FDA Extends Public Comment on Products Containing Cannabis


The Food and Drug Administration has extended the public comment period related to cannabidiol by two weeks, from July 2 to July 16, the agency’s principal deputy commissioner Amy Abernethy announced yesterday. The official notice was published to the Federal Register this morning.

The FDA held an all-day hearing in late May seeking to “obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.” (Read Cannabis Wire’s comprehensive coverage of this FDA hearing.)

At the hearing, people asked for a 30-day extension, according to the FDA. “The requests conveyed concern that the current 60-day comment period does not allow sufficient time to develop meaningful or thoughtful responses to the questions that appeared in the notice requesting data and other evidence in support of answers,” reads this morning’s notice.  

After consideration, the FDA decided to give another 14 days for people to submit comment, either publicly or confidentially, which the Agency is allowing, if the comment is labeled properly. The two-week extension “allows adequate time for interested persons to submit comments without significantly delaying any potential further action on these important issues.”

The FDA reiterated that they will take public comment into account as they draft rules to regulate the CBD industry, which has ballooned in the US after the passage of the 2018 Farm Bill. The notice reads, “The information from the hearing and comments provided to the docket will inform our regulatory oversight of these products and is an important step in our continued evaluation of cannabis and cannabis-derived compounds in FDA-regulated products.”

(Read previous Cannabis Wire coverage of the national crackdown on CBD-infused products.)

A CBD status update

Abernethy, along with the FDA’s principal associate commissioner for policy Lowell Schiller, authored a blog post last Friday that indicated that the shifting legal cannabis landscape is changing some aspects of their jobs.

“As these other laws have changed, and as more cannabis products come to the market (whether lawfully or otherwise), the FDA’s role is becoming more practically relevant to many affected stakeholders,” the post noted. “We recognize the need to be clear and open about where things stand, and about the efficient and science-based way in which we are moving forward.”

The FDA had “several significant takeaways” from the hearing, including that several commenters expressed a “desire for a regulatory pathway to enable lawful marketing of cannabis-derived products (especially CBD) in food and dietary supplements, with appropriate regulatory oversight.” In other words, the FDA is well-aware of the “substantial public interest in marketing and accessing CBD in food, including dietary supplements.”

But, there are some indications that the path to CBD rules could be long. Abernethy and Schiller noted that, when it comes to CBD, many safety questions remain, including: how much CBD is safe to consume in one day, and what kinds of drug interactions could CBD cause?

“These and other questions need to be considered if there is interest in exploring a framework under which CBD might be available more widely,” the post highlighted.

And as Cannabis Wire has reported, it could take the agency years to fully craft these CBD regulations. At a Brookings Institution event in March, former FDA Commissioner Scott Gottlieb said, just before he departed his position, that while the 2018 Farm Bill legalized hemp, when it comes to CBD, the law only allows the FDA to contemplate putting a substance in the food supply if it goes through a rule-making process. Under typical circumstances, this process can take three years.

With CBD, Gottlieb said he expected the process could take even longer.

“The FDA’s approach to cannabis and cannabis-derived compounds has been consistent,” Abernethy and Schiller’s post noted. “We treat substances derived from cannabis just like we do any other substances, and they are subject to the same authorities as any other substance. That said, some other relevant laws have changed, and so has the market.”

A parallel track in Canada?  

Also yesterday, Health Canada kicked off a process similar to what’s happening with the FDA and public comment on CBD. But up north, they’re calling it a “consultation on potential market for Cannabis Health Products that would not require practitioner oversight.” While not explicitly about CBD products, which are currently under the purview of prescriptions, it’s likely the government is responding to public pressure to make some CBD products available for human and animal consumption.

As we noted in an early May newsletter, the Canadian Health Food Association and the Canadian Hemp Trade Alliance released a white paper titled “A call for smart regulation of CBD” in which they explained their position that the federal government should remove CBD from the “prescription drug list in certain dosages for use in therapeutic (natural health) products and supplemented foods.”

The paper even notes the 2018 Farm Bill’s legalization of hemp in the US and the potential CBD boom. It reads, “Canada has been a world leader in hemp production and is the largest exporter of hemp products. However, competitors in the US, Europe, Australia, China and other countries could dominate this new and potentially very lucrative market because governments in those countries are amending regulatory regimes to allow for the inclusion of hemp-derived CBD in therapeutic products.”

The priorities of Canadian health officials are not unlike those of our FDA: health claims, ingredients, retail environments, packaging/labeling, protecting youth, etc. And they list the questions they are interested in answering, some directed specifically at consumers⁠—“Do you have preferred product formats for CHPs (e.g., cannabis extracts, topicals, tinctures, or others)?”⁠—and others to industry, like “Are you interested in manufacturing and selling CHPs on the Canadian market? Why or why not?”

The comment period in Canada is open until September 3, 2019.

Source link

WhatsApp WhatsApp Us