CBD Lotion Firm’s ‘FDA Certified’ Claim For 'OTC Drug' Is Certifiably Noncompliant
In addition to CBD, Elixicure is formulated with OTC external analgesics monograph ingredients camphor and menthol, But CBD isn't a monograph drug nor approved for use in any pharmaceutical product other than GW Pharmaceutical's Epidiolex.
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FDA includes cannabis product regulation in FY 2021 food safety priorities, “key areas where resources have been historically underfunded and for which there are rising public health needs as growing markets outpace increases to Agency resources,” it states in its budget request.
Recent statement that FDA has not found evidence supporting CBD as GRAS for use in human or animal food potentially points to NDI notifications as the only option manufacturers, marketers and other businesses will have to convince agency about safety for CBD and other hemp-derived substances used in dietary supplements.
In addition to FDA and FTC attention, pediatric claims by Rooted Apothecary could get attention of US lawmakers, who FDA is asking to authorize it to more directly enforce against adulterated supplements. Violative claims include “Increasing evidence suggests that CBD oil is a powerful option for pain and autism. It seems like an attractive and safe option for children.”