Cannabis/CBD

Ongoing regulatory issues and restrictive marketing rules are prompting CBD brands to pivot to functional mushrooms, the market for which in the UK is predicted to reach a value of £62m by 2025. With both reportedly offering cognitive health benefits, marketing mushrooms and CBD makes good strategic sense, explains Nootro Group CEO Cary Holmes in this HBW Insight deep dive. 

Italy reclassifies natural CBD as a narcotic drug. The decision may see challenges from companies marketing in Italy natural CBD supplements registered in other European countries, given that the European Court of Justice (CJEU) overturned a similar position taken by France in 2020.  

Dietary supplements containing unsafe or unauthorized substances, including a number marketed to enhance sexual performance, were reported to the European Commission by national regulators on more than 50 occasions in the second quarter of 2023.

Market's direction depends on different influences, according to witnesses testifying at recent House hearing looking at FDA’s position on using hemp ingredients in food and dietary supplements. Rising costs and plummeting prices hit marketers as acreage for hemp and amount harvested shrink.

Republicans don’t waver from stance that FDA not only doesn’t need additional tools but also should’ve already established regulation of hemp products. Democrats recommend giving FDA a chance.

Warnings to firms in Fargo, ND, and Norwalk, CA, come two weeks after FDA included delta-8 and CBD in first list of food ingredients determined to have unsafe uses as unapproved food additives and after warnings to six businesses offering candy, cookies and other snacks containing delta-8 in packaging similar to name-brand food products.

All legislation introduced in Congress on establishing hemp as lawful dietary ingredient also would extend change to food ingredients. Two hemp derivatives among 12 ingredients on FDA’s first list of food ingredients unsafe for use in food.

FDA long has doubted safety of using cannabinoids in food products while saying it’s open to finding a pathway for allowing hemp-derived ingredients’ use in supplements. Warning letters to six businesses could be exhibit A for FDA’s argument against cannabinoids’ use in food.

Tomasi moves from CCO to lead Bayer North America consumer health; Cabrera heads Hemp Industries Association Cannabinoids Council; and CRN adds legal, government affairs staffer.

Whether lawmakers will favor legislation aligning with FDA’s thinking or hemp industry’s preferences isn’t known, says Jonathan Miller, US Hemp Roundtable general counsel. “We're feeling pretty confident that something's going to happen.”

US Hemp Roundtable general counsel cautions congressional leaders about “agency’s misguided use of incomplete safety data as the basis for its continued refusal to regulate CBD as a dietary supplement or food additive.”

Pathway separate from FDA’s regulation of drugs and food would include rules on content limits, labeling, disclosure of ingredients– including assurances of no contaminants, and requirements to mitigate accidental ingestion.

Hemp Industries Association, National Industrial Hemp Council and US Hemp Roundtable say their “unprecedented alliance among 31 nonprofit hemp organizations portends promise for congressional enactment of the industry’s agenda.”

Food supplements containing unsafe or unauthorized substances were reported to the European Commission by national regulators on around 30 occasions in the first quarter of 2023.

FDA becoming increasingly strict in regulating bioactive, or functional ingredients in food and supplements. Planning ahead and incorporating R&D into regulatory compliance key to quicker approval.

Summer 2024 is the earliest that the UK Food Standards Agency expects CBD applications to be fully authorized, according to its most recent board meeting. However, even this belated deadline could slip if the Home Office complicates matters or if the FSA is flooded with other regulated product applications. Meanwhile, the official CBD list has swelled to over 12,000 products, with thousands now validated and a few “removed” by mistake.