Researchers have determined that several dietary supplements — some of which are available in GNC stores on military bases — contain a synthetic stimulant never tested in humans.
A report published online Oct. 8 in Drug Testing and Analysis found a compound, DMBA, or 1,3-dimethylbutylamine, also marketed as AMP Citrate or 4-amino-2-methylpentane citrate, in 12 dietary supplements marketed as weight loss supplements or pre-workout boosters, available online and at some GNC and Vitamin Shoppe stores.
But according to the researchers from Harvard Medical School, the Netherlands Health Protection Center and NSF International, DMBA is closely related to the banned stimulant 1,3-dimethylamylamine, DMAA, and has not undergone rigorous scientific testing.
“We found that at least a dozen supplements sold by U.S. distributors contain DMBA in dosages from 13 to 120 mg per serving. Given the potential health risks of untested pharmacologic stimulants, we strongly recommend that manufacturers immediately recall all DMBA-containing supplements,” the researchers wrote.
The tested supplements include a product called AMP Citrate, marketed by GenomyxLLC, AMPilean from Lecheek Nutrition, and Frenzy, a new product from Driven Sports that is not sold in the U.S. online or through stores.
Frenzy is marketed by the same company that pulled another product, Craze, from shelves in January after it was found to contain an unlisted ingredient similar in molecular structure to methamphetamine.
Marc Ullman, an attorney for Driven Sports, said Oct. 8 that like previous research conducted on Craze by the same scientists, the most recent review in Drug Testing and Analysis is simply a report and not a study subject to peer review.
The article, according to Ullman, makes several false claims — like noting that no evidence on human safety is needed to market dietary supplements in the United States — that should “call for serious skepticism of the rest of” the researchers’ work.
“[Driven Sports] takes great exception to the authors’ efforts to falsely imply that this product is available for sale to U.S. consumers. It is not. … Driven Sports determined not to offer Frenzy for sale in the U.S. because it contained a bioidentical synthetic version of a botanical ingredient,” which U.S. law does not allow, Ullman said.
Ullman added that the company has sent a libel letter to the researchers urging them to retract any statements about Frenzy in the report or face legal ramifications.
Dietary supplements are not as tightly regulated by the FDA as medications. By law, companies that make and sell supplements are responsible for determining that they are safe, and in the case of a new ingredient, must provide the FDA with the evidence it relies on to substantiate safety or effectiveness.
Manufacturers and organizations that represent the dietary supplement industry argue that the system works because companies must police themselves to stay in business and are required to meet safety and efficacy standards.
But consumer advocates and lawmakers pressing for tighter industry regulation say the system gives companies free rein to use questionable ingredients in their products, placing consumers at risk.
In 2011 and 2012, three soldiers who died of heart failure during physical training were found to have used DMAA-based products Jack3d or OxyElite Pro, prompting the Army to conduct a study of the ingredient.
The research concluded there wasn’t enough evidence to prove the ingredient caused the soldiers’ deaths, but a Pentagon safety panel found nonetheless that DMAA posed enough of a health risk that it should not be sold in any base facilities.
In late 2013, the reconfigured OxyElite Pro was pulled from GNC shops on base and Navy and Marine Corps exchanges after it was implicated in at least 47 cases of acute hepatitis and liver failure in Hawaii.
The maker of OxyElite Pro said the product likely was tainted, but the FDA determined that that supplement contained a new ingredient, aegeline, which was not proven as safe.
At least two of the products tested in the most recent report are marketed as containing DMBA derived from pouchung tea.
The researchers said they found no evidence, other than a small Chinese study, that DMBA can be extracted from tea — and if that study were true, manufacturers would still need 2,200 pounds of tea to extract 12mg of DMBA.
Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., issued a statement Oct. 8 asking the FDA to inspect products containing DMBA and to issue warning letters to manufacturers if necessary.
“We urge you to exercise the full range of your authority to rein in adulterated and misbranded products, which includes warning letters to facility inspections, product seizures, injunction and criminal prosecutions,” the senators said.
The lawmakers have been pressing for legislation that would mandate more detailed labeling on supplements and require manufacturers to register products and ingredients and provide proof of health claims.
An FDA spokesman said the administration is aware of the recent DMBA report and said officials “will consider taking regulatory action as appropriate to protect consumers.”
“We take this matter seriously and are considering the next steps,” FDA spokeswoman Jennifer Corbett Dooren said.
Dr. Pieter Cohen, an assistant professor at Harvard Medical School and co-author of the DMBA paper, said the FDA is not doing enough to protect consumers.
“These are the kind of drugs people would have to go out and find for ‘legal highs,’ such as bath salts. In the past, these kind of designer stimulants were used by people who knew they were experimenting with their health, but now we are seeing them in mainstream supplements,” Cohen said.
The products containing the ingredient are:
Contraband
Redline White Heat
Evol
MD2 Meltdown
OxyphenXR AMP’D
OxyTHERMPro
Oxyfit Xtreme
Synetherm
AMPitropin
Decimate Amplified
AMPilean
Frenzy
No comments:
Post a Comment