Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -112

Accepted - Volume 298

Comment Record
Commentor Dr. Dyan Kaufman Date/Time 2003-03-07 17:30:43
Organization The Wellness Group
Category Individual

Comments for FDA General
Questions
1. General Comments Dyan S. Kaufman, PhD 1209 Manhattan Avenue Manhattan Beach, CA 90266 Gentlemen: I agree that nutritional products should be regulated. There are many unscrupulous companies that are only interested in profit. Certainly where the public’s health is concerned, there needs to be enforced guidelines. In May of 1998 I had a burst appendix and had 6 feet of my small intestine and 6 inches of my large intestine removed. At that time I found my days shortened to 7 PM instead of my usual 10 or 11PM. I am a single mother and simply had no energy to work and do what I needed to do to care for myself and my children. I began using the product “Biolean”. Biolean has a mere 25 mg of ephedra in the morning dose and 12.5 mg of ephedra in the afternoon dose — just ¼ the recommended daily dosage the FDA lists. Biolean is in the Physician’s Desk Reference for Nonprescription Drugs (the Bible for doctors, pharmacists and insurance companies) and is being used in a double blind study at Johns Hopkins Hospital. Biolean gives me the energy I need, keeps me detoxed and helps me utilize my nutrition. The product gives me a normal life. I have recaptured my evenings. Although I did not need to loose weight, as a side effect, I did loose fat while maintaining good muscle mass — something every woman wants. The only negative side effect I have had is a slightly dry mouth when I don’t drink water. My children and over a hundred of my patients and friends have used the Biolean products with good effects. If taken too late in the day, some patients said they had so much energy and focus they went to bed later than usual but did not report tiredness the next day. The RAND report confirms the safety of ephedra products if used properly. Any product has detrimental effects if used to excess or improperly – certainly we have seen that with many pharmaceutical and recreational drugs. Alcohol and cigarettes are legal and lethal. Even Tylenol is lethal if you take more than 8 tablets in one day and any child can purchase Tylenol. I believe the makers of Biolean sought to get their products in the PDR to guarantee quality and consistency of their products and to promote honestly in labeling with full disclosure. Biolean’s label is much more extensive that the FDA requires even suggesting a physician review the user’s health history and product ingredients to make sure there are no contraindications in their use of Biolean. Clearly, the other ephedra products on the market are quite different with their ephedra content ranging from 75% to 95% of either plain ephedra or an ephedra/caffeine combination. In fact, the ephedra accounts for only a tiny fraction of the total formula and Biolean has only 10 mg of green tea caffeine which is water-soluble. I would urge you to support legislation to regulate the quality of supplements available over-the-counter by encouraging the companies use FDA approved pharmaceutical laboratories and have truth in labeling and advertising. I would also encourage you to protect my rights as an individual to purchase these products by keeping ephedra available to the public in the correct dosages for optimum health. Sincerely, Dyan S. Kaufman, PhD




EC -112