It’s been a rather significant week for the CBD industry following last week’s announcement that the Food and Drug Administration submitted draft policy guidelines for possible regulatory oversight of the sector to the White House Office of Management and Budget. The document, “Cannabidiol Enforcement Policy; Draft Guidance for Industry; Availability,” is the culmination of over a year of pressure from insiders and promises to police the cannabidiol sector, ridding it of bad actors that have plagued the nascent CBD industry since the beginning.
According to a recent report from Cannabis Wire, at least three Hemp Industry groups have met with White House officials in the past few days to discuss the policy. Beginning on July 30, the U.S. Hemp Roundtable, the National Industrial Hemp Council, and Washington State hemp farm Ziese Farms went to Washington to speak with officials about the plan.
For years, fly-by-night companies have skirted FDA rules and regulations, promising consumers that cannabidiol can cure or alleviate everything from Parkinson’s to substance use disorders and more. Over the past few months, the FDA has had to issue a number of warning letters to industry stakeholders who have made the erroneous claim the CBD can cure COVID-19, a claim that is both false and dangerous.
The new policy is seen by many as the culmination of a years-long process that began with the passage of the Farm Bill in 2018. That legislation, spearheaded by Senate Majority leader Mitch McConnell, legalized all cannabis plants with a THC content lower than 0.3 percent, as well as any cannabinoids that are THC-free. However, it kept CBD in a grey area, as FDA officials debated whether or not the compound could be used in edible products and be advertised like a medication.
Industry stakeholders are hopeful that the new draft policy guidelines will clear up any remaining confusion within the sector, allowing cannabidiol manufacturers to move forward and realize the potential of their businesses.
“I am planning to share the hemp industry’s perspective on the need for a clear regulatory path for the sale of CBD products, and will be urging the White House and FDA to institute immediately a safe harbor for the sale of CBD products that are manufactured under current FDA regulatory guidelines for foods and dietary supplements and do not make improper disease remediation claims,” said Jonathan Miller, General Counsel of the US Hemp Roundtable in an interview with Cannabis Wire.
Over a year ago, the FDA held a public meeting, inviting a number of groups from both sides of the CBD question to comment. The much-talked-about meeting received wall-to-wall media coverage, generating tons of buzz within the industry. Insiders had hoped that the agency would quickly turnaround and present regulations. However, from that point on, it was a waiting game.
“We had a good listening session with the FDA on Monday,” Larry Farnsworth, a spokesperson for the NIHC, told Cannabis Wire in an interview. “We’re looking forward to continuing that conversation with OMB on Friday. We want to continue to press our case for enforcement discretion and sensible regulations. No regulations in place right now leaves room in the market for bad actors.”
“We’re advocating for a regulatory scheme that promotes consumer safety and that’s what we’ll communicate on Friday to the White House,” he continued.