Effect of DSHEA on FDA Dietary Supplement Regulation | Steve Leuck, PharmD | RxEconsult

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Dietary Supplement, Vitamin, or Quack Category: Diet & Weight Loss by - March 29, 2013 | Views: 30616 | Likes: 0 | Comment: 0  

Vitamins, Dietary Supplements

The Truth about Advertising Claims for Vitamins and Dietary Supplements

Have you ever seen an old movie where a slick gentleman rides into town in a covered wagon and sets up shop near the town square? He creates a stage in front of his wagon and then begins his sales call. He has this fabulous “tincture of something” where he claims that it will treat pain, nerves, your heart and maybe even cancer. Who was regulating what he was selling? More importantly, if he came into town today, who would be regulating him? Based on current law, as long as he has permits and uses the appropriate terminology, he would be allowed to sell all he wants―even if it is quack. He could continue until the FDA stumbles upon his quack product and then evaluates its safety and efficacy to see if the product is safe to take and is doing what it is advertised to do.

This had been a concern that was noted and in the early 1990s, Congress set out to attempt to place some limitations and safety guidelines on the sale of dietary supplements. They wanted to help the consumers by decreasing fraudulent advertising. Congress had a plan to limit false advertising claims and increase labeling requirements on dietary supplements. The health and food industry, with its incredible lobbying power, heard about this impending regulation and created a national scare. At this point, the health food industry convinced the public that it was the plan of Congress to limit the ability to purchase vitamins.

This scare prompted so many letters from individuals to congressmen that the restrictive guidelines and dietary supplement laws were changed. The Dietary Supplement Health & Education Act (DSHEA) of 1994 was the compromise that passed Congress. In a nutshell, this states that dietary supplements cannot be advertised with unsubstantiated drug claims listed on the label. This also states that the label cannot state that a particular product is intended for the prevention or treatment of disease.

In my opinion, here are the problems with the DSHEA:

The dietary supplement law does not exclude herbs, botanicals, metabolites, extracts, amino acids, or any combination of the above. The original intent was to define dietary supplements as nutrients provided to replace nutrients that are missing from the diet.

Even though the advertising cannot include cures or treatments, it may include terms such as support (i.e., this item has been shown to support a healthy immune system, or this item supports super brain function, etc.)

Before marketing and selling, the company does not need to get approval from the FDA showing that it does what it says it does. It is up to the FDA to search for products being marketed, test them, and then force them off the market if they are advertised inappropriately. This allows for companies to advertise new products however they want. If they get caught by the FDA, they need to remove it from the market, however; they can then reformulate the packaging and sell it again under a new label.

The FDA is not able to take a product off the market that has been proven to be useless, yet not harmful. A company may still sell it with claims that it “may support certain disease states”.

Products that are similar in structure to illicit street drugs may be marketed as dietary supplements without FDA approval. The product will be on the market until the FDA finds out about it, tests it, and then bans it.

The “burden of proof” lies within the FDA, not the manufacturer or advertiser who is selling the dietary supplement.

Prior to The Dietary Supplement and Non Prescription Drug Consumer Protection Act of 2006, manufacturers were not required to report any serious adverse reactions or deaths related to their product. How can an industry have so much lobbying power that they were able to prevent this for such a long time?

“The FDA has never had enough resources to cope with the enormous amount of deception in the supplement and health-food marketplace. DSHEA has made the problem worse. If I were FDA Commissioner, I would drop any pretense of being able to protect the public. Instead, I would announce that unless Congress provides an adequate law, the FDA cannot protect the public from the deceptive marketing of what DSHEA calls dietary supplements.” Stephen Barrett, MD

Helpful Resources

National Institute of health: Dietary Supplements

How the Dietary Supplement Health and Education Act of 1994 Weakened the FDA, by Stephen Barrett, M.D.


About The Author

Dr. Steve Leuck is currently a community pharmacist in a hospital out-patient pharmacy, where he educates and motivates patients to participate in their own pharmaceutical care. He is also owner of AudibleRxTM where OBRA 90 based Medication Specific Counseling SessionsTM are available in audio format.


This medication summary is for information only and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.


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