In late January, a popular alternative health site posted this somewhat inflammatory claim: “the FDA just outlawed CBDs and hemp oil extracts by claiming all plant molecules now belong exclusively to Big Pharma.” The article, purportedly written by a physician, quickly went viral. It caused some alarm among people who have come to rely on CBDs and hemp oil for alleviating chronic pain and other medical issues.
The FDA is in the process of regulating active marijuana compounds, which is not the same as outlawing them. On their FDA and Marijuana: Questions and Answers page, the FDA states:
Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, respectively. … There is an exception to sections 201(ff)(3)(B)(i) and (ii) 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. … (I)t is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added. The existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex.
In these sections, the FDA is basically saying that because there has been plenty of research evidence that THC and CBDs act as legitimate medicinal substances, they need to be treated as drugs rather than as dietary supplements. Which is certainly a logical conclusion to draw. Furthermore, regulating these compounds potentially benefits consumers down the road because pharmaceuticals are subject to far more stringent quality assurance than dietary supplements are. The FDA is also saying that because these are active pharmaceutical ingredients, manufacturers can’t put them in foods and pass those foods off as dietary supplements, just the same as the FDA prohibits bakers from putting Viagra in cake batter and selling the resulting cupcakes as a Valentine’s Day romance aid.
However, they are also saying that if a CBD-containing supplement or food (for instance, hemp oil) was already on the market before formal drug investigations and clinical trials took place, it’s exempt from the agency’s prohibitions. Furthermore, the FDA indicates that they (like most federal agencies) have limited funding and staffing and have to pick their battles. They may not be likely to pursue products that are in violation of its rules unless they pose an obvious public health hazard. From their FAQ:
Will FDA take enforcement action regarding THC and CBD products that are marketed as dietary supplements? What about foods to which THC and CBD has been added?
A. When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.
So far, the FDA mostly seems to have gone after companies that have made specific claims that that their CBD products cure cancer and other serious diseases. Companies that produce safe CBD products accompanied by honest marketing should be relatively safe from FDA enforcement actions.
[ed note: this post is a best-faith effort to be helpful and informative, but should not ever be considered legal advice. This post is also not medical advice. We are not your lawyer or your doctor, we are an internet website. Be smart, consult a professional if you need professional advice.]