According to the notification published on the EU’s Rapid Alert System for Food and Feed (RASFF) a batch of “unauthorised novel food ingredient aegeline (presence) in super thermo powder from the US” bound for the Netherlands and Germany was detected at the German border.
Back in 2013 our sister publication NutraIngredients-USA reported that aegeline (also known as N-[2-hydroxy-2(4-Methoxyphenyl) Ethyl]-3-Phenyl-2-Propenamid) had been put under the regulatory spotlight after USP Labs' product OxyElite that contained the ingredient was linked to liver damage in Hawaii.
The US Food and Drug Administration (FDA) sent the company a warning letter at the time ordering them to stop distribution because the weight loss and muscle building product contained aegeline - something it classified as a new dietary ingredient (not marketed in the US before 15th October 1994). The FDA said the company failed to prove that the ingredient was safe.
USP Labs’ lawyer Peter Barton Hutt told us he and his European colleagues from the law firm Covington & Burling were in contact with the German Federal Office of Consumer Protection and Food Safety (BVL) to determine whether the products in question were OxyElite.
The product was officially recalled in the US in 2013, and an international campaign to return the products was also launched. “To the best of their knowledge [the products blocked by Germany] should not be their products,” Hutt said.
However, he said it was impossible to guarantee that all had been returned to the company. If it was found to be OxyElite, two other possibilities remained: that the product was left over stock from before the recall or it was counterfeit, something the firm said it had had issues with in the past.
The BVL told us it could not disclose more information since details of the RASFF alerts were confidential under article 52 of the European General Food Law.
The spokesperson said the system was an internal network designed to swiftly exchange information between national authorities on health risks related to food and feed. However, this specific product information was communicated amongst other national authorities.
The US and German regional authorities had been notified, he said.
Defining the matter
In the past the company said the ingredient had a long safe history of consumption through its botanical origin Bael (Aegle marmelos), a citrus fruit tree found in some parts of Asia. The FDA said the ingredient was a synthetic version of an alkaloid that existed naturally in the tree. Regulators in Europe considered it to be an unauthorised novel ingredient and in the US it would need to apply for new dietary ingredient status via the FDA.
The German authority's spokesperson said: “In October 2013 the novel food status of aegeline was discussed, triggered by a warning for the food supplements OxyElite Pro and Versa-1 by the FDA in the US, as a consequence of several cases of non-viral hepatitis, which were brought in connection with this substance.
“The competent food safety authorities of the federal states were consulted: Bavaria, Saxony-Anhalt and Saxony indicated, that no significant consumption as food or food ingredient neither for the plant parts of the Bengali quince nor for the substance aegeline is known in Germany before the 15th of May 1997.”
The UK authority also considered it to be a novel substance, the BVL said. At the time of the liver damage cases, the UK's Food Standards Agency also warned against another USP Labs product VERSA-1, which contained the disputed ingredient.
The product - as well as USP Labs' Jack3d - was also subject to international bans for its use of the controversial stimulant DMAA. This ingredient was later cut from the products by the firm.