April 4, 2003 - CAOMA responds to the FDA's proposed new ephedra labeling standards.
Docket No. 095N--0304
BEFORE
THE UNITED STATES OF AMERICA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
COMMENTS OF THE
COUNCIL OF ACUPUNCTURE AND ORIENTAL MEDICINE ASSOCIATIONS
AND THE
CHINESE HERBAL MEDICINE COALITION
ON THE PROPOSED RULE FOR
DIETARY SUPPLEMENTS CONTAINING EPHEDRA ALKALOIDS
UPON THE REOPENING OF THE COMMENT PERIOD
April 4, 2003
The Council of Acupuncture and Oriental Medicine Associations is the largest representative organization for professionally licensed practitioners of traditional oriental medicine who are specifically trained, examined, and licensed to prescribe and dispense dietary supplements, herbs, plant, animal, and mineral products that are not dangerous drugs or controlled substances. We have previously commented on legislation that would regulate the packaging and labeling of products containing ephedrine alkaloids, and also submitted comments to the FDA on the original 1997 proposal. In response to our testimony and the testimony of others, legislation in California and other states has been amended to take into consideration the continued availability of ephedra-containing products to trained and licensed health care professionals.
In 2002, after three years of successive attempts, and after adopting revisions and amendments recommended by the dietary supplement industry and by licensed health care professionals, California passed a new law that sets labeling standards for dietary supplements containing ephedrine alkaloids. (SEE ATTACHMENT 2).
Please take into serious consideration the fact that Ephedra is the very first herb that is taught in traditional Chinese herbal medicine, and that it is typically used in a manner consistent with OTC cold remedies; namely for bronchial and sinus congestion related to upper respiratory conditions, and only for short durations. It is never prescribed for weight loss. It would be a direct insult to many traditional Asian cultures if you were to single out ephedra.
Recently, the death of a Major League Baseball pitcher was attributed to ephedra without any substantiating evidence. By immediately pointing the finger at the “dangers of ephedra,” attention was steered away from more thorough investigation into abuse by professional athletes, team owners, managers, and physicians who all have financial incentives to contribute to the behaviors that lead to such tragic and unnecessary deaths. The true villains are policy-makers who allow the American public to go uneducated about the relationship between diet, exercise, and health, and which allow the diet and weight lose industries to take advantage of their ignorance.
Back to the issue at hand..... The following are our comments:
1. LABELING STANDARD 1. LABELING STANDARD
We understand that the FDA is proposing specific labeling standards for dietary supplement products that contain ephedrine alkaloids. (ATTACHMENT 1)
RECOMMENDATION:
Adopt the labeling standards California Health and Safety Code, Section 110423. This law was the result of years of negotiations between legislators, the dietary supplement industry, and licensed health care professionals. The law went into effect January 1, 2003, so most manufacturers should already be in compliance, as California is home to many of the manufacturers and consumers of these products. (SEE ATTACHMENT 2).
Furthermore, we recommend that you allow the same exemption that the California law allows for products sold directly to “a licensed health care practitioner practicing within his or her scope of practice who prescribes, dispenses, or both, herbs in the course of treatment of patients under the care of the licensed practitioner.”
The FDA's proposed labeling standard shows certain bias that are not substantiated by the available data. For example, you fail to list coffee and tea in your list of substances with which the “risks of serious side-effects from this product can increase.” In fact, the weight-loss products associated with adverse events usually contain much higher concentrations of caffeine than they do ephedrine. You also recommend that consumers “contact a doctor” for various concerns. Some doctors have their degrees in engineering and other non-health related subjects. Using the phrase “consult a physician or licensed qualified health care professional” would be more appropriate.
Our previous comments from 1997 still stand. (SEE ATTACHMENT 3)
2. SIGNIFICANT RISK UNDER ORDINARY CONDITIONS OF USE 2. SIGNIFICANT RISK UNDER ORDINARY CONDITIONS OF USE
We understand that FDA also intends to consider, whether in the FDA should determine that dietary supplements containing ephedrine alkaloids present a “significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use.”
RECOMMENDATION:
We do not believe that sufficient evidence exists to determine that dietary supplements containing ephedrine alkaloids present a significant or unreasonable risk of illness or injury under ordinary conditions of use. Since we consider “ordinary conditions of use” for ephedra and products containing ephedrine alkaloids to be for upper respiratory conditions for short durations (less than 2-3 weeks), and since such use poses minimal risk, we find that no such determination is necessary. However, and more appropriately, the FDA should probably consider that the very nature of using dietary or pharmaceutical products for weight loss is simply unnatural, and does pose a significant and unreasonable risk of illness or injury. Once again, it is the use of the product, and not the contents, per se, that present the danger to the consumer.
3. ADDITIONAL LEGISLATIVE AUTHORITIES 3. ADDITIONAL LEGISLATIVE AUTHORITIES
We understand that the FDA is seeking comment on what additional legislative authorities, if any, would be necessary or appropriate to enable FDA to address this issue most effectively.
RECOMMENDATION:
We do not recommend any additional legislative authority in regards to dietary supplements at this time, though we may not be opposed to efforts that strike some balance of safety and consumerism.
SUGGESTION:
We feel that the FDA should consider whether to use its existing legal authority and persuasive powers with existing medical experts to simply classify obesity and related conditions of excess weight, including the psychological obsession or desire to be thin without exercise, as true medical conditions, and to classify any product or device used to correct such medical conditions, including weight loss products, as being used for medical purposes, and to regulate such products and devices accordingly. As such, “dietary supplements” used for weight loss would no longer be classified as dietary supplements, but as “drugs.”
Respectfully Submitted,
Brian C. Fennen
Executive Director
Council of Acupuncture and Oriental Medicine Associations
1217 Washington Street
Calistoga, CA 94515