In 1994, Congress enacted the Dietary Supplement Health and Education Act (DSHEA). This act allows for the marketing and sales of “dietary supplements” with little or no regulation. This act is the work of folks like Tom Harkin (who took large contributions from Herbalife) and Orrin Hatch, whose state of Utah is home to many supplement companies.

DSHEA has a couple of very important consequences (aside from filling the pockets of supplement makers).

What does the FDA require of “supplements”?

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.* Manufacturers must make sure that product label information is truthful and not misleading.

To paraphrase: “sell whatever you want, just don’t let us catch you.”

What’s more frightening than this inexcusable lack of oversight is that many of the products marketed under DSHEA aren’t just vitamins and such, but products that claim to do the same things as real medicines. How do they get away with that?

By using the Quack Miranda Warning, that’s how. Anyone who lives in the States knows this one almost as well as the “real” Miranda warning:

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

I put in the asterisk because there’s always an asterisk. The warning always appears at the bottom of a back page in very fine print. This statement is required when making any clinical claims regarding a product, and it is up to the manufacturer to make sure all claims are true.

Here’s the thing: many products covered by DSHEA are, by their advertising, clearly “intended to diagnose, treat, cure or prevent…disease.”

Googling the warning itself is a great way to hunt for quackery. I did just such a search recently and came up with PectaSol. It’s hard to tell from the ad who exactly is making these claims: the maker of the product, the online store selling it, or both. Either way, here are some of the claims:

  • enhance your immune system function, especially if you have a chronic disease
  • maintain your optimal health by removing toxic and radioactive metals in your body
  • slow down the doubling time of your PSA (male prostate) levels when cancer is present
  • help prevent aberrant cells from adhering to your critical organs and tissues like the prostate, breast, colon, lymphatic system, skin, brain and larynx
  • promote normal cholesterol levels
  • take a supplement that has been successfully clinically tested
  • shown to reduce your total body burden of toxicity from Mercury by up to 70% in six months when consuming 15 grams of PectaSol per day

If you follow the link that purports to support their claim of “clinically tested”, a blank page is all you get.

Clearly, they are claiming to treat or prevent disease. What else could they mean by their claim about PSA or their claim about cholesterol? These statements may or may not adhere to the letter of the law, but what concerns me more is their adherence to the spirit of the law. DSHEA was created specifically to allow these companies to make claims that would otherwise be of questionable legality. DSHEA, as it was written and as it was intended facilitates the legal marketing of quackery.

This legislation must go. It’s dangerous and costly for consumers, and provides protection for business entities whose apparent purpose is to promote quackery for profit. The lawmakers behind this bill should be ashamed.


Posted by Peter Lipson

Peter A. Lipson, MD is a practicing internist and teaching physician in Southeast Michigan.  After graduating from Rush Medical College in Chicago, he completed his Internal Medicine residency at Northwestern Memorial Hospital. He currently maintains a private practice, and serves as a teaching physician at a large community hospital He also maintains appointments as a Clinical Assistant Professor of Medicine at Wayne State University School of Medicine and at Oakland University William Beaumont School of Medicine, the first being a large, established medical school, the latter being a newly-formed medical school which will soon be accepting its first class of students.  He blogs at White Coat Underground at the Scientopia blog network. A primary goal of his writing is to illuminate the differences between science-based medicine and everything else.  His perspective as a primary care physician and his daily interaction with real patients gives him what he hopes is special insight into the current "De-lightenment" in medicine.  As new media evolve, pseudo-scientific, deceptive, and immoral health practices become more and more available to patients, making his job all that much more difficult---and all that much more interesting. Disclaimer: The views in all of of Dr. Lipson's writing are his alone.  They do not represent in any way his practice, hospital, employers, or anyone else. Any medical information is general and should not be applied to specific personal medical decisions.  Any medical questions should be directed to your personal physician.  Dr. Lipson will not answer any specific medical questions, and any emails and comments should be assumed public. Dr. Lipson receives no compensation for his writing. Dr. Lipson's posts for Science-Based Medicine are archived here.