FDA's evaluation of NDI notifications for cannabinoids currently is pointless, say industry stakeholders asking for a rule exempting hemp-derived cannabinoids from the agency’s prohibition against using in dietary supplements any ingredient studied or approved for use as a drug.
Just because hemp-derived cannabinoids are unlawful for use in dietary supplements doesn’t mean the US Food and Drug Administration won’t consider whether they’re safe as dietary ingredients. It even will ask for additional information after identifying a cannabinoid as excluded from the regulatory definition of a dietary ingredient.
The agency's approach to evaluating new dietary ingredient notifications for cannabidiol and other cannabinoids, say industry stakeholders, currently is pointless.
France's food safety regulator ANSES is proposing a reproductive toxicity category 1B classification for CBD under the EU's CLP regulation, which would mean an effective ban on CBD in cosmetics and foods. However, French hemp industry association UIVEC hopes that new evidence coming out of a European Commission review will put the issue to bed before it gets that far.
Provision in Wyden and Merkley’s “Cannabinoid Safety and Regulation Act” referencing FDA authority outside hemp-derived ingredients could provide agency with needed authority to force from the market products labeled as supplements but containing drugs or eliminate the use of many safe ingredients in supplements.
Democrats Wyden and Merkley author Cannabinoid Safety and Regulation Act to limit sales to consumers 21 and older and authorize FDA to order recalls and impose bans on cannabis products with dangerous chemicals or additives. It also would establish regulatory structure for using cannabinoids found naturally in hemp and allowing “semi-synthetic” ingredients while prohibiting artificial or fully synthetic cannabinoids.
Philip Morris described a scenario of being essentially blacklisted by the health care sector and its CDMO partners as it threw in the towel on its £1.1bn acquisition of UK inhalation specialist Vectura. It agreed to offload the firm at a fraction of the initial cost.
Limited capacity and a two-to-three year timescale for reformulation could mean that many VMS supplements disappear from the market, warns EPPA partner Alexandra Bocquillion, speaking at the AESGP Annual Meeting in Warsaw, Poland.
The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”
Bayer's Iberogast Advance's combination of six herbal ingredients may produce a synergistic effect that acts on multiple underlying issues contributing to digestive disorders like functional dyspepsia (FD) and irritable bowel syndrome (IBS), a recently published study suggests.
