FDA Hearing Tomorrow on Cannabis Extracts

“Based on available evidence, FDA has concluded [9] that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food) to which THC or CBD has been added. When this statutory prohibition applies to a substance, the substance cannot be added to any food that is sold into interstate commerce unless the Secretary of the Department of Health and Human Services (the Secretary),[10] in the Secretary’s discretion, has issued a regulation approving the use of the substance in the food (section 301(ll)(2) of the FD&C Act. To date, no such regulation has been issued for any substance.

For similar reasons, FDA has determined that products that contain THC or CBD cannot be marketed as dietary supplements.[11] By statute, if an ingredient is approved as a new drug under section 505 of the FD&C Act or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the statutory definition of a dietary supplement (sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act. There is an exception if the substance was “marketed as” a dietary supplement or as a food before the new drug investigations were authorized. Based on available evidence, FDA has concluded that this is not the case for THC or CBD. There is also an exception if FDA has issued a regulation finding that the article would be lawful under the FD&C Act (section 201(ff)(3)(B) of the FD&C Act). At this time, no such regulation has been issued. Some ingredients are derived from parts of the cannabis plant that may not contain THC or CBD, in which case those ingredients might fall outside the scope of this exclusion, and therefore might be able to be marketed as dietary supplements.”

We need to stay one step ahead of a government that may be glorifying some as ‘experts’ to give their input, so it seems, but instead are gathering what they need to keep product development in the hands of those with tons of money and away from the startups we see all over. According to FDA Commissioner Scott Gottleib, “the FDA understands that Congress wants there to be a pathway for CBD to be available.” Gottleib qualified this by saying that CBD access is not a straightforward issue because CBD has already been investigated and approved as a drug, Epiodiolex. FDA-approved drugs cannot be added to food, or used and marketed as health supplements. Over the past few years, the FDA has issued warning letters (and fines) to companies who have made health-benefit, disease treatment claims regarding CBD but those warnings didn’t result in much more than a media parade. Now we’re about to see a whole new world of cannabidiol that likely will cater to those that can meet very stringent guidelines.

Best advice to give anyone that’s giving testimony in person or electronically – Don’t make health claims and be prepared for the pro-regulation crowd to be in strength. We do need consumer safety, I agree, but we don’t need to be misled into thinking a hearing is about making CBD available to all when we see what’s within the Federal Register notice.