Dietary supplements, regulation and the FDA

by James Hubbard, M.D., M.P.H.

The FDA has put out a primer called FDA 101: Dietary Supplements. There is nothing new but loads of information you need to know. Supplements are defined as vitamin, mineral, herbal, botanical or amino acid products, or enzyme supplements. The thing is they are not regulated in the same way as medications

Some take-home messages from the report are:

  • Dietary supplements are not intended to treat, diagnose, cure, or alleviate the effects of diseases.
  • Using supplements improperly can be harmful. Taking a combination of supplements, using these products together with medicine, or substituting them in place of prescribed medicines could lead to harmful, even life-threatening, results.
  • Some supplements can have unwanted effects before, during, or after surgery. For example, bleeding is a potential side effect risk of garlic, ginkgo biloba, ginseng, and Vitamin E. In addition, kava and valerian act as sedatives and can increase the effects of anesthetics and other medications used during surgery. Before surgery, you should inform your health care professional about all the supplements you use.
  • 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.

This explains all of those wild claims in commercials. It is a pity that those ads, infomercials and the like that prey on the vulnerable and make it where you don’t know what to believe or whom. Supplements can be definitely be good. We know calcium and vitamin d prevent rickets and osteoporosis, folic acid taken during pregnancy helps prevent birth defects, etc. There are multiple other good uses. Just make sure you have good, reliable information that you can go back to when needed and buy reputable products. Take supplements seriously like the medications they potentially are.

What do you think about the regulation as it stands? Did you know the facts above? Should there be more oversight?

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6 Responses to “Dietary supplements, regulation and the FDA”

  1. Mark Salinas Says:

    A number of things that I was not aware of. I am wiser and more aware I thank you!

    Mark Salinass last blog post..Clear Food Choices

  2. cathy Says:

    Good to know. It’s easy to forget that the supplements can have unwanted side effects, and doctors don’t always think to ask what kind of supplements a patient is taking. I do wish that there was more oversight on supplements – especially since they can have serious consequences.

    cathys last blog post..HFCS-free bread and buns review

  3. James Hubbard, M.D., M.P.H. Says:

    Thanks Cathy and Mark,

    Some supplements have the same active ingredient as prescription meds, such as St. John’s Wort and red yeast rice. There is no standard for strength, quality or purity so “buyer beware”.

  4. lhubbard Says:

    This information is so important for all of us to know. I still find it hard to believe that supplements are so easily put on the market and they can almost make whatever claims they want until someone complains. Thank you for the rundown.

    Leigh Ann Hubbard
    Managing Editor
    James Hubbard’s My Family Doctor

  5. James Hubbard’s My Family Doctor Blog » Blog Archive » Is a product really FDA-approved? Some facts about how to know. Says:

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