FDA scientists have found a "non-natural" amphetamine-like compound in nine dietary supplements, according to a scientific journal article.
For the second time in recent weeks, scientists have found a "non-natural" amphetamine-like compound in dietary supplements – yet federal regulators have issued no warnings to consumers about the ingredient.
Tests of 21 supposedly all-natural supplements by U.S. Food and Drug Administration scientists found nine products that contain the compound, according to their findings published in the Journal of Pharmaceutical and Biomedical Analysis.
All 21 of the supplements list an ingredient called Acacia rigidula, which is a bushy plant found in Texas and Mexico. The FDA scientists reported they couldn't find the substance in verified samples of the plant. The compound appears to have never been tested for safety on humans, they said.
FDA officials would not comment on their study or release the names of the supplements tested or the nine found to contain the compound, beta-methylphenethylamine. The Acacia rigidula supplements tested were marketed for such things as weight loss, energy boosting and mood stabilizing, their paper said.
"This is a brand new drug being placed into a number of supplements under the guise of a natural ingredient," Pieter Cohen, an assistant professor at Harvard Medical School, said after reading the FDA's paper.
Cohen was part of another research team that last month reported finding a methamphetamine-like compound in a popular pre-workout supplement called Craze. Cohen expressed dismay that the FDA hasn't issued any warnings to the public about Craze or the nine supplements flagged in the new research paper. The FDA has known about the nine supplements since at least July 15, the date that agency scientists submitted their article to the journal.
"The laws are incredibly weak," Cohen said, "but the FDA is not moving as fast as it could to remove hazardous products."
Acacia rigidula is listed as an ingredient in several weight loss and energy supplements made by Hi-Tech Pharmaceuticals of Norcross, Ga., including Fastin-XR, Stimerex and Lipodrene Hardcore, according to a USA TODAY review of dietary supplement labels compiled in a National Institutes of Health database. The company has had repeated run-ins over the years with federal regulators over ingredients and marketing practices, records show.
The FDA announced Monday it seized $2 million in supplements last week from Hi-Tech that contained the controversial stimulant ingredient DMAA. The Federal Trade Commission is seeking to send Hi-Tech's president, Jared Wheat, back to prison for contempt of court, alleging breaches of sanctions stemming from a false advertising claims prosecution in 2004, court records show. Wheat was sentenced to 50 months in federal prison in 2009 for conspiracy to commit wire and mail fraud, and introduction of unapproved new and adulterated drugs into interstate commerce, prison records show. He was released from the sentence in 2011.
Wheat said he's used Acacia rigidula in supplements for several years without receiving any reports of safety problems. Wheat said the FDA has never mentioned any concerns about Acacia rigidula and had not heard of the agency's study until contacted by USA TODAY. Wheat points to a 1998 journal article by Texas A&M scientists about compounds found in the plant as proof that the substance is naturally occurring. "They're just absolutely wrong," Wheat said of the FDA scientists' statement that the compound is "non-natural."
The FDA's scientists, in their journal article, noted that the Texas A&M study provided little information about how those earlier tests were done.
Wheat's company sued the FDA this month, alleging the agency has engaged in a wrongful "campaign of intimidation" against supplement makers using DMAA. The FDA has said it is unaware of any "reliable science" documenting that DMAA is found naturally in plants and says the ingredient carries health risks, including heart attack and neurological and psychological conditions. Hi-Tech, in its lawsuit, contends — as have some other companies — that DMAA is naturally found in a type of geranium plant and points to four studies it says prove it's natural.
Several Hi-Tech supplements list both DMAA and Acacia rigidula among their ingredients.
Wheat said he believes his company is the largest supplier of Acacia rigidula in the country, supplying the ingredient or making supplements for other companies. Wheat said the chemical signatures published in the FDA's research paper indicate to him that six or seven of the nine flagged supplements are likely made by his company.
Another company, iForce Nutrition, lists Acacia rigidula as an ingredient in its Dexaprine XR weight loss supplement. Dexaprine has been the subject of safety warnings from Dutch health officials. Officials at iForce Nutrition didn't respond to interview requests.
Steve Mister, CEO of the Council for Responsible Nutrition, a supplement industry group, said if there's a health risk, the FDA should name names and take swift enforcement action. Mister said companies should have the right to synthetically reproduce compounds found in plants, "but companies that are creating analogues of amphetamines and claiming they come from plants are doing something illegal and potentially dangerous for consumers."
The FDA's research paper notes that an athlete was disqualified in May 2012 after anti-doping tests detected beta-methylphenethylamine in the athlete competing in the International Canoe Federation's European qualifying competition for the 2012 London Olympics.
Amy Eichner of the U.S. Anti-Doping Agency said Acacia rigidula appears to be the latest in an industry trend of spiking dietary supplements with stimulants. "Due to this practice by some in the supplement industry, USADA continues to warn athletes about the dangers of dietary supplements, including those that claim to be herbals," she said.
To read more articles in USA TODAY's "Supplement Shell Game" series, go to: supplements.usatoday.com
Follow USA TODAY investigative reporter Alison Young on Twitter: @alisonannyoung