Malcolm Spicer, Managing Editor – US
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Latest From Malcolm Spicer
While contract manufacturer ABH Nature' complied with consent decree, Sen. Chuck Schumer says FDA is late in enforcing against noncompliant firms across the supplement sector. Other recent consumer health recalls include more OTC ranitidine tablets due to the potential carcinogen NDMA found in the heartburn ingredient and four versions of Sure 48HR Anti-Perspirant & Deodorant with labeling errors.
Bounce Back Drinks sought to establish its bona fides as a registered consumer product provider, but statements referencing ASA, EFSA and MHRA imply the agencies reviewed and approved its product and advertising. Plus, hangover remedy claims are prohibited under UK regulations.
CDER Office of New Drugs changes its organization including establishing Office of Nonprescription Drugs and splitting the office into Division of Nonprescription Drug Products I and DNDP II. A Division of Regulatory Operations for Nonprescription Drugs will be comprised of regulatory staff from the ONPD divisions and will report to OND’s regulatory office. Non-clinical ONPD staff will report to the office director.
FDA has little in the way of good information it can list on its CBD policy agenda so far, says Principal Deputy Commissioner Amy Abernethy. At recent regulatory conference, she said, "Like it or not, there is a massive human experiment going on right now. There’s CBD in most different product categories and people of many different backgrounds with potential vulnerabilities taking CBD."
“We ought to deal with this. There are questions on long-term safety and questions on efficacy claims that are just not proven,” says the Maryland Republican. “The biggest threat hanging over, in my mind, the farmers who want to grow hemp, is what if the FDA comes out tomorrow and says, ‘You can't sell any product’? The market collapses,”he said at a CBD policy conference.
Minnesota Democrat Collin Peterson’s bill, the first targeting FDA’s CBD question, could provide an entire answer or it could set table for discussion in Congress about legislation on establishing an FDA regulation on using CBD, and potentially other hemp-derived substances, in products other than drugs subject to its oversight.