Nuway Distributors LLC recalled APEXXX after FDA tests found the products, which were marketed as dietary supplements, contained sildenafil, the active ingredient in the erectile dysfunction (ED) drug Viagra. This incident is another reminder to the supplement industry to test ingredients and products, and verify the supply chain.
"As Nuway Distributors LLC receives this product from overseas in a sealed package, representing that it contains only lawful and legitimate ingredients, we are relying on the representations of the Food and Drug Administration that the public interest would best be served by voluntarily complying with their request to get the product off the shelves," stated Nuway Distributors in a press release from FDA. “Our goal is to protect the safety of the consumer."
APEXXX was marketed as a dietary supplement for male sexual enhancement, and was sold from June 2014 to June 2015 in a retail store located in Orlando, Florida for further sale in smoke shops, convenient stores and gas stations. APEXXX may also have been further sold online, according to the FDA press release.
Including pharmaceuticals in supplement products is illegal per the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Nuway is also removing lots of another product—OPAL tablets—because it is sourced from the same vendors as APEXXX.
Supplier verification is so important in the supplement industry, and brands need to do their due diligence. Relying on the vendor’s word or certificate of analysis (CoA) is not enough. This will continue to be an issue in 2016, and I noted in my 2016 predictions blog. The time to verify the supply chain is now.