Several dietary supplements are being tested again in the United States and the Netherlands because of a new synthetic stimulant widely used in these products. The stimulant has been untested on humans. Federal regulators have taken no action, although the government has been urged by scientists to look closer.
The chemical DMAA, a stimulant as labeled by the U.S. Food and Drug Administration (FDA), is illegal when mixed with dietary supplements or any other product consumed by humans. DMAA is an ingredient that carries the risks of heart attacks, seizures and neurological problems. That compound is also listed on labels as AMP Citrate. AMP Citrate is a close relative of the compound DMAA.
Pieter Cohen, an assistant professor at Harvard Medical School and a co-author of an article of the scientific journal Drug Testing and Analysis, stated, “We want the FDA and we want the stores to immediately remove these products from the store shelves,” referring to products sold to the public containing DMAA. According to the research published, 14 products were tested that listed AMP Citrate, 4-amino, 2-methylpentane citrate or some of the other chemical names used to describe the new stimulant. According to Cohen, these are marketing names.
DMAA is a banned ingredient. The Council for Responsible Nutrition, a dietary supplement industry group, sent a letter to the FDA urging action on AMP Citrate. The group said that AMP Citrate is just another DMAA and made special note of stating that those companies who are selling and marketing the stimulant products are endangering the public. None of them have filed the required “new dietary ingredient” paperwork with the agency to substantiate its safety.
According to the council’s president, Steve Mister, the FDA has not responded. Mister believes that FDA has the power to conduct recalls and send out alerts, but it hasn’t done so.
According to a USA Today article, Sen. Dick Durbin (D-Ill.) and Sen. Richard Blumenthal (D-Conn.) have sent a joint letter to the FDA commissioner requesting that the agency take steps related to products that contain this stimulant.
The lists of the products that can be considered stimulants are sold at the large stores like Wal-Mart, GNC, Amazon.com and the big chain drug stores. The tests that were done showed that the stimulants varied in the products sold. For example, some products have larger amounts of the ingredient than others. The highest level of the AMP Citrate was found in a fat burner marketed by a company known as LeCheek Nutrition and the product is called AMPilean. The LeCheek Nutrition product has 120 mg of AMP Citrate per dose. Three other products delivered 110 mg per serving, which included:
• Frenzy, a pre-workout marketed by Driven Sports.
• AMPitropin, sold as a “brain enhancer,” also marketed by LeCheek Nutrition.
• MD2 Meltdown, a weight-loss product is sold and distributed by VTX Sports.
Smaller dosages per serving are found in products marketed and made by Iron Forged Nutrition, OxyThermPro made by deNovolads and Evol marketed and made by Genomyx.
In two other stimulant products, Preamp by Hybrid and Genomyx’s AMP Citrate were not detected.
Currently, the labeling for these products and others is incomplete because they do not list the new stimulant in their labeling for these products. A new pre-workout supplement known as Unstoppable is sold in the Netherlands where adverse affects have been reported. Individuals have found that after taking it, they have a feeling of rushing and difficulty sitting still. The company that makes Unstoppable, Dedicated Nutrition, was unwilling to respond to requests made for an interview requested by USA Today.
The world of dietary supplements is one that has associations with some less than reputable individuals and companies. For example, the pre-workout product Frenzy, which contains the new stimulant, is run by Matt Cahill, who was charged with a felony. Cahill’s company is Driven Sports. That company was also selling pre-workout Craze, which was featured in a 2013 USA Today investigation and story. Frenzy was banned for sales in the United States, but the company has a “Craze 2.0” that is about to be marketed soon, according to its spokesperson.
The case against Cahill is pending. Cahill is alleged to have put a supplement called Rebound XT sold around March 2008. It contained a drug that is used to reduce estrogen. In the Cahill matter, he is accused of illegally putting a supplement called Rebound XT on the market. The case is being prosecuted in the U.S. Attorney’s Office in San Jose, Calif.
The USA Today article indicated that if an adverse event is experienced to call the FDA at 800-332-1088 or contact this office for assistance. Alison Young of USA Today was the author of this recent and informative article on dietary supplements and their dangers.
Kreisman Law Offices has been handling dietary supplement product defect cases for more than 38 years in and around Chicago, Cook County and its surrounding areas, including Cicero, Joliet, Romeoville, Rosemont, Richton Park, Calumet Park, Riverdale, Hodgkin, LaGrange Park, Yorkfield, Oakbrook Terrace, Franklin Park, Schiller Park and Villa Park, Ill.
Related blog posts:
Use of Actos Suspended Across Europe After Studies Link Its Use to Increased Risk for Bladder Cancer
Dietary Supplements Make Up 20% of Drug-Related Liver Injuries
Insurance Liability Exclusion Upheld by Chicago’s U.S. Court of Appeals