms “dietary ingredient” and “new dietary ingredient” as components of dietary supplements. In order for an ingredient of a dietary supplement to be a “dietary ingredient,” it must be one or any combination of the following substances:

  • a vitamin,
  • a mineral,
  • an herb or other botanical,
  • an amino acid,
  • a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or
  • a concentrate, metabolite, constituent or extract.

What is FDA’s role in regulating dietary supplements versus the manufacturer’s responsibility for marketing them?

In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements.

All manufacturers need to register themselves pursuant to the Bioterrorism Act with FDA before producing or selling supplements. In June, 2007, FDA published comprehensive regulations for Current Good Manufacturing Practices for those who manufacture, package or hold dietary supplement products. (SeeCurrent Good Manufacturing Practices (CGMPs) – Dietary Supplements) These regulations focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements.

When must a manufacturer or distributor notify FDA about a dietary supplement it intends to market in the U.S.?

The Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor notify FDA if it intends to market a dietary supplement in the U.S. that contains a “new dietary ingredient.” The manufacturer (and distributor) must demonstrate to FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply.

What information must the manufacturer disclose on the label of a dietary supplement?

FDA regulations require that certain information appear on dietary supplement labels. Information that must be on a dietary supplement label includes: a descriptive name of the product stating that it is a “supplement;” the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product.

Must all ingredients be declared on the label of a dietary supplement?

Yes, ingredients not listed on the “Supplement Facts” panel must be listed in the “other ingredient” statement beneath the panel. The types of ingredients listed there could include the source of dietary ingredients.

Are dietary supplement serving sizes standardized or are there restrictions on the amount of a nutrient that can be in one serving?

Other than the manufacturer’s responsibility to ensure safety, there are no rules that limit a serving size or the amount of a nutrient in any form of dietary supplements. This decision is made by the manufacturer and does not require FDA review or approval.

What is FDA’s oversight responsibility for dietary supplements?

Because dietary supplements are under the “umbrella” of foods, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency’s oversight of these products. FDA’s efforts to monitor the marketplace for potential illegal products (that is, products that may be unsafe or make false or misleading claims) include obtaining information from inspections of dietary supplement manufacturers and distributors, the Internet, consumer and trade complaints, occasional laboratory analyses of selected products, and adverse events associated with the use of supplements that are reported to the agency.

Does FDA routinely analyze the content of dietary supplements?

In that FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law. The remaining funds are used for routine monitoring of products pulled from store shelves or collected during inspections of manufacturing firms. The agency does not analyze dietary supplements before they are sold to consumers. The manufacturer is responsible for ensuring that the “Supplement Facts” label and ingredient list are accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label. FDA does not have resources to analyze dietary supplements sent to the agency by consumers who want to know their content. Instead, consumers may contact the manufacturer or a commercial laboratory for an analysis of the content.

Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?

No, a product sold as a dietary supplement and promoted on its label or in labeling* as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved–and thus illegal–drug. To maintain the product’s status as a dietary supplement, the label and labeling must be consistent with the provisions in the Dietary Supplement Health and Education Act (DSHEA) of 1994.

*Labeling refers to the label as well as accompanying material that is used by a manufacturer to promote and market a specific product.

Who validates claims and what kinds of claims can be made on dietary supplement labels?

FDA receives many consumer inquiries about the validity of claims for dietary supplements, including product labels, advertisements, media, and printed materials. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, and, in the case of advertising, with the Federal Trade Commission.

By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims. Some of these claims describe: the link between a food substance and disease or a health-related condition; the intended benefits of using the product; or the amount of a nutrient or dietary substance in a product. Different requirements generally apply to each type of claim, and are described in more detail.

Why do some supplements have wording (a disclaimer) that says: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease”?

This statement or “disclaimer” is required by law (DSHEA) when a manufacturer makes a structure/function claim on a dietary supplement label. In general, these claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not approved by FDA. For this reason, the law says that if a dietary supplement label includes such a claim, it must state in a “disclaimer” that FDA has not evaluated this claim. The disclaimer must also state that this product is not intended to “diagnose, treat, cure or prevent any disease,” because only a drug can legally make such a claim.

How are advertisements for dietary supplements regulated?

The Federal Trade Commission (FTC) regulates advertising, including infomercials, for dietary supplements and most other products sold to consumers. FDA works closely with FTC in this area, but FTC’s work is directed by different laws. For more information on FTC, go to the FTC web site. Advertising and promotional material received in the mail are also regulated under different laws and are subject to regulation by the U.S. Postal Inspection Service.

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