FDA Warnings Could Signal Start of Heavier Scrutiny on Cannabis Industry

By John Schroyer

In late February, the U.S. Food and Drug Administration sent stern letters to six companies peddling CBD products over what the agency said were unfounded medical claims.

The letters charged that the companies “misbranded” the products and warned that failure to correct the violations “may result in regulatory action without further notice, such as seizure and/or injunction.”

The move appears to mark the first time the FDA has cracked down on cannabis-related companies, raising concerns in the marijuana industry that this is the first shot across the bow.

Though cannabis professionals are used to federal intervention – such as raids from the Drug Enforcement Administration and lawsuits by U.S. district attorneys – the FDA has typically kept out of the cannabis fray.

Some insiders now wonder if the FDA’s recent action signals a larger policy shift at the federal level.

“Once you come out with this sort of acknowledgement, now you’re faced with, ‘What is the plan of the FDA to oversee this issue?’” said Avis Bulbulyan, a cannabis consultant based in California.

Bulbulyan noted that only CBD companies had received warning letters – not infused product manufacturers, some of which make similar claims about their products. He speculated that the FDA probably wanted to target smaller fish first and avoid a potentially much bigger battle with well-funded companies.

“If you take on one or two of the THC-infused product manufacturers, then you have a real fight on your hands,” Bulbulyan said. “I think (the FDA is) feeling their way around it.”

Zeta Ceti, of Green Rush Consulting in California, said this is likely a sign of things to come.

He advises infused products businesses and CBD companies to follow general FDA standards to avoid potential conflicts with the federal government down the road, and to prepare for the eventuality of oversight.

That way, “they at least have a fighting chance to prove they’re not breaking the law” if the FDA does initiate a crackdown.

“The FDA is going to step in eventually. It’s going to happen,” Ceti said.

Regardless, the issues brought up by the FDA will probably be fairly easy for most – if not all – of the six companies to resolve. The complaints mostly centered on online advertising regarding claims of medicinal benefits.

“We’ll absolutely modify our website to comply with the FDA,” said Moe Asnani, co-owner of CBD Life Holdings and the company’s web site, ultracbd.com, which was one of the targets of the FDA letters. “At this point, we’re just going to omit whatever information they want us to.”

Asnani is also a partner at Arizona Dispensary Solutions, which manages several dispensaries and also provides consulting services. He added that his attorney is crafting a formal response to the FDA warning, but that it won’t be a major problem to comply with the agency’s directives.

“We only had links to research articles, and we’re going to modify that,” Asnani said.

Sarah Brandon, a principal at Canna Companion, a Washington State-based company that also received a warning letter, said only in an email that her company is “working closely with the FDA…in order to take appropriate corrective action.”

Asnani and Brandon were the only principals at any of the six companies that agreed to comment on the story, and the FDA did not return a call seeking comment.

Another company that was served with a warning letter, South Carolina-based Twin Falls Bio Tech, now has a disclaimer on its site, arisitol.com, to clarify that its products are not FDA-approved. (It’s not clear whether the disclaimer predates the FDA warning or was recently added.)

Bulbulyan, for one, expects to see many more such notices from the FDA over the coming year.

“Now they’re in the fight,” Bulbulyan said.

John Schroyer can be reached at [email protected]

7 comments on “FDA Warnings Could Signal Start of Heavier Scrutiny on Cannabis Industry
  1. Mendo Bruce on

    Mo Asnani is going to have to do a LOT more than change his website! I doubt the trustworthiness of Arizona Dispensary solutions as well after his response as he never responded to the fact that ultracbd was a bogus product

    “The FDA tested two separate samples of “UltraCBD,” sold by CBD Life Holdings LLC (a one ounce bottle costs $45 on their website or Amazon). Of the samples tested, one did not contain any cannabinoids — CBD or otherwise — while the second contained only .02% CBD. Of all products tested by the FDA that were found to contain some CBD, the “UltraCBD” products contained the smallest percentage.

    Reply
  2. CAT on

    In some respects, I think it’s great the FDA is starting to regulate these businesses. It is not hard to comply with FDA regs – much as the existing supplements industry already does. The advise I give to edible makers is to design and build as if the FDA is regulating (to the extent that you can) because it will at some point – so get ahead of the curve. And, to the companies making bad products, I welcome your regulation and hope your black marks don’t continue to mar legitimate cannabis companies from making good products for people in need.

    Reply
  3. Will Anderson on

    I don’t know what all the fuss is about. The Uniyted States Department of Health and Human Services patent on CBDs and there legally established what THEY claim the medical benefits are. See US Patent 6630507 titled “Cannabinoids as antioxidants and neuroprotectants.” Any claims the feds make should be able to be made by anyone who sells it.

    I quote:

    Cannabinoids as antioxidants and neuroprotectants

    Abstract
    Cannabinoids have been found to have antioxidant properties, unrelated to NMDA receptor antagonism. This new found property makes cannabinoids useful in the treatment and prophylaxis of wide variety of oxidation associated diseases, such as ischemic, age-related, inflammatory and autoimmune diseases. The cannabinoids are found to have particular application as neuroprotectants, for example in limiting neurological damage following ischemic insults, such as stroke and trauma, or in the treatment of neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease and HIV dementia. Nonpsychoactive cannabinoids, such as cannabidoil, are particularly advantageous to use because they avoid toxicity that is encountered with psychoactive cannabinoids at high doses useful in the method of the present invention. A particular disclosed class of cannabinoids useful as neuroprotective antioxidants is formula (I) wherein the R group is independently selected from the group consisting of H, CH.sub.3, and COCH.sub.3. ##STR1##

    Reply
  4. Paul on

    Blue Naturals was recently inspected by the FDA and had some comments regarding our label. We’ve made the changes they suggested/requested. I was “looking for a fight” but the whole process was handled very professionally and cooperatively.

    Reply
  5. bongstar420 on

    I get $16/bottle for stuff that is 74mg CBD/CBDA + 74 mg THC/THCA..Those were indoor flowers with low CFU counts to start with not outdoor garbage like what they use.

    Reply
  6. The Cannabis Informer on

    Any major medical claim should be investigated by a third party, otherwise it looses legitimacy. The FDA is in charge of doing just that. The very small amount of CBD that they did find in the samples of hemp derived CBD oils was not surprising. In actuality, the hemp plant does not produce very much CBD compared to medical cannabis. And if there are phonies passing off tinctures of water as medicine, I want them investigated because I do not want that in the medical cannabis culture. Medical cannabis is legitimate and we have no need for homeopathy to promote it.

    Reply

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