On today’s episode of Call Me Cannabinoids, we’re joined by Frank Lampe, Vice President of Communications & Industry Relations at United Natural Products Alliance. Frank talked with our host, Pete Thornton, about hemp’s staying power in the marketplace, the coming FDA regulations surrounding hemp-derived CBD, and how CBD companies can navigate the uncertain regulatory future in the interim.
Where will CBD ultimately settle in within the government’s regulatory structure? According to Frank Lampe, that’s the $60 billion question.
Frank is the Vice President of Communications & Industry Relations at United Natural Products Alliance (UNPA), a trade association that deals exclusively with dietary supplement companies. UNPA represents over 120 companies around the world. They work with their clients on regulatory and legislative issues at both the state and federal level.
He attributes CBD’s unprecedented boom to the number of different players joining the industry at a rapid rate.
“You’ll see something come on the market, and if it’s got legs, suddenly everybody wants to have a piece of it,” he says. “And the industry has been driven by the product of the moment, whatever that might be.”
Hemp CBD: More Than A Passing Fad
According to Frank, he’s expecting to see some measure of course-correction in the aftermath of CBD’s massive growth. Companies will need to establish business models that are sustainable in the long term and lay a solid groundwork for moving forward. Still, he asserts that CBD isn’t just a fad.
“It’s very clear–through all of the consumer demand already, as well as just kind of a high level of consumer awareness of hemp products and CBD–that this is a long-term trend,” he says.
According to Frank, companies in the CBD space should stay within the boundaries of existing scientific research and should be careful not to present CBD as an all-encompassing magic bullet for a plethora of health issues and conditions.
“Word of mouth is the strongest advertising tool anybody could ever have,” he says. “And so things spread from there, and you get anecdotal evidence, the media picks it up, and suddenly you’ve got a phenomenon on your hands.”
3 Factors That Will Affect CBD’s Life Cycle in the Marketplace
Frank says there are a number of factors that could affect CBD’s life cycle in the marketplace, including tighter regulations, potential questions about the supplement’s safety, or alleged injuries and deaths associated with the product. The first factor is the FDA’s stance on CBD in food and beverages.
“The Food and Drug Administration says that it’s illegal to sell food, beverage, or dietary supplement products that contain CBD,” he says. “Clearly, there are thousands of products out there. The FDA realizes that they’ve got an issue here.”
Second, according to Frank, the FDA wants to “protect the intellectual property that’s been created through the drug business. And in this case, it happens to be GW Pharma’s Epidiolex product.”
Third, the FDA still has concerns about CBD’s safety. At the FDA’s public hearing on CBD on May 31, 2019, the panel asked for safety data on hemp CBD. Unfortunately, little data exists, as research on the plant has been limited.
How CBD Companies Can Prepare for the Coming Regulations
In the interim, industry leaders believe companies in the hemp industry need to establish their own regulatory rules that anticipate what kind of future regulation may be required by the FDA.
“We look at this whole situation right now as just being it’s the Wild West out there,” Frank says.
“The market is way ahead of both science and the regulation here. So let’s start putting some controls on that by making some core requirements that will automatically increase the quality of the products and reduce the likelihood of there being any safety issues or inadvertent adulteration issues that might take place as part of the production process.”
As more hemp CBD companies enter the industry, he says “the more products are going to be out there, the more claims are going to be made, the more rogue players” will be operating within the market. Normally, it takes three to five years for the FDA to create regulations around a dietary supplement product. But because of the market’s rapid growth, Frank says it’s not possible to wait three to five years.
“The obvious answer is to have Congress work with FDA to come up with some legislation that could be enacted and potentially voted on and enacted by the end of this year,” he says.
Dietary supplements were first legally defined when Congress passed the Dietary Supplement Health and Education Act in 1994–a law the FDA opposed.
“That’s the law that essentially created the modern dietary supplement industry,” Frank says. “It gave dietary supplements a home as a subset of foods within the canon because a lot of people wanted dietary supplements to be considered drugs, which would have changed the game completely.”
Because the FDA opposed this law (which Congress unanimously passed), Frank believes that Congress will partner closely with the FDA on the direction of hemp regulations.
“FDA and Congress will work very closely together on this because they both realize that we’ve got a real situation that needs attention,” he says.
If no rules are in place by the end of 2019, it could be well into 2020–or even after the next election cycle–before regulations are enacted. Still, Congress and the FDA will have to consider the pre-existing rules that:
Ingredients in a drug (like Epidiolex) can’t be sold as dietary supplements if the drug was on the market first;
The only legal way to bring a supplement to market is through a new dietary ingredient application (which isn’t an approval process, but a notification to the FDA;
The scarcity of safety studies on CBD is also a concern going forward, as studies are normally required before the FDA approves a new dietary supplement. While it’s possible the FDA can make an exception, it’s still uncertain what direction the administration will go.
Currently, many hemp CBD companies adhere to standard dietary supplement requirements like Good Manufacturing Practices, adverse event reporting, and labeling restrictions. Frank says that companies who tread carefully in the space in terms of label claims, safety, and adhere to Good Manufacturing Practices are more likely to avoid scrutiny in the short term.
“Look at the regulatory structure for dietary supplements, and follow that the letter of that law; you’re going to be in a much better place to defend your position [in the market], or be much less likely to be pursued by FDA,” he says.
Companies making claims that CBD can cure specific diseases should stop making claims, for the good of both the company and its customers. Adhering to better overall practices in processing, marketing, and manufacturing CBD products will ensure that the industry can grow in a healthy, responsible way.
To learn more about the United Natural Products Alliance and how it’s coming alongside hemp industry leaders, visit the UNPA website.