CBD, or not to CBD: Is the cannabis extract in a ‘gray area’?
At center, Office of Medical Marijuana Use interim director Courtney Coppola after a Wednesday House committee hearing. (Photo: Jim Rosica)

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The FDA head, for instance, says he's "aware of the growing public interest" in CBD products.

The state’s top medical marijuana official on Wednesday told a House panel that the burgeoning line of products with CBD, a substance extracted from cannabis, was in a “gray area.”

But U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb sees black and white. He recently opined that the federal government still has “authority to regulate products containing cannabis or cannabis-derived compounds.”

Moreover, he says, it’s illegal under federal law “to introduce food (like gummies) containing added CBD or THC into interstate commerce, or to market (certain) CBD or THC products.”

Tell that to the scores of over-the-counter products claiming CBD as an ingredient on shelves in specialty shops, independent pharmacies and even some supermarkets.

Courtney Coppola, interim director of the Department of Health’s Office of Medical Marijuana Use, appeared at the House Health Quality Subcommittee for a medicinal cannabis presentation.

Rep. Kim Daniels, a Jacksonville Democrat, mentioned hearing of a person stopped by law enforcement with a CBD product and told they had a “felony level” amount of cannabis.

Cannabidiol (CBD) and tetrahydrocannabinol (THC) are the major compounds in cannabis plants. The ‘non-euphoric’ CBD is mostly extracted from hemp, a form of cannabis, and used for treating pain and relieving inflammation. THC is the “psychoactive” ingredient that causes marijuana’s “high.”

“This is a problem,” Daniels said. “It’s being sold, people are buying it, and they’re being stopped by the police.”

Coppola said that generally patients with medical marijuana state ID cards and product from an approved provider shouldn’t have a problem.

“There is no currently approved hemp retailer in Florida,” Coppola said. “These products are kind of in a gray area. Many are sourced from states that do have hemp retail programs … These products may not be tested and may contain THC as well.”

According to the FDA’s Gottlieb, such products shouldn’t even be sold in the Sunshine State.

The Farm Bill that was passed and signed by President Trump last year legalized regulated production of hemp.

And in November, then-Attorney General Pam Bondi issued an emergency rule allowing a new drug for child epilepsy patients that contains CBD. It’s marketed under the brand name Epidiolex, the first cannabis-based medication approved by the FDA.

Otherwise, “we’ll take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and are being marketed in violation of the FDA’s authorities,” Gottlieb said in a Dec. 20 statement.

“The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer,” he added. “Some of these products were in further violation … because they were marketed as dietary supplements or because they involved the addition of CBD to food.”

In Tallahassee recently, local police seized a half-million dollars’ worth of hemp-derived products from the Natural Life store under a federal warrant. Coppola later said that shop was the only one her office has sent a cease and desist letter to.

Gottlieb’s agency is “aware of the growing public interest” in CBD products, but he said “we treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance.”

Jim Rosica

Jim Rosica is the Tallahassee-based Senior Editor for Florida Politics. He previously was the Tampa Tribune’s statehouse reporter. Before that, he covered three legislative sessions in Florida for The Associated Press. Jim graduated from law school in 2009 after spending nearly a decade covering courts for the Tallahassee Democrat, including reporting on the 2000 presidential recount. He can be reached at [email protected]


2 comments

  • Ben James

    February 6, 2019 at 1:49 pm

    Cannabis prohibition is a ridiculous waste of police, court and taxpayer resources. Data from the Centers for Disease Control proves that cannabis is much safer than alcoholic beverages and tobacco products which are completely legal. Based on that fact alone cannabis should be completely legal. Cannabis prohibition wrongfully persecutes and criminalizes cannabis consumers for selecting a recreational substance that is MUCH safer than booze or cigarettes!

    In the USA 10 states have fully legalized recreational cannabis including: Michigan, Washington, Maine, California, Vermont, Massachusetts, Nevada, Colorado, Oregon, Alaska plus Washington DC. Canada, Uruguay, Jamaica all completely legal for recreational cannabis! 33 states and counting have legalized “medical” cannabis!

    Celebrate democracy at work with FREE states ending government corruption! Citizens demanding the return of their rights and their freedom!

    The Madness is over, Legalize Recreational Cannabis Nationwide!

  • Debby McKinney

    February 8, 2019 at 1:11 pm

    There is so much ignorance and confusion around this and it’s hurting good businesses that strive to do the best for their customers, who test their products and work within the regulations of the FDA and it is hurting people who clearly want Industrial Hemp derived products. (even if they don’t know the correct name.)

    First – Industrial Hemp derived products are not the same as Cannabis derived CBD.
    Industrial Hemp derived CBD is 0.3% or less.

    From the U.S. Hemp Roundtable –
    As a consequence of the Farm Bill 2018, hemp prohibition is over and is off the CSA – Controlled Substance Act. Accordingly, According to the DEA, no longer has any claim to interfere with interstate commerce of hemp products, so long as the THC level is at or below 0.3%

    The FDA retains authority to regulate ingestible and topical products, including hemp and hemp extracts such as CBD.

    From Health and Human Services:
    There is little indication that CBD has abuse potential
    No evidence for a classic drug withdrawal syndrome for CBD and no evidence that it causes physical or psychic dependance.
    CBD doesn’t appear to have abuse potential under the CSA

    For more information check out the Hemp Round Table organization

    Is the real issue that medical claims are being made and lack of common standards or that Big Business is in bed with the FDA?
    How is it that such a harmless plant as Industrial Hemp is getting railroaded?

    There are laboratories that test products and give information regarding the levels of THC and other components. Why not utilize this?

    Research the CBD offered by GW Pharmacuetical – the cost, the specific use for it. How many people potentially will help based on cost and what it’s for? It’s another example of Big Business trying to monopolize an industry.

Comments are closed.


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