FDA Withdraws Milestone CBD Policy

Please note: the use of CBD for medical or recreational purposes may be illegal in your country.

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Ever since the 2018 legalization of cannabis in certain parts of the U.S., the CBD industry has been growing as fast as it can manage. It could be growing faster, though; key regulations have been slow to materialize, sometimes because of the time it takes to conduct research, sometimes because of bureaucracy.

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Image source: unsplash.com

In the case of the FDA’s long-anticipated CBD enforcement policy, it was a bit of both; the FDA spent more than a year reviewing CBD and various other cannabinoids before it submitted the policy for approval. Once they’d sent the Cannabidiol Enforcement Policy Draft Guidance for Industry to the White House Office of Management and Budget (OMB) for review, they waited for six months, only to withdraw it on January 21st.

Isn’t this an important set of regulations for the CBD industry?

On the scale of importance, this policy is pretty high up there; its absence is one of the main barriers keeping pharmaceutical companies from taking advantage of CBD’s legality.

The FDA didn’t withdraw the document because something was wrong with the it; rather, it was just a case of dumb luck. January 21st happened to be the day after President Biden was inaugurated, and it’s typical for new presidential administrations to do some spring cleaning where pending regulations are concerned. This is because of how the White House OMB works – its function is to make sure that all the policies coming from federal agencies are in line with the current president’s goals for the country. With this in mind, the FDA drafted a policy that would be approved by the OMB under the Trump administration. Once Biden took office, however, the pending regulations were all withdrawn because they had been written during the previous administration.

The FDA hasn’t released any details about the contents of their CBD regulations, and according to CBD retailer Premium CBD Supply, nobody can say for sure how they’ll affect the CBD industry once they’re published. There’s no telling how close the OMB was to approving the FDA’s regulations, but under the Trump administration, they did organize meetings with industry leaders like General Nutrition Centers, a retailer that wants to expand their CBD-related offerings, and GW Pharmaceuticals.

Now that the FDA’s policy has been withdrawn, the CBD industry is treating it as a fairly serious setback. After all, the FDA has already taken this long to get the first draft out – how long before the second draft is finished and re-submitted to the OMB? After that, there’ll be more waiting for the OMB to review and approve the document. Fortunately, once these two hurdles are cleared, the regulations will likely be announced to the public within weeks. The FDA hasn’t given a timeline for when they might submit a second CBD enforcement policy, but given the amount of industry pressure for regulations, maybe it won’t take as long as last time.

It isn’t just the pharmaceutical industry that wants to ramp up production of CBD-derived products – the dietary supplement industry stands to benefit too. The recently withdrawn CBD enforcement policy doesn’t apply to the supplement industry, but it will probably end up being a guiding force for future policies for the manufacture and sale of CBD products.

The new year hasn’t been all bad news for the CBD industry, though.

Just a week before Biden assumed office, the USDA announced new regulations for hemp farmers. There had already been interim regulations in place since 2019, but farmers weren’t happy at all about certain aspects of the rules. The main sticking point was the way they were required to destroy any part of the hemp crop that contained more than 0.3% THC. Since anything above this limit is considered a Schedule 1 Substance, the USDA’s interim rules required all farmers to get either law enforcement or DEA agents to cart the illegal plant material away and destroy it. Not only was this a hassle, but it was costing them an average of $200 an acre.

As the USDA was formulating the official regulations, they got feedback from farmers all over the U.S. on what should be different; as a result, hemp farmers are now allowed to dispose of high-THC plants on their own farms, using any method that would make it unusable for anything besides soil enrichment. Acceptable methods include:

  • Burning
  • Burying under the ground
  • Tilling, disking, or plowing into the dirt
  • Composting, mulching, bush-mowing, or chopping to make fertilizer

These methods are a part of traditional agriculture’s way of getting rid of unwanted plant material, so there’s very little burden on the farmers. They already have to dispose of hemp that’s stunted, diseased, or destroyed by pests or bad weather, so this is just a normal part of the process. Best of all, the cost has gone down to just $14.25 an acre. To make sure that everything is correct and above-board, hemp farmers keep records of the high-THC hemp they destroy; these records go to both state and federal authorities.

The CBD industry is doing its best to flourish, even with policy-related setbacks. Large sections of commerce are being held back for lack of regulation, but even so, the industry is still finding a way to grow every single day.

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