We can make that happen 
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I’ll smoke whatever brotha as long as it’s thc derived lol and found to be safe
I’ll have some cbn also I’m going to make it today
I’ll have testing on it also
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6 of one, half a dozen of the other. Did you catch the LEO/DA looking for fame? Do you have the money to fight it and become the legal precedent? Such gray area. A DA could push the analogue act past many people’s budget. With enough money and appeals, I believe the courts would let you off and place it at the feet of Congress. This is all completely hypothetical and involves plenty of assumptions.
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Bring a slab to MJbizcon
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That’s the plans
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“Since the moment they approved Epidiolex for clinical trials, CBD cannot be used in any product for human consumption as it’s defined as a drug.”
This is not accurate. CBD is grandfathered (particularly full spectrum) because it was made and sold before Epidiolex. There’s some teeth to an FDA argument against purified CBD due to the purified, standardized nature of Epidiolex. However that argument erodes for any CBD product that’s not standardized. aka pretty much all cbd extracts.
I do understand your point re nobody wants to be the precedent. And I agree, (face it everybody agrees with that). That said, regulations rarely tell you what you CAN do. They tell you exactly what you can’t do. Know the regs, and stay within those bounds. The kingofthekush seems to know where the line is, (love to see guys who actually read regs instead of going to Reddit to figure out their business plan).
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@anon1342 Can you provide anything stating CBD extracts are “grandfathered in”?
What “regs” are you referring too?
The FDA has explicitly stated their opinion, as has the DEA and USDA. States like Colorado have clearly defined hemp programs and are writing new ones per the USDA requirements, with the input of stakeholders in the industry.
It is the FDAs stated opinion that all CBD products can not be used in dietary supplements or foods due specifically to the FDA approving CBD in Epidiolex. I’ll post their statements if you’d like.
As stated by David Heldreth, the fda has clear precedent here with Red Rice yeast and statins
Topicals are the only gray area as they are not ingested.
The FDA also clearly defines how plant extracts can be approved as Botanical Drug Substances. An extract containing CBD is regulated the same as purified CBD isolate
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Actually its worse than that. The grandfather argument was addressed by the FDA in their Nov 25 letter and soundly rejected. Yikes. I had not read that new guidance and stand firmly corrected. After reading that FDA note I was left trying to figure out how the F any CBD can be put in anything or sold in any form. They shot down the grandfathered, the GRAS argument the food additive and the supplement argument. State laws specifically allow sales of specific forms, but that requires knowing every state reg loophole for every state and hoping the state regs aren’t re-written to comply with FDA guidance. wow. color me corrected.
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Depending on how you, your attorney, your states hemp program, and the district attorney coordinate their interpretation of the regulations I would expect this to be a short lived loophole. We will see what the impact of possible federal legalization and the FDA have on it, but I just cant see states or the feds allowing the production of psychotropic drugs under a basic agricultural license.
Let’s also consider that med/rec companies will most likely push against this. They’re not going to be happy to pay for the license and deal with the compliance of med/rec if all it does is give them freedom to work with D9 while all the hemp guys can pretty much everything else. I know first hand that the med/rec companies already hate the hemp industry for producing just CBD. I’m not saying it’s right or what I believe in, but a lot of those guys have financial and networking resources that most hemp companies don’t have and they’re lobbying the government for sure.
Would an open cannabinoid market in the US be awesome? Abso-fucking-lutely. Will there be an open cannabinoid market in the US? I highly doubt it.
I guess I just never put it past the states and feds to ruin great things that empower their citizens both financially and in health. ¯_(ツ)_/¯
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Here’s the FDA guidance that’s freaking out guys invested in hemp (me included); my initial take home is to hug the state regulations which specifically authorize sale of specific medicinal forms of CBD. If you comply with state law, you have a safe harbor within your state, crossing state lines or selling over state lines?
Questions and Answers
Below are a number of frequently asked questions and answers on this topic.
- What are cannabis and marijuana?
- How does the 2018 Farm Bill define hemp? What does it mean for FDA-regulated products?
- Has FDA approved any medical products containing cannabis or cannabis-derived compounds such as CBD?
- Aside from Epidiolex, are there other CBD drug products that are FDA-approved? What about the products I’ve seen in stores or online?
- Why hasn’t FDA approved more products containing cannabis or cannabis-derived compounds for medical uses?
- What is FDA’s reaction to states that are allowing cannabis to be sold for medical uses without the FDA’s approval?
- Has the agency received any adverse event reports associated with cannabis use for medical conditions?
- Is it legal for me to sell CBD products?
- Can THC or CBD products be sold as dietary supplements?
- Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added?
- In making the two previous determinations about THC, why did FDA conclude that THC is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act? In making the two previous determinations about CBD, why did FDA determine that substantial clinical investigations have been authorized for and/or instituted, and that the existence of such investigations has been made public?
- Can hulled hemp seed, hemp seed protein powder, and hemp seed oil be used in human food?
- What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?
- Will FDA take action against cannabis or cannabis-related products that are in violation of the FD&C Act?
- Can I import or export cannabis-containing or cannabis-derived products?
- What is FDA’s role when it comes to the investigation of cannabis and cannabis-derived products for medical use?
- Does the FDA object to the clinical investigation of cannabis for medical use?
- How can patients gain access to cannabis or cannabis-derived products for medical use through expanded access?
- Can patients gain access to cannabis or cannabis-derived products for medical use through Right to Try?
- Does the FDA have concerns about administering a cannabis product to children?
- Does the FDA have concerns about administering a cannabis product to pregnant and lactating women?
- What does the FDA think about making CBD available to children with epilepsy?
- What should I do if my child eats something containing cannabis?
- I’ve seen cannabis products being marketed for pets. Are they safe?
- Can hemp be added to animal food?
- Can approved human drugs containing CBD or synthetic THC be used extralabel in animals?
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Not used to people changing their opinions, Nice.
You are very correct that the state programs are what is saving us currently.
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Also saving us is that CBD is very low priority for the FDA. Public support would make enforcement on companies following GMP protocols and making standardized products would be negative press for the FDA, which they want to avoid.
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here’s the FDA addressing their argument CBD is grandfathered due to marketing prior to Epidiolex:
“There is an exception to section 201(ff)(3)(B) if the substance was “marketed as” a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD.”
Notice the “available evidence” leaves room for them to course correct.
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This is interesting. I will call my lawyerz.
This is what my circle has been telling me. They are going to be forced to meet in middle.
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To be clear, farming and manufacturing of Hemp and CBD are completely legal. It’s once it’s formulated and marketed for retail, it becomes illegal under the FDA ruling.
Also hemp cigarettes are still also very gray legally. They are in no way a dietary supplement, cosmetic, food, medicine, etc. Where do they fall in all this is anyone’s guess
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the first paragraph of this item is also important:
14. Will FDA take action against cannabis or cannabis-related products that are in violation of the FD&C Act?
“A. The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.”
Below are the warning letters. These give a really good idea of the things not to do (make claims) and how to do other things correctly (include adequate directions for use)
2019 Warning Letters
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The old adage - what is more important, the car or the gas?
I can make 1,000,000 kilos of CBD. If I can’t formulate/market for retail it’s almost totally useless.
Jet setting - won’t be able to rebutle for an hour or two.
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