Sales Of Drug-Spiked Rhino Supplements Trouble FDA After Importer's Arrest
This article was originally published in The Rose Sheet
FDA's consumer warning about "Rhino" brand male enhancement products "due to a recent rise in reported health issues" marks latest detected use of ED ingredients in products fraudulently labeled as supplements and latest example of businesses flouting s regulatory framework that allows sales of most supplements without any pre-market approval process. FDA also uses announcement to recommend consumers ask for a health care provider's advice before "using or considering using any product marketed as a dietary supplement."
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Warning letter says Empire Distributors sold product branded “Rhino Black 5K Plus” that FDA analysis found contained sildenafil and tadalafil. FDA officials found on its websites, including an Amazon.com storefront, supplements bearing others brands used for products previously found with ED ingredients, including "Black Mamba Premium,” “Libigrow,” ““Rhino 25K,” and “Stamina-Rx.”
Importer Pure Assay Ingredients, owners Lynn Chau and Bao Luu charged in seven-count indictment with conspiring to deceive US Customs with stimulants labeled as melatonin, sucralose or other dietary ingredients. Also charged are two Chinese citizens who worked for Pure Assay in Chengdu, China, to bring the illegal substances to the US.
FDA has little priority, and limited resources available for finalizing its 2016 draft guidance on NDI notifications and for establishing a process that certifies dietary ingredients as being available before October 1994, says regulatory attorney Miriam Guggenheim.For both of those developments, she says, "I'm not holding my breath."