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What are the FTC guidelines?

FDA generally does not approve dietary supplement claims or other labeling before use. Under the FDC Act, a firm is responsible for ensuring that the dietary supplements it manufactures or distributes are not adulterated, misbranded, or otherwise in violation of federal law.

Do nutritional supplements need FDA approval?

While vitamins and nutritional or dietary supplements can be beneficial to your health, they can also involve health risks. Notably, the Food and Drug Administration (FDA) does not have the authority to review dietary supplement products for safety and effectiveness before they are marketed.

What are the FTC guidelines for dietary supplements?

The FTC typically requires claims about the efficacy or safety of dietary supplements to be supported with competent and reliable scientific evidence, defined in FTC cases as tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have been conducted

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

Either the manufacturer or distributor of a dietary supplement that contains an NDI, or the manufacturer or distributor of the NDI, must notify FDA at least 75 days before marketing the article in the United States, unless the NDI has been present in the food supply as an article used for food in a form in which the