The Head of the FDA Resigned. What Does that Mean for CBD?   

The Head of the FDA Resigned. What Does that Mean for CBD?   

March 10, 2019

Just weeks after announcing his agency would revisit its CBD policies, FDA Commissioner Scott Gottlieb announced his resignation last week, sending industry stocks crashing and chilling speculations about the industry’s growth.

What Does Brian Gottlieb’s Resignation Mean for the CBD Industry?

Despite the legalization of industrial hemp production, the CBD industry has been on tenterhooks as it waits for state and federal authorities to establish avenues of access for CBD-infused foods and drinks to enter the consumer marketplace.

While the federal government legalized CBD that’s derived from hemp in December 2018, the FDA’s current rules prohibit companies, stores, and restaurants from adding CBD to food or drinks. Despite this, CBD start-ups, cannabis food companies and cafes and restaurants forged ahead by way of state legal cannabis markets. Since then, everything from CBD topicals to CBD water have launched in various state and national markets, some of them earning the censure of state and federal regulators.

Why Does the CBD Industry Need FDA Approval?

Part of the issue, is the mandate contained in the 2018 Farm Bill which gives the FDA and USDA jurisdiction to monitor CBD as a drug ingredient and establish consumer safety rules that CBD products must follow before they’re allowed to be marketed to the public at large. However, both federal bodies have failed to release plans or timelines for the development of CBD rules; inaction which has drawn the censure of both consumers and Congress.

Gottlieb told lawmakers at the end of February that he heard them “loud and clear” when Congress legalized hemp-derived CBD late last year. Stating his intent to create a working group of senior officials to help draft new CBD regulations, Gottlieb’s testimony before the House Appropriations Committee, indicated that the FDA would hold its first public hearings addressing CBD regulations in April. During his testimony, Gottlieb also outlined some possibilities for what the regulations might look like.

“For CBD to be legally marketed in a food or dietary supplement, the law requires that the FDA would first need to issue a regulation to permit such marketing,” he said. “We’re planning to seek broad public input on this pathway including information on the science and safety behind CBD. But we know that this process could take time. We’re also interested in hearing from stakeholders and talking to Congress on possible alternative approaches to make sure that we have an appropriately efficient and predictable regulatory framework for regulating CBD products.”

Just a week after his testimony before Congress, Gottlieb surprised industry regulators and executives alike when he announced that he would be stepping down from his position at the FDA in April, before the hearing is conducted or any policy is drafted, much less implemented.

One of the reasons for industry concern is that Gottlieb’s successor has yet to be named. While Gottlieb experienced and responded to the pressure consumer demand for CBD, the next head of the FDA may not see CBD as a priority. According to Jonathan Havens, co-chair of the cannabis law practice at Saul Ewing Arnstein & Lehr, ambivalence from the FDA would be a worst-case scenario for the industry. “In times of transition, issues like this that are not of highest priority could get delayed,” Havens told reporters.

While Gottlieb was a conservative appointee, his management of the FDA had earned him bipartisan praise his stance on tobacco and success at targeting deceptive drug pricing schemes. According to Michael McGuffin, President of the American Herbal Products Association, Gottlieb was one of the most engaged commissioners he’s worked during his decades’ long tenure in the supplements industry.

“No other commissioner has embraced the agency, and his public role, anywhere near as effectively as Scott Gottlieb,” he said. Unfortunately, that also means that Gottlieb’s resignation could mean traction around CBD regulations could stall, McGuffin said. “Everybody’s crying out for some sort of rational clarity and there’s none. This slows it down, at best.”

Following FDA resignation, what’s next for hemp CBD?

Despite this new hurdle facing the CBD industry, the pathway to experiencing the health benefits of hemp isn’t as complicated or illegal as you may think. Find out where to find legal CBD products with myCBD.orgtoday!

 

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