Pharmaceutical

More than $2 million in illegal dietary supplements seized from Hi-Tech Pharmaceuticals by the FDA

fda logo More than $2 million in illegal dietary supplements seized from Hi Tech Pharmaceuticals by the FDADue to the presence of the unapproved food additives known as 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent, U.S. marshals have seized more than $2 million worth of dietary supplements manufactured and held by Hi-Tech Pharmaceuticals, Inc. at the request of the U.S. Food and Drug Administration (FDA) and its investigators.

According to the complaint filed in the U.S. District Court for the Northern District of Georgia, the illegal products were adulterated, as said by the Federal Food, Drug, and Cosmetic Act, because of the DMAA, an unapproved food additive found to be unsafe for the public.

The use of DMAA has been outlawed after researchers found that it causes elevation of blood pressure which could possibly lead to cardiovascular problems including heart attack, shortness of breath and tightness in the chest area. This biological activity found within DMAA leads the FDA to believe that it may also be particularly dangerous when paired with caffeinated substances.

The FDA encourages consumers to always check product labels and avoid any dietary supplement containing DMAA, which can referred to on different product labels with a variety of names that can be found on the FDA’s DMAA Q&A page.

“This company has a responsibility to ensure its products are safe for distribution and human consumption,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “We have taken action to protect consumers and demonstrate our commitment to their safety by keeping these products from entering the distribution system.”

Beginning in October 2013, the FDA inspected Hi-Tech Pharmaceuticals, Inc. in order to identify the following 11 products labeled to contain DMAA or its chemical equivalent:  Black Widow, ECA XTREME, FASTIN, FASTIN-XR, Lipodrene, Lipodrene HARDCORE, Lipodrene XR, Lipodrene XTREME, LIPOTHERM, Stimerex-ES, and YELLOW SCORPION.

Bulk DMAA’s raw ingredients were also observed by the FDA’s investigators at the Hi-Tech Pharmaceuticals facility. On Nov. 1, 2013, the FDA placed an administrative detention on the company, causing it to temporarily hold the products until seizure.

Supplements containing DMAA have been linked to numerous reports of illnesses and death by means of heart problems and nervous system or psychiatric disorders, the FDA has found. Consumers that have witnessed or suffered an adverse event or illness believed to have been related to the use of a dietary supplement can report it by calling 1-800-FDA-1088 or visiting the FDA’s website. The consumer’s health care provider can also report health issues involving a dietary supplement by calling the FDA’s MedWatch hotline at 1-800-FDA-1088.

In order to remove all of dietary supplements containing the illegal food additive DMAA from the market, the FDA issued warning letters in 2012 notifying companies that products containing DMAA need to be taken off the market or reformulated to remove this outlawed substance.

Source:
FDA