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Failed NDI Notifications Suggest Futility Of Current US Position On Cannabinoids In Supplements

 
• By Malcolm Spicer

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.

• Source: Alamy

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.

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More from Cannabis/CBD

French Agency Proposes Effective EU Ban On CBD In Foods And Cosmetics

 
• By David Ridley

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.

Senate Hemp Regulation Bill’s Broad Prohibition On Synthetics In Supplements Has Industry Attention

 
• By Malcolm Spicer

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.

Senate Hemp Regulation Bill Offers Option To House’s Blanket Limit On Levels Of All THCs

 
• By Malcolm Spicer

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.

Tobacco Giant Philip Morris Sells Medical Device Business, Keeps Consumer Health Footprint

 
• By Dean Rudge

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.

More from Ingredients & Safety

Melatonin And Buccal Acyclovir On German Switch Committee Agenda

 
• By David Ridley

An application for melatonin as an OTC medicine is on the agenda for the next German switch committee meeting, despite the hormone being widely available in food supplements. Acyclovir as a buccal tablet and second-generation antihistamine rupatadine are also up for discussion.

Plenty For Industry To Do As EU Wastewater Directive Faces Legal Challenges

 
• By David Ridley

Engaging with EU member state legislators, stressing the impact of national EPR systems on the accessibility, availability, and affordability of medicines, reformulating products to reduce their financial contribution, and lobbying for expanding the scope of EPR schemes to include other polluting industries are all ways that the European consumer health industry can try and influence the way that the revised Urban Wastewater Treatment Directive is transposed into national legislation, law firm Mason Hayes & Curran explains.

French Agency Proposes Effective EU Ban On CBD In Foods And Cosmetics

 
• By David Ridley

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.