Thursday, September 21, 2023

Federal CBD Regulations Remain Murky

FDA Looks For More Data Avenues


The uncomfortable relationship between the law and CBD may be coming to an end soon. Last month the U.S. Food and Drug Administration said it would begin analyzing “novel” sources of information like Reddit and other online forums to better understand public health issues around CBD and other popular cannabinoids.

According to the agency’s website, to become better informed before making policy decisions, the FDA is initiating what it calls the Cannabis-Derived Products Data Acceleration Plan (DAP), “a portfolio of pilot initiatives and partnerships focused on advancing data-driven safety signal detection and building advanced technology capabilities.” The plan will involve looking at consumer-generated content and using advanced analytic techniques to “identify current and emerging safety vulnerabilities in the CDP market.”

This is incredibly good news, as CBD consumable products—while legal thanks to the 2018 Farm Bill—are technically banned from being sold over-the-counter by the FDA, presumably because of safety concerns. If the agency determines that they are safe for human consumption, the ban could be lifted.

Legality of CBD

As many CBD enthusiasts and salespeople will tell you, CBD derived from hemp was legalized with the 2018 Farm Bill. The law differentiates between hemp and marijuana, defining hemp as cannabis that contains less than 0.3 percent of THC by volume, so CBD and any other cannabinoid that can be extracted from hemp other than THC is also legal.

The problem is that CBD is also the active ingredient in the FDA-approved pharmaceutical Epidiolex, a drug used to treat extremely rare forms of epilepsy in children. According to federal law, it’s illegal to sell over-the-counter consumables containing any active ingredients used in pharmaceuticals.

The law protects consumers from purchasing compounds known to have serious health effects or negatively interact with medications. In most cases, it’s a welcome one. But in this instance, it cut off a number of companies who were planning to freely sell CBD at the knees.

Since the FDA clarified the legal status of CBD, companies have continued to sell products that are technically illegal, putting them at risk of penalty.

Legal Gray Zone

For most companies, selling CBD products has been a breeze. Thanks to state protection, many enjoy the freedom of being able to sell their wares without hassle. But there have been a number of instances where federal regulators have put down the proverbial boot.

In 2019 the FDA clarified its position on CBD, saying that it is illegal to add the compound to foods, drinks or supplements. The agency issued letters to 15 companies warning about violations regarding the sale of CBD products that were marketed to treat diseases or for other therapeutic uses for humans or animals.

Letters weren’t the only steps taken by authorities at the time. Earlier that year a tobacco shop in Duncanville, Texas, was raided by police for selling CBD products. The officers confiscated the personal cell phones of employees on duty and seized the store's CBD products and thousands of dollars. In Nebraska a woman and her son were arrested after opening a CBD shop, despite the fact that other stores in the area carried the somewhat illegal substance. In Ohio two men were arrested and charged with felony possession of a Schedule I substance when police caught them transporting 7,040 liquid ounces of CBD oil. Perhaps most newsworthy was the arrest of a 69-year-old great-grandmother at Walt Disney World who was carrying CBD oil in her purse.

After a large amount of public outcry over what seemed like an exaggerated response to what is seen as a relatively harmless drug, the FDA ultimately advised companies that they would not be penalized for selling CBD products until further regulation had been decided upon—as long as those companies refrained from making any health claims about their products. On a number of occasions since then, the FDA and Federal Trade Commission (FTC) have had to reprimand companies for breaking this rule. One of the most recent cases happened last March. Otherwise, the feds have mostly turned a blind eye to CBD dealings.

Renewed Push For Approval

The FDA hasn’t been completely deaf to the vast number of people begging for a regulatory framework under which to sell CBD legally. In August 2020 the agency announced it was looking for a contractor to study the health effects of CBD. Last January the agency published an article by Commissioner of Food and Drugs Stephen M. Hahn and Principal Deputy Commissioner Amy Abernethy that assured readers that the agency was making efforts to inform the public about CBD while also listening to the concerns of industry stakeholders and citizens with an open mind.

It seems like the FDA is acting in good faith to properly research CBD before making a strong decision, but from another angle, the agency seems to be dragging its feet. Every deadline has been delayed and a number of setbacks have kept CBD in limbo for years. In August CBD producer Charlotte’s Web requested that it be allowed to include CBD as an ingredient in a dietary supplement. The FDA rejected the request on the grounds that the agency “has concerns about the adequacy of safety evidence” about the drug, according to its letter to the company.

Earlier this year Rep. Kurt Schrader (D-Ore.) introduced HR 841 in the U.S. House. The bill would allow hemp, CBD derived from hemp or any other ingredient derived from hemp to be in a dietary supplement, provided that the supplement meets other applicable requirements. The bill does not mention food or drinks containing CBD. It’s unclear whether the bill has seen any action over the last few months, but if passed, it would help to clear up a lot of problems.


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