CBD Oil products contain cannabidiol which is extracted from the Cannabis sativa plant. CBD oil products are legally produced from cannabis plants containing 0.3% THC by dry weight, though the FDA’s stance on interstate commerce is murky—at best. Here’s a rundown of several noteworthy official statements on whether CBD oil is legal.
TL;DR: Hemp-derived CBD Oil is legal but Marijuana-derived CBD Oil products are not. The FDA says it’s illegal to sell CBD Oil products that cross State lines. We’re currently in limbo awaiting Congressional exemption for CBD to be allowed in dietary supplements (not something the FDA regulates.) Until such time, GRAS status isn’t likely for Cannabidiol.
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Legal Grey Area
The legality of Cannabidiol and CBD Oil products falls in a grey area. Major commercial outlets such as Walgreens now carry it, every local health food I’ve been store has it, and the FDA has even approved cannabidiol-based treatments. Still—CBD Oil products are technically illegal in most US States. Given the accelerated growth of marijuana-based legislation and CBD Oil based research my guess is that CBD Oil with probably be completely legal by the time I finish writing this article.
2018 Farm Bill (Agriculture Improvement Act)
The 2018 Farm Bill legalized the interstate commerce of hemp, a non-THC-containing variety of Cannabis sativa. Hemp plants contain trace amounts of THC and should any register above a 0.3% THC level they are considered marijuana, legally speaking. Not that anyone smoking is likely to consider as such.
FDA Issues “What You Need to Know” Statement
Current as of July 2019, the FDA has a public statement posted on the website regarding the legality of CBD oil products (among other concerns.) They discuss the 0.3% THC rule, re-iterate that only a single CBD Oil product (Epidiolex) has been approved to treat any health condition. That just means CBD Oil products can’t be advertised as treating health conditions—the same thing goes for 99.9% of dietary supplements.
The statement then goes on to warn against possible liver damage from long-term usage. This helpful tidbit was gleaned from drug-testing conducted prior to the Epidiolex’s approval. For what it’s worth—that’s also a very isolated and chemically processed form of cannabidiol. However, the FDA then makes the following statement:
We are aware that there may be some products on the market that add CBD to a food or label CBD as a dietary supplement. Under federal law, it is currently illegal to market CBD this way.
Drugs & Food Ingredients
Under FDA regulation, it’s illegal to add a compound that’s been approved as an ingredient in a prescription medication used to treat a health condition. There are some exceptions to this rule but, overall, it’s pretty encompassing. It would be easy to interpret the approval of Epidiolex as a signal of the growing acceptance of cannabidiol as a legitimate medical treatment. I suspect however that it may have been one of the first swings against cannabidiol-based consumer products like CBD Oil. Pure speculation on my part.
Dietary supplements like Vitamin D, B12, Magnesium, and even more drug-sounding compounds like Beta-1,3/1,6-D-Glucan are allowed in dietary supplements under the technical classification of “food ingredient.” They can’t be marketed as treating health conditions but consumers can use them however they please. They also aren’t found as primary ingredients in FDA-approved medications—that’s why you can buy them at the local health food store. The FDA phrases this as such (PDF):
… expressly excludes from the definition of a dietary supplement a substance that is an active ingredient in an approved drug, or a drug for which substantial clinical investigations have been instituted and made public, unless the substance was marketed as a dietary supplement or food before approval or before clinical investigations were instituted …
That sounds promising, being that CBD Oil was already being sold as a supplement prior to Epidiolex’s approval. The FDA doesn’t think so and has this to say:
An exception to this is if FDA promulgates regulations that use of such substance in a dietary supplement is lawful (21 U.S.C. §321(ff)(3)). Because CBD is an active ingredient in an approved drug (i.e., Epidiolex®) and was the subject of clinical investigations before it was marketed in food, FDA has determined that it may not be marketed in or as a dietary supplement. (emphasis added)
In April of 2019, the FDA reiterated the previously-stated stance that it is illegal to use CBD oil in dietary supplement products that are intended to cross state lines. They phrased it as such:
“unlawful under the [FFDCA] 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.
As it stands, the legality of CBD Oil is hard to understand. Hemp production is now legal at the federal level, and cannabidiol-containing products can be produced from such plants. However, the inclusion of cannabidiol as an active ingredient in Epidiolex has further complicated matters. Personally, I’m not thinking twice about buying CBD Oil if Walgreen’s can put out a press release detailing their plans to sell CBD Oil products without legal consequence.
