| Comment Record|
Ms. Susan Koppi ||
2003-04-04 14:42:11 |
The Endocrine Society |
| Comments for FDA General |
1. General Comments
Food and Drug Administration
Dockets Management Branch (HFA-305)
5630 Fishers Lane, rm.1061
Rockville, MD 20852
RE: Dietary Supplements Containing Ephedrine Alkaloids
On behalf of The Endocrine Society, I would ask that you review the following comments regarding the February 28, 2003 notice of the reopening of the comment period for the proposed rule entitled “Dietary Supplements Containing Ephedrine Alkaloids”. The Endocrine Society represents over 10,000 researchers and clinicians in the field of endocrinology and is committed to the dissemination of new knowledge leading to the research, prevention, treatment, and cure of disease. Many of our members see first hand the dangers of ephedrine use and we thank you for accepting further comments on this important issue.
The potential risks of ephedrine, the principle active alkaloid in ephedra, have been recognized by the FDA and the scientific community and have led to significant regulation in dosing and manufacturing practices because it is regulated as a drug. Scientific evidence is now being produced that revels similar health risks for ephedra, which is identified as a dietary supplement and subject to different regulatory standards under the Dietary Supplement Health and Education Act (DSHEA).
The RAND study , commissioned by the National Institutes of Health, reviewed recent evidence on the risks and benefits of ephedra and ephedrine. The study found limited evidence of an effect of ephedra on short-term weight loss, and minimal evidence of an effect on performance enhancement in certain physical activities. It also concluded that ephedra is associated with higher risks of mild to moderate side effects such as heart palpitations, psychiatric and upper gastrointestinal effects, and symptoms of autonomic hyperactivity such as tremor and insomnia, especially when it is taken with other stimulants.
This study provides the most compelling data to date that the claims of ephedra manufactures (weight loss and athletic performance enhancement) are misleading. The study further concluded that use of ephedra or ephedrine and caffeine is associated with increased risk of psychiatric, autonomic, or gastrointestinal symptoms, and heart palpitations. The Endocrine Society has reviewed this study and agrees that it presents adequate evidence to support further FDA regulation on ephedra use.
This study and others like it, coupled with recent high profile deaths associated with ephedra use, signal that further regulation of ephedra use is needed. To this end, The Endocrine Society supports the FDA’s proposed rule regarding warning statement for dietary supplements containing ephedrine alkaloids. This proposed warning label provides consumers with a fair assessment of the risks associated with the use of ephedrine alkaloids based on scientific data.
The Endocrine Society also supports the FDA’s efforts to contact ephedra manufactures to notify them that they are in violation of the Federal Food, Drug, and Cosmetic Act by making unsubstantiated claims on the benefits of ephedra use. Based on the current scientific data, claims of long-term weight loss and increase athletic ability cannot be supported.
The Society believes that this new scientific evidence is sufficient for new restrictions for products regulated under DSHEA. DSHEA severely ties the hands of the FDA and limits the regulatory body from restricting supplements such as ephedra even in the face of solid scientific evidence. However, DSHEA allows for regulation of dietary supplements if it “presents a significant or unreasonable risk of injury”. This implies that the FDA can assess whether or not a dietary supplements known or suspected risks outweigh its known or suspected benefits as applied to the claims a product makes under ordinary use.
The RAND study clearly shows that ephedra use does not support the claims of its manufactures; furthermore, its use can present adverse effects. Using the benefit claim vs. suspected risks template, The Endocrine Society feels that the FDA has clear authority to pursue further restrictive actions on ephedra use in the form of warning labels and product claim restrictions.
Perhaps the most important aspect to assess the risk associated with ephedra and other dietary supplements is to support further research on their effects. Given the current regulatory framework under DSHEA the burden of proof is on the Department of Health and Human Services (HHS), the FDA and the scientific community to prove that a dietary supplement presents a risk of illness or injury. As such, The Endocrine Society would encourage HHS to support increased research efforts and grant allotments on the effects / benefits of dietary supplements. This increase in resources and attention is needed given the fact that burden of proof for dietary supplement is for government to prove harm as opposed to drug regulation where the burden of research is on industry.
John D. Baxter, MD
President, The Endocrine Society