RegeneSlim Appetite Control Capsule Under Drug Recall for Undisclosed DMAA

Regeneca Worldwide, a division of VivaCeuticals, Inc, has issued a drug recall after the FDA discovered an undisclosed stimulant in its diet capsules, RegeneSlim.

An FDA analysis confirmed the presence of DMAA, or 1,3-dimethylamylamine, methylhexanamine, or geranium extract. DMAA was commonly used as a pre-work out stimulant and weight loss ingredient in dietary supplements, but it can cause arteries and blood vessels to narrow, leading to a rise in blood pressure that can trigger cardiovascular problems such as shortness of breath, arrhythmia, tightening of the chest, and heart attack.

The FDA banned the use of DMAA in workout and dietary supplements after the death of two US soldiers who used products containing DMAA as part of a workout routine. At least three other deaths have been associated with the dietary supplement.

A number of other countries heavily regulate the use of DMAA in sports and on pharmacy shelves. While some small dosages are allowed, the stimulant can be dangerous in amounts greater than 4 mg per dose.

There have been no reported cardiovascular incidents or other illnesses associated with the supplement.

Regenenca is investigating how DMAA was introduced to RegeneSlim.

The lot numbers under drug recall are lot # EX0616R15814 and lot #11414RE5516, and the company recommends that any consumer with those lot numbers immediately stop using the product and return it to the place of purchase for a full refund.

The FDA and Failure to Regulate Dangerous Drug Recalls

Mitchell Katz, MD, said in an editor’s note that the number of dangerous drug recalls ”grossly underestimates the number of products on sale with unapproved ingredients.”

“Dietary supplements should be treated with the same rigor as pharmaceutical drugs and with the same goal: to protect consumer health,” Katz wrote.

A 2011 study conducted by Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School, found that even supplements that had fallen under Class I dangerous drug recalls could still be purchased. According to Cohen, although the FDA issued the serious recall, it was still voluntary because the FDA has no oversight specifically over supplements. For example, the weight loss supplement Pai You Guo, recalled in 2009 because it contained a banned dangerous drug, could still be bought in 2011.

In March 2013, the FDA issued a notice to consumers that many sexual enhancement drugs contained unreported pharmaceuticals, including Viagra.

Cohen suggested that consumers who want to buy supplements should stick to those with only one ingredient, or just vitamins and minerals. Consumers could also look for supplements that have been certified by the US Pharmacopeial Convention or NSF International, which can provide assurance that the supplements do not contain illegal or unregulated pharmaceuticals.

The Strom Law Firm Can Help with Dangerous Drug Recall Cases

Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous drug recalls and defective devices. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using a dangerous drugs such as dietary or weight loss supplements with undeclared ingredients, contact our dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800