The Food and Drug Administration has four answers about N-acetyl-L-cysteine use as a dietary ingredient in the US: two answers close the door on requests to deem it lawful and the other two are maybes about a rulemaking to make it lawful and about allowing sales to continue in the interim.
NAC Gains Tentative Safety Clearance As US Industry Contests FDA's Attempt To Remove It
FDA answers reach supplement industry sounding like a siren that the agency may take same enforcement step it has with NAC with other ingredients long used in supplements. Answers also might not be enough to convince firms to return NAC-containing supplements to their lineups.
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HBW Insight catches up with PAGB CEO Michelle Riddalls to chat about the association's new five year plan. Riddalls also reflects on the successes of the last five years, including relaunching the UK Reclassification Alliance, which has published a list of Rx-to-OTC switches the government would like to see applications for. Part one of two.
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Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.
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Eisai aims to support people in Japan with severe heartburn and discomfort caused by gastric acid related conditions by switching from prescription to OTC status its Pariet-branded proton pump inhibitor.
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Reclassifying ethanol as a carcinogenic, mutagenic, or reprotoxic substance - something the European Chemicals Agency seems likely to do in the near future - would be “tantamount to a de facto ban” with “fatal consequences” for medical care in Germany, says Pharma Deutschland in a joint paper with 13 other German healthcare industry associations.
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Eisai aims to support people in Japan with severe heartburn and discomfort caused by gastric acid related conditions by switching from prescription to OTC status its Pariet-branded proton pump inhibitor.
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A round-up of the latest industry moves in Europe: Pharma Deutschland elects board of new Brussels operation; MHRA's new CEO gets to work; Futura names non-executive director.
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“If this doesn’t get reauthorized, look at the number of the ingredients out there, the number of products, what would happen all those products out there for the consumer, on that shelf, in the drugstore or someplace?” says Rep. Bob Latta during House hearing.