![]() In 2018, the FDA approved CBD for use in the Epidiolex pharmaceutical for treatment of seizures associated with rare and severe forms of epilepsy. It also provides a basis for the argument that CBD should not be precluded by the drug exclusion rule but be considered a new dietary ingredient. “Yet the FDA refuses to review this same data.”ĬbdMD has filed a citizen petition with the support of the Natural Products Association requesting that its safety study have the opportunity for review in the US. ![]() “The safety study cbdMD executed on our broad-spectrum extract covered multiple systems and was more than sufficient for the rigorous review in the UK and EU,” she said. Swift referenced the extensive safety data submitted to the United Kingdom Food Standards Agency and European Food Safety Authority, which recently validated the cbdMD’s novel food application for its broad-spectrum CBD formulation. ‘Plenty of safety data’ĭuring the open hearing portion, industry players like NSF International, an independent product testing, inspection, certification organization headquartered in Ann Arbor, Mich., agreed that there is “plenty of safety data on CBD”, both in publicly available literature and from companies around the world. ![]() “ However, they continue to ignore recent studies that demonstrate that CBD does not pose significant safety concerns at the levels typically found in many dietary supplements and foods, and that also address the specific safety concerns raised by FDA,” he added. Jonathan Miller, general counsel to the US Hemp Roundtable, also expressed disappointment, noting that that FDA staff once again blamed lack of progress on safety concerns emanating from studies of the high dose CBD prescription drug Epidiolex. “I appreciate that we were provided the opportunity to speak, but after watching the entire day of presentations from FDA, particularly those in the afternoon session, I am left with the impression that FDA does not actually understand the dietary supplement industry,” Swift added. Commenters provided their views in an open public hearing prior to the session. In the afternoon, the agency focused on its own ongoing CBD safety reviews and concerns. Swift has also served as Senior VP for Scientific & Regulatory Affairs at the Natural Products Association and as associate director for research and strategy at FDA.ĭuring the daylong session, FDA experts highlighted the scientific and regulatory challenges of marketing CBD and other cannabinoids as dietary supplements due to their pharmacological effects. “I view Tuesday’s FDA Science Board hearing as another delay tactic,” Sibyl Swift, vice president of Scientific & Regulatory Affairs at CBD brand cbdMD, told Nutra Ingredients-USA. ![]() With thousands of CBD products on the market and clear consumer demand, industry advocates say that the stalling has only led to the proliferation of unregulated and potentially harmful products. China: Probiotic supplements in e-commerce.Digestion and immunity probiotic supplements in e-commerce.Explained: The US e-commerce probiotic supplements market.Probiotic supplements: Global e-commerce 2018-2020, forecast for 2021.The gut-brain axis: Psychobiotic opportunity in 25 countries.
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