The Food and Drug Administration (FDA) has issued a warning letter to a California company for allegedly marketing an injectable cannabis product while making unsanctioned claims about its potential health benefits.

FDA sent the warning last week, advising the company Pico IV Inc. about numerous violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other federal statutes connected to the sale of its intravenous CBD product.

The agency gave Pico IV 15 working days to take corrective action and notify it about what steps were taken.

“Your ‘Pico IV’ product is especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users,” FDA said. “Injectable products are delivered directly into the body and therefore bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.”

The warning letter also references multiple posts on social media, where it says the company made a variety of health claims about the IV cannabis item, suggesting that it can effectively treat chronic pain, improve sleep and manage anxiety, for example.

“This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product,” the agency said. “You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.”

“This letter notifies you of our concerns and provides you an opportunity to address them,” it said, as first reported by SFGATE. “Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.”

This appears to be the first publicized warning letter from FDA related to cannabis that has been issued under President Donald Trump’s second term. However, the agency has increasingly relied on such notices as an extension of its enforcement authority as the cannabis market has expanded.

For example, on the heels of an FDA warning letter to the manufacturer of CBD-coated tampons marketed to relieve period pain, the company said in early January it pulled the products off the U.S. market.

FDA had written to the company, Anne’s Daye, maker of Daye tampons, in mid-December, asserting that the “adulterated” tampons were not approved for sale in the U.S. and were being “misbranded” due to the addition of the cannabinoid.

The agency has issued a rash of warning letters to cannabinoid businesses since the legalization of hemp through the 2018 Farm Bill. For the most part, that agency and the Federal Trade Commission (FTC) have exercised discretion in taking enforcement action against businesses targeting those whose packaging or claims about medical benefits are especially misleading.

While CBD was a chief target early on, more recent enforcement actions have emphasized intoxicating cannabinoids such as delta-8 THC. Last summer, for example, FDA and FTC sent warning letters to several companies for allegedly marketing products containing delta-8 THC “in packaging deceptively similar to many foods children eat such as Froot Loops and Chips Ahoy! chocolate chip cookies.”

The agencies noted at the time that it was the second time they sent joint cease-and-desist letters to hemp companies over unapproved marketing of the cannabis products. They made contact with another set of businesses about the “copycat” issue last July.

Meanwhile, bipartisan lawmakers and industry stakeholders have sharply criticized FDA for declining to enact regulations for hemp-derived CBD, which they say is largely responsible for the economic stagnation.

Questions around how to free up hemp businesses to legally market products like CBD as dietary supplements or in the food supply have also come up in discussions around the next Farm Bill.

The hemp industry continues to face unique regulatory hurdles that stakeholders blame for the crop’s value plummeting in the short years since its legalization. Despite the economic conditions, however, a recent report found that the hemp market in 2022 was larger than all state marijuana markets, and it roughly equaled sales for craft beer nationally.

Overall, the hemp market started to rebound in 2023 after suffering significant losses the prior year, the latest annual industry report from the U.S. Department of Agriculture (USDA) that was released in April found.

President Donald Trump’s pick to lead FDA, meanwhile, is a medical marijuana skeptic, having promoted claims that cannabis use is linked to cardiovascular issues and mental health problems for youth. He has also suggested that marijuana is a gateway drug.

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Photo courtesy of Jernej Furman.