Vol. 6, No. 49-- August 2, 2019 - Edited by Dr Lloyd Covens
NEW YORK KICKS OFF NO. 1 PROCESSING CENTER-- Sen. Chuck Schumer (D-NY) joined senior Canopy Growth Corp. planners and NHA's Geofff Whaling(arms crossed) to open the nation's premier Hemp Business Center in Brome County, New York. Expected to collect hemp biomass from all over the Northeastern U.S., the $150Mil center will bring state-of-art technology to all areas of hemp processing, formulations and finished goods.
Senate Will Bring CBD Fix Bill by Fall Without FDA Interference
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 plan 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 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'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 dosing. 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.
ABOVE: Still down about 5%, CBD Isolate was estimated to be $4,570 in July estimates from Hemp Benchmarks. Industrial hemp seeds shot up on global demand, rising to $7.20 per pound, a gain of 169%. All data copyright, New Leaf Data Services at www.hempbenchmarks.com
A BLUES BROTHER ENTERTAINS NCIA, June 22 -- With a new "Blues Brothers" brand of cannabis launching in California this fall, frontman Jim Belushi came to San Jose to fete more than 8000 show attendees at last week's NCIA show. While heavy on exhibitors offering growing products, the NCIA once-again set the high standard for content on all things cannabis, and a new focus on hemp-derived products as well. More on NCIA session news next week.
Major CANNABIS Expos This Fall... Aug 3-4: PORTLAND – 3rd IndoExpo Conference Aug 14-15: DENVER - 6th CBOutLook & UnLocking 1090 Aug 16-18: SEATTLE – 28th HempFest Sep 4-7: TORONTO- 2nd MJBizCon/Global Sep 4-6: PORTLAND Cannabis Science Conference Sep 6-7 - NASHVILLE -- SouthEast Hemp Expo Sep 15-16: VANCOUVER - ICBC: Intl Biz Conference Sep 25-28: LOS ANGELES: Cannabis World Congress Oct 8-9: LONG BEACH- Calif. Cannabis Indus Assn/NCIA Oct. 10-11 SAN FRANCISCO - New West Summit Oct 23-26: BOSTON- Cannabis World Congress- Expo Nov 1-4: CHARLOTTE (NC)– 6th Hemp Industry Assn Nov 20-22: CALGARY: Canada Hemp Trade Alliance Dec 5-6: SAN DIEGO: CANNABINOID-Natural Products Dec. 11-13 LAS VEGAS – MJ BIZ National Show Dec. 14-15 SONOMA, CA – Emerald Cup
Gottlieb Thinks FDA Could Act on CBD By Scott Gottlieb-- WASHINGTON POST - July 30
Cannabidiol — better known as CBD — is everywhere, from small specialty shops to large national retail chains. It can be found in foods, supplements, drugs, oils, creams, pet foods and more, and sellers purport that the compound treats everything from cancer to depression. Analysts say the market could surpass $20 billion by 2024.
But many of the compound’s expansive benefits are fanciful, and in fact, the sale of much of the product is illegal under current law. The Food and Drug Administration must act to make sure commercial interests don’t strip away any legitimate value that the compound might have.
Much CBD is derived from hemp, the commodity that was legalized in the 2018 farm bill. But the law still prohibits putting the chemical in food or pet food, and the FDA has issued repeated warnings and actionson the blooming CBD industry. In fact, there’s only one legally available purified form of CBD: the drug Epidiolex, approved by the FDA in 2018to treat seizure disorders.
This doesn’t mean there can’t be a route for CBD to be legally sold in other forms, including as a food ingredient. Nor does it mean that CBD can’t offer potential benefits. But a legal path should be based on a clear and efficient regulatory process and sound science to guide its proper use.
CBD has risks: It can cause damage to the liver at high doses, and it may have a cumulative effect. If you eat CBD in your breakfast, lunch and dinner, you could get a toxic dose. Currently marketed products might also have undeclared ingredients and impurities, including the psychoactive compound found in marijuana, delta-9-tetrahydrocannabinol (THC).
Any path to allow CBD to be added to food products needs to preserve the incentive to study the compound in rigorous clinical trials to prove its therapeutic potential as a medicine. It’s not appropriate or legal to make such claims otherwise.
The conflict in grappling with these illegal products stems from the misperception that the 2018 farm bill fully “legalized” CBD. When Congress passed the bill, it established a category of cannabis from hemp defined by extremely low concentrations of THC. But in doing so, Congress explicitly preserved the FDA’s authority to regulate CBD-containing products to make sure they’re safe and that their claims are valid.
Under current law, CBD is permitted in food or dietary supplements only if the FDA issues a regulation allowing its use. This is a multiyear process subject to notice and comment, requiring a substantial amount of scientific data that the FDA must evaluate.
Given the pressure on the FDA to create a more immediate path for CBD products, this route might simply take too long. But there is a way that the FDA can fulfill its public-health obligations and meet the political demand for these goods: It can approve the sale of some CBD products immediately, while effecting a framework for their safe and proper regulation and a pathway for an enforceable market for these goods.
The FDA could put the onus on manufacturers to bring forward petitions to demonstrate that CBD can be safely added to products such as food. These submissions can take the form of new dietary ingredient notifications or food additive petitions, which would include toxicity studies to evaluate the safety of CBD. These are the same standards any new food ingredients are held to. Congress can help by passing language saying that the FDA doesn’t need to issue a broad regulation on CBD and can instead rely on petitions filed by individual, prospective producers.
In the meantime, the FDA could exercise enforcement discretion to allow CBD to be marketed in food so long as the products meet certain conditions. These criteria can include meeting good manufacturing requirements, demonstrating traceability, adhering to safe levels for the purity and potency of the CBD being added, and demonstrating that CBD is being added to food products only in very low concentrations that are unlikely to pose health risks.
In setting such a policy, theFDA 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. 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.
The FDA is being pushed by all sides to act quickly. Meanwhile, responsible food makers waiting for regulators to address the legal and safety considerations before launching CBD products are being eclipsed by unscrupulous purveyors. Obligating the industry to do the front end of this scientific work — and sweeping the market o f those who won’t — could advance a safe path and help establish the stable market for hemp-derived CBD envisioned by lawmakers.
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