BY DR. LLOYD COVENS
The more than 4500 files sent into the Food and Drug Administration last month may look like the start of a major fact-finding journey to prepare a reasonable solution to the “CBD food/drink additive” issue.
But savvy Washington watchers are in agreement– FDA has no plan to bring an interim arrangement to deal with the CBD-confusion it has created– and it will be compelled later this year when a Congressional enactment of a solution will be introduced.
“FDA could make clear that any CBD products that remain on the market — subject to a limited period of enforcement discretion — may not make any claims to treat disease. Other claims — for example, that it might help with relaxation — would have to be substantiated with evidence,” writes former FDA head Scott Gottlieb. In a Washington Post newspaper editorial, Gottlieb argues “this framework should also be expressly unique to CBD. Otherwise, there’s a risk it becomes a precedent for food and supplement makers seeking a back door to add other drugs to foods,” said Gottlieb. See his full article on CBD below,” Gottlieb writes.
Now, with major parts of the industry dependent on some clarity from FDA– and an equally large part of the farming industry waiting for USDA guidance— the US hemp industry must now hold on until October for rules to allow legal production of CBD, and an equally important set of policies to bring responsible new CBD-based products to market.
Of special interest will be the rules allowing CBD into non-alcoholic drinks— something being closely monitored by giants like Coca Cola, Diageo, Proctor and Gamble, Constellation Brands, Molson-Coors and Anheuser-Busch. All the majors have contacted CBD makers to respond to a ton of analytical questions over hemp sourcing, CBD purity, and technical responses which the beverage makers think will make their drinks successful in a market expected to surpass over $2Bil per year after 2021.
Pressure from hemp state Senators–consumer groups, anti-Chinese American farm interests, and a rising tide of patients wanting unfettered CBD access now (not after 2 or 3 years of clinical studies) means the political winds swirling around the FDA will not slow down until the agency issues an interim temporary rule.
They may decide to allow some low level of CBD, such as 12MG, to be combined in one serving of a food or a beverage. For over-the-counter daily oils, capsules or other “medicine-looking” formulas, the FDA could allow daily dosing to reach 60MG/daily without any prescription or healthcare oversight. And then, a pharma-grade dose (only available from your physician by RX) could be permissible for daily use exceeding 61MG, much like the several hundred milligram dosing supplied by GW Pharmaceutical’s Epidiolex.
Other OTC items– like Aleve-naproxen or like fish oil– have been allowed a dual higher/lower dose to enter the market where lower dosing ensures the public is unlikely to face adverse effects from suggested use. In fact, GW itself says its years of clinical study of CBD found no consumer side effects until dosing surpassed 65MG a day, suggesting “liver toxicity” might occur beyond that level. A prescription ensures that those levels will be monitored by a physician, adding to consumer safety.
Meanwhile, certain states– California and Connecticut continuing to move ahead to join Colorado and New Mexico— are moving ahead to pass laws which will allow the non-adulterated addition of CBD into that state’s food, drinks and cosmetics. Those laws will initially keep those products only being sold within their state boundary, bottled up by the FDA’s continuing “unproven” challenge that CBD has not been found safe. Consumer Reports estimates more than 4.6Mil. US consumers are now actively taking CBD products within the past 30 days. And not one of those users (let alone another 2.6Mil medical cardholders in the US) have reported a hospitalization, a long-term sickness, or a fatality from the use of CBD.
Following on last week’s Senate Agriculture hearing, Washington is expecting the offices of the FDA, the EPA and Ag to be visited by a strong message from Kentucky’s senior Senator, Mitch McConnell, and other farm state Senators. Their message: Let this American agriculture community thrive and reduce/remove barriers to a wide–and completely legal access to tested CBD for human consumable products.
–Based in Denver, Dr. Lloyd Covens, DBA is a seasoned cannabis industry journalist and the publisher of West420 NewsWeekly. Writing his doctorate on diffusion of innovations, Covens has been an expert journalist/researcher for 20 years chronicling new technology, global television and renewable energy advancements. He has reported on developments in the cannabis and hemp industry with weekly reports since 2014 covering the western U.S. for legal medical cannabis, recreational sales and hemp production. Covens is also the creator of the annual CO Hemp CBD Conference held in Pueblo, Colorado.