The US Food and Drug Administration has warned Amazon.com about its distribution of products labeled as dietary supplements but containing undisclosed erectile dysfunction drugs 10 months after it began warning consumers about the products bought on the e-commerce giant's site.
Amazon Receives Year-End Greetings From US FDA
Warning references consumer alerts FDA published in February and August about products agency officials purchased on Amazon.com and determined to contain undisclosed sildenafil or tadalafil, PDE-5 inhibitors approved for use in Rx drugs with an ED indication.
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FDA says “extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.”
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UK industry association is offering online courses on subjects ranging from UK medicines regulations basics to deep dives on complex topics such as CBD.
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Trade group ready to work hand-in-hand with agency and other supplement industry stakeholders on potential regulatory changes or improvements, says president and CEO Steve Mister. “None of them are upsetting the basic balance of things that DSHEA was attempting to do, but there are things with 30 years that we've identified that need to be kind of fixed.”
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New Jersey Assembly passed bill amended to expand extensively in defining which products, or ingredients, would be subject to a ban on sales to consumers younger than 18.
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Eliminating self-affirmation process would require companies to publicly notify FDA of their intended use of ingredients and provide safety data before they’re introduced. Kennedy says the process is “a loophole” for introducing ingredients and chemicals “with unknown safety data.”
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Supplements already under close scrutiny in the EU have been linked to severe adverse effects on the musculoskeletal system and liver, even at low doses.
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Kyle Diamantas was a partner with the Jones Day firm when he was tabbed as acting deputy commissioner to lead the FDA’s Human Foods Program, established in the agency’s reorganization which became effective in October.