FDA Stalls on Regulating CBD/Hemp, yet Consumer Protections Needed Now

It’s been nearly five years since Congress gave the regulatory control of CBD products to the FDA (Food and Drug Administration) under action of the 2018 Farm Bill. For five years the industry has asked and waited for regulatory clarification from the FDA but was met with little-to-no feedback.

Today the FDA finally took action. The result – The FDA has kicked it back to Congress, concluding that “existing regulatory frameworks for foods and supplements are not appropriate for cannabidiol.” The next step will be the FDA working with Congress to develop a new way forward, ideally with industry input along the way to help clean up some of the bad and ugly that’s evolved over the last couple years. Could Cannabis fire back too?

FDA’s Historical Position on CBD

For years the FDA has held the position that CBD was a drug before a supplement and therefore could not be marketed as such. They’ve issued warning letters to companies that violate FDA regulations, primarily for companies making outrageous medical claims related to CBD’s ability to “prevent COVID” and curing diseases like epilepsy, Parkinson’s and cancers, all of which have yet to be proven in clinical trials outside of the GW Pharmaceutical’s FDA approved drug Epidiolex.

Regulating the CBD industry is an important part of establishing a safe, reliable and consistent market for consumers. It ensures that products on the market are safe for use, free from contamination, and that consumers can have confidence in the companies and products they purchase. And this isn’t necessary just for CBD, but plant-derived cannabinoids in general like CBG, CBN, CBC and natural forms of delta-9 THC, alongside the myriad of synthetic cannabinoids now being freely sold.

Hemp Market Flooded with Synthetic Derivatives with No Historical Safety Data

Without FDA action and due to lack of a regulatory environment and industry compression, the market has gotten creative since 2020, capitalizing on a legal loophole, using CBD isolate to artificially create intoxicating cannabinoids not normally found in the plant like delta-8 THC, delta-10 THC and HHC, among others. While the FDA may have concern over the safety of CBD due to lack of research (even though in 2017 the World Health Organization reported CBD had a high safety profile), a higher concern should be placed on these new synthetically produced cannabinoids which have zero historical safety data related to the compounds and concentrations ingested today.

The FDA should be the main organization responsible for regulating this dynamic industry in the US, but its lack of movement has left states to make their own regulations. It has also left businesses in a grey-market, fairly free to operate – for better or worse – but mostly has left consumers with little to no protection. This is of particular concern as new artificial cannabinoids continue to roll out in an expedited fashion to sales channels nationwide like delta-8 THC, delta-10 THC, THCP, THC-O, HHC and even an artificial version of the holy grail cannabinoid and traditionally natural intoxicant, delta-9 THC.

Why are these Synthetic Derivatives of Concern?

Yes, delta-8 THC, delta-10 THC, THCP, THC-O, HHC etc are all synthesized and artificial. Don’t be fooled by natural claims that you’ll find on packaging because the FDA is not taking enforcement action. Even most hemp-derived delta-9 THC on the market is synthetically converted from CBD isolate (unless your CBD to THC ratio is about 7:1 or higher and there are other cannabinoids like CBC, CBG and CBN found on the product’s COA you’re consuming fake THC).

The conversion process to make these synthetic cannabinoids occurs using acidic reagents and residual solvents to catalyze a reaction. During this process, CBD isolate converts to delta-9 THC and further into delta-8 THC. From there you can further process the extracts into other forms like HHC using a variety of chemical processes.

The concern over these compounds exists because for many reasons.

  1. The reagents used are not tested in the final product. Contaminants like pesticides, heavy metals or residual solvents can be tested to see if they still remain and at what concentrations in the product but no one is testing for these reagents.
  2. During the conversion process other compounds are created in the process. Many of these have been characterized but the safety and effects of these new compounds are unknown.
  3. Possible most importantly, there is ample data on the safety profile of CBD and plant-derived delta-9 THC. We have been consuming it since the dawn of humans, but these new cannabinoids have never been consumed. There is NO HISTORICAL SAFETY DATA. We have no idea how these compounds will impact our health in 5, 10, or 50 years from now. Even delta-8 THC (which can be found in extremely low concentrations in the plant) has not ever been consumed at the concentrations it is being consumed today. You are the test subject.

It’s an overwhelming market to understand, even for someone deep in the trenches, so the consumer must feel 100x more overwhelmed by what is real, what is fake and what is safe. This is where the FDA traditionally is supposed to help the consumer.

Industry Requests Regulation, FDA Pauses on Next Steps

For the last 5 years the industry has asked the FDA to step up and regulate the product as it does other products, like a supplement (we are supplementing our endocannabinoid system with these phyto-cannabinoids after all). As a supplement, the FDA would require manufacturers to include specific language on their labels and adhere to advertising regulations, as well as comply with good manufacturing practices (GMPs).

These labeling and advertising regulations were initially established in 1906 under the Pure Foods and Drug Act back when cannabis was still legally sold in apothecaries across the nation. The regulations are meant to protect the consumer and avoid misrepresentation as to what is in the product and what is not. Additional protective measures like preventing medical claims regarding a product’s ability to diagnose, treat, cure or prevent any and ensuring companies follow required testing protocols are both important to ensure safety and quality of the products.

Supplement regulations under the Dietary Supplement Health and Education Act of 1994 (DSHEA) put in place an extensive system of measures to ensure that products are of high quality and are safe to use. This includes requiring companies that produce and sell CBD products to obtain FDA approval before bringing products to market by submitting a New Dietary Ingredient Notification (NDIN). However, the few CBD companies who have tried this approach to date have been denied by the FDA who stated more research was needed for approval and claiming CBD is a drug not a supplement.  

The United Kingdom initiated a similar protocol in 2020 under their Novel Foods Act process which required companies to submit toxicological studies, stability studies and pharmacokinetics studies called ADME (“absorption, distribution, metabolism and excretion” or how the compounds digest in the body). A variety of companies participated in and submitted 100+ page dossiers per product to seek approval for this NFA framework but the United Kingdom has yet to take any serious approval action.

What’s Next?

So beyond the FDA punting regulation back to Congress what is next for bringing clarity in this very grey market? Only more questions…

Will a working group be created to establish safe levels of consumption, packaging guidance, and testing parameters?

Will Congress take action on the upcoming Farm Bill?

Will Big Pharma have a say in these regulations?

What about the other elephant in the room, Big Cannabis, who are now threatened by legal loopholes in hemp’s regulatory framework that permits the retail sale of synthesized and isomerized cannabinoids like delta-8 and delta-10 in convenience stores without the tax burden and excessive oversight as cannabis?

How soon will this all play out?

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