© 2018 by Sanford Severin, MD

Dr. Sanford L. Severin

San Ramon, CA 94582 USA

trienergeticsblog@gmail.com

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Is there any Safety Monitoring of Dietary Supplements?

November 30, 2017

You should know the following if you are considering using a dietary supplement.

  • Federal law requires that every dietary supplement be labeled as such, either with the term "dietary supplement" or with a term that substitutes a description of the product's dietary ingredient(s) for the word "dietary" (e.g., "herbal supplement" or "calcium supplement").
     

  • Federal law does not require dietary supplements to be proven safe to FDA's satisfaction before they are marketed.
     

  • For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to FDA's satisfaction that the claim is accurate or truthful before it appears on the product.
     

  • In general, FDA's role with a dietary supplement product begins after the product enters the marketplace. That is usually the agency's first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.
     

  • Dietary supplement advertising, including ads broadcast on radio and television, falls under the jurisdiction of the Federal Trade Commission.
     

  • Once a dietary supplement is on the market, FDA has certain safety monitoring responsibilities. These include monitoring mandatory reporting of serious adverse events by dietary supplement firms and voluntary adverse event reporting by consumers and health care professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotion.
     

  • Dietary supplement firms must report to FDA any serious adverse events that are reported to them by consumers or health care professionals.
     

  • Dietary supplement manufacturers do not have to get the agency's approval before producing or selling these products.
     

  • It is not legal to market a dietary supplement product as a treatment or cure for a specific disease, or to alleviate the symptoms of a disease.
     

  • There are limitations to FDA oversight of claims in dietary supplement labeling. For example, FDA reviews substantiation for claims as resources permit.
     

  • Learn to spot false claims. If something sounds too good to be true, it probably is.

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