The US Food and Drug Administration’s latest regulatory goals update includes October as the target date for publishing final rules on moving more drug ingredients to OTC and on exemptions from investigational new drug clearance for clinical trials to evaluate food, dietary supplements or cosmetics.
ACNU Switch And IND Exemption Final Rules Targeted For October In FDA Regulatory Goals
Semi-annual regulatory agenda of non-binding target dates also sets December goal for an NPRM to recognize N-acetyl-L-cysteine as a lawful dietary ingredient. Like IND exemptions rule, item on NAC included for first time in FDA’s list.
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In response to an IPA Europe complaint, European Ombudsman Emily O’Reilly finds that the Commission’s interpretation of EU food legislation in relation to probiotics is “reasonable and in line with the main goal of this legislation, which is to ensure a high level of consumer protection.”
Vitamin, mineral and supplement products “may bear nutrient content claims, including ‘healthy,’’ if they meet structure/function claim criteria “without being subject to the requirements of the ‘healthy nutrient content claim” stated in the final rule FDA published recently.
UK food toxicity committee says substantial exceedances of the Acceptable Daily Intake of turmeric - such as through excessive supplement use - represents a potential health risk to humans.
Texas bill filed in advance of the state’s next legislative session starting in January while bills proposing prohibiting sales of supplements and OTC drugs for weight loss or bodybuilding to minors remain active in three states where current sessions continue, Massachusetts, Michigan and New Jersey.
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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.”