Waiting For Cannabidiol Guidance? US FDA Reminds Industry Of ‘Many Other Requirements’
Two months after submitting CBD enforcement draft guidance for OMB review, FDA published separate draft guidance on studies for bioequivalents of an approved cannabidiol-based drug. But the draft guidance that the supplement industry awaits in pitched anticipation remains under review.
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At FDLI annual meeting, attorneys cast doubt on CBD rules outlook. Paul Joseph says regulations are at least a year away while Jonathan Havens doubts FDA is even working on regulations, including GMPs, because it is still asking industry for specific safety details.
Four major trade organizations applauded the introduction of HR 8179, which would remove statutory impediments to CBD’s lawful use in dietary supplements, subjecting CBD to the same requirements in place for any new dietary ingredient. The Natural Products Association, on the other hand, is calling the bill a misstep.
FDA’s latest COVID-19 warnings note fewer violative claims than identified in previous warnings to consumer health firms. One had a single noncompliant claim on its website, while another’s violations included identifying potential symptoms of COVID-19. Four men associated with a Florida church face counts of conspiracy to defraud the US and of contempt of court stemming from COVID-1 claims for a bleach solution.