The bill was introduced today by US Sens. Ron Wyden, D-OR, Rand Paul, R-KY and Jeff Merkley, D-OR.
FDA has ruled that CBD is not a legal dietary ingredient because it was first investigated as a drug. That drug, Epidiolex from GW Pharmaceuticals, has been approved to treat seizures in children suffering from two forms of intractable epilepsy.
FDA policing claims, but not production
Despite this prohibition, thousands of CBD products have made their way to market. Even though all of these products are technically violative, FDA has taken enforcement action only against those companies that have been making allegedly unsubstantiated disease treatment claims. In the warning letters to those companies the Agency typically notes the regulatory impediments that the ingredient suffers, but so far as can be determined to date no company has been warned by FDA based solely on the fact that it is using CBD in its products.
While the Agency has been policing claims on these products, it has not been inspecting the facilities where they are made, ostensibly because it lacks a clear legal mandate to do so. The bill introduced today would change that.
According to a statement from Sen Wyden’s office, the bill would “ensure hemp-derived CBD products are regulated by the US Food and Drug Administration (FDA) like other legal products used in dietary supplements, foods and beverages – an action that is essential to protecting consumer safety and treating hemp producers fairly.”
Specific exemption for hemp-derived products
The bill has yet to be assigned a number and at the moment goes by the working title Hemp Access and Consumer Safety Act. The bill would insert the phrase “other than hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp” in several sections of the FD&C, including in the so-called ‘exclusion clause’ which prohibits the use as a dietary ingredient for any substance previously investigated as a drug.
“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,” Wyden said. “It's been more than two years since I worked with colleagues to have Congress legalize hemp and hemp-derived products. It's long past time for the FDA to get with the program, for the sake of American consumers and farmers.”
“The Hemp Access and Consumer Safety Act directs the FDA to regulate hemp products properly and provides a huge relief to hemp farmers, processors, and merchants,” Sen Paul said.
Bill welcomed by industry
The introduction of the bill was welcomed by industry stakeholders. The American Herbal Products Association was one of the first groups within the supplement industry to tackle the issue, having formed its Cannabis Committee a number of years ago.
“The leadership of Senators Wyden, Paul, and Merkley in resolving this matter is greatly appreciated. Americans deserve to have assurances that the hemp and CBD products they include in their food and dietary supplement choices are properly regulated. AHPA supports this legislation since it would clarify the lawful pathways for bringing such products to market,” said Michael McGuffin, AHPA’s president.
“A lawful regulatory pathway will provide long-term certainty in the hemp-derived CBD market and protect consumers from potentially unsafe products,” said Scott Melville, president and CEO of the Consumer Healthcare Products Association (CHPA)