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What claims can manufacturers make for dietary supplements and drugs?

The types of claims that can be made on the labels of dietary supplements and drugs differ. Drug manufacturers may claim that their product will diagnose, cure, mitigate, treat, or prevent a disease. Such claims may not legally be made for dietary supplements.

The label of a dietary supplement or food product may contain one of three types of claims: a health claim, nutrient content claim, or structure/function claim. Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition. Nutrient content claims describe the relative amount of a nutrient or dietary substance in a product. A structure/function claim is a statement describing how a product may affect the organs or systems of the body and it can not mention any specific disease. Structure/function claims do not require FDA approval but the manufacturer must provide FDA with the text of the claim within 30 days of putting the product on the market. What Is The Best Fat Burning Weight Loss Pills  Product labels containing such claims must also include a disclaimer that reads, “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”

How does FDA regulate dietary supplements?

In addition to regulating label claims, FDA regulates dietary supplements in other ways. Supplement ingredients sold in the United States before October 15, 1994, are not required to be reviewed by FDA for their safety before they are marketed because they are presumed to be safe based on their history of use by humans. For a new dietary ingredient (one not sold as a dietary supplement before 1994) the manufacturer must notify FDA of its intent to market a dietary supplement containing the new dietary ingredient and provide information on how it determined that reasonable evidence exists for safe human use of the product. FDA can either refuse to allow new ingredients into or remove existing ingredients from the marketplace for safety reasons.

Unlike drug products, there are no provisions in the law for FDA to “approve” dietary supplements for safety or effectiveness before they reach the consumer.Which Is The Best Weight Loss Pill That Burns Fat While You Sleep  Once a dietary supplement is marketed, FDA has to prove that the product is not safe in order to restrict its use or remove it from the market. In contrast, before being allowed to market a drug product, manufacturers must obtain FDA approval by providing convincing evidence that it is both safe and effective.

The label of a dietary supplement product is required to be truthful and not misleading. If the label does not meet this requirement, FDA may remove the product from the marketplace or take other appropriate actions.

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