FDA Dietary Supplements

FDA dietary supplements are vitamins and minerals and herbs. In October 1994, the Dietary Supplement Health and Education Act (DSHEA) became law with President Clinton’s signature. Prior to this, dietary supplements were subject to the same regulatory requirements as were other foods. The new law amended the Federal Food, Drug, and Cosmetic Act by creating a new regulatory framework for the safety and labeling of dietary supplements.

Under DSHEA, a company is responsible for determining that the dietary supplements it manufactures or distributes are safe. Any representations or claims made about them must be substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from the FDA before they are marketed.

Manufacturers need to register themselves with the FDA before producing or selling supplements. In June 2007, the FDA published comprehensive regulations for the Current Good Manufacturing Practices for those who manufacture, package, or hold dietary supplement products. These regulations focus on practices that ensure the identity, purity, quality, strength and composition of FDA dietary supplements.

Companies with more that 500 employees had until June 2008 to comply; companies with less than 500 employees had until June 2009 to comply, and companies with fewer than 20 employees had until June 2010 to comply with the new regulations. In addition to vitamins, minerals and herbs, a dietary supplement could also be:

• An amino acid
• Enzymes or tissues from organs or glands
• A concentrate, metabolite, constituent or extract

FDA regulations require that an FDA dietary supplement contain certain information on the dietary supplement label. Information that is mandatory includes:

• A descriptive name of the product stating it is a “supplement”
• The name and place of the:

o   Manufacturer

o   Packer

o   Distributor

• A complete list of ingredients
• Net contents of the product

In addition, each dietary supplement must have nutrition labeling in the form of a “Supplement Facts” panel. This label must identify each dietary ingredient contained in the product. 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 the dietary ingredients. An example is: rose hips as the source of vitamin C and technical additives such as gelatin, starch, colors, stabilizers, preservatives and flavors.

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 FDA approval. Since manufacturers and distributors do not need FDA approval, the FDA does not keep a list of manufacturers, distributors or the dietary supplement products that they sell.

By the statute (DSHEA), the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for the FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer. Under DSHEA, once the product is marketed, the FDA has the responsibility for showing that a dietary supplement is "unsafe," before it can take action to restrict the product's use or removal from the marketplace.

Manufacturers and distributors of dietary supplements must record, investigate and forward to FDA any reports they receive of serious adverse events associated with the use of their products that are reported to them directly. The FDA is able to evaluate these reports and any other adverse event information reported directly to them by healthcare providers or consumers to identify early signals that a product may present safety risks to consumers. Ephedra is an example of FDA action.

The FDA 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. The 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.

Frequently a dietary supplement will claim to affect the structure or function of the body. The law says that if a dietary supplement label includes such a claim, it must state in a "disclaimer" that the 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.

The Federal Trade Commission (FTC) regulates advertising, including infomercials, for dietary supplements and most other products sold to consumers. The FDA works closely with the FTC in this area, but different laws direct the FTC’s work.

FDA dietary supplements are under an extended arm of the FDA. Serious side effects can be reported using the MedWatch program described elsewhere on this web site.

Written by: Margaret Stenerson

10 16 2010