Another 'Rhino' Marketer Horned By US FDA About ED-Spiked Supplements
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.”
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FDA warns 10 businesses they’re marketing unapproved and misbranded drugs by making claims for supplements to treat depression. Supplement also found with one of, if not the most common violations in the US supplement market: it contained an undisclosed ED drug.
HBW Regulatory Roundup: Spiked 'Vitamin C' Found, SC Johnson Facility GMP Problems, AHPA Labeling Guidance
Fitoterapia USA recalls 190,000 bottles of Metro Macho Artificial Passion Fruit Flavored Vitamin C Liquid Supplement tainted with tadalafil; FDA sends GMP warning letter to SC Johnson facility making antimicrobial hand soaps ; and AHPA revises its herbal supplement labeling guidance.
FDA's notice for a May 16 public meeting say it intends to ensure its "regulatory framework is flexible enough to adequately evaluate product safety without unnecessarily restricting innovation." But FDA makes clear adherence with its NDI notification requirement is focus of the spurring improvement in VMS product industry's overall compliance with regulatory framework established by DSHEA.