A recent FDA-driven shipment seizure targeting ephedra underscores a rebirth of the banned botanical ingredient as an adulterant.

FDA acknowledged that enforcement activity on ephedra has been a lower priority than other adulterants –particularly prescription drug active ingredients and their analogues – since ephedrine alkaloids were banned for use in supplements in 2004.

Daniel Fabricant, director of FDA’s Division of Dietary Supplement Programs, said ephedrine alkaloids are unique as an adulterant because they are not Rx ingredients or analogues, but “the ban’s there and they are illegal.”

“The presumption was that it was banned and people were abiding by the law. Unfortunately, those sorts of assumptions don’t always hold true, so we have to remain vigilant,” Fabricant said.

“We know that there has been just so much focus on the active pharmaceutical ingredients, specifically spiking with drugs,” said Cara Welch, the Natural Product Association’s VP for scientific and regulatory affairs.

On Dec. 6 in Rancho Dominguez, Calif., U.S. Marshals seized 4,000 pounds of raw materials – labeled as Cissus quadrangularis and Cassia angustifolia extracts – imported by a firm identified as Infinity Marketing Group, Inc. the agency said. The materials contained ephedrine alkaloid pharmacological compounds estimated to be worth more than $70,000. The shipping drums bore no labels indicating the material contained the banned ephedrine alkaloids, but FDA’s chemical analysis confirmed the presence of the alkaloids.

Undeclared Ephedra

Supplements containing ephedrine alkaloids had been promoted for weight loss, sports performance and energy, but data showed little evidence of the compound’s effectiveness except for short-term weight loss without any clear health benefit. Meanwhile, research showed the alkaloids raised blood pressure and otherwise stressed the circulatory system, effects linked to significant adverse health outcomes, including heart attack, stroke and death.

“It’s not just writing a warning letter, but actually getting to the source, seizing the material, getting it out of the marketplace. That’s the kind of FDA we need, some of these high-profile enforcements to really discourage people.”

–CRN’S Duffy MacKay

The Supreme Court in 2007 declined to hear an appeal of FDA’s decision to ban ephedrine alkaloids for use as a supplement ingredient Also see "Supreme Court Refuses Ephedra Case, Battle Against Risk-Benefit Continues" - Pink Sheet, 21 May, 2007..

Douglas “Duffy” MacKay, the Council for Responsible Nutrition’s VP for scientific and regulatory affairs, said although ephedra is not a pharmaceutical product, it still is among the ingredients bad actors will attempt to market in supplements.

“It’s these illegal actors looking for ways to do business. It’s the same group that would be willing to put unlabeled, illegal drug ingredients in a product,” MacKay said.

And those firms are meeting demand for their products, the trade group executives noted.

“There must be consumers looking for ephedra and there’s someone willing to break the law to sell it and it definitely needs to be addressed,” MacKay said.

“They’re going to keep coming up as we’ve seen with weight-loss products,” Welch said.

Seizure Sends Strong Message

MacKay added that the enforcement against Infinity Marketing may prove to be a deterrent.

“It’s not just writing a warning letter, but actually getting to the source, seizing the material, getting it out of the marketplace. That’s the kind of FDA we need, some of these high-profile enforcements to really discourage people.”

Fabricant would not comment on whether FDA anticipates additional seizures or other enforcement actions on ephedra-adulterated products. But he said there are other products available in the U.S. that contain undeclared ephedra.

“We’re aware of that there are some things like that out there in the marketplace,” he said.

While FDA is aware of the possible adverse events linked to ephedra ingredients and to some other adulterants, some supplements are marketed with violative ingredients about which little is known.

Fabricant pointed out the agency’s enforcement against spiked supplements runs the gamut of ingredients, from those well studied in clinical trials to those few researchers have seen.

“There are a number of them that not only have never been approved, but have never been trialed. They’ve never been put to any sort of clinical trial, so the safety margins are really unknown on those sorts of things and they are really concerning,” he said.

Ephedra Back On Regulatory Radar As Supplement Adulterant

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