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.
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FDA warns Wave Miami that its Lipro Dietary Capsule weight loss product contains tadalafil and the firm has not recalled it despite requests from the agency. FDA says the firm makes claims including helping users lose 30 pounds in 30 days.
FDA provides "step-by-step instructions on how to convert" units of measure for folate, niacin and vitamins A, D and E to units required in the agency's 2016 final rule for Supplement and Nutrition Facts labels. Compliance date for firms with sales of $10m and up.
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.”