FDA Unveils List of Suspected Unlawful Ingredients in Dietary Supplements

FDA Unveils List of Suspected Unlawful Ingredients in Dietary Supplements (pewtrusts.org)

[PEW, 5/14/19]  The Food and Drug Administration unveiled a new effort last month to protect consumers from potentially unsafe dietary supplements that may contain unlawful ingredients.

The Dietary Supplement Ingredient Advisory List,

an online tool, alerts the public to chemical compounds that may not meet legal requirements for use in supplements.

Only substances that meet FDA’s definition of dietary ingredients can lawfully be included in supplements. But the process for making final determinations can take time, and consumers may unknowingly consume unlawful ingredients during that process. With the new list, FDA can flag suspect ingredients before a final decision.

Dietary supplements are regulated by FDA as a category of food.

Supplement manufacturers—unlike drug companies—do not need to prove that a product is safe and effective before marketing it, but there are rules about which ingredients can be included in supplements.

Qualified ingredients can be vitamins, herbs, botanicals, or amino acids, among other substances. To be considered lawful, older ingredients must have been in the food supply when the law that governs FDA authority over supplements was enacted in October 1994 and they cannot be chemically altered. On the other hand, manufacturers of any product that contains a new dietary ingredient that was not in the food supply at that time must demonstrate a history of use or other evidence that the ingredient “will be reasonably expected to be safe,” according to FDA standards.

Housed on the FDA website, the new list can be used by consumers who do not want to buy dietary supplements containing questionable substances as well as manufacturers eager to avoid including these ingredients in their products. The Council for Responsible Nutrition, a dietary supplement industry group, supports the approach, issuing a statement characterizing the tool “as a clear warning to bad actors in the fringes of our industry—the regulators are coming for you if you attempt to skirt the law.”……..


Read the Full Article at: PEW

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Jaelin Stickels, CNM, WHNP

Owner, SHEis & Holistic Heritage, Spring, TX

 

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