Ephedra: Experts Speak Out On The Good, The Bad And The Ugly
This article was originally published in The Tan Sheet
Executive Summary
Left to its own devices FDA might not conduct a new risk/benefit analysis; however, a citizen petition asking for an analysis of an herb could spur FDA to action, Attorney Marc Ullman told "The Tan Sheet."
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Left to its own devices FDA might not conduct a new risk/benefit analysis; however, a citizen petition asking for an analysis of an herb could spur FDA to action, Attorney Marc Ullman told "The Tan Sheet." Additionally, herbs that could be viewed as improving "lifestyle" rather than providing a medical benefit are in particular danger, according to the partner at New York, N.Y.-based Ullman Shapiro & Ullman. The agency was given the go-ahead to employ a risk/benefit analysis to determine whether a dietary ingredient presents an unreasonable risk of illness or injury last week by the 10th Circuit Court of Appeals (1 (Also see "FDA Gets Green Light For Risk-Benefit Analysis From Ephedra Ruling" - Pink Sheet, 21 Aug, 2006.), p. 3). Following the decision, food and drug law expert Scott Bass asserted the ruling would "embolden FDA to challenge products that have a bad safety profile," and American Herbal Products Association President Michael McGuffin advised firms to "make very certain" that the benefits of their products were well-substantiated. However, a larger issue highlighted by the looming risk/benefit analysis is FDA's idea of what constitutes a benefit, Ullman and McGuffin pointed out. In its rulemaking process, FDA determined that any benefit of weight loss associated with the use of ephedrine alkaloid dietary supplements were "benefits that are temporary or rely on subjective measures such as feeling or looking better," the 10th Circuit notes. The benefit of cosmetic weight loss is an issue under debate at the agency, as GlaxoSmithKline made a bid to switch the Rx weight-loss drug Xenical to OTC. FDA issued an "approvable" letter in April, but the question of whether the product was beneficial was fiercely debated at the advisory committee meeting and the agency expressed interest in reviewing weight loss as an OTC indication (2 (Also see "Glaxo’s Alli Advances Toward OTC Sale With “Approvable” Letter" - Pink Sheet, 10 Apr, 2006.), p. 8 and 3 (Also see "Alli Sparks Reevaluation Of OTC Weight-Loss Indication" - Pink Sheet, 6 Feb, 2006.), p. 6). With the ephedra rulemaking, in addition to negating the benefit of weight-loss, the agency deemed any benefits of ephedra related to its traditional use - as a bronchodilator, for instance - drug indications and therefore irrelevant to the risk/benefit analysis, McGuffin added. A botanical like kava kava, which is largely used for relaxation purposes, is the type of herb FDA might not find beneficial, Ullman pointed out. The herb's safety profile has been under heavy fire; in fact, the UK Food Standards Agency reaffirmed its ban of the botanical earlier this month (4 'The Tan Sheet' Aug. 7, 2006, In Brief). Black cohosh, which has been targeted by several federal agencies across the globe, is another potential example. In addition to substantial concerns arising from the risk/benefit analysis, the court's interpretation of DSHEA's de novo clause also is worrisome, Bass and Ullman stress. Under the de novo clause, an applicable agency action would be reviewed by an appellate court from the ground up. Otherwise, the court would assume the decision itself was correct. According to the 10th Circuit ruling the de novo clause does not apply to an FDA administrative action, such as rulemaking. Therefore, an appellate court would not be required to reopen and scrutinize a rule promulgated by FDA. The court would only be required to review anew enforcement actions taken by the agency. Notably, the 10th Circuit is not the first court to interpret the clause in this way. The decision reaffirms the 3rd Circuit's 2005 interpretation in NVE vs. HHS. According to Bass, who helped write DSHEA, "there wasn't thought given to a separation of functions" in the drafting of the de novo clause. However, Ullman noted, "as part of the compromise that got DSHEA passed, there is no legislative history on which the courts can fall back," and "now we've had two separate courts conclude that if [the authors] intended something else, they did not make that clear enough." Overall, ephedra is an example of "bad product making bad law," Bass said; however, "I do think it's good that at least FDA didn't have its ephedra efforts thrown out because then it would have invited more congressional legislative restrictions." A decision overturning the ban was also a concern for drafters of the recently introduced mandatory adverse event reporting bill. Council for Responsible Nutrition President Steve Mister noted a court order overturning the ban could hurt industry's ability to get federal preemption into the bill (5 (Also see "Ephedra Litigation Could Threaten AER Preemption Provision – CRN’s Mister" - Pink Sheet, 8 May, 2006.), p. 9 and 6 (Also see "Bipartisan AER Bill Requires Reporting For All OTC Drugs, Supplements" - Pink Sheet, 26 Jun, 2006.), p. 3). Sen. Tom Harkin (D-Iowa), another DSHEA author, also saw a bright side to the decision. "I am pleased that the Tenth Circuit Court of Appeals has agreed, and has issued its decision upholding the ban, and strengthening DSHEA," he told "The Tan Sheet." - 7 Katia Fowler |