• Darby Hemp

Hemp Industry News: The FDA Speaks after 2018 Farm Bill Passage

See the latest statement issued by the FDA regarding hemp and hemp-CBD products in late December after passage 2018 Farm Bill, with a little commentary of course.

We knew this was coming.

After reading through the recent FDA Statement released December 20th, from FDA Commissioner Scott Gottlieb regarding their response to the 2018 Farm Bill - more specifically the Agricultural Improvement Act of 2018 - I’m honestly relieved.

Let’s go through this step by step. First, the blanket statement declaring cannabis-hemp is now more under the microscope than it's ever been.

“In short, we treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of the source of the substance, including whether the substance is derived from a plant that is classified as hemp under the Agriculture Improvement Act.”

Good. Some folks seemed to think after the end of hemp prohibition it would just be this completely wild free for all without any regulation. And, in some ways I do love the mental pictures that thought evokes. But, we’re talking about a trillion $$$ industry that’s likely to reshape the modern world within a couple generations - governments and regulatory agencies need to be involved. This is just one quasi-hemp-battleground out of hundreds to come involving energy, bioplastics, infrastructure, and so on.

“Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce. This is the same standard to which we hold any product marketed as a drug for human or animal use.”

Again, this was inevitable. In the future there are likely going to be a variety of different hemp-product classifications. Some, for supplementation of the Endocannabinoid System similar to products like multi-vitamins, or amino acids, etc (Dietary Supplements). Others will be specifically for food-based nutrition (hemp seed goods), while others will most definitely be classified as drugs and used to help with a variety of medical conditions. Listen, we WANT the medical 'system' to love hemp, and CBD. The confusion is really happening because we’re only in the beginning stages of truly unleashing ECS science on the populace.

“Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes) are considered new drugs or new animal drugs and must go through the FDA drug approval process for human or animal use before they are marketed in the U.S.”

See, that’s confusing to a ton of folks - consumers and small business owners or entrepreneurs. It should be right now. People like me completely understand putting all-natural hemp plant extract in your body helps the ECS do a wondrous amount of things, one of which is to decrease and modulate anxiety. Soon, most everyone will be aware of this as well, so companies won’t need to make any claims other than being very clear about what’s in the product - ingredients, cannabinoid levels, processing, etc. Not a big deal. There are endless ways for companies to educate consumers about the ECS, remaining completely factual and within the law.

So, if I'd like to get into the hemp-CBD industry and sell tinctures to folks dealing with anxiety, I can simply educate them on how the ECS functions naturally (without any supplementation). See the difference? At least this is my understanding, I could be wrong. And that's just one example.

I’m already seeing more uniformity in the hemp CBD market, and this was developing before the passage of the Agricultural Improvement Act by about a year or more. Companies began offering more uniform tinctures for example, with uniform CBD amounts (e.g. 30mg, 250mg, 500mg, 1000mg etc.). Fact is, while things are improving, it’s HARD to be an informed hemp CBD consumer right now. Thankfully, with the help of regulators and corporate brands this is going to change. For less serious physiological reasons, it’s not as big of a deal, but consider all the parents out there looking for CBD for children right now, or people dealing with serious issues who turn to the hemp CBD market here in late December, 2018.

I for a fact know there’s a lot of shady practices going on, and these are soon to be weeded out or dramatically minimized.

“Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments raises significant public health concerns, as it may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”

See, if I’m trying to sell you a hemp CBD product, or just a hemp tincture with CBD in it, and I tell you it’s to boost your endocannabinoid system, how is this unsubstantiated? It's not. We have TONS of ECS research already on the books with mountains more to be published in the coming years. While I agree companies shouldn’t be able to tell people hemp CBD can ‘cure’ anything, using ECS science as the selling point should be perfectly legal. We’ll have to see how this goes, but again, we’re…

  • In the absolute beginning stage of the end of hemp prohibition.

  • Within a matter of couple years not only will public education be magnitudes more widespread, but there will be SO many products with hemp there’s going to be NO WAY regulators will be able to really steer the industry. They can sort of reign it in, but not control.

One way they’re seeking to try and contain things is through interstate commerce:

“Additionally, it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.”

And in connection, here comes big pharma. But it seems to only apply within the bounds of interstate commerce. Perhaps we’ll see some implications for ecommerce moving forward, or, maybe not. This position has been theirs for a while now, and the online sales of hemp CBD are hitting a fever pitch regardless.

“This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug.”

To Summarize

  • You cannot sell hemp CBD products AND make any therapeutic claims without FDA approval < big pharma move. This needs to happen, as ECS medicine is likely to revolutionize our healthcare system approach to helping the body maintain homeostasis. We want 'the system' to integrate endocannabinoid-based medicine.

  • There are likely in the future to be a variety or spectrum of hemp products containing CBD that span many different categories. This is a first regulatory step after the end of hemp prohibition.

  • Selling CBD foods, drinks, or dietary supplements is illegal across state lines. No interstate commerce. Hemp seed, hemp hearts, hemp seed oil, and hemp seed protein are all perfectly fine. This will be IMPOSSIBLE to control, as the sheer amount of products containing hemp plant compounds will be profound. It will mainly apply to medium and larger-sized businesses. It’s unknown if or how this will impact the current online hemp CBD industry.

According to a Erin Broden who spoke with an analyst within the industry for Business Insider,

“As long as CBD products are sold without therapeutic claims and within state lines, they appear to be considered legal.”

Make no mistake, the U.S. Government, the USDA, and FDA are all WELL aware of the people’s choice, seen in the demand for hemp and hemp-CBD products and the passage of the 2018 Agricultural Improvement Act. The FDA is now starting to really engage, not just big pharmaceutical companies, but the people who will be responsible for helping carve out regulations over the coming years (hemp industry players).

“Given the substantial public interest in this topic and the clear interest of Congress in fostering the development of appropriate hemp products, we intend to hold a public meeting in the near future for stakeholders to share their experiences and challenges with these products, including information and views related to the safety of such products.”

They're seriously considering using the FDA's authority to issue a regulation to specifically allow hemp-derived CBD ingredients in foods and supplements. No doubt, this isn't far off.

Get involved. Make your voice heard. Call an official or the FDA! In my mind, the people have spoken already. Are the USDA and FDA awesome? No. Look at the state of public health and our food system (insanely centralized by Big Ag). Good lord! But, hemp is going to really help us turn things around and we need both to not only get to know hemp well, but help the people contain this thing so we do it right. I'm glad these agencies are aboard, but then again, I'm a hempen idealist who believes not only can we save ourselves through harnessing this resource on all levels, but we can save hemp too.

What's Darby Hemp About?

Human societies are only as strong as their resources. Our platform is inspired by the desire to support a resurgent American hemp industry - its people, its economic impacts, its environmental promises.

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