Articles

DSHEA: a travesty of a mockery of a sham

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 in: Health Fraud, Herbs & Supplements, Politics and Regulation, Science and Medicine

Leave a Comment (15) ↓

15 thoughts on “DSHEA: a travesty of a mockery of a sham

  1. mattfenn says:

    I agree that the law is awful, but you can’t shine a light and shade the truth at the same time. Making it sound like it was only the evil Republicans who passed this law is an outright falsehood. Bill Clinton signed it into law and was extremely pleased with himself. This was bipartisanship at its best (and worst).

    “The initial sponsors of the Dietary Supplement Health and Education Act of 1994 were Senator Orrin Hatch (R-UT) and Congressman Bill Richardson (D-NM). At the time of final passage, the legislation had been cosponsored by 65 Senators and 261 members of the House of Representatives — almost two-thirds of the Senate and more than half of the House.”

    So, let’s heap the blame on everyone who deserves it. It makes a better argument.

  2. mattfenn says:

    And commenting on a blog also shows how a quick review of the facts make me look like a dope. Harkin is, of course, a Dem. My apologies!

  3. Versus says:

    Actually, the GAO and the FDA pretty much agree with you:

    “GAO recommends that the Secretary of Health and Human Services direct the Commissioner of the FDA to request additional authority [from Congress] to oversee dietary supplements, issue guidance on new dietary ingredients and to clarify the boundary between dietary supplements and foods with added dietary ingredients, and take steps to improve consumer understanding of dietary supplements. In commenting on this report, FDA generally agreed with GAO’s recommendations.”

    For the full report, see U.S. Government Accountability Office, GAO 09-250, “Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding,” January 29, 2009. http://www.gao.gov/products/GAO-09-250

  4. mckenzievmd says:

    Unfortunately, even with egregious violations of the weak consumer protections on supplements and other unapproved treatments, the FDA simply doesn’t have the resources to monitor the enormous CAM market. At a recent CE conference I stopped by the FDA booth to get clarification on the rules for treatment claims on the veterinary side, just to make sure all those quack websites I was thinking about reporting really were breaking the law. The FDA representative agreed the advertising I was concerned about was illegal, but made a point of telling me that the agency really only bothers going after large-scale operations because they don’t have the manpower to prsue quackery more aggressively. Obviously, this is even more of an issue for the veterinary part of the agency, but I imaginee it applies to quackery for humans as well.

    Brennen McKenzie
    http://ww.skeptvet.com
    http://skeptvet.com/Blog

  5. The Blind Watchmaker says:

    “promote normal cholesterol levels”….

    Well heck, I do that. I promote it and endorse it. But my promoting it doesn’t do anything to my cholesterol (and neither does Pectasol). To actually affect it, I must do other things.

    But that’s no fun. “Pectasol” is a cool name though.

  6. qetzal says:

    “Pectasol” sounds like something one might use to combat infestations by certain blog commenters.

  7. Gabor Hrasko says:

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

    You are not quite right. Ckick on the menus on the top – say “Video library”. The first item there is a text and video about how vaccines are dangerous.

    Even worst than if it would be empty…

  8. Scott says:

    “But my promoting it doesn’t do anything to my cholesterol (and neither does Pectasol).”

    Don’t be so sure of the latter. It’s somewhere between possible and likely that the stuff contains a statin.

  9. Joe says:

    @Scott on 21 Jul 2009 at 9:43 am “Don’t be so sure of the latter. It’s somewhere between possible and likely that the stuff contains a statin.”

    Reliable evidence?

  10. Joe says:

    I should add that if it contains a prescription drug it should be regulated like one.

  11. Scott says:

    “Reliable evidence?”

    Dr. Kroll posted an extensive discussion of the issue recently – see
    [url=http://www.sciencebasedmedicine.org/?p=457]here[/url].

    “I should add that if it contains a prescription drug it should be regulated like one.”

    Absolutely. But more broadly, if it contains a drug at all, it should be regulated like one. That’s the whole point of the post!

  12. Scott says:

    Sorry about the link – I need a preview!

    Try this.

  13. Joe says:

    @Scott on 21 Jul 2009 at 9:43 am

    Okay, I see you meant to imply that a statin found in pectasol would be an adulterant.

    @Scott on 21 Jul 2009 at 12:18 pm wrote “… more broadly, if [a supplement] contains a drug at all, it should be regulated like one.”

    You are right, thanks for pointing that out.

Comments are closed.