FDA Consumer Health Market Oversight Stays In Spotlight In Gottlieb's Final Week
In four days before Scott Gottlieb's stint as commissioner ended, FDA announced official start of initiative to consider regulatory pathways to make CBD compliant as a dietary ingredient, launched another shot across kratom sector's bow and noted more examples of e-cigarette marketers crossing regulatory lines.
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FDA for several years has noted opportunity for e-cigarettes and other electric nicotine delivery systems products to help adult smokers switch to a potentially less harmful form of nicotine delivery. "But we’ve also been clear that, even for adults, e-cigarettes are not risk free," says FDA Commissioner Gottlieb and Principal Deputy Commissioner Abernethy. Most seizures reported by youth and young adult e-cigarette users.
With public hearing scheduled May 31 and a related public comment period, FDA "is interested in whether there are particular safety concerns that we should be aware of as we consider the FDA’s regulatory oversight and monitoring" of CBD products. Also influencing FDA's consideration is that CBD and other cannabis-derived substances are approved and being studied as drugs products, making their use as dietary ingredients noncompliant with agency regulations.