Two Pivotal Issues Will Define Hemp and CBD in 2019

Two Pivotal Issues Will Define Hemp and CBD in 2019

Hemp testing and FDA regulation of CBD will be two important issues in 2019.

In light of the 2018 Farm Bill becoming law, we can be sure that there will be a number of legal issues to address in the world of hemp and CBD. Of the emerging issues, there are two pivotal ones that will define and shape the industry in 2019. I encourage everyone with an interest in hemp and CBD to educate themselves (and their politicians and regulators), and to make their voices heard. The issues, in no particular order of priority, are hemp testing protocols and FDA regulation of CBD.

TESTING PROTOCOLS

One of the issues involves the appropriate testing protocol for measuring delta-9 THC concentrations in hemp. (I recently wrote at length about the issue here.) Since hemp is defined as cannabis with delta-9 THC concentrations that do not exceed 0.3% on a dry weight basis, coming to a proper resolution of this issue is foundational. Using the proper testing protocol is crucial to ensuring that farmers have access to an abundant variety and adequate supply of hemp strains to meet market demand.

One of the primary testing methods, gas chromatography (GC), increases levels of delta-9 THC in the sample being tested as part of the testing process. In other words, the test itself increases the very compound being measured. This alone should disqualify it from being used for hemp testing. The other method, high performance liquid chromatography (HPLC), does not modify the delta-9 THC levels and is highly reliable. It is the test that should be used for all hemp testing.

The testing issue revolves around the interpretation of a phrase in the 2018 Farm Bill regarding provisions that are required for states and Indian tribes to opt out of federal hemp regulations by creating their own regulatory plans. The provision requires plans by states and Indian tribes to have “a procedure for testing, using post- decarboxylation or other similarly reliable methods, delta-9 tetrahydrocannabinol concentration levels of hemp produced in the State or territory of the Indian tribe[.]” GC is the “post-decarboxylation” method. HPLC is the “similarly reliable” (it is actually the most reliable) method. States and the federal government should mandate that HPLC be used as the primary testing method.

FDA REGULATION OF CBD

The other issue involves how the FDA will treat CBD that is added to ingestible products. I have written about this issue here and here. The FDA released a statement (Statement) shortly after passage of the 2018 Farm Bill in which it discussed its position on CBD.

The short answer is that no one knows what the FDA will do about CBD. Its non-binding position (which is not a rule, mind you) is that CBD cannot be sold as a dietary supplement or added to food that is sold in interstate commerce. It is important to note that the FDA has held this position for approximately two years but has done nothing to enforce it. The FDA easily could have stamped out CBD before it got as big and popular as it is now. The fact that it hasn’t done so is significant in and of itself. (By way of comparison, it has taken substantial action, in the form of over 30 cease and desist letters, to stop manufacturers from making disease claims.)

The proverbial horse is out of the barn. Aside from the multitude of companies and consumers currently engaged in the industry, the multinationals are poised to jump into the fray. For example, Budweiser’s parent, InBev, is partnering with Tilray to to produce a non-alcoholic CBD beverage. A number of other multinational companies are also entering the CBD industry. I cannot imagine that the FDA will attempt to put the brakes on at this juncture. It’s too late and there is too much money and power at stake at the highest levels.

My personal belief is that one of three things will occur:

1. The FDA will utilize a little used procedure to authorize CBD as an ingredient for food, notwithstanding that it has been approved as an investigational new drug (Epidiolex). It is planning a meeting of stakeholders to consider this very thing. In fact, in the Statement it said: “While products containing cannabis and cannabis-derived compounds remain subject to the FDA’s authorities and requirements, the FDA will continue to take steps to make the pathways for the lawful marketing of these products more efficient.

2. The FDA will continue its unofficial policy of holding its present position without enforcing it.

3. The FDA will attempt to enforce its position, in which case it may prevail, at least from the technical legal perspective. (Given CBD’s popularity, safety, and apparent efficacy for dealing with a number of health issues, it will lose catastrophically in the court of public opinion.) The battle will then move from CBD isolate to CBD in the context of “full spectrum hemp”, or even less purified CBD “isolate” (ie, purity of less than 98%). The FDA’s position is much weaker on this front and, at the very least, I believe that full spectrum will not be regulated the same as isolate.

CONCLUSION

With passage of the 2018 Farm Bill and consumer demand for CBD and hemp products continuing to ramp up, 2019 promises to be a year of explosive growth for the industry. There will be many issues that arise. Of those issues, hemp testing and FDA regulation will largely define the direction the industry takes. I intend to follow up on these issues, and many others, as they unfold.

December 26, 2018

Rod Kight is an attorney who represents lawful cannabis businesses. He speaks at cannabis conferences across the country, drafts and presents cannabis legislation to foreign governments, is regularly quoted on cannabis matters in the media, and maintains the Kight on Cannabis legal blog, where he discusses legal issues affecting the cannabis industry. You can contact him here.

8 comments on “Two Pivotal Issues Will Define Hemp and CBD in 2019Add yours →

  1. Great article on CBD – Thank you so much for sharing. Definitely a bright future foc CBD but as you mentioned some issues are coming alongside all the good elements (especially those around testing protocols) so it’s important to keep those in mind! 🙂

  2. Thank you for your thoughtful comments on my blog page regarding the legality of CBD.Incredibly radiant texture! The issues, in no particular order of priority, are hemp testing protocols and FDA regulation of CBD.

  3. Thank you for keeping tabs on this most important development. ALL of us Hemp involved need to really understand that we must help our industry and keep it from becoming a DRUG MARKET commodity.!! I feel we can and should impress processors to stay away from producing CBD as a specific “PURE ONLY CBD WHITE POWDER Product” and stick with FULL SPECTRUM HEMP derivative products.

    Also, I too agree HPLC needs to be our standard for laboratory testing. Thank you for being on board and helping us with our KNOWLEDGE and sticking togather as a HEMP community. There is so much more to HEMP than CBD!! The BIO REMEDIATION capabilities have not even been discussed and they should!. Also the new GREEN INDUSTRIES like Hemp-Crete, Hemp fiber, etc., will create a renaissance of multiple HEMP products and strain developments. As long as WE HEMP Growers et. al., realize that now the Industry future will depend on us. Being thoughtful in our future growth is paramount.

  4. Hi Rod,
    EXcellent article: I’m grateful for how you advocate so effectively for emerging hemp producers!

    I agree with you that the FDAseems to be on a strong position to assert jurisdiction over CBD isolates that make medical claims. While it’s a little crazy that a bureaucracy can go straight from “cannabis has no medical value” straight to “GW has CBD isolate tied-up thanks to their recent tests on Epidiolex, the law does seem pretty clear.

    But you make your most important point about whole plant / Full-spectrum extracts are being story entirely. GW Pharma / Epidiolex has not tested, or patented, Whole plant / Full-spectrum hemp extracts, nor could it.
    Beyond what you outlined here, I think it’s important to note that whole plant extracts are quite protected under DSHEA as long as producers refrain from any medical claims whatsoever. The hemp industry should indeed press hard on this front. The results of this fight will have broad implications for not only the hemp industry, but the whole herbal / natural products world.

    When it comes to dietary supplements and DSHEA, the FDA can mandate Good Manufacturing Practices for such products to be sold, but they cannot ban hemp flower extracts as a whole. I have not seen any specific statutory authority cited by any of the folks talking about CBD disappearing entirely: not in the FDA press release, nor in any of the alarmist opinion pieces stemming from it.

    In the FDA’s 12/20/18 press release, they engage in quite a bit of linguistic sleight of hand, switching from “CBD” to “cannabis or cannabis-derived compounds” as if they are the same. As you and your readers well know, they are not. CBD’s approval as a pharmaceutical ingredient of Epidiolex should not implicate any more FDA authority over hemp extracts than would the 100+ year old patent on aspirin implicate FDA authority over willow bark extracts. Can I make medical claims for a willow bark tincture? No. But can I sell one as a dietary supplement, assuming all GMP requirements are met? Yes, in my understanding. The case should be similar for hemp producers.

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