The ruling on a consent decree sought by the Food and Drug Administration was issued by the Central District of California against VivaCeuticals (dba Regeneca Worldwide) and its owner Matthew A. Nicosia for the continued distribution products containing ingredients that FDA has ruled to be unsafe, including 1, 3-dimethylamylamine (DMAA).
FDA had sent the company a warning letter in 2012 taking the company to task over the presence of DMAA in its products. The company reportedly recalled lots of its RegeneSlim dietary supplement about two years after receiving FDA’s letter. DMAA, also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, has been commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. FDA has warned that DMAA is potentially dangerous to health as it can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack. It has also decided that the ingredient is synthetic, and not of natural origin, though some formulators claimed it was a derivative of geranium.
But according to FDA’s complaint, the company continued to sell DMAA-containing products after this date. “Despite assurances that Regeneca was correcting violations noted in the warning letter, Regeneca continued to distribute a dietary supplement that was found to contain DMAA,” the agency said in a statement.
Safe, or unsafe?
Not everyone agrees with FDA’s take on DMAA, although almost all of the major players who were manufacturing or marketing supplements containing the ingredient have gone along with FDA and have removed the ingredient from the market.
The lone above board hold-out on the DMAA front is Norcross, GA-based Hi Tech Pharmaceuticals, which has a number of DMAA products on the market. Hi Tech CEO Jared Wheat has sued FDA over its position on DMAA, and while the agency has declined to comment on a situation that includes ongoing litigation, the status quo seems to be hands-off on Hi Tech’s products while the case winds its way through the courts.
RegeneSlim was distributed through an independent sales force in the US and Puerto Rico and also through online sales. The company could not be contacted for comment on the injunction.
FDA said the consent decree prohibits Regeneca from marketing unapproved new drugs, and adulterated and misbranded dietary supplements. Before Regeneca can resume operations, the company must, among other things, hire good manufacturing practice and labeling experts, implement procedures to comply with good manufacturing practice and labeling requirements and receive written permission from the FDA to resume operations. In addition, the decree requires Regeneca to destroy all remaining products.