Hemp’s most popular derivative, cannabidiol (CBD), has seen explosive growth since first arriving on market about 10 years ago. Recently, Nikken Foods named CBD 2019’s Ingredient of the Year, as it began to become ubiquitous in health food shopping. CBD can now be found in everything from food to skincare to supplements, to sports care, pet treats, candy, and much, much more. CBD even made it’s way into pillows and bracelets.
Now, three senators are pushing for FDA regulation of CBD products, via the Hemp Access and Consumer Safety Act.
Despite the emergence of the ingredient, it’s legality has constantly been in the grey area. First, it was unclear to many what distinguished hemp from marijuana (the latter of which is not considered a legal source for CBD). This was more or less put to rest with the 2018 Farm Bill, with the Final Rule published earlier this year.
Why FDA Regulation of CBD Matters
A remaining question, and one with enormous repercussions for CBD companies, was how it would be regulated by the Food and Drug Administration. Any newcomer to the conversation much realize this conversation starts with the FD&C.
The Food, Drug, and Cosmetics Act (FD&C) expressly prohibits any new dietary ingredient, food, or beverage from entering the market, if it has been studied or approved as a drug. This is the case with CBD. In 2018, the FDA approved Epidiolex, which contains a purified form of the drug. Epidiolex is used for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome.
Now, all CBD products are in a tricky spot: thousands of manufacturers are making and selling ingredients, foods, beverages, and supplements that contain CBD. Fortunately, there’s a solution: the FDA has the authority to exempt items from this prohibition.
The Senators, and hundreds of industry advocates, argue this should obviously be the case for CBD: the sheer number of innocuous CBD items reflects that the consumer CBD industry is different from the pharmaceutical applications of the drug.
In a joint press release, introducing the Hemp Access and Consumer Safety Act, Senator Wyden argued that “CBD products are legally being used and produced across the nation. Yet because the FDA has failed to update its regulations, consumers and producers remain in a regulatory gray zone.” Moreover, Wyden argued that “it’s long past time for the FDA to get with the program, for the sake of American consumers and farmers.”
Senator Rand Paul, who is also sponsoring the bill, similarly voiced that the FDA “unfortunately, hasn’t treated [hemp businesses] like any other food additive or dietary supplement.” Senator Jeff Merkley of Oregon echoed this, pointing out that the FDA has dragged it’s feel, which has caused businesses to lose out on “real economic gains” across the country.
Industry leaders are also pushing for common sense FDA regulation of CBD products.
Dawson Hobbs, the Executive Vice President of Wine and Spirits Wholesalers of America commended the Senators action on the the HACSA. In a statement, Hobbs recognized that “The lack of clarity on the legality of hemp-derived CBD products…has been a significant source of confusion in the marketplace.” Moreover, the legal businesses that produce these items need “clarity from federal regulators regarding the legal status of CBD products,” specifically when it comes to direction from the FDA.
Hemp.inc will continue to cover the progress of the Hemp Access and Consumer Safety Act, as it makes its way through the legislative system.
A one-page summary of the legislation can be found here.
Bill text can be found here.