Emord Extends Effort To Liberalize QHCs With Selenium, Antioxidant Petitions
This article was originally published in The Tan Sheet
Executive Summary
Attorney Jonathan Emord continues his effort to force FDA to allow more expansive qualified health claims for nutritional supplements with two petitions relating to the capability of selenium and antioxidant vitamins to reduce the risk of site-specific cancers
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Attorney Jonathan Emord continues his effort to force FDA to allow more expansive qualified health claims for nutritional supplements with two petitions relating to the capability of selenium and antioxidant vitamins to reduce the risk of site-specific cancers. Emord, who served as the lead plaintiff's counsel in a 1999 lawsuit - Pearson v. Shalala - that led to FDA's current QHC policy, said he intends to file suit should the agency deny the petitions. The 1999 ruling by a federal appeals court overturned a lower court decision. The appeals court said FDA's refusal to permit certain supplement claims was a First Amendment violation and recommended the agency clarify its "significant scientific agreement" standard on permissible health claims (1 (Also see "FDA Tackles Observational Studies In Draft Health Claims Guidance" - Pink Sheet, 9 Jul, 2007.), p. 10). At the time, FDA said the decision "lowers the bar" by allowing weak and possibly false health claims into the marketplace (2 (Also see "Pearson v. Shalala "Lowers The Bar" For Health Claims Reliability - FDA" - Pink Sheet, 22 Mar, 1999.), p. 3). Emord has since petitioned for numerous QHCs on behalf of nutritional supplement firms, a challenge considering FDA's general opposition to new supplement claims. In an interview, Emord said FDA has taken a position on QHCs "directly contrary to the legislative intent." The agency operates under a policy that allows only nutrient disease prevention health claims and does not allow nutrient disease treatment claims, he added. Under FDA's policy, disease treatment claims "may only be made by drug companies under the drug approval process," Emord said. He said supplement companies generally refrain from submitting QHC petitions because with an unpredictable marketplace, they often lack an economic incentive. When petitioners seek claims from FDA, "they can't know what claim they're going to get" and "they can't know what the market is going to be like in the future," he said. "They can't know with any degree of certainty whether the consuming public will still have an interest in the kinds of products that they are marketing with those ingredients." History Of Petitions, Litigation A petition Emord submitted in 2003 was approved for claims relating to the "limited and not conclusive" evidence of the anti-carcinogenic effects of selenium, vitamin C and vitamin E. However, FDA in 2005 rejected a petition Emord submitted to allow 30 QHCs linking lycopene with reduced risk of certain cancers (3 (Also see "Lawsuit Will Question Supplement Exclusion From Lycopene/Cancer Claims" - Pink Sheet, 14 Nov, 2005.), p. 9). Emord also represented Nutraceutical Corp. in its unsuccessful appeal of FDA's ban of ephedrine-alkaloid dietary supplement based on a risk-benefit standard (4 (Also see "Supreme Court Refuses Ephedra Case, Battle Against Risk-Benefit Continues" - Pink Sheet, 21 May, 2007.), p. 3). The latest petitions, which FDA has accepted and posted for public comment, say subsequent studies offer proof to warrant "persuasive, but not conclusive" claims for the supplements. The more recent claims "are not to be substitutes for the old ones, but rather complement them because of the evolution in science since that time, which has now identified the certain sites at which cancer risk reduction is demonstrable," Emord explained. He submitted the petitions in February on behalf of Chula Vista, Calif.-based supplement manufacturer Youngevity. Also named as a petitioner is the Coalition to End FDA and FTC Censorship, organized by Emord and with members including supplement firms, researchers and health care advocates. Youngevity CEO Steve Wallach says he does not expect stronger QHCs to boost the company's sales, given that its "direct competitors are able to use those claims." Wallach emphasized the importance of informing consumers with "FDA-vetted information on labels." While the Council for Responsible Nutrition says FDA should consider claims for beneficial effects of antioxidants, selenium and carotenoids working in combination, it maintains there is insufficient evidence to warrant strengthened anti-cancer claims for antioxidants or selenium in isolation (5 (Also see "Soy, Selenium Claims Should Perhaps Be Expanded, Not Weakened – CRN" - Pink Sheet, 10 Mar, 2008.), p. 11). - Dan Schiff ([email protected]) |