| Ephedra |
| Concerns about the use of ephedra in weight-loss products began in the early 1990s, when the FDA began collecting reports of “adverse events.” The September 1994 FDA Medical Bulletin included a report on “Adverse Events with Ephedra and Other Botanical Dietary Supplements.” |
| In late 1995, the FDA convened a “Special Work Group on Food Products Containing Ephedrine Alkaloids.” This group concluded with a list of concerns, including “an association between the types of serious events reported and the use of ephedrine alkaloids, . . . the presence of ephedrine alkaloids near or at OTC drug levels, . . . lack of adequate data to establish "dose" or serving limitations.” Recommendations included “a per-unit limitation of 20 mg ephedrine (25 mg total ephedrine alkaloids), with a daily intake of no more than 80 mg ephedrine (100 mg total ephedrine alkaloids), consistent with current maximum OTC drug levels,” warnings labels on products containing ephedrine alkaloids, and further clinical research and adverse event monitoring. In discussion, it was “suggested that this degree of labeling not be extended to the crude (i.e., unprocessed) herb itself, such as might be found in a Chinese herbalist's shop.” Nice of them to consider us. |
| In April, 1996, the FDA warned consumers “not to purchase or consume ephedrine-containing dietary supplements with labels that often portray the products as apparent alternatives to illegal street drugs such as "ecstacy," because these products pose significant health risks to consumers.” |
| In June, 1997, the FDA proposed safety measures for ephedrine dietary supplements. These proposed guidelines required labeling “that recommends or suggests conditions of use that would result in an intake of 8 mg or more in a 6-hour period or a total daily intake of 24 mg or more also would not be allowed. In addition, the proposal would require label statements instructing consumers not to use the product for more than 7 days.” |
| However, the House Committee on Science requested that the Government Accounting Office (GAO) examine the scientific bases for the ephedrine alkaloids proposal and the agency's adherence to the regulatory flexibility analysis requirements for Federal rulemaking. On August 4, 1999, GAO released its report entitled ``Dietary Supplements: Uncertainties in Analyses Underlying FDA's Proposed Rule on Ephedrine Alkaloids.'' |
| In this report, the GAO expressed concerns about the use of the reported adverse events in supporting the proposed dosing level and duration of use limit, and concluded that the agency needed additional evidence to support these restrictions. The GAO recommended that FDA ``provide stronger evidence on the relationship between the intake of dietary supplements containing ephedrine alkaloids and the occurrence of adverse reactions that support the proposed dosing level and duration of use limits.'' In addition, GAO recommended that FDA improve the transparency of its cost-benefit analysis in its final rulemaking. |
| In the Spring of 2000, after receiving nearly 15,000 documents commenting on the proposed regulations, including a number from our professional organizations, the FDA withdrew some of the specifics of their proposed rules, announced the availability of new ephedrine and "street drug alternative" documents, and began promoting its adverse event reporting system for dietary supplements. Basically, they were responding to the growing marketing of ephedrine and caffeine products as athletic and sexual enhancers, stimulants, weight-loss products and what they referred to as legal “street drug alternatives” intended to create a psychological high, stating that “street drug alternatives are unapproved and misbranded drugs that can be subject to regulatory action, including seizure and injunction.” |
| They held another public meeting in August of 2000. Their understanding of Chinese herbal medicine had not improved, exemplified by a statement in the meeting summary. “Traditional Chinese medicine (TCM) has used ma huang (plant-derived ephedrine) for short durations to treat upper respiratory conditions; however, indications are not well-established except through the practices handed down and recorded in textbooks of TCM.” |
| Further they noted that “a related compound, phenylpropanolamine (PPA), is an ingredient in numerous OTC and dietary supplement products marketed for weight loss and as a decongestant. Both synthetic and naturally derived forms of PPA are available; OTC products contain synthetic PPA, while dietary supplements containing PPA can be synthetic, naturally derived, or some combination thereof.” PPA was banned late last year for serious adverse events associated with sinus and allergy products containing PPA. |
| This group concluded |
| Given the current widespread use of EADS, a consumer education campaign about these products is warranted. Good manufacturing standards are needed, reasonable dose and duration levels determined, and warnings and contraindications clearly indicated on labels. A research agenda should be established. Therefore, the research community should take the next logical step by conducting a systematic review of the world's literature on ephedra. After compiling the state of the science and identifying the limitations and gaps of the current research, an appropriate agenda can be established. In this regard, the National Center for Complementary and Alternative Medicine of the National Institutes of Health already is requesting proposals to study herb-drug interactions. |
| In the mean time, California legislators were not about to wait, especially since California was home to a large number of manufacturers of dietary supplements. On February 24, 2000, Assembly Member Susan Davis (San Diego) and Senator Jackie Speier (San Francisco) authored Assembly Bill 2294, to set labeling standards for products containing ephedrine alkaloids. After discovering that this bill would adversely effect the practice of Chinese herbal medicine by Licensed Acupuncturists, the Council of Acupuncture and Oriental Medicine Associations (CAOMA) requested that acupuncturists be exempted, so that manufacturers could sell ephedra products to acupuncturists, and acupuncturists could prescribe and sell them to patients without the written warning labels. Dietary supplement manufacturers also asked for less restrictive language. In June, compromise amended were made to AB 2294, and it passed through and to the Governor’s desk in September. However, this bill was vetoed by Governor Davis on September 29, 2000. The Governor felt that this was a national issue that should be handled by the FDA. |
| Not to be deterred, Senator Speier reincarnated AB 2294 as SB 397, and introduced it on February 21, 2001. This bill has been further amended. Essentially, the bill requires labeling that is nearly identical to that already on many of these weight-loss products. The bill was last heard in the Assembly Health Committee, where it passed out 11-2 on August 21. SB 397 looks promising to go to Governor Davis, who will have passed or vetoed it by now. The other major difference between this year and last year is that the California Medical Association has signed on in support. Basically, the bill has health care providers supporting it, and dietary supplement manufacturers opposing it. During the August 21 hearing, the grocers and manufacturers complained about the requirement that these products only be sold to persons over the age of 18. The chair of the committee, Assemblywoman Thompson, asked why they were opposed when product labels already stated that it should not be sold to persons under 18. |
| Another issue with Ephedra, that is not well publicized, is that bulk ephedrine, such as that used in the manufacture of sinus and allergy drugs, was being diverted for the production of methamphetamine. California is the heartland of methamphetamine production in the United States. |
| In another effort to protect our scope of practice, Senator Don Perata of Oakland, has authored our scope of practice legislation again this year, in the form of SB 341. It was written to allow acupuncturists to continue practicing Chinese herbal medicine without the dangers of narrow interpretations of law that could have restricted us. It basically separates herbs from nutrition and dietary supplements, adds animal and mineral products (that we already consider “herbs”), adds diet (which we had presumed to already be included in the definition of “nutrition”), and further adds magnets, heat, and cold to our list of modalities. Hopefully, this bill will have been signed into law by the Governor by now. |