Ephedra Banned, Other Supplements to Follow?
ROCKVILLE, Md.In a 363-page final rule published 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 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 ephedras link to other benefitsenhanced energy, improved athletic performance and an increase in alertnessFDA reported there was no scientific evidence to support these short-term benefits.
A range of botanicals containing ephedrine alkaloids are covered by 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 infection) rather than chronic use. According to the rule, these preparations are beyond the scope ... because they are not marketed as dietary supplements.
However, the American Herbal Product Associations (AHPA) president, 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 AHPAs legal counsel so the association can be prepared to help TCM practitioners and manufacturerssuch as Blue Poppy, which sells to these practitioners comply with the new rule.
The Council for Responsible Nutrition (CRN), the National Nutritional Foods Association (NNFA) and the Utah Natural Products Alliance (UNPA) released a joint statement Feb. 12 that they would not challenge FDAs ban. Even though the associations do not agree with every point FDA used as a justification for the ban, they believe FDA used a balanced rationale to come to its conclusion. Ephedra has been a controversy for a long time that has done some damage to the industry, and were glad its been resolvedone way or another, said John Hathcock, Ph.D., vice president of scientific and regulatory affairs for CRN.
AHPA, however, wanted to keep the door open to challenge the governments ban if need beespecially since the final rule is still being waded through by the industry. Theres much more than ephedra is banned in the final rule, McGuffin said. Its saying too much too soon to say we wont challenge the rule.
The effects of the ban are not just relegated to ephedra supplementsalready, the government is taking a closer look at those supplements waiting to take ephedras place. In a Jan. 20 address at the University of Mississippi, FDA Commissioner Mark McClellan, M.D., Ph.D., expressed concern that there are currently supplements in the marketplace that may pose similar health risks. We are particularly concerned about the possible health impacts of the growing number of ephedra alternatives now on the market, he said. Some of these contain ephedrine alkaloids that will be covered under the new rule, and we will be taking those off the market soonthough again, I think any responsible manufacturer or distributor would do that now.
Particular dietary ingredients McClellan singled out included bitter orange (Citrus aurantium), aristolochic acid and usnic acid, which is derived from lichens. (FDA issued consumer advisories about aristolochic acid and usnic acid in 2001.) McClellan said FDA will be doing more work in the coming months to more closely evaluate the potential safety risk of these products.
Congress has already taken up the cause against bitter orange. In a letter to McClellan dated Feb. 1, Sen. Charles Schumer (D-N.Y.) recommended FDA immediately ban the herb. I am concerned that if we wait before banning bitter orange, we will start to see horrible effects, including heart failure and death, like we did with ephedra, he wrote.
Time columnist Leop Jaroff asked in the Feb. 10 issue how the industry could support ephedra alternatives that also pose dangers to consumers? The answer lies in ill-conceived and reprehensible legislation approved by Congress in 1994 [the Dietary Supplement Health and Education Act].
Hathcock expressed concern over the possible domino effect the ephedra ban would have on DSHEA. We just hope there are no landmines within these pages of the final rule that will bring another round of bad publicityand give legislative opponents of DSHEA more fodder, he said.
FDA, however, said working within the confines of DSHEA may have been a stumbling block when trying to get ephedra regulations out in a timely manner. 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.
