FDA Issues "Final Rule" to Regulate Safety of Dietary Supplements

According to its website www.fda.org, on June 22, the FDA announced the establishment of a "final rule" establishing current good manufacturing practice requirements (CGMPs) for dietary supplements. According to Robert E. Brackett, PhD, Director of FDA's Center for Food Safety and Applied Nutrition, "The dietary supplement CGMPs should increase consumers' confidence in the quality of the dietary supplement products that they purchase. These regulations provide more accountability in the manufacturing process so that consumers can be confident that the products they purchase contain what is on the label."

The FDA's website explains that the final rule ensures that supplements will not have "wrong ingredients, too much or too little of a dietary ingredient, improper packaging, improper labeling, contamination problems due to natural toxins, or bacteria, pesticides, glass, lead, or other substances."

The final rule is an attempt to shore up some deficiencies of the Dietary Supplement Health and Education Act of 1994 (DSHEA). DSHEA established that dietary supplements, unlike new drugs, don't have to go through review by FDA for safety and efficacy prior to being marketed. In an interview on abcnews.com, Vasilios Frankos, division director of the office of dietary supplements at the FDA, explained that "[The final rule] tries to be more specific about regulating the processes used to make diet supplements, which are quite different from the way you process food."

Experts see the rule as a positive step, but remain skeptical about the FDA's ability to enforce the new regulations. ABCnews.com cites Keith Ayoob, associate professor of pediatrics at Albert Einstein College of Medicine, who states "The ruling is appropriate, but it will just be a paper tiger if there is no FDA staff to monitor things. The big pharm companies that do supplements will be compliant. The ones I'm more worried about are the fringe companies that produce nothing but supplements. ... If they get caught, they'll just fold up shop and reopen under another name."

In addition, many note that the final rule does not address the effectiveness of dietary supplements. ABCnews.com quotes Dr. Jerry Avorn, chief of pharmacoepidemiology and pharmacoeconomics at Brigham and Women's Hospital, who says it best: "Knowing you have pure and well-made useless crap is a little better than having impure useless crap, but not by much."

Finally, the new regulations do not change how the FDA monitors the safety of dietary supplements. With new drugs, the pharmaceutical companies are responsible for demonstrating the safety of the drug. However, in the case of dietary supplements, the FDA has the responsibility of proving that the drug is unsafe before it is pulled.

Sources:

http://www.abcnews.go.com/Health/Story?id=3307441&page=2

http://www.fda.gov/consumer/updates/dietarysupps062207.html