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INSIDER Law
Scales of Justice 2019

FDA wins appeal over DMAA in dietary supplements

A decision Friday by the U.S. Court of Appeals for the Eleventh Circuit marked a victory for FDA and a loss for a dietary supplement manufacturer—Hi-Tech Pharmaceuticals—over the legality of an ingredient in dietary supplements. But the case may not be over.

A federal appeals court on Friday affirmed a lower court ruling that DMAA is neither an herb nor GRAS (generally recognized as safe) by experts.

The decision by the U.S. Court of Appeals for the Eleventh Circuit marked a victory for FDA and a loss for a dietary supplement manufacturer—Hi-Tech Pharmaceuticals—over the legality of an ingredient in dietary supplements.

FDA officials have long asserted DMAA poses potential safety concerns and doesn’t belong in dietary supplements. But in litigation pending for years, Hi-Tech has maintained DMAA is a safe and lawful ingredient in such products.

A three-judge panel of the Eleventh Circuit ultimately sided with the government, affirming a summary judgment order in 2017 that held DMAA is not a dietary ingredient.

“DMAA is not an ‘herb or other botanical,’” District Judge Robert Hinkle wrote in the Eleventh Circuit’s decision. “It is not a ‘constituent’ of an herb or other botanical. And it is not generally recognized by qualified experts, as adequately shown through scientific procedures, to be safe under the conditions of its intended use.”

Circuit Judge Gerald Tjoflat joined in Hinkle’s opinion. Hinkle is a District Judge in the Northern District of Florida, but sometimes judges hear cases in other courts in which they don’t ordinarily belong.

Circuit Judge Adalberto Jordan dissented, in part, from the majority’s opinion.

“As I read the statute and the record, the FDA was not entitled to summary judgment,” Jordan wrote. “I would remand for a trial on whether DMAA is a ‘constituent’ of geraniums.”

Jared Wheat, owner of Hi-Tech Pharmaceuticals, said Jordan’s interpretation was correct, and he said the company would seek an en banc rehearing. If granted, a full panel of about a dozen judges would hear the case.

An FDA spokeswoman said the agency does not comment on litigation.

 

TAGS: Ingredients
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