At the July 27 congressional hearing about CBD, a bicameral Request for Information (RFI) was announced for subject matter experts and stakeholders to weigh in on FDA regulation of CBD. Multiple stakeholders have submitted comments, including cbdMD, one of the leading CBD dietary supplement brands in the market.
“This really is historic. You don’t see bicameral, bipartisan requests, particularly on a subject that has languished for years,” Dr Sibyl Swift, cbdMD’s Chief Science Officer and VP of Regulatory Affairs, told NutraIngredients-USA. “We are encouraged that the request came out, especially after an oversight hearing, so it appears that we’re finally making headway in Congress, in terms of getting their attention.”
During a wide-ranging interview, Dr Swift discussed evidence of the presence of a cannabis extract (a Full Spectrum Tincture product) in commerce in the mid-1800s. The extract was also clearly documented in the United States Pharmacopeia (USP) Compendium around that time, she said.
“According to the rules and regulations, you are supposed to demonstrate that the article was in commerce. This was the best marketing we could find prior to it being yanked and scheduled by DEA,” said Dr Swift.
“And we’ve spoken to some of our friends and colleagues at the University of Mississippi and identified it and it was actually an Extract of Cannabis. The Agency will push back because the rules surrounding this state also that you must be able to identify that that article that was in commerce is the exact same as what is currently in commerce. If it’s not, then you simply need to do the requisite safety studies to demonstrate that your current article … has a similar safety profile or is also safe.
“We’ve argued that point around drug exclusion… and if we take any further action around this, that will be one of the arguments we use.”
FDA has also expressed on multiple occasions that is has concerns around the safety of CBD, predominantly based on the data from drug trials.
“Our studies demonstrate, and we’ve moved through regulatory review in other countries, they demonstrate that 160 mg per day in a 70 kg human are safe,” said Dr Swift. “And they’re safe for extended consumption, so if we wanted to take it to a higher level for a shorter duration, completely appropriate.
“We also looked at reproductive toxicity – there were no concerns from our perspective. We looked at hepatotoxicity – we did not identify any concerns,” she added.
Success overseas, frustration at home
The interview also discussed how is it that other countries – for example, the UK – have found a way to move forward with CBD products in the market, but the US, led by the FDA, has not.
“We are frustrated that other countries have found a way through,” said Dr Swift. “The Agency published a guidance document this year that indicated they would start looking to other countries for expertise. They aren’t doing it for CBD. They aren’t doing it for supplements, but they are starting to recognize outside expertise.”
Quoting the Natural Products Association’s Dr Daniel Fabricant, Dr Swift noted that “the mice don’t drive on the other side of the road in the UK”, meaning there is nothing special about the toxicological studies in the UK compared to the US. “The data is the data,” she said. “And the data should stand, and it should demonstrate that things are safe.”
Watch the full video for all od Dr Swift’s insights.
To read cbdMD’s statement at the July 27 hearing, and its responses to the RFI, please click HERE.
Moving CBD-containing dietary supplements out of the shadows and into the bright light of regulatory compliance
Many other stakeholders have submitted comments, including the Natural Products Association, the Council for Responsible Nutrition, while joint comments were filed by the American Herbal Products Association (AHPA), the United Natural Products Alliance (UNPA), and the Consumer Healthcare Products Association (CHPA).
In a release from AHPA, Michael McGuffin, the association’s president, stated: “FDA could today, under its current authority and in the existing regulatory framework, move CBD containing dietary supplements out of the shadows and into the bright light of regulatory compliance.
“AHPA remains committed to advocating for FDA's prompt initiation of rulemaking to grant an exception to the exclusionary clauses for CBD as a dietary supplement, with appropriate controls, under the existing regulatory framework.”
Steve Mister, CRN President and CEO, said in a statement: "Congress is asking the right questions because they created...a framework that CBD, and their reasonable expectations for FDA around this ingredient were not met. Meanwhile...the agency continues to place an entire industry in innovation-stifling limbo and consumers at continued risk in a needlessly unsupervised environment."
“For more than five years, Americans have been asking the FDA to make a safety determination for CBD,” said Daniel Fabricant, Ph.D., president and CEO of the NPA. “Instead of using existing regulatory authority, FDA has resisted fulfilling their mandate for years and now chasing the fantasy of a ‘center’ for hemp and cannabis products that would mimic the Center for Tobacco Products. Through DSHEA, Congress has provided the FDA with broad authority to review safety data for new dietary ingredients like CBD to enter commerce.
“Our proposal demonstrates that putting a clock on FDA to use existing authority is the most efficient and straightforward pathway for public health and to stabilize a robust marketplace for dietary supplements and foods containing CBD.”
