ED-Spiked Supplements Sold On Amazon Fill US FDA’s Recall Plate
Announcements for seven adulterated male sexual enhancement products were published across the work week, concluding with NANA Collection LLC’s products branded PremierZen Platinum 5000, found with undisclosed tadalafil, and Triple SupremeZen 3500, found to contain tadalafil and sildenafil, on 2 April.
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CDER compliance office director Donald Ashley offers a cautionary note to temper expectations for the FDA’s enforcement in the supplement sector. “We continue to warn the public about products very often sold as dietary supplements that contain hidden drugs,” he says.
Contract manufacturer showed compliance with Supplement Safety & Compliance Initiative standards to globally harmonize benchmarks for natul products. Retailers including Amazon and Walmart acknowledge SSCI as benchmarks companies must meet in order to sell products on their platforms.
Amazon requires firms selling supplements on its site in the US to demonstrate their products comply with FDA regulations for labeling and GMPs. Marketers that don’t submit documentation face removal of their products from the site.