ROCKVILLE, Md.--In a 363-page final rule to appear in the Feb. 11 Federal Register, the Food and Drug Administration (FDA) explained why it decided to take products containing ephedrine alkaloids off the market. The ban is slated to go into effect April 12.
FDA concluded that, per Part 119 under Section 119.1 under the Federal Food, Drug and Cosmetic Act, products containing ephedrine alkaloids are adulterated because they present an unreasonable risk for illness or injury. The agency felt it met the burden of proof to show “unreasonable risk” by showing the risks outweighed the benefits. “The presence of even a relatively small risk of an important adverse health effect to a user may be unreasonable,” the agency wrote. “For example, isolated adverse events alone might not be expected to constitute substantiation of risk, but adverse event reports combined with pharmacological and other clinical evidence might be expected to do so.”
FDA added the herb shows only a modest, short-term benefit in weight loss, which is not enough to positively affect cardiovascular risk factors or other health conditions associated with being overweight or obese. In regard to ephedra’s link to other benefits--enhanced energy, improved athletic performance and an increase in alertness--FDA reported there was no scientific evidence to support these short-term benefits.
FDA listed a range of botanicals containing ephedrine alkaloids that would be part of the ban: ma huang, Sida cordifolia L. (also known as country mallow and bala), Pinellia ternata (also known as ban xia), Ephedra sinica Stapf, Ephedra equisetina Bunge, Ephedra intermedia var. tibetica Stapf and Ephedra distachya L. The ephedrine alkaloids that appear to be pharmacologically active in plants and which are covered by the ban include l-ephedrine, d-pseudoephedrine, l-norephedrine, l-methylephedrine, d-norpseudoephedrine and d-methylpseudoephedrine.
FDA clarified that most American species of ephedra do not contain ephedrine alkaloids (e.g., Mormon tea) and are therefore not part of the ban. The final rule also does not apply to conventional foods (such as teas) that contain ephedrine alkaloids, nor does it apply to over-the-counter and prescription drugs.
The rule will also not affect preparations prepared under Traditional Chinese Medicine (TCM), either, since they are geared for episodic (e.g., respiratory infections) rather than chronic use. However, the American Herbal Product Association’s (AHPA) Michael McGuffin said this may create a loophole in the regulatory system. “Chinese practitioners are going to have to get the White-Out and remove ‘dietary supplement’ from the products they sell,” he said. When McGuffin talked to INSIDER, he was still in the midst of reading the rule; however, he said he had already spoken with AHPA’s legal counsel so the association can be prepared to help TCM practitioners and manufacturers--such as Blue Poppy, which sells to these practitioners--comply with the new rule.
“Ephedra has been a controversy for a long time that has done some damage to the industry, and we’re glad it’s been resolved--one way or another,” said John Hathcock , Ph.D., vice president of scientific and regulatory affairs for the Council for Responsible Nutrition (CRN). “We just hope there are no landmines within these pages that will bring another round of bad publicity--and give legislative opponents of DSHEA [the Dietary Supplement Health and Education Act] more fodder.”
However, FDA may have already stoked the fire under DSHEA. In the final notice, FDA reported that during this process, it received quite a few letters saying FDA had failed to act sooner against ephedrine alkaloids due to the seeming inadequacy of DSHEA. “We must regulate supplements under our existing authority,” FDA said in response. “Accordingly, we are unable to take action regarding suggestions for amendments to DSHEA because any such amendments must result from congressional action rather than rulemaking.”
The final rule can be found at www.fda.gov/OHRMS/DOCKETS/98fr/1995n-0304-nfr0001.pdf.
