Tresquire doesn’t endorse any specific products of any kind, this is just a visual aid.
CBD 101—the Background
The Cannabis plant has two main strains the United States government is concerned with: hemp and marijuana. Under the 2018 Farm Bill the federal government defines any such plant with more than 0.3% THC as marijuana, and 0.3% or less THC as hemp. Hemp is legal federally, and marijuana is illegal nationwide. Even in those states where marijuana is “legal” it’s actually still illegal under federal law, the federal government is just choosing not to enforce the law in those states.
One of the chemical components found in all cannabis plants is cannabidiol, aka CBD. In terms of federal law, which beats state law in legal rock-paper-scissors, CBD sourced from marijuana plants is illegal, because the marijuana plant itself is illegal. CBD sourced from hemp plants, on the other hand, is totally legal.
Even though hemp derived CBD is ok to sell nationwide according to the federal government, some states have their own laws that directly that restrict hemp sales. In such states hemp derived products can be treated the same as marijuana products, on a gram for gram basis. On the other end the spectrum, many states have accepted the federal government’s stance on CBD, and allow people to buy and sell it as long as the product is in line with FDA regulations.
The Cliffnotes FDA Rule
Under FDA regulations, you basically don’t want to make any kind of claim that it can treat diseases or be used for any other therapeutic uses; you also don’t want to include it in any food or beverage. If you do you’re breaking the law as enforced by the FDA.
11/25/19 Press Release and Guidance
The FDA released a public statement on November 25 (available here) where they let the country know they sent warning letters to 15 different companies, naming each such company. Each of these companies was given a couple of weeks to figure out how they’ll get in compliance, or risk being shut down.
Here’s why the FDA public release was important:
1. Maybe most importantly, the FDA concluded that it couldn’t conclude CBD is generally recognized as safe (aka “GRAS”…please, no jokes). One might reason this is evidence that the FDA is getting concerned about CBD safety, and may start regulating sales more heavily.
2. They issued 15 different warning letters. For perspective, it issued 1 in 2018, and 4 in 2017. See point 1 above.
3. Between the press release itself and a Consumer Update that the press release mentions, it looks like the FDA is specifically concerned about the following areas:
a. Safety overall, primarily liver toxicity, drug interactions, and effects on the male reproductive system
b. Marketing products to infants and children
c. Marketing products for animals that produce food for humans
d. Marketing food products or CBD containing items as dietary supplements
e. Marketing products to treat diseases or be used for therapeutic purposes
While the FDA’s official statements are limited to what they said in the official press release and the Consumer Update, it does seem like the FDA is getting more concerned about CBD, and is positioning itself to regulate CBD from a stronger position. If you’re selling CBD products, this is a really good time to make sure you’ve set up a program that’s in compliance with FDA Regulations, which are obviously much more complex than the “cliffnotes” version above. When in doubt, find a lawyer.
What’s the TL;DR?
The FDA is still forming its opinion on CBD, but right now it looks like they’re starting to crack down on sales. If you’re selling CBD products, take a close look at your product and practices to confirm compliance.
Genuine disclaimer: this is an extremely simplified explanation of CBD and general cannabis policy in the United States. Please don’t make any business or life decisions based on something you read on the Internet. When in doubt, find a lawyer experienced in this area who is also licensed in your state.