FDA Wants To Add Hemp-Derived Cannabinoid Product Option To Federal Form About Negative Consumer Experiences
January 22, 2025
In an effort to better track the health impacts of hemp-derived cannabinoid products in the U.S., the Food and Drug Administration (FDA) is proposing that CBD and other hemp-derived cannabinoids be added as selectable options on federal documents used by healthcare professionals, patients and consumers to report adverse events.
Published on Friday in a Federal Register notice, the proposal would revise the “Product Type” field of FDA safety reporting documents to include a selection for “Cannabinoid Hemp Products (such as products containing CBD).”
Specifically, the change would add the selection to field D5 of FDA Forms 3500 and 3500A, which currently include options for only over-the-counter, generic, compounded and biosimilar drugs. It would also clarify that another form used for mandatory industry reporting, 3500B, should be used for cannabinoid hemp product issues.
The agency will accept comments on the proposal to add the cannabis option to the forms until March 18. Submissions can be filed either electronically or by mail.
The move—designed to more actively gather information about adverse health effects that might be linked to hemp-derived products—comes amid a number of other CBD-focused actions from FDA.
Earlier this month, for example, the agency asked for comments from veterinarians and the broader public about the use of cannabis-derived products—in particular CBD—in animals. The agency wants to know more about usage trends, potential drug interactions, quality standards and other issues related to the veterinary use of cannabinoids.
FDA also wrote last month to the maker of CBD-coated tampons, asserting that the “adulterated” products are not approved for sale in the U.S. and are being “misbranded” due to the addition of the cannabinoid. The agency said at the time that it had previously raised the issue with company leadership last April.
Following FDA’s warning letter, the company, Anne’s Daye, pulled the products off the U.S. market earlier this month.
FDA 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 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 last 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.
A scientific review published last April listed a variety of ailments that CBD might help manage, including pain and aspects of epilepsy, cancer, schizophrenia, diabetes and COVID-19, among others.
The National Football League also announced last year a partnership with Canadian researchers on a clinical trial to test the safety and efficacy of CBD for pain management and neuroprotection from concussions.
In 2023, meanwhile, researchers at Rutgers University and the University of Texas published research indicating that CBD may alleviate acute dental pain and may provide an equally effective but far safer alternative to opioids. A study last year from the National Animal Supplement Council (NASC) found that CBD is “safe for long-term use” in dogs.
Meanwhile, late last year, the federal Centers for Medicare & Medicaid Services (CMS) clarified that marijuana products are not eligible for coverage under certain health plans for chronically ill patients because “they are illegal substances under Federal law.” The agency included CBD on a separate list of items that cannot be covered as a supplemental benefit.