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Vol 9, No. 3 -- January 27, 2023 -- Edited by Lloyd Covens, DBA
Is Pharma-Friendly Woodcock On
Track to Destroy CBD at FDA? Creating doubt about CBD and distrust among consumers, media and healthcare providers would be expected had any of the past nine years reported deaths, hospitalizations or CBD side effects.. But with more than 10 million regular users (and an estimated 30 million adults who have tried CBD), the unregulated (and non-euphoric) cousin of marijuana has repeatedly heard positive outcomes for pain, sleep and anxiety.
Responsible CBD makers — ensuring safe sourcing, testing and honest labeling—for nearly 10 years got the final “nail” from FDA undersecretary, Dr. Janet Woodcock issued her Jan. 25th memo, Dr Janet Woodcock is calling for a brand-new pathway for FDA to judge CBD safety and efficacy—not even allowing scrutiny under existing rules for dietary supplements.
In her January 26 determination, Woodcock writes: “The working group, which I chair, has closely examined studies related to the CBD-based drug Epidiolex… as well as studies both conducted and commissioned by the agency. Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives. For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods. “ [Full press release:https://bit.ly/3kNV0BP]
Janet Woodcock(at right) is the strategically-placed pharma chokepoint. After paving the way for Oxycontin and other opioid pain killers—she likely will enter her retirement with a nice payday (executive job) by the billion-dollar pharma gods after fomenting market failure and government harassment to further to kill CBD access. Her past 15 years of shilling for pharma is on the record:
Dr. Andrew Kolodny, a senior scientist and medical director of Brandeis' Opioid Policy Research Collaborative, stated “It’s no exaggeration to say that she presided over the worst medical regulatory failure in U.S. history.” (USA Today, Feb.3, 2021)
“In its opioid decision-making, Dr. Woodcock, and the division she supervised, consistently put the interests of opioid manufacturers ahead of public health, often overruling its own scientific advisors and ignoring the pleas of public health groups, state Attorneys General” (Link below)
Woodcock defended the FDA’s opioid approval process, stating that “although higher total daily dosages were associated with fatal outcomes, it cannot be concluded that the higher total daily dosages are causally associated with fatalities … there is no maximum dose for opioids.”
2013-15: Woodcock oversaw the approval of a series of controversial opioid painkillers. An FDA advisory committee had voted 11-2 against approving Zohydro, a narcotic painkiller five to 10 times more powerful than Vicodin, Woodcock and the FDA instead pushed it through.
While Purdue Pharma (maker of OxyContin) had no clinical trials for proof, the FDA during Woodcocks oversight allowed the deadly label wording for Oxycontin: “for the management of moderate to severe pain when a continuous, around the clock analgesic is needed for an extended period of time.”
Analysis: Woodcock is nearing her retirement within years, and having failed to be named to head the FDA (in 2021) over her past coziness with pharma –and 15 years of making pro-opioid access decisions—it now seems that Woodcock has been called up to KILL THE LEGAL CBD sector. Since May, 2019, CBD makers have been promised action by the FDA to set up regulatory “pathways” which would assist evaluation.
Industry could ask the head of Health and Human Services—Sec. Xavier Becerra—to deliver on his promise to “expedite” review on cannabis (and cannabinoid) safety, in response to the Pres Joe Biden October 6, 2022 directive. The industry could put new hope into clarification language in the upcoming (must-pass) Agricultural funding “Farm Bill.” Just as the CBD industry has attempted to educate Congress for years – and even as 10-plus legislative bills dropped with bi-partisan support (from conservative Kentucky Rep. James Comer and liberal Rep. Earl Blumenauer of Oregon)-- nothing is moving. Now this week’s FDA plan to delay any review with new procedures could easily push trials past 2026 or even later. By then, pharma can swoop in and buy any remaining CBD providers for pennies. Maybe pharma can even wait for the inevitable legalization of all naturally grown cannabis.
But even as we wait—continuing to supply safe CBD with the most troublesome FDA oversight possible, one thing is clear: Janet Woodcock must be replaced.
ABOVE: The first of NCIA'S 2023 socials gets underway Jan. 31 in the Bay Area. Follow-on socials ($50 non-NCIA members) will be hosted in Los Angeles (2/7), Denver (2/15), St. Louis (2/22) Seattle (3/8) and Boston (3/30). Register at: https://thecannabisindustry.org/ncia-events/industry-socials/
Oklahoma Vote March 7th on RMJ -- Now with more than 7000 medical-MJ farms operating in the state (with the easiest MMJ card qualifying--a push for RMJ would make Oklahoma number 22 on the RMJ access list. To find out more on the campaign- visit: https://www.yeson820.com/
BELOW: Special panel on Edible Safety-- One hour discussion also deals with Delta-8 safety issues, and the safety issues for cannabis products for consumers. At the Food Integrity Conference, Jan. 25, 2023. Replay at: https://www.youtube.com/watch?v=R61icBezjpU
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