CBD Regulatory Update

Aug 12, 2019 at 12:54 am by Staff


By MICHAEL PATTERSON

With the passage of the 2018 Farm Bill, Hemp and all by-products from hemp including CBD are now 100 percent legal...sort of. Congress passed the 2018 Farm Bill and President Trump signed it into law in December 2018. However, the regulations have not been written or approved regarding the cultivation of hemp and the sale of CBD by the Federal agencies charged to oversee the process.

The US Department of Agriculture (USDA) will be in charge of writing the rules on how hemp can be grown from seed to harvest. The USDA has come out publicly stating that they will have final regulations approved in the third or fourth quarter of 2019. The FDA is in charge of the manufacturing, distribution, and sale of CBD and CBD infused products. The FDA had their first public hearing on regulating CBD in Washington, DC on May 31, 2019.

The FDA has publicly stated that regulations could take up to two years to approve and implement. However, in the interim, they have provided guidelines on how to proceed with sales of CBD products until final regulations are enacted. The guideline is very simple, if companies do not market or advertise anything regarding CBD and its medical benefits (i.e. cures cancer, eliminates colitis, etc.), then the FDA will not shut your business down. However, if CBD companies advertise CBD as a "cure-all" or in any way promote unproven benefits, the FDA will shut down your operation.

The current strategy of FDA of regulating CBD is to create a "demarcation line" to delineate pharmaceutical grade CBD and food grade CBD. FDA Commissioner Gotlieb, prior to his resignation in May 2019, testified in front of Congress that the FDA wants to incentivize pharmaceutical manufacturers to continue to research CBD and find more benefits the cannabinoid can offer patients. Also, the FDA does not want to disrupt the current CBD market by requiring all CBD to go through FDA clinical trials. Therefore, the FDA is looking at a percentage of CBD or concentration of CBD within a product that would determine whether a product is pharmaceutical grade or food grade. For example, if the FDA comes out with regulation that any CBD product containing more than 100mg of CBD per dose would be classified as pharmaceutical grade CBD requiring FDA clinical trials. However, if the CBD product has less than 100mg of CBD per dose, then it would be considered food grade and would only have to pass a food grade certification process (remember, this is only an example).

This "demarcation" strategy is comparable to OTC medications and pharmaceutical medications. A person can take OTC ibuprofen and purchase it anywhere if the ibuprofen is 200mg or less per pill. However, if they want pharmaceutical grade ibuprofen (800mg per pill), they must go to a physician and get a prescription.

Florida CBD legal Update

The Florida legislature just passed SB 1020 in June 2019 regulating the production of hemp in Florida. It was signed into law by Governor Desantis last month. Based on this new law, the Florida Department of Agriculture will be in charge of regulating CBD sales within Florida. At a press conference in June 2019, Ag Commissioner Nikki Fried stated, "I think I have made it very clear along the way that I have a concern about what's on the marketplace right now. We have no idea what is in those products. We have no idea if there is THC or CBD, if there are other types of chemicals."

"There's going to be a window of time where everybody in the state of Florida will have to be compliant and bring in products that have the right labeling and the right testing standards. "said Fried. "For all of the other stuff that is on the shelves that does not comply, then they are outside the law."

If you are a physician and you would like to sell CBD in your office, based on the FDA policy of no enforcement as long as you do not advertise benefits of CBD, you can sell it legally. However, based on the comments from FL Ag Commissioner Nikki Fried, you must be selling lab tested consistent product. Therefore, follow these steps prior to selling CBD at your practice:

  • Only work with reputable brands. If you have an individual coming into your store and wants to distribute CBD, and they are not from a reputable company, do not meet with them. Reputable companies can be verified online and from references.
  • Ensure the CBD you are selling has lab tested results available at any time. Reputable CBD companies are now putting QR codes on individual bottles which allow anyone to check the lab results of each bottle in real time! This is extremely important during a spot inspection or complaint inspection by FL Dept. of Ag or potentially the FDA.
  • Seek legal counsel with a licensed Florida healthcare attorney. Selling CBD at your practice can be beneficial for your patients and your practice, but you want to ensure you are following the law.

Michael C. Patterson, founder and CEO of U.S. Cannabis Pharmaceutical Research & Development of Melbourne, is a consultant for the development of the medical marijuana industry nationwide and in Florida. He serves as a consultant to Gerson Lehrman Group, New York and helps educate GLG partners on specific investment strategies and public policy regarding Medical Marijuana in the U.S. and Internationally. He can be reached at mpatterson@uscprd.com