The Dietary Supplement Health and Education Act (DSHEA) states that the Food and Drug Administration (FDA) is not authorized to approve dietary supplements for their safety and effectiveness before they are marketed. This means that in many cases, companies can legally introduce dietary supplements to the market without notifying the FDA. Since the DSHEA was passed, the dietary supplement industry has grown exponentially. Manufacturers are responsible for adhering to safety regulations and labeling requirements of dietary supplements, as well as complying with current good manufacturing standards.
There are no laws or regulations that limit the serving size of a dietary supplement or the amount of a dietary ingredient that a serving of a dietary supplement can contain. This decision is made by the manufacturer and does not require FDA approval. Ingredients that are not listed in the supplement information panel should be included in the list of other ingredients below. Class I devices, which present a low risk of harm to the user (e.g., non-motorized breast pumps, elastic bandages, lingual depressants, and exam gloves), are subject to general controls only and most are exempt from pre-market notification requirements.
Additionally, any statement about food products must be truthful and not misleading, and must meet the regulatory requirements for the type of statement, as appropriate. Dietary supplements, like conventional foods, can make other labeling claims that are not defined by law or regulation (e.g., by law, the FDA does not approve dietary supplements or their labeling, although certain types of claims that are sometimes used in the labeling of dietary supplements require pre-marketing review and authorization). The FDA recommends that consumers consult with a health professional before deciding to take a dietary supplement. The Federal Trade Commission (FTC) regulates advertising, including infomercials, of dietary supplements.
If you have purchased supplements and noticed this statement on the label, it means that the Food and Drug Administration has not evaluated these claims. Consequently, DSHEA requires that when the label of a dietary supplement or other label includes such a claim, it must be accompanied by a disclaimer informing consumers that the FDA has not evaluated the claim.
