A federal appeals court was asked Tuesday to reconsider a case in a long-running dispute with FDA over the legality of DMAA (1,3-dimethylamylamine) in dietary supplements.
Hi-Tech Pharmaceuticals Inc. requested a full panel of judges take up the case after a three-judge panel of the Eleventh Circuit in a 2 to 1 vote upheld a district court decision that DMAA does not belong in supplements and is not GRAS (generally recognized as safe).
“If that ruling stands, it will stifle innovations in this multi-billion-dollar sector of the economy and preclude beneficial ingredients from being incorporated into dietary supplements in the future,” lawyers for Hi-Tech wrote in their brief.
The Eleventh Circuit’s majority opinion held an artificially produced substance for commercial sale that “may be found in trace amounts in a plant” does not meet the definition of a “botanical” or “constituent” of a botanical in the Dietary Supplement Health and Education Act of 1994 (DSHEA).
“[I]t is unlikely that Congress used the term ‘constituent’ to mean a substance that is present in a plant in only trace amounts and that has never been derived from a plant for use in any medicinal, cosmetic or dietary product,” U.S. District Judge Robert Hinkle, who wrote the Eleventh Circuit’s majority opinion, stated.
In its 23-page petition for a panel rehearing or rehearing en banc, Hi-Tech countered Congress did not impose such limitations in DSHEA.
“The words ‘trace amounts,’ ‘physically derived’ and ‘medicinal, cosmetic or dietary’ use, deemed dispositive by the majority, were not written by Congress,” lawyers for the company noted in their brief. “They were written by the majority, which effectively redlined these words into the United States Code.”
The majority’s decision, Hi-Tech’s attorneys wrote, “calls into question current processes for producing beneficial dietary ingredients,” such as pterostilbene, an antioxidant in blueberries identified in trace amounts.
“Scientists constantly uncover new and beneficial plant compounds,” the brief added. “When future technological and scientific leaps reveal these compounds in trace amounts, the majority’s decision will preclude their use in presumptively marketable supplements no matter how beneficial they may be.”
Hi-Tech requested the Eleventh Circuit in Atlanta grant a rehearing and reverse the decision of the U.S. District Court for the Northern District of Georgia.
An FDA spokeswoman, Lindsay Haake, said the agency does not comment on pending litigation.