As defined by the American Congress, the term “dietary supplement”, at its most basic, is a product that contains a “dietary ingredient” that is meant to supplement the diet without being the sole ingredient of it. It should be a product a person ingests by mouth. Any of these qualify under the “dietary ingredient” mentioned in the definition: minerals, herbs or other botanicals, amino acids and vitamins. Other substances such as organ tissues, enzymes, metabolites and glandulars also come under dietary ingredients.
Does the FDA regulate dietary supplements?
No. The FDA does not regulate dietary supplements, but has guidelines by which manufacturers have to ensure that the product is safe for use, does not make false or misleading claims, and complies with the FDA’s requirements in all other respects. However, the FDA does step in to handle cases where there are adverse events or other issues arising out of use of dietary supplements
In this sense, its oversight is vastly different from the regulation it does of pharmaceutical medicines and other healthcare products.FDA dietary supplements also require manufacturers to adhere to guidelines on labelling, which should contain mention of the ingredients in specific format.
Another important element of FDA rules on dietary supplements is that since dietary supplements are not medications per se but are supplements to diets; the FDA expects the user to use her or his discretion in using these. It also suggests that users take medical opinion before consuming FDA-regulated dietary supplements, as too much intake of nutrients can be detrimental to the user.
FDA dietary supplements emergency contact
FDA rule on dietary supplements has an FDA lifeline under the MedWatch program, to which people who experience serious adverse effect should report. They can call up FDA at 1-800-FDA-1088, or fax at 1-800-FDA-0178. They can also report online by visiting the FDA website.