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FDA Hearing: Should FDA allow CBD in food and dietary supplements (and animal feed!)?
 
The Food and Drug Administration held a historic hearing last Friday at which scientists, physicians, CBD manufacturers, legalization opponents, law firms representing the industry, state agriculture department administrators, patients, and others testified.
 
So enamored has the nation become with CBD, most testifiers missed the point of the hearing: to gather information about products containing marijuana as well as products containing marijuana components.
 
CBD can be extracted from both marijuana and hemp, but it is marketed as non-psychoactive. Marijuana CBD is psychoactive. Several states have legalized CBD for medical use and their statutes allow CBD to contain up to 5 percent THC. Hemp can contain no more than three-tenths of one percent THC.
 
What’s more, Ryan Vandrey of Johns Hopkins University, testified that, although different from THC, hemp CBD produces a drug effect – relaxation, calm, somewhat sedating – that would make it inappropriate to call non-psychoactive.  
 
The 2018 Farm bill removed hemp from the Controlled Substances Act, making it legal to grow hemp, manufacture products from it, and ship them across state lines. That has led to an explosion of CBD products being marketed for every conceivable use. And, as the New York Times notes, the CBD industry is pushing FDA to loosen restrictions on CBD products.
 
But FDA’s acting Commissioner, Norman Sharpless, MD, pointed out in his opening remarks to some 140 people waiting to testify, that FDA statutes prohibit active drug ingredients from being added to food or dietary supplements. “Although the law says that FDA can issue regulations to create new exceptions to these statutory provisions, FDA has never issued a regulation like that for any substance,” he said. (See next story for more of his remarks.)
 
Hunter Buffington, pictured above testifying at the FDA hearing, asked FDA to allow CBD to be added to animal feed, providing a way for the drug to be consumed indirectly through the meats we eat as well as directly by infusing it into candies, baked goods, sodas, and coffees. She represents the Hemp Feed Coalition, whose parent is the Colorado Hemp Industries Association.
 
While the industry is united in its demand to be able to add CBD to food, supplements, and animal feed, the scientific and health communities are equally united in their insistence that there is not enough evidence to support such a step, as well as potential evidence of harm.
 
Alice Mead, GW Pharmaceuticals, noted that it wasn’t until GW sought FDA approval of purified CBD (Epidiolex) that its clinical trials established that CBD can be toxic to the liver.
 
Barry Gidal, University of Wisconsin, warned of the potential of multiple drug interactions with CBD, some of which were unveiled in GW’s clinical trials.
 
Ryan Vandrey pointed out that hemp CBD contains other cannabinoids for which there is no controlled research demonstrating their pharmacological effects in humans. Some of these products are already on the market.
 
Elise Weerts, Johns Hopkins University and incoming president of the College on Problems of Drug Dependence, explained that marijuana is addictive. About 30 percent of users are addicted, she said and only about twenty percent of them are able to maintain abstinence. The outlook for treatment is not good for them.
 
The one area where researchers and industry agree is the issue of fraudulent labeling of CBD products and the presence of contaminants in many products.  
 
Jaclyn Brown of the International Association for Cannabis Testing says her organization tested the 10 top selling CBD brands in January-February of this year. They found 30 percent are plus or minus 20 percent of the CBD value listed on the label. They contained 34 parts per billion of lead, which is the highest amount of any consumer or food product they have ever tested.
 
Summarizing what he took from watching the hearing, Robert DuPont, MD, the first director of the National Institute on Drug Abuse, writes,
 
“As a Harvard Medical School graduate, a board-certified and practicing psychiatrist, a veteran of NIH training and a clinical professor at Georgetown Medical School since 1980, I’ve witnessed many dramatic changes over my career. Yet the hoopla and hysteria surrounding the medical use of marijuana and cannabinoid-containing products is unlike anything I have ever seen. It is frightening to me and should be to all who are trusted to protect the public’s health and safety. . .
 
“The FDA must act. It’s time to require CBD-product manufacturers making health claims to subject their products to robust pre-clinical and clinical trials, and ultimately submit their data to FDA for review and, if appropriate, clearance for marketing.”
 
Read the New York Times’s “Cannabis companies push FDA to ease rules on CBD products” here.
Read Dr. Robert DuPont’s commentary on CBD here.
Watch You Tube Video of FDA hearing here.
(Note – the first four speakers at the hearing are not captured in this video. FDA is expected to post the full hearing on its website soon.)
 

Executive Editor’s note: Dr. Vandrey serves on National Families in Action’s Science Advisory Board.
Disclosure: The Executive Editor holds stock in GW Pharmaceuticals.

 
FDA Acting Commissioner Norman Sharpless says critical questions remain about the safety of THC and CBD in foods and dietary supplements
 
Here are excerpts from the prepared opening remarks of FDA Acting Commissioner Norman Sharpless, MD:

“Under FDA’s authorities, the relevant legal requirements vary depending on which type of product we’re talking about. 

“For example, if a product is being marketed as a drug – meaning, for example, that it’s intended to have a therapeutic effect such as treating a disease or affecting the body’s structure or function – then it’s regulated as a drug, and it generally cannot be sold without FDA approval. . . .

“Food, including dietary supplements, is regulated differently, but with the same overarching goal of protecting consumers.

“We know that American consumers depend on FDA to help make sure that the food they eat, and that they serve to their families, is safe. We do this through a number of requirements.

“For example, while we don’t generally require foods to be approved by FDA before coming to market, we do require that a new food additive be approved as safe by FDA before being put in the food supply, unless the substance is generally recognized as safe, or GRAS.

“This requirement applies to cannabis-derived ingredients, just as it does to any other substance. Americans deserve to know that substances being added to their foods are safe, regardless of the source. . . .

“As I mentioned earlier, however, some compounds found in cannabis – specifically, CBD and THC – have been studied and even approved as drugs. It’s important to note that the Federal Food, Drug & Cosmetic Act prohibits adding drugs to human or animal food in interstate commerce.

“That includes both substances that have been approved as drugs, as well as compounds for which substantial clinical investigations have been instituted. Similarly, the law excludes these products from the statutory definition of a dietary supplement. . . .

“There are important reasons to generally prohibit putting drugs in the food supply. When FDA approves a drug, we carefully evaluate the risks and benefits of a specific formulation, dosage form, and strength for a particular population.

“Often, we conclude that to be safely used, it requires a prescription or other medical supervision to help protect against potentially dangerous misuse.

“THC and CBD are no exception.

“There are real risks associated with both those substances and critical questions remain about the safety of their widespread use in foods and dietary supplements, as well as other consumer products – including cosmetics, which are subject to a separate regulatory framework. . . .

“. . . how much CBD is safe to consume in a day? What if someone applies a topical CBD lotion, consumes a CBD beverage or candy, and also consumes some CBD oil? How much is too much? How will it interact with other drugs the person might be taking? What if she’s pregnant? What if children access CBD products like gummy edibles? What happens when someone chronically uses CBD for prolonged periods?

“These and many other questions represent important and significant gaps in our knowledge. . . .

“There are lots of questions we will need to answer to ensure that FDA is taking an appropriate, well-informed, and science-based approach to the regulation of cannabis and cannabis derivatives, including CBD.”

Read Dr. Sharpless’s full remarks here.

 
Here is a two-minute summary of the FDA hearing created by CNBC.
 
To view video, click here.

 
Here is a brief interview with Scott Gottlieb, MD, former FDA Commissioner who stepped down from that job a few months ago. Before he left, he created the FDA Working Group that organized last Friday’s hearing, which is looking into whether or how to regulate CBD and other marijuana products.
 
Perhaps the most interesting revelation in this interview is Dr. Gottlieb’s statement that the pressure on regulators to allow CBD to be put in food is coming from the big packaged food companies.
 
To view video, click here.
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