FDA lawyer: Agency still worries people think CBD is proven safe or ‘can’t hurt’

Over-the-counter CBD isn’t legal and continues to worry federal drug regulators as more people take it and give it to animals, a lawyer for the U.S. Food and Drug Administration said Friday.

Randall Gnatt, senior counsel at the FDA, told the nation’s veterinarians that the FDA thinks there are “data gaps and safety concerns” about any CBD products sold outside pharmaceutical channels.

Gnatt told the American Veterinary Medical Association at its annual convention that there’s a “high degree of interest” in CBD products for human and pets.

But he told them flatly that cannabinoid products are illegal without a prescription, and never legal for animals. He said the agency plans to continue sending warning letters to people selling CBD over the counter.

“We’re seeing CBD in particular being marketed in a number of different products of all stripes for people and animals,” he said.

“We understand there’s high demand with consumers seeking out these novel products for a variety of perceived health-related or other reasons.

“But as the agency has stated before, we are concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by us and determined to be safe, or simply that using CBD can’t hurt.”

Industry advocacy

Gnatt’s comments came as hemp and CBD producers are working to persuade the FDA to give them guidelines for making and selling CBD outside pharmaceutical channels.

Just last week, the National Industrial Hemp Council told the FDA that medical studies support safe human consumption of CBD in dosing appropriate for dietary supplements and conventional foods.

Other advocates have made in-person appeals in recent weeks to argue that existing laws on dietary supplements can be applied to CBD.

But Gnatt told the veterinarians that the FDA doesn’t believe there’s enough research to approve CBD without a doctor’s prescription. He reiterated “potential harm from CBD products,” citing:

  • Potential liver injury.
  • Interactions with other drugs.
  • Male reproductive toxicity.
  • Drowsiness.

“There is still much we do not know about other potential risks,” Gnatt said.”We know little about the potential effects of sustained or cumulative long-term use of CBD.”

Next steps

There was some good news from Gnatt on CBD. He told the veterinarians that the agency encourages the study on cannabinoid medicine and has an action plan to explore its safety.

He laid out a four-point plan for how the FDA plans to move ahead on cannabis treatments:

  • Coordinate a scientific review focusing on CBD safety.
  • Evaluate policy options for a regulatory path forward for non-drug products.
  • Continue to send warning letters/consider enforcement action as needed to protect public health.
  • Continue to engage and communicate with federal and state regulators.

Gnatt gave no timeline for how long the steps would take. He reminded the veterinarians that the agency encourages research on CBD safety and has made its call for public submissions permanent; he also told them that the FDA is “open for business” when it comes to accepting applications to investigate new food and drugs for animals.

He reminded the veterinarians that FDA-approved cannabinoid medicines are legal only for humans, and that even hemp without CBD can’t legally be used in animal food.

“There is still a lack of data covering the different animal species for which products may be marketed,” Gnatt said. “And there is scant data available on the accumulation of residues in the edible tissues of food-producing animals that might consume CBD. There is a great need for more rigorous scientific research into both safety and potential therapeutic uses.”

Gnatt went on to specifically cite treats containing cannabis extracts.

“There are many CBD and other hemp-derived pet treat products on the market for pets, but importantly, none are marketed legally.”

His warning comes as the market for pet CBD booms, jumping from niche retailers to mass-market giants like Petco and PetSmart. The pet CBD market went from almost zero in 2016 to some $7.4 million last year, according to market analytics giant Nielsen Global Connect.

“The bottom line is that there are no legally marketed animal food products containing cannabis-derived products such as hemp or CBD,” Gnatt said.

Kristen Nichols can be reached at [email protected]

14 comments on “FDA lawyer: Agency still worries people think CBD is proven safe or ‘can’t hurt’
  1. Jeffrey D Elton on

    ”We know little about the potential effects of sustained or cumulative long-term use of CBD, says Gnatt of the FDA.” BFD! You guys, our FDA, don’t even know the long term affects of Opiate/Opioid use!!! And you want us to believe you about anything cannabis??? NEXT!!!

    Reply
  2. Dr. Post on

    You do know, don’t you, that the FDA is not out to protect anyone, right? Their rules and recommendations have been, and will continue to be, bought out by Big-Pharma and Big-Ag. Case in point, food companies putting 500mg or less of TRANS FAT (per serving) in your food can now label it as ZERO. Big-Ag bought the right to redefine zero. You should look up the bad health effects of trans fat, it isn’t good for you and it will never be good for you. Ingestion of it adds at least millions of dollars to the healthcare tolls and costs of Americans.

    The FDA is a farce, they are liars and manipulators. Sometimes directly, other times indirectly. I don’t trust the FDA’s rules or regulations on trans fat, CBD or anything else.

    Reply
    • Robin VanDonselaar on

      I totally agree with Dr. Post here! They do know and aren’t here for safety…. many things have been approved yet to find out few years later how bad it is for you. FDA is in bed with big pharma companies, 80% of their wages are paid by pharmaceutical companies. I believe FDA is stalling so they can turn CBD over to the pharmaceutical companies so we can’t get it without a script, more money more money for big pharma. If CBD is bad for us, then why are so many of us seeing the benefits so clearly… study real life cases, that’s proof for me!

      Reply
    • Hogweed on

      Well said, the next big thing is how do we stop the FDA for all its corruption with trying to stop anything healthy from being properly studied and released for public use without the greedy pharma companies making a dangerous product out of it? We need Trump to fire the people in control of the FDA, and put in people who wont be bought off.

      Reply
  3. Don't worry about it on

    Let’s change the “not legal” to our governments havent found a way to tax the ever living shit out of the common folk so we will give generic facts about it’s toxicity with no sourced studies to scare people. Who is the fuck wrote this article, seriously? I see the name but good God where did they get their information from?

    Reply
  4. Mattttt on

    Seriously shut the fuck up about this, if you “drug regulators” really care about the lives of others than press the side effects of all your bullshit pharmaceutical drugs that takes millions of lives each year. You guys are a joke and a half for trying to destroy life, just like the man made fires that spread every year, ya some people don’t have short term memory and record you corruption knowing your ravaging the land for your profit….shows how much I care about animal life as well

    Reply
    • Shawn Crawford on

      But it’s ok to give synthetic heroin to kids(oxycodone)?!?! FUCK the FDA and USDA, just more corrupt government agencies!!

      Reply
      • Ray on

        Let’s not forget the DEA and ATF. These agencies deal in death and Americans pay their salaries with our taxes to keep it that way. And why isn’t the EPA promoting the benefits of hemp as a soil remediation option.

        Reply
  5. Heather on

    Hemp derived CBD and CBD products have been legal since the 2018 farm bill was passed. Also, the FDA has stated that there are no risks associated with CBD. I’m not sure who wrote this, but there is a LOT of incorrect information in this article. Definitely looks like the author has a bogus agenda. Please work on getting unbiased, well educated authors for future articles.

    Reply
  6. Khristiaan Ummel on

    Lol FDA is a joke. They will approve all sorts of man-made garbage with very little research proving it’s safe because big pharma and the lobbyist who throw cash at them only to find out years later whoops guess people shouldn’t be doing that at least the FDA isn’t the one paying all the lawsuits , which still don’t add up to the profit the company made on there pharmacrap. Think of women’s birth control throughout the years. Just to name one. FDA is garbage and CBD is not illegal goddamn moron it was passed as part of the farm and ag bill signed into law 2018 which is the same bill that made it illegal to eat your cat/dog. Not to mention CBD was made by the same chemical reaction the created us, and the earth (science, or whatever made up deity you believe) but yet alcohol is legal. Oh right because we learned from prohibition and realized we can make money on this poison. Apply your prohibition lessons to THC

    Reply
  7. Jason Morris Barker on

    All the lawyer did was share his legal OPINION. If there was any truth to what he said to the DVM’s then there would not be any publicly traded stocks for companies making these products but guess what there are. My dog has epilepsy and the cannabis oils I give him (using my medical card) do far more in preventing his epilepsy as compared to the FDA drugs his DVM prescribes. Here is his story:
    https://www.kob.com/albuquerque-news/advocates-petition-to-allow-medical-cannabis-to-be-administered-to-animals/5574622/

    Reply

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