Ephedra Banned, Other Supplements to Follow?

Ephedra Banned, Other Supplements to Follow?

ROCKVILLE, Md.In a 363-page final rule published in the Feb. 11 FederalRegister, the Food and Drug Administration (FDA) explained why it decided totake products containing ephedrine alkaloids off the market. The ban is slatedto go into effect April 12.

FDA concluded that, per Section 119.1 under the Federal Food, Drug andCosmetic Act, products containing ephedrine alkaloids are adulterated becausethey present an unreasonable risk for illness or injury. The agency felt it metthe burden of proof to show unreasonable risk by showing the risksoutweighed the benefits. The presence of even a relatively small risk of animportant adverse health effect to a user may be unreasonable, the agencywrote. For example, isolated adverse events alone might not be expected toconstitute substantiation of risk, but adverse event reports combined withpharmacological 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 otherhealth conditions associated with being overweight or obese. In regard toephedras link to other benefitsenhanced energy, improved athleticperformance and an increase in alertnessFDA reported there was no scientificevidence 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), Pinelliaternata (also known as ban xia), Ephedra sinica Stapf, Ephedraequisetina Bunge, Ephedra intermedia var. tibetica Stapf and Ephedradistachya L. The ephedrine alkaloids that appear to be pharmacologicallyactive in plants and which are covered by the ban include l-ephedrine,d-pseudoephedrine, l-norephedrine, l-methylephedrine, d-norpseudoephedrine andd-methylpseudoephedrine.

FDA clarified that most American species of ephedra do not contain ephedrinealkaloids (e.g., Mormon tea) and are therefore not part of the ban. The finalrule also does not apply to conventional foods (such as teas) that containephedrine alkaloids, nor does it apply to over-the-counter and prescriptiondrugs.

The rule will also not affect preparations prepared under Traditional ChineseMedicine (TCM), either, since they are geared for episodic (e.g., respiratoryinfection) rather than chronic use. According to the rule, these preparationsare beyond the scope ... because they are not marketed as dietarysupplements.

However, the American Herbal Product Associations (AHPA) president,Michael McGuffin, said this may create a loophole in the regulatory system. Chinesepractitioners are going to have to get the White-Out and remove dietarysupplement 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 alreadyspoken with AHPAs legal counsel so the association can be prepared to helpTCM practitioners and manufacturerssuch as Blue Poppy, which sells to thesepractitioners comply with the new rule.

The Council for Responsible Nutrition (CRN), the National Nutritional FoodsAssociation (NNFA) and the Utah Natural Products Alliance (UNPA) released ajoint statement Feb. 12 that they would not challenge FDAs ban. Even thoughthe associations do not agree with every point FDA used as a justification forthe 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 tothe industry, and were glad its been resolvedone way or another,said John Hathcock, Ph.D., vice president of scientific and regulatory affairsfor CRN.

AHPA, however, wanted to keep the door open to challenge the governmentsban if need beespecially since the final rule is still being waded through bythe industry. Theres much more than ephedra is banned in the finalrule, McGuffin said. Its saying too much too soon to say we wontchallenge 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 takeephedras place. In a Jan. 20 address at the University of Mississippi, FDACommissioner Mark McClellan, M.D., Ph.D., expressed concern that there arecurrently supplements in the marketplace that may pose similar health risks. Weare particularly concerned about the possible health impacts of the growingnumber of ephedra alternatives now on the market, he said. Some of thesecontain ephedrine alkaloids that will be covered under the new rule, and we willbe taking those off the market soonthough again, I think any responsiblemanufacturer or distributor would do that now.

Particular dietary ingredients McClellan singled out included bitter orange (Citrusaurantium), 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 closelyevaluate the potential safety risk of these products.

Congress has already taken up the cause against bitter orange. In a letter toMcClellan dated Feb. 1, Sen. Charles Schumer (D-N.Y.) recommended FDAimmediately ban the herb. I am concerned that if we wait before banningbitter orange, we will start to see horrible effects, including heart failureand death, like we did with ephedra, he wrote.

Time columnist Leop Jaroff asked in the Feb. 10 issue how the industrycould support ephedra alternatives that also pose dangers to consumers? Theanswer lies in ill-conceived and reprehensible legislation approved by Congressin 1994 [the Dietary Supplement Health and Education Act].

Hathcock expressed concern over the possible domino effect the ephedra banwould have on DSHEA. We just hope there are no landmines within these pagesof the final rule that will bring another round of bad publicityand givelegislative opponents of DSHEA more fodder, he said.

FDA, however, said working within the confines of DSHEA may have been astumbling 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 afew letters saying FDA had failed to act sooner against ephedrine alkaloids dueto the seeming inadequacy of DSHEA. We must regulate supplements under ourexisting authority, FDA said in response. Accordingly, we are unable totake action regarding suggestions for amendments to DSHEA because any suchamendments 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.