April 5: FDA Head Departs with "Concerns," Ideas for CBD Access

by Lloyd Covens, Editor, West420 NewsWeekly

In a whirl-wind of activity, outgoing Food and Drug Administration commissioner Scott Gottlieb delivered headlines--and industry heartburn-- with actions and comments on CBD marketing claims, mass-market CBD entrants and a high-level study group ready to host a May 31 stakeholder day in DC. But by then, Dr. Gottlieb-- a two-year commissioner who pushed hard to control teen-nicotine vaping and struggled to address high drug prices -- will be back in his Connecticut home, and out of the DC-glare. Intense Congressional pressure reportedly continues on the FDA, as lawmakers want the agency to act to clarify the confusing drug/food/supplement patchwork of FDA oversight. https://www.fda.gov/NewsEve…/PublicHealthFocus/ucm421168.htm

On May 31, a full day of written and verbal comments will be taken by the FDA's CBD Working Group, chaired by Dr. Amy Abernethy(FDA deputy commissioner) and Lowell Schiller (FDA associate commissioner for policy). Pointing to the high-level policy group, Gottlieb was also "asking the group to consider whether there are legislative options that might lead to more efficient and appropriate pathways that might be available under current law." And FDA re-iterated agency goals to continue to incentivize additional research and new future cannabinoidiol /terpene products from commercial/drug company channels. Sign-ups and further information on the hearing are available at: www.federalregister. gov/documents/2019/04/03/2019-06436/scientific-data-and-information -about-products-containing-cannabis-or-cannabis-derived-compounds


      "There are open questions about whether some threshold level of CBD could be allowed in foods without undermining the drug approval process," said Gottlieb's notice. The comment clearly elevated the prospect for an FDA-approved dual-dosing CBD scheme (one for medicine and one for Over-the-Counter access) as has previously occurred with a handful of dietary supplement products. In a fairly quick process, the FDA is empowered to create rules for low (10 to 30MG) CBD versus higher by-prescription-only access (potentially daily CBD doses above 50MG) or the daily GW Epidiolex base line of 500 MG per day for intractable children's epilepsy. This approach would mimic the years-old treatment of fish oil, which is available only by prescription (for its trigliceryde/amino-acid content) in drugs like Lovaza(840mg EPA/DHA) or Epanova. At the same time, the FDA-approved lower doses of "over-the-counter" fish oil as a regulated dietary supplement. If a 25milligram threshold was FDA allowed-- or a consumer beverage limit, of 12MG per non-alcoholic drink-- a potential one milligram of CBD per one ounce of beverage-- hemp/cannabis-derived CBD would begin fighting to be ever-more bio-available in consumer delivery products.

And Gottlieb on April 3 underscored his "concern" over CVS and Walgreens' intention to begin selling certain CBD pain salves, sprays and transdermal patches in a limited number of states. After tweeting his "concern" about possible consumer expectations of pain-relief, the outgoing FDA head told a Congressional hearing the next day, "So you now see big-box stores seeking to market CBD products for some uses where the claims seem to be potentially over the line, for the treatment of pain, for example," Gottlieb said. No plans from either Walgreens or CVS have yet even considered human/animal CBD consummables, and with the direct FDA control over cosmetic products, observers expect the drug-chains to remain slow to expand CBD offers. For the start of sales, topical products from Massachusetts-based Curaleaf will be available in about 800 CVS stores in 7 states, with Walgreens looking to add topicals in 1500 stores, in 9 states..

CALIF LEGALIZATION WAS THE EASY PART- Three years ago, now-Gov. Gavin Newsom helps kick off the successful AUMA vote for RMJ. Now, with only one-in-three Calif. MJ purchases going to legal channels, Newsom's administration plans to go after unlicensed and illicit operations. While the state did bring in $205Mil. in 6-month taxes, budget writers have lowered annual expectations of $355Mil., or one-third of AUMA projections. The state's 22-member citizen advisory board released its annual report(link below) finding significant concerns with "the needs of tribal businesses, the development of a state equity program, comprehensive banking, and reducing the barriers associated with onerous taxation... Many committee members have publicly expressed concern about having enough impact on policymaking." Read here:

https://www.bcc.ca.gov/about_us/documents/cac_annual_report_2018.pdf

Congress Smells FDA Hand In Sudden State CBD Crackdowns

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