Members of Congress are asking the US Food and Drug Administration (FDA) to come up with a final rule on how to regulate and administer CBD infused products as the market continues to grow at a rapid pace.
In a letter to acting FDA commissioner Ned Sharpless, 26 members of Congress urged the FDA to quickly adopt a policy of “enforcement discretion” for CBD and consider adopting an “interim final rule” to regulate CBD- infused food additives and dietary supplements. They also asked the agency to establish a “robust framework” to evaluate safety and labeling of CBD products.
After last year’s 2018 farm bill removed CBD and hemp-derived products from the Controlled Substance Act under federal law, state-by-state regulation was open to controlling the legality of these products, and most states showed leniency towards the drug-which fueled rapid growth in this emerging market.
“Business and consumer interest in CBD and hemp products has skyrocketed and companies are already capitalizing on the growing demand,” the letter states.
Despite this, CBD as a food additive or dietary supplement is still illegal under federal law, since the FDA has only approved CBD as a drug to treat epilepsy.
Although there are no legal guidelines, everything from CBD-infused coffee, beer, candy, and fast food have flourished across the US. This has made lawmakers restless for the FDA to establish a legal framework for CBD products made for therapeutic and recreational use.
As the market continues to grow, the FDA has already issued nine warning letters to businesses who sell CBD products over “fraud and egregious health marketing claims.”
While Congress supports their actions, it claims the FDA has the power to establish a framework for standardization, health claims, and correct dosages, minimizing confusion and uncertainty for manufacturers as well as keeping consumer risk at bay.
In addition, Mitch McConnel, the Sen. Majority Leader added language to the $23.1 billion dollar agriculture appropriations bill, giving the FDA 120 days to seek an enforcement discretion policy on CBD, as well as provide Congress with a progress update after 90 days. The proposal has yet to be debated on the Senate floor.
Furthermore, a Nielsen report predicts the US hemp-derived CBD market will be worth $6 billion dollars by 2025, adding more pressure for the FDA to form a regulatory pathway so businesses and farmers can profit off this growing market.
As of now, the FDA has indicated to lawmakers its rulemaking could take anywhere from three to five years, and their commissioners pride themselves on being a “science-based regulatory agency” committed to “protecting and promoting public health.”
With this in mind, it’s clear the agency does not want to disappoint or rush through its analysis on the risks and benefits associated with recreational CBD, especially with so many consumers excited to try it. As of now, it seems the FDA would rather take its time, making sure its framework is 100 percent accurate before it gives the nation the official green-light for these products.