February 21, 2019
Peter Pitts, former associate commissioner with the FDA and president of the Center for Medicine in the Public Interest, discusses why CBD remains unlawful under FDA regulations to be marketed as a dietary supplement, regardless of whether or not the substances are hemp derived.
Recently, the FDA announced that it was going to crack down on snake oil claims and low-quality products being sold as dietary supplements. There's a lot of confusion out there about the difference between dietary supplements and drugs. That's a good question and probably a good place to start this conversation.
Because of peculiarities in legislation, dietary supplements are actually regulated as food under the dietary supplement act, which is called DSHEA, which is the Dietary Supplement, Health and Education Act. The joke, not really a joke but what people say, is that the E for education is silent. The FDA wants to change that.
When it comes to dietary supplements, the two big issues for the FDA are, obviously, quality, because no substandard product should be on the market.
Quality is generally measured by the FDA, initially as, is what's on the label of the product actually in the product? Are there adulterated elements in the product that are not on the label that should not be on the product? That is largely a manufacturing conversation.
The second big issue is that of communications. How can dietary supplements present themselves to the public? As I said earlier, dietary supplements are regulated as food, not drugs. As a result, dietary supplements can't make drug claims. What does that mean?
A drug claim means that a dietary supplement can't say that it cures cancer or ameliorates pain from arthritis. Those are things that prescription drugs and over the counter drugs do. If a dietary supplement makes such claims, it's violative behavior. In other words, you can't avoid being regulated like a drug and claim to be a drug.
Many dietary supplement retailers come very close to that line. Many go way over it, especially on their online promotions.
What the FDA said in that recent announcement was that those supplements that made claims to cure Alzheimer's disease or cure cancer, that address really serious, life‑threatening conditions, that are taking advantage of those who are most liable to be looking for any type of hope, will be looked at by the FDA and dealt with appropriately.
I think that it's long overdue. The problem is, obviously, that the FDA doesn't really have the additional budget to do that because there are so many manufacturers out there, both online and in brick and mortar retail shops, that it's hard for the FDA to handle every problem.
What they said was they're going to address the most serious ones on a risk‑based basis. That's certainly a good place to start.
Front and center, I think in everybody's mind, when it comes to dietary supplements, is the issue of cannabidiol oil, or CBD oil and its various types of derivatives. People think that CBD is something that you can get high on, so it oftentimes can be a hemp derivative or a marijuana derivative.
I guess the place to start is to dissuade people of that misconception. You can't get high from CBD. Those who think that it's allowing people to buy something they can get high on as a backdoor pathway to legalize recreational use of marijuana that's not what this is about. This is an entirely different issue.
The issue with CBD oil is that it is an ingredient in a prescription drug that treats a serious condition. As a result, it can't be defined as a dietary supplement. Yes, it is being sold as a dietary supplement. There are issues there.
The reality is that it's very complicated. Let's look and talk a little bit about how the FDA is focusing its time, and effort, and resources on CBD.
Just before the end of last year, the Agricultural Improvement Act of 2018, also known as the farm bill, was signed into law. Among other things, the farm bill changed certain federal authorities relating to the production and marketing of hemp. These changes included removing hemp from the Controlled Substances Act.
This means that CBD will no longer be considered an illegal substance under federal laws. That's an important point. CBD is not illegal. But, just as important for the FDA is what the law didn't change. Specifically, Congress preserved the agency's current authority to regulate products containing cannabis or cannabis‑derived compounds such as CBD.
On the one hand, CBD is no longer illegal. On the other hand, it's still very much under FDA's regulatory authority. What does this mean?
It means that CBD remains unlawful under FDA regulations to be marketed as a dietary supplement, regardless of whether or not the substances are hemp‑derived. Whether it's a hemp‑derived CBD or whether it's cannabis‑derived CBD, it can't be marketed to the public as a legal dietary supplement.
Under the Food, Drug and Cosmetics Act, which is the large federal legislation that allows the FDA to do its job, it's illegal to introduce drug ingredients like these into dietary supplements. Since CBD is used in drugs such as Epidiolex, it can't also be used as a dietary supplement. It's either‑or.
Farm bill or no farm bill, the FDA's made it clear that hemp‑derived CBD is not a legal dietary supplement. That's clear. It's unambiguous but you would never know that by looking online at CBD dietary supplement stores, such as GNC, and seeing if you could buy it.
Here's what the FDA said. They said, "We'll take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis‑derived products that could put consumers at risk and are being marketed in violation of the FDA's authority."
The FDA's got a very strong stake in the ground relative to CBD oil and what it's going to do about it. Just earlier this month, earlier in February 2019, the FDA's commissioner, Dr. Scott Gottlieb, announced a newly created Botanical Safety Consortium.
Again, I think the worry here is very important because you're saying botanical. It very clearly points to the cannabis and cannabis‑derived products.
What this is going to be is a public/private partnership that's going to gather leading scientific minds from industry, from academia, and from government to promote scientific advances in learning how to evaluate the safety and efficacy of botanical ingredients and mixers in dietary supplements.
The FDA realizes this is not a one shot issue. It's got to evolve over time. This group, the Botanical Safety Consortium, is going to look at new and novel ways to use cutting edge toxicology tools, including alternatives to animal testing, for example.
In the commissioner's announcement, no mention was made specifically of hemp‑derived CBD, but that's certainly viewed by many as becoming the 800‑pound gorilla sitting in the regulatory corner. Even though the commissioner didn't tee it up clearly, it's on everybody's mind.
We have to ask, what's the relevance for this nascent but swiftly growing CBD industry? You just close your eyes and pretend it's not there. It's there. It's popular. It's growing. It's going to continue to grow.
The first thing we have to recognize is that those who are manufacturing and retailing CBD oil have to recognize that their marketing plans, I think, need to slow down, if not put on hold, now that the FDA really has stepped up to the plate.
If the FDA has identified CBD as an important public health issue, on the one hand, and on the other hand, manufacturers and retailers want to accelerate their marketing plans, there's going to be a collision. When that happens, I think the player with the bigger stick, in this case it's the FDA, is going to come out on top.
They wield a big stick. When they choose to, they know how to use it. I think friction is not the best way to move these things forward. Collaboration is. In that respect, rather than aggressive marketing, the industry should find ways to participate in this Botanical Safety Consortium. We'll see what happens.
Obviously, a lot of people feel this is regulatory overreach. I'm not going to inject my value judgments here. There are facts here relative to the FDA's authority and no way is pure Big Brotherism. The important public health role of the FDA doesn't make the agency's position or authority any less real and relevant.
It's important for people in the CBD industry and dietary supplements industry, more broadly, aware of that. I think it's time for the denizens of CBD, and that includes many highly vocal patients, physicians, pharmacists, manufacturers, and distributors, to become part of the solution.
They need to step up to the plate and participate with the FDA's new Botanical Safety Consortium. That's important for lots of reasons, not the least of which is a very well‑known saying inside the beltway in Washington, which is, "If you're not at the table, you're on the median."