The FDA regulates dietary supplements as foods.
A company is accountable for ensuring that the dietary supplements it produces or distributes are not tampered with, misbranded, or in any other way in violation of federal law under the FD&C Act. When a manufacturer or distributor places a claim on the label of a dietary supplement about the effects on the structure or function of the human body, a benefit related to a classic nutrient deficiency disease, or a claim about general wellbeing, the company must have proof that the claim is accurate and not deceptive. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and its implementing regulations require facilities that produce, process, pack, or hold dietary supplements or dietary ingredients for consumption in the United States to register with the FDA before starting such operations. The FDA is in charge of upholding the rules and laws governing dietary supplements.
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