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Statement from FDA Commissioner Scott Gottlieb, MD, on new steps to advance agency’s
continued evaluation of potential regulatory pathways for cannabis-containing
and cannabis-derived products
 
Outgoing FDA Commissioner Scott Gottlieb outlined a series of steps to blend FDA authorities with the change in federal law brought about by the 2018 Farm Bill, which “establishes a new category of cannabis classified as ‘hemp’ – defined as cannabis and cannabis derivatives with extremely low (no more than 0.3 percent on a dry weight basis) concentrations of . . . THC.” The Farm bill removed hemp from the Controlled Substances Act, which means hemp is no longer illegal under federal law.
 
He notes that cannabidiol (CBD) made from hemp and currently being marketed for a variety of uses falls under all of FDA jurisdictions: human drugs, dietary supplements, conventional foods, animal foods and drugs, and cosmetics, among other things. He adds that FDA has a duty “to protect public health and safety with respect to such products,” and that Congress explicitly maintained FDA’s authority to regulate them.
 
He announces four new steps:
  • A public hearing May 31, as well as an opportunity for public comment, for stakeholders to share their experiences and challenges with these products,
  • The formation of a high-level internal working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed,
  • Updates to the FDA webpage FAQs to help the public understand how FDA requirements apply to these products, and
  • The issuance of multiple warning letters to companies marketing such products with egregious and unfounded claims that target vulnerable populations. 
He then explains each of these steps in detail.
 
He also announces that FDA, in collaboration with the Federal Trade Commission, has issued warning letters to three more companies – Advanced Spine and Pain LLC (d/b/a Relievus)Nutra Pure LLC and PotNetwork Holdings Inc. – for making unsubstantiated claims for different products on multiple webpages, online stores, and social media websites. “The companies used these online platforms to make unfounded, egregious claims about their products' ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases, without sufficient evidence and the legally required FDA approval.”
 
Read full statement here.

 
Cannabis during pregnancy
may bump psychosis risk in offspring
 
Two weeks ago, we reported on the ABCD study, a unique effort to image the brains of more than 11,000 9- and 10-years-olds and follow them into adulthood to measure all kinds of health behaviors and outcomes.
 
Today, a new study from the data is reported by researchers from Washington University in St. Louis. They find that pregnant women who use marijuana after learning they are pregnant may slightly elevate the risk their unborn children will develop psychosis during middle childhood or about age 10. These findings follow several national studies showing an increase in marijuana use by pregnant women, including one from the researchers' institution that found past-month marijuana use among pregnant mothers increased by 75 percent between 2002 (2.85 percent) and 2016 (4.98 percent).
 
The researchers suggest one possible explanation for why the risk may be elevated only after mothers learn they are pregnant. The endocannabinoid system in the fetal brain does not begin to develop until 5 to 6 weeks of gestation. Mothers in the study learned they were pregnant at an average of 7.7 weeks. “it is plausible that any impact of THC on psychosis risk would not arise until sufficient endocannabinoid type 1 receptors are expressed," says Ryan Bogdan, senior author of the study, who directs the Washington University BRAIN Lab where the research took place.
 
This study was conducted before all families were recruited into the ABCD Study. Data included survey responses from 3,774 mothers about marijuana use during 3,926 pregnancies. The risk of psychosis in the 4,361 children born from these pregnancies between 2005 and 2008 was measured with a questionnaire designed for children to assess psychotic-like experiences. It was administered to the children between ages 8.9 and 11 years. Of this group, 201 (4.61 percent) were reported to have been exposed to marijuana before birth. Of these, 138 were exposed before mothers knew they were pregnant; 61 were exposed before and after mothers learned they were pregnant, and two were exposed only after they learned of their pregnancies. “Marijuana use after knowledge of pregnancy was associated with increased offspring psychosis proneness.” 
 
The researchers conclude that mothers who are pregnant should be cautioned not to use marijuana during their pregnancies until more is know about its impact on the fetus.
 
Read JAMA Psychiatry abstract here. Read Science Daily summary here.

 
Misinformation vs truth:
Americans spread astonishing amount of false news about marijuana and cancer on social media
 
Researchers used a Google tool to track queries about standard cancer treatments vs. cannabis cancer “treatments” in medical marijuana states and recreational marijuana states between 2011 and 2018. They find queries about cannabis as a “treatment” for cancer increased in both medical and recreational states, and cancer authorities have done little to correct the false news.
 
They identified the top ten news stories on cannabis use in cancer on social media. The number one false news story proposing marijuana as a cure for cancer, “Cancer institute finally admits marijuana kills cancer,” generated 4,260,000 engagements on social media. An accurate story –  a Snopes takedown challenging the accuracy of the false news story – generated 2,207 total engagements. The most popular accurate news story debunking the false news, “Pot doesn’t cure cancer and stop saying it does,” by the FDA, generated only 36,000 total engagements on social media.
 
The researchers say this presents an opportunity for cancer institutions to debunk false news about marijuana as a cancer “treatment,” and replace it with news of cancer treatments that are effective.
 
Read this fascinating new research published in Cureus here.

The Marijuana Report is a weekly e-newsletter published by National Families in Action in partnership with SAM (Smart Approaches to Marijuana).

Visit National Families in Action's website, The Marijuana Report.Org, to learn more about the marijuana story unfolding across the nation.

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The Marijuana Report Staff
Executive Editor
Sue Rusche
Editor
Nicole Carter
IT Consultant
Lee Clontz
Social Media Coordinator
Margarita Eberline
 
We are grateful to our Board of Directors and Senior Adviser for their support of National Families in Action, which produces The Marijuana Report website and e-newsletter.
 
National Families in Action
Board of Directors

William F. Carter, Chairman of the Board
Realtor Berkshire Hathaway HomeServices – Georgia Properties, Atlanta.

Sue Rusche, President and CEO, Atlanta.

Richard L. Brown, Secretary
Attorney (Ret.), Lakewood Ranch, Florida
Founder & Chairman, Sudden Cardiac Arrest Association 

Jeannine F. Adams, Director
President and CEO, J. Addams & Partners, Atlanta.

Jack L. Arbiser, MD, PhD, Director
Thomas J. Lawley Professor of Dermatology
Winship Cancer Institute, Emory University, Atlanta

William H. Avery, Director
Partner (Ret.), Alston & Bird, LLP, Atlanta.

Margarita Eberline, Director
Strategy Director, 360 Marketing Plus, Atlanta.

Robert Margolis, PhD, Director
Founder, Caron Solutions Intensive Outpatient Program, Roswell, Georgia.

Shannon Murphy, MD FAAP, Director
Birmingham, Alabama 
 
Senior Adviser
Kent “Oz” Nelson, Chairman and CEO (Ret.)
United Parcel Service, Atlanta.
 
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