Articles of Interest Ad Hoc Committee Proves Safety of Dietary Supplements   For over three years, the Ad Hoc Committee for Dietary Supplement Safety has taken a leading role in opposing the non-science-based, and thus unreasonable, state and federal efforts to regulate dietary supplements made from the herbal plant ephedra. The following is a summary of the 103 page docket submitted by the committee to the FDA on December 2, 1997, in which extensive, well argued and science-based comments opposing the FDA’s unjust position are clearly stated. 1. Ephedra herb dietary supplements, containing 25 mg of 6-8% naturally occurring ephedrine alkaloids, have been consumed safely for decades in the United States and around the world. Numerous scientific reviews, clinical studies and animal tests show their safety at the usual single and daily doses.   A. Two independent reviews of the scientific literature of ephedra and its natural constituent ephedrine alkaloids, including a report by the Herb Research Foundation, conclude that ephedra herb dietary supplements are “as safe or safer that non-ephedra products available over the counter”. B. Two recent animal studies of ephedra in rats, mice and dogs found that herbal ephedra was safe when consumed in amounts equal to a single human dose of 200 or more tablets. A National Toxicology Program animal study of ephedrine alkaloids likewise found that the lethal level for rats was the equivalent of an average human consuming between 185 and 392 25-mg tablets in a single dose. These animal studies show that herbal ephedra “does not pose any unreasonable health risks to the general population.”   C. Data from the Texas Poison Prevention Bureau shows that a single dose of as much as 100 tablets of an ephedra herb product caused no permanent adverse effects. Infants who accidentally consumed dozens of ephedra herb tablets also suffered no ill effects. The Texas Department of Health has only 23 reports of alleged adverse events from consumption of ephedra herbs during 1995-1996, and most of these complaints lacked medical substantiation.   D. Preliminary results from two late 1997 human clinical trials of ephedra show no adverse effects whatsoever from 20-30 mg doses up to four times a day. 2. Ephedra herb products, containing 25 mg or less ephedrine alkaloids per serving, have never been reported anywhere in the scientific or medical literature to have caused death, stroke, heart attack, psychosis or other serious health effect. This is hardly surprising, given their long standing, widespread use in OTC consumer products.   A. FDA regulations (21 CFR 341.76) provide that ephedrine containing drug products are safe at single doses of 25 mg, up to six times per day, for use over an unlimited period of time. Anyone can purchase these 25 mg drug products at any time without a prescription. Since FDA has declared that 25 mg of synthetic ephedrine alkaloids are safe, it is biologically implausible that 8 mg of natural ephedrine alkaloids could be hazardous. B. Goodman & Gilman, the toxicology “Bible” used by every physician, states that ephedrine alkaloids are safe for use at doses of 25-50 mg, up to six times per day. C. In dozens of peer reviewed, carefully conducted studies of ephedra and ephedrine reported in the scientific literature, there is not a single report of any deat stroke, heart attack, seizure, psychotic episode or other serious acute effect resulting from consumption of the product at 25 mg or less.   3. Ephedra herb and its natural constituent ephedrine, when combined with caffeine, has been shown in more than 30 clinical studies to be effective as a weightloss product without producing toxic side effects. Excessive weight is a major public health problem in the United States. There is no question that, in effectively treating weight loss, ephedra herb products provide far more benefits than risks to Americans.   A. FDA has absolutely no data or evidence that the serious adverse events it describes occur more frequently in individuals consuming ephedra herb products than in the population at large, and thus might be caused by ephedra. FDA has never conducted an appropriate scientific study to compare the incidence of serious adverse events occurring in a control group that does not consume ephedra herb products, to a treatment group of individuals who do use these dietary supplements. Because DSHEA places on FDA the obligation to prove a dietary supplement is unsafe, it is FDA’s burden to conduct such appropriate studies before restricting ephedra herb products — not the industry’s burden to prove they are safe (although, of course, they are) before marketing them. B. Department of Health and Human Services data shows that emergency room admissions resulting from the consumption of various OTC products greatly exceed those reported for ephedrine alkaloids. For example, in the past three years, FDA claims to have 800 adverse incident reports on ephedra herb products. Yet HHS’s data shows that over a three-year period, there were over 93,000 hospital admissions for acetaminophen ingestion; 66,000 such admissions for aspirin consumption; 40,000 for ibuprofen; 19,000 for OTC sleep aid products; and more than 7,000 hospital admissions relating to the consumption of caffeine. Ephedrine-containing OTC drugs ranked 69th among all products sending people to the emergency room, and ephedra herb dietary supplements had too few reports to be ranked.   C. Prescription drug weightloss products and the OTC drug PPA — both approved by FDA as safe — have been implicated in far more identified adverse events, including deaths, than ephedra herbs. Thus, ephedra herb dietary supplements appear to be as effective as prescription and OTC weightloss products, much less expensive, and certainly safer.   4. FDA’s real target is the protections provided by DSHEA. No reasonable FDA regulator could regard ephedra herb supplements as hazardous at the 25 mg per dose level FDA has already found to be safe for the drug ephedrine. The addition of 40 mg caffeine, less than half a cup of coffee, could not possibly render ephedra herb products dangerous. A. FDA’s ephedra herb proposal creates a brand new section of its regulations, Part 111D, which it entitles “Restrictions on Dietary Supplements.” FDA’s plan is to extend those restrictions to other herbal and botanical ingredients. B. DSHEA provides that a dietary supplement is hazardous only if it creates a “substantial or unreasonable risk” at the labeled dosage. FDA’s proposal admits there were only 13 cases of alleged injury at consumption below 20 mg. That is neither substantial nor unreasonable.     5. There is simply no valid scientific basis to support a finding that ephedra herb products are hazardous at single doses of 8 mg or more; that consumption of low doses of ephedra alkaloids for more than seven days is hazardous; or that the combination of up to 25 mg ephedra alkaloids with small amounts of caffeine (less than the caffeine in one cup of coffee) is hazardous. A. The limitation on single dosages to less than 8 mg of ephedrine alkaloids (no more than 24 mg total per day) has no substantiated scientific or medical basis. FDA has approved a single dosage of 25 mg of ephedrine alkaloids as safe for decades, and there is no evidence whatsoever that natural herbal ephedra is more hazardous than the synthetic drug form. In fact, according to four different distinguished toxicologists who have reviewed the scientific literature, there are no reports of “adverse effects of ephedra … in the open medical or toxicologic literature of the 20th century.” (T.M. Farber, 1997). B. Plasma levels of ephedrine alkaloids stabilize between one and four days. Thereafter, they do not increase even though an individual continues to take the product. Thus, after four days, an adverse event is almost impossible. Any adverse event occurring later would presumably have another cause.   C. In clinical studies, combining caffeine with ephedrine did not increase the side effects. Indeed, caffeine reduced the sensation of racing heart that some subjects felt. Caffeine at the levels used in ephedra herb weight-loss products is unlikely to have the slightest effect on safety.     1 Supporting citations available. 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