FDA disapproves of widely-distributed diet supplement
Users of dietary supplements in New Jersey and the rest of the nation are warned to steer clear of an ingredient called aegeline in two products sold at GNC and on the internet. Physique Enhancing Science or PES sells two products that are known to contain aegeline: Enhanced, a pre-workout product and Alphamine, a post-workout product.
PES posted on their website that they were reformulating their aegeline-containing products, and later announced that they would be discontinued. The recall is effective for Alphamine that was distributed from Sept. 9 to Nov. 12, and recall of Enhanced pertains to products distributed from Feb. 4 to Nov. 5. Consumers are asked to return these products to the vendor for a refund.
The Food and Drug Administration flagged the mysterious ingredient, that is claimed to be derived from an Asian tree, in a prior investigation involving liver traumas that could have resulted from the use of aegeline. The FDA says that they do not have enough information about aegeline to know if it is safe for human consumption. Media reports do not indicate if the FDA forced the PES recall or if the company took action alone.
The widespread distribution of a potentially threatening ingredient that is not approved by the FDA poses serious a product liability issue. We have seen countless cases like this in the dietary supplements industry, some of which result in fatalities and other in grave health complications. Attorneys and their clients should work to hold this company accountable for their negligence in selling a non-FDA approved supplement despite the known risks.
Source: USA Today, “Ingredient spurs firm to recall two sports supplements“, Alison Young, November 21, 2013