To better track health effects of hemp-derived products, the Food and Drug Administration proposes that CBD and other cannabinoid-based hemp products be included as options in federal documents, which are used by patients, consumers and healthcare professionals to report adverse event.
The proposal, published on Friday by the Federal Register in an notice would include “Cannabinoid hemp products (such as CBD-containing products)” under the field “Product Type”.
The change will add the option to the field D5 on FDA Forms (3500 and 3500A), which only includes options for over-the counter, generic, compounded, and biosimilar medications. The change would clarify the fact that a different form, 3500B (used for industry mandatory reporting), should be used to report cannabinoid-hemp product concerns.
Until March 18, the agency is accepting comments about the proposed addition of the cannabis option on forms. You can submit your submissions either electronically or via 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 would like to learn more about cannabinoids’ veterinary uses, including trends in usage, drug interactions and quality standards.
FDA wrote to the manufacturer of CBD-coated pads last month, stating that these “adulterated products” are not allowed to be sold in the U.S.A. They are also “misbranded”, due to their addition of cannabinoid. The FDA said that they had raised this issue in April with the company’s leadership.
Anne’s Daye, following FDA’s letter of warning, pulled products off U.S. markets earlier this year.
FDA has issued a rash of warning letters to cannabinoid businesses since the legalization of hemp through the 2018 Farm Bill. The Federal Trade Commission and that agency have acted with discretion to take enforcement actions against companies whose claims or packaging are misleading.
The FDA and FTC have been focusing on intoxicating cannabinoids like 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. Last July, they contacted a second group of businesses regarding the issue.
Bipartisan legislators and stakeholders in the industry have criticized FDA’s refusal to implement regulations on hemp-derived CBD. They say this is responsible for 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.
In the few years following its legalization, the hemp industry has faced unique regulatory challenges that have caused the market value to plummet. 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.
Donald Trump’s nominee to head the FDA is also a medical cannabis skeptic. He has promoted the claim that marijuana use in youth is associated with cardiovascular problems and mental health issues. His comments on marijuana as a gateway drug are also noteworthy.
In a scientific review that was published in April, CBD may help with a number of conditions, such as pain, epilepsy and schizophrenia. It could also be helpful for diabetes, COVID-19 and cancer.
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.
The National Animal Supplement Council’s (NASC) study from last year found CBD to be safe for use in long-term doses by 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.” CBD is included in a list that excludes CBD as an supplemental benefit.
CBD reduces alcohol cravings among people with drinking problems, a new study shows
Kimzy Nanney provided the photo.