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USDA & FDA Are Listening to Your Feedback!

The USDA and new commissioner at the FDA are listening!! We want to kick this off by saying that please continue to be outspoken when it comes to how you feel about hemp and CBD products because both the USDA and the FDA are listening to all stakeholder (consumers, farmers, extractors, manufacturers, etc.) feedback.

As anyone following news related to the hemp industry knows, the regulatory environment changes on a weekly basis with state and federal views changing constantly. With that said, the last week of February has been filled with promising news from the USDA on their IFR and the FDA on how they anticipate they are going to regulate the hemp / CBD markets.

 

FDA | Recognizing Consumers Want CBD Products!

This one came as a surprise to us as it’s the first real tangible feedback directly from the FDA (not the ex-commissioner or speculation from the market) since the barrage of non—compliance letters went out end of November and since the new commissioner was appointed in December. Here are the Commissioner Dr. Stephen Hahn, MD’s comments:

“We know one thing, the American people are using CBD products. We’re not going to be able to say you can’t use these products. It’s a fool’s game to try to even approach that”. He added “We have to be open to the fact that there might be some value in these products and certainly Americans think that’s the case. But we want to get them information to help them make the right decisions”.

This is particularly important because one of the main issues pharmaceutical companies are going to press on (and the FDA as a result) is the Drug Exclusion Rule which disallows anything that’s been investigated or approved as a drug cannot be put into a dietary supplement or food unless it was marketed as a supplement or food before-hand. This barrier can be overcome if the FDA commissioner issues regulation after providing notice to the market/public and receiving comments that reiterate the proposed regulation would be in compliance with the Food, Drug, & Cosmetic Act.

While the statement is simple, we’re incredibly excited with this change in tone, because this is one of the only times anyone from the FDA has come out recognizing that consumers not only want CBD products but that there may be a good reason for it. It sounds like they may be shifting their focus to ensure people are well informed as opposed to blocking & removing CBD from the market.

 

USDA Responds to Comments on IFR Proposal

The USDA made two important announcements on their USDA IFR Proposal one of which is a delay in labs being required to be registered with the DEA and the other around options farmers have for disposal of non-compliant crops. Additional details below:

  • The date that labs are required to be registered with the DEA has been pushed back to Oct. 31, 2021 or when the final rush is published (whichever comes first) instead of Oct. 31, 2020 and will be open for comment again if consumers & the industry as a whole continue to feel this is unnecessary and criminalizing something that shouldn’t be. Equally important, it will allow labs around the country to work on becoming DEA compliant so farmers have more options (some states don’t even have a single DEA registered lab) to test with so testing doesn’t become a bottle neck which causes crops around the country to become non-compliant.
  • Additionally, the date for requiring DEA-registered reverse distributors for disposing of non-compliant cannabis was also pushed back to Oct. 31, 2021 or when the final rush is published (whichever comes first) allowing time for more comments and preparation in case this does ultimately become the process. More importantly, instead of solely allowing destruction of the material with no productive use, farmers will now be able to at the very least do the following:
    1. Plowing non-compliant plants underground beneath the subsoil
    2. Cutting the crop down and blending with other agricultural material and using it for “green” composting. Must be used on the same land and cannot be commercialized.
    3. The rest of the additional options provided by the USDA involve the destruction of the material

 

To Cap it All Off

All in all, the most important takeaway from these actions / statements is that regulators are listening to all stakeholders. Please continue to voice your opinion and let the USDA and FDA know how you feel and that the industry should be governed in a way that allows farmers, companies, and consumers to benefit (safely) alike, not suffocated. Let us know if you have any questions on the regulatory environment or if we can help in any way.

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