Micheal McGuffin, president of the American Herbal Products Association, said AHPA had a meeting scheduled earlier this week with FDA to discuss how CBD products could be lawfully brought to market. Because of the shutdown, the meeting was canceled.
Possible compromise on CBD issue
Late last year, after the 2018 Farm Bill was signed into law, FDA Commissioner Scott Gottlieb made a statement that said that while CBD products had not instantly become ‘legal’—as many in the sector have been claiming—that a compromise was possible.
Gottlieb did not back down on FDA’s position that CBD is not a lawful dietary ingredient because of the fact that it had been investigated as a drug prior to coming to market as an ingredient in supplements.
But that wouldn’t necessarily be the end of the story, he said. A compromise would have to include an opportunity for the agency to evaluate the safety of CBD, such as via a NDI Notification.
“FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement. We are taking new steps to evaluate whether we should pursue such a process. However, the FDA would only consider doing so if the agency were able to determine that all other requirements in the FD&C Act are met, including those required for food additives or new dietary ingredients,” Gottlieb wrote.
CBD discussion could be a lengthy one
But any move in that direction will require a significant amount of work on the part of regulatory agencies in cooperation with industry. On Saturday the federal government shutdown will become the longest in history, and with the increasing histrionics surrounding the border wall issue—the major sticking point between the Republicans and Democrats—there is no end in sight.
McGuffin said there’s no telling now when the CBD discussion might be restarted, given the severe backlog of regulatory agency work that is sure to develop.
“There are increasing concerns in the industry that the policies, programs and services run by the Food and Drug Administration (FDA) and the US Department of Agriculture (USDA) could be threatened the longer the shutdown is extended,” McGuffin said.
“In particular, the Farm Bill provisions regarding hemp require some implementation by the USDA. That this law be implemented promptly is important to hemp agriculture interests and hemp-based product manufacturers. The failure of prompt implementation could slow the beneficial impact of this important legislation. And even when the shutdown ends, there are concerns about long-term effects due to backlogs,” he added.
Several tweets that Gottlieb sent out last week indicated some inspectors still working in the field and laid out some financial workarounds to make their work less onerous. But these employees are in portions of FDA supported by user fees. Employees in the Office of Dietary Supplements, including the director, Steven Tave, are still on furlough.
Paperwork backlog foreseen
Larissa Pavlick, vice president of regulatory and compliance for the United Natural Products Alliance, experienced a prior government shutdown in 2013 when she was an FDA inspector. She said it is likely that very few if any inspections are going on and few employees would be at work, with one important exception.
“It is my understanding that there are no inspections occurring. This is partly from my previous experience during the 2013 furlough and from discussions with our political advisors from earlier today. During the 2013 shutdown, the only staff reporting to the office or allowed to conduct any government operations were existing investigators who are part of the Public Health Service. Since PHS is a uniformed service, they continued to report and all other ‘non-essential’ staff were sent home. Nearly all civilians at the FDA were classified as ‘non-essential.’ I imagine it is the same as this time,” she said.
Pavlick said the concerns about a backlog were well founded. In the 2013 shutdown, she said employees were required to show up on the first day to set up out of office voicemail and email messages, and then were sent home. They were required to suspend any and all work that was ongoing, included inspection reports or other paperwork that was in progress.
