CBD On OTC Industry Radar As Regulatory Questions Cloud Runway
With US market of hemp- and CBD-containing supplements and food booming, likelihood is growing products made with ingredients will gain approval in the country to be marketed with consumer health indications, said consumer health business executives during a panel discussion at CHPA conference. Legalization of marijuana sales and use by some states and other countries also will influence future of CBD use in US consumer health products, they say.
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Perrigo doesn't want to miss out on the opportunity presented by CBD to offer consumers a new type of self-care product, according to the firm’s managing director, UK & Ireland, and International vice president, Neil Lister.
Examples of unfinished business from 2019 include no legislation passed to reform OTC monograph program; FDA putting off until May the planned publication of an NPRM to allow firms to submit OTC NDAs with extra-label information to help guide consumers' self-selection; and no OTC naloxone for opioid overdose approved even after FDA's unprecedented step of developing model DFLs sponsors could use for their own label comprehension studies.
Bills proposing changes the supplement industry prioritized during Congress' 2017-18 session weren't written by Sen. McConnell, or other Republican leadership members, unlike hemp provision passed as part of farm bill. "When the majority leader of the Senate puts his weight behind legislation on behalf of his constituency, that makes a big difference," says Mike Greene, Council for Responsible Nutrition's government affairs chief.