Supplements maker puts ephedrine back on market

Pump Nutrition owner Aaron Garza said in media reports that his company’s products were legal because they were derived from different alkaloids to those banned by the Food and Drug Administration (FDA) in 2004.

The ban followed a series of adverse events linking ephedra, also known as ma huang, with severe health problems including a professional sportsperson who died less than 24 hours after using ephedra to help control his weight.

The Mayo Clinic says possible health risks associated with ephedra include high blood pressure, heart rate irregularities, sleeplessness, seizures, heart attacks, strokes and death.

Since 2004, there have been legal challenges to the ban from supplements manufacturers that felt it disproportionate, but these have not succeeded and the Chinese herb remains off-market.

The Pump Nutrition product - XP2G – comes in capsule form and lists ma huang and sida cordifolia as active ingredients. It also bears claims that it can promote weight loss.

Ban sources​

​The FDA says ma huang​ and sida cordifolia​ are sources of banned ephedrine alkaloids.

But Garza said despite the use of the same sources, Pump’s formulations contained no banned alkaloids and hence did not present the public health threat of other ephedra alkaloids.

Because of this, it did not have the same metabolism-raising effect as ma huang.​

A Texas Department of State Health Services (TDSHS) spokesperson said product testing was required to determine the presence of otherwise of banned substances.

The TDSHS spokesperson told The Monitor ​newspaper: "What these people have done is realized there's a few plant species in the ephedra family that don't contain any of those six (banned) chemicals. Technically, they can still call it ephedra, because they've sidestepped that ephedra alkaloid (prohibition)​.”

University of Maryland professor Dr Fermin Barrueto questioned the legality of the products, calling their marketing a “gimmick”.​

Extraction​

Only via a complicated extraction process could banned substances be removed from products, a rare action and one that was unlikely to be performed by a small company like Pump.

She said it's still a difficult area for regulators, since the only way to verify claims like Garza's is through laboratory testing of the supplements in question.

Ephedrine, a stimulant and thermogenic, is banned as a food or supplement ingredient in the European Union as it is in most international jurisdictions.

Ephedra​ supplements have been used by sportspeople and those in training environments because its 'herbal speed' associations are thought to boost performance. Its ability to raise metabolism also made it a favourite in the weight loss sector.

The 2004 US ban was preceded by the death of a professional baseball player who was found to have toxic levels of ephedrine, one of the active constituents from the ephedra plant, in his system.