By Eric Brand

I just got some feedback on my recent Ma Huang blog from an industry expert that is a major authority on FDA regulations, and it sounds like I had some misunderstandings in my interpretation of the law around Ma Huang. I apologize for the confusion, here is a correction based on the most authoritative advice I can find.

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Apparently the situation with Ma Huang is far worse than I thought. Basically, raw herbs can be sold as dietary ingredients (raw materials for use in making dietary supplements), conventional foods, or dietary supplements. The difference between these three categories is largely associated with labeling and other regulations. Finished products with herbs that are ready for ingestion are generally labeled and marketed as dietary supplements. Dietary ingredients (raw materials) and conventional foods exist in a slightly more relaxed regulatory tier.

Previously, I mistakenly believed that the form of the herb had an effect on its classification, meaning that I thought pills, powders, liquids, capsules, etc. were automatically dietary supplements while bulk herbs were not. In actual fact, the form has nothing to do with it, as DSHEA 21 U.S.C. 350 ( c )( 1 )( B ) states:
(i) is intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form, or
(ii) if not intended for ingestion in such a form, is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet.

Additionally, if the product is labeled as a dietary supplement it is one (even if it is a bulk herb) and if it is not labeled as a dietary supplement it is not one (even if it is pills). However, the problem with Ma Huang is this: 1) It cannot be sold as a conventional food, food additive or dietary ingredient, and 2) It cannot be sold as a dietary supplement. So what is it? Unfortunately, the expert I spoke with has been to FDA seminars that specifically discussed this issue about ephedra and TCM, and FDA’s response to this question is that Ma Huang is a drug, based on their understanding that it is used in a clinical setting to treat disease. TCM practitioners are not generally permitted to prescribe drugs to treat disease and it doesn’t appear that full-spectrum Ma Huang extracts qualify as approved drugs in the first place, so we are out of luck as far as I can tell.

A second expert confirmed that Ma Huang has no known loopholes in terms of being able to be sold as a food or supplement, so it is effectively banned completely from trade. As pure drugs, ephedrine and pseudoephedrine can be sold OTC, but the product must comply with the USP monographs for purity and must be manufactured at a drug facility. Could a drug company make a full-spectrum Ma Huang extract and market it as an OTC drug? Apparently not, from my reading of the FDA law:

Sec. 341.76 is pretty clear that only single ingredient ephedrine products are permitted as a drug, and they emphasize that mixed alkaloid products are not permitted:

“Ephedrine used in a drug product in the treatment of asthma needs to meet the United States Pharmacopeia (USP) standards of identity, strength, quality, and purity…Botanical sources of ephedrine alkaloids contain ephedrine and other sympathomimetics, including norephedrine, pseudoephedrine, and methylephedrine… In previous Federal Register notices (47 FR 35344, August 13, 1982; 48 FR 52513, November 18, 1983; and 49 FR 26814, June 29, 1984), FDA recognized the negative consequences of combining multiple sympathomimetic ingredients or a sympathomimetic plus caffeine in the same drug product… FDA has not permitted marketing of OTC drug products containing more than one sympathomimetic drug because of safety concerns.”

"FDA continues to believe that OTC drug products containing single ingredient ephedrine are generally recognized as safe and effective and are not misbranded under the conditions of use in the bronchodilator FM and with the labeling in this proposed rule."

Furthermore, it appears that a special set of DEA rules also apply towards the sale of ephedrine drugs:

"Drug Enforcement Administration (DEA) requirements restricting the sale of ephedrine, its salts, optical isomers, and salts of optical isomers that became effective after FDA published the 1995 proposal are in effect and, among other things, require single-
ingredient ephedrine drug products to be sold behind the counter. Therefore, access to these products is controlled."

In other words, Ma Huang (or anything with ephedrine alkaloids) is classified as a drug if it is intended for ingestion, but no natural, full-spectrum plant extracts are currently permitted as approved drugs because the law only allows single-ingredient ephedrine to be sold. Mixed alkaloid natural products have not been permitted for OTC marketing, so it looks like Ma Huang is banned for internal use altogether. This is a crushing blow for Chinese medicine, and very few practitioners realize that the ban is truly in effect.

At this point, we need to come together as a community and pool our resources to protect our future access to Chinese herbal medicine. If you are currently using Ma Huang, be careful because there appears to be no defensible legal position to take if something goes wrong. If you know someone in the community that uses Ma Huang, do not publicize it or draw attention to them. The prohibition against Ma Huang is unlikely to end its bona fide medical use but the illegality surrounding it means that its use will be driven underground and our community will be deprived of the research and evidence-based data that we would need to accumulate to regain access to it.

All that said, there may be one other gray area to explore: the differences between state and federal laws. While Federal FDA law imposes a blanket ban on all dietary supplements that contain ephedra, the law states that Traditional Asian Medicine is excluded because the products used are not dietary supplements. FDA apparently views them as drugs, which makes it questionable as to whether or not we have the right to prescribe them. However, California and New York state laws exempt traditional medicine practitioners from their respective state bans (Illinois does not).

California law basically states that "The act prohibits the sale of dietary supplements containing ephedrine group alkaloids unless a California licensed health care practitioner who is practicing within his or her scope of practice and who prescribes or dispenses, or both, dietary supplement products containing ephedrine group alkaloids in the course of the treatment of a patient under the direct care of that licensed health care practitioner, except that a licensed health care practitioner shall not prescribe or dispense dietary supplements containing ephedrine group alkaloids for purposes of weight loss, body building, or athletic performance enhancement."

NY law states: "(b) This section shall not apply to ma huang (ephedra sinica) sold or dispensed by any practitioner of acupuncture or oriental medicine, whose qualification to use ma huang and other herbs is explicitly established via evidence of an active certification issued to such individual from an entity accredited by the National Commission of Certifying Agencies (NCCA), or any physician or any practitioner of acupuncture licensed by the state of New York as long as it is not sold or dispensed as a dietary supplement for weight loss, for body building, or as an "energy food"."

Illinois has no exemption for traditional medicine practitioners, and the penalty potentially includes up to one year of jail time plus a fine of up to $5,000. Compare that to NY, which only gives a civil violation with a maximum $500 fine for illegally selling Ma Huang.

The trouble is, according to these state laws, licensed practitioners in NY and CA can prescribe dietary supplements containing ephedra. But according to federal law, a dietary supplement cannot contain ephedra. Adverse effects have only been found at doses of 150mg+ of ephedrine, and 30mg doses totally 90mg/day showed no adverse effects. Hysteria is ruling instead of science, and the apparent discrepancy between state and federal law puts us in a very awkward situation as health care professionals. If anyone has any updates, please post a comment to this blog.