Home | Jobs | News & Articles | Job Advice | Search | Protocols | Fun | @RealLabRat
Lab Rat with DNA

Post your resume
Candidates - post your resume

Search job listings
Candidates - search biotech jobs

Post job openings
Employers - post job openings

Email Login
New users
sign up!
HOME > Review > Supplements - snake oil or good for you?
Supplements - Snake oil or good for you?

As I was getting this article ready GNC pulled ephedra containing products: "We believe that ephedra-based products are safe when used as directed," GNC President and Chief Executive Michael Meyers said. "Nonetheless, the current business climate dictates that we move in a different direction."

Congressional action

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.

President Clinton's statement regarding signing of the DSHEA: "After several years of intense efforts, manufacturers, experts in nutrition, and legislators-- acting in a conscientious alliance with consumers at the grassroots level-- have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law." The White House press release concluded by saying "in an era of greater consciousness among people about the impact of what they eat on how they live and how long they live, it is appropriate that we have finally reformed the way Government treats consumers and supplements in a way that encourages good health."

theLabRat notes that herbs are not consumed for a nutritional purpose and often are marketed with therapeutic claims.

What was the fallout?

Innocent until proven guilty: While the FDA can pull drugs that are harmful, it has no mechanism to pull drugs for no efficacy. This has led to a number of useless supplements that make veiled or sometimes bold claims of efficacy (such as increasing the size of body parts). U.S. congressional investigators said they could not directly establish a link between ephedra and reported health problems, including heart attacks, seizures, strokes and deaths. But the U.S. Food and Drug Administration has proposed a tough new label for ephedra products that warns about potential side effects. Herein lies a good part of the problem - unless these products are a part of a controlled study, it is very difficult to make a direct link between a pharmaceutical product and an adverse drug reaction.

The Bad: There were too many ways this process can be abused. If a new dietary supplement ingredient is introduced, the manufacturer must have evidence of safety and must supply this evidence to FDA 75 days before marketing the product. This evidence is usually much less than is required for a pharmaceutical. Obviously ephedra is a good indication of how drugs can fall through the system.

The Good: In the past, FDA has repeatedly attempted to define dietary supplements as drugs or food additives and subsequently remove them from the market. The legislation makes it clear that these products may not be regulated as food additives or drugs under most circumstances.

Pharmaceuticals making the transition to Supplements?

One trend seen of late is when pharmaceuticals enter clinical trials and then exit to emerge as supplements. The usual claim is that the trials were of poor design or other issues prevented the FDA from approving our drug, but we are proud to offer it as a supplement. I guess this is a little better, since there is some rigorous safety testing, but the potential for misuse here is enormous...

What should be done?

theLabRat's opinion: At a minimum supplements that are not a normal part of a diet should have to go through a trial similar to a Phase I clinical trial (dose escalation) and not allowed to put claims on the labels unless they prove efficacy in a controlled study.

Good sites for more information:

QuackWatch: http://www.quackwatch.org/index.html

Public Citizen: http://www.citizen.org/hrg/drugs/articles.cfm?ID=5195


theLabRat.com 2005. All Rights Reserved.