A US firm with drug and dietary supplement manufacturing quality control problems and an Indian firm inadequately testing for diethylene glycol in an ingredient typically used in toothpaste are among the consumer health businesses recently warned by US regulators.
US FDA Warns NJ Firm On Drug And Supplement GMPs, Indian Firm On Diethylene Glycol Testing
Agency’s latest posting of warning letters submitted also includes more warnings about OTC hand sanitizer production failing to meet GMP requirements.
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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.”
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.
In first of two articles from recent interview, president and CEO Steve Mister discusses examples the trade group provides for self-regulation, “where people or companies who might not do it on their own because it would put them at a disadvantage if they were the only ones.”
The Federal Trade Commission’s Consumer Protection head Sam Levine says bipartisan leaders at the state and federal levels are taking on consumer protection issues like never before and using the FTC’s approach as a model for legislation.
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Latest regulatory goals update also includes April as target date for final rule on exemptions from IND clearance for clinical trials to evaluate food, dietary supplements or cosmetics and May for an NPRM would recognize N-acetyl-L-cysteine as a lawful dietary ingredient.
FSA now aims to send the first recommendations for the authorization of CBD novel food products to UK government ministers in 2025, according to its most recent board meeting. The agency is closely scrutinizing trace THC levels and is planning to ban use of CBD food products by under 18s.
Direct-selling giant say “despite widespread use, nearly half of respondents – 47% – mistakenly believe that the FDA approves these products before they are sold to the public.”