WTF Is Going on with CBD and the FDA?

Welcome to our first installment of Nice News with Tonic CBD. Every two weeks we'll talk to experts in the hemp and CBD space to help brands (and consumers) navigate the cluster that is selling products that contain CBD, claims that come out and promising studies that get published. To sign up for this biweekly newsletter click here.

First things first, what did the FDA letter say? “The FDA is doubling down on their stance that CBD can not be labeled as a dietary supplement, a stance they have maintained. The only drug they have approved is GW’s drug application for Epidiolex, the anti-seizure medication. They went so far as to say that there is no data that it’s safe and even further noting it’s potentially harmful. It’s interesting how they used a limited data set disregarding studies (both clinical and non) that look to [CBD’s] positive benefits” says Castetter.

Translation? Either the FDA is only getting their information from pharmaceutical companies with vested interests in owning the right to CBD, or they did a very narrow search on NIH where there are reams of studies available (plus the fact that they’re ignoring the fact that the general population has been guzzling CBD for the better part of two years). They claimed in the letter that CBD consumption can lead to liver damage and male sex organ complications amongst other potential issues with little to no sourcing. The only source they used was pertaining to a liver damage warning from GW pharmaceuticals. The dose they were seeing liver damage at? Over 600mg of CBD per day, another important detail; when liver damage was observed patients were on other drugs at the time meaning it was not conclusively linked to a single substance.

Is anyone selling CBD at a 600mg/day level? No. For one, it’s cost prohibitive, but, if anything, this showcases the need for better regulation and testing. While there needs to be regulatory oversight due to the proliferation of snake oil and ineffective products, that’s not what the FDA is campaigning for, if anything, they are making it harder for brands to be transparent. So, without FDA guidance or clear nation-wide guidelines, what should you do?

The letter went on to note that any health claims made by your company on any platform subjects you to oversight. This includes commenters on Instagram which the FDA would classify as a testimonial. While the FDA will issue warning letters, if the FTC or Federal Trade Commission gets involved, this could lead to ramifications for your company. While the FDA evaluates the safety of foods and drugs, the FTC looks into the advertising claims made by companies. Wiping claims around anxiety and pain from your site and social media until there is more clarity means you’re most likely safe but as Carbone notes; “how are we supposed to communicate to our consumers what actually works? There is no guarantee they won’t be punitive” she says.

The answer is, when it comes to marketing CBD by the FDA’s rules, you can’t communicate what your product does; anxiety, pain and inflammation are all health claims.

“I’ve been very anti-testimonial… whether it’s anything around kids or health claims we try to stay away from it” says Pryor. “Even if you’re using flowery language to try to get around making direct claims], it doesn’t matter, the FDA and now the FTC is going to issue warnings to your company if they see it” Carbone added. That means that if you decide to leave a review, comment or post up on social media around health claims, and use that for your marketing, you could have the FDA and eventually the FTC on your proverbial doorstep. “They’re making it as difficult as possible to communicate the benefits of CBD while actively disseminating misinformation about potential risks” Carbone says.

This is where the federal vs state family drama starts to kick off. Governor Cuomo signed a bill that went in direct opposition to the FDA letter requiring CBD companies selling in New York to label their products as a dietary supplement. Additionally, CBD brands are required to use QR codes or similar technology to showcase batch-specific lab results and sourcing information, specifically stating where the crop was grown. New York isn’t stopping at saying products simply need to be labeled as a dietary supplements, they need to be manufactured to the same standards as dietary supplements; this means adhering to DSHEA/cGMP standards. Though it wasn’t explicitly stated in the bill, we can expect dosing to be a part of regulations too. 

All of this is a good thing; it protects consumers and the brands that are doing it right. As Carbone put it; “the only people that will be unhappy about this bill are the brands and facilities that aren’t prepared to meet these higher standards. It will be hard for small businesses to make quick changes to their labels and incur the costs of keeping up with compliance, but I think we need to focus on the bigger picture of what this could mean for consumer confidence” 

In terms of timelines, labeling and manufacturing standards will be enforceable from May-June 2020 and in the state of New York, to sell CBD which will require a permit, enforcement will start in 2021.

While it’s unclear how any of this impacts the topical market, particularly beauty, Castetter notes that brands can anticipate scrutiny around pain claims. If cosmetics are left out of the debate, all that means is that as a consumer, you will have to be more vigilant in vetting your products. Sephora is not checking batch tests and has no way or processes in place to ensure your CBD beauty product actually has CBD in it. As a WWD article noted; to get into Sephora you just have to supply one CoA, not continually provide batch tested CoAs for every production run. For consumers, you’re going to have to ask the brand before buying.

If you sell in New York, invest in some stickers that say “dietary supplement” so you can legally sell here. In all seriousness, operating in the space, particularly if your brand makes claims around anxiety, pain or anything health related will be increasingly challenging until the FDA comes out with their final findings. Stick to education while not focusing outright on your brand in addition to explaining specific studies and research that is coming out from labs and the medical community. If you see testimonials from consumers that say your product “cured” them of [insert illness here], know that leaving that up for other consumers to read makes your brand more susceptible to being targeted by the FDA and FTC. 

While we would love to give you hard and fast rules, uncertainty is the nature of working in the hemp industry. Looking to New York, clarity around labeling, dosages and testing is on the right track, but you can expect to be confused on how to nationally market and sell throughout 2020 if not longer. While the New York rules makes mention of requiring brands selling in New York to source from the state, the regulations net out to farming practices needing to be consistent with New York state rules which is a good thing. This means that out of state brands can continue to distribute in New York, as long as they meet New York’s labeling and farming standards.

Best thing you can do if you want the FDA to listen to more perspectives? Contact your representative, particularly if you’re in a market outside of New York. The more states that adopt laws similar to New York, the more challenging it’ll be for federal agencies to override it. Also, be cautious. Don’t make anything with incredibly high dosing and it goes without saying; health claims. 

While New York will be one of the safer markets to buy from once these rules and regulations come into play, until that happens, continue to be wary and research the brands you buy from. While the FDA letter felt like fear-mongering, the sourcing they used is flawed so unless you are guzzling hundreds of milligrams of CBD a day while taking other drugs, your 15mg daily dose is fine. 

TLDR; New York is starting the path to regulatory clarity for CBD. The FDA on the other hand is still frozen in its opinions reinstating what they’ve said in the past and presenting misinformation. If we all want a safe but accessible CBD market, you’re going to have to call your local representative and tell them you’ll be looking at this issue when it comes to their next primary.