When Ed Donnelly’s wife fell and injured her back, she found relief in a CBD topical cream, but the product’s strong menthol odor proved to be a huge downside, along with the couple’s discovery that the product contained THC.
Looking for a better solution, Donnelly applied his 35 years of health care experience to launching AmourCBD, his very own CBD product line. He then embarked on a journey to get the company’s pain-relieving cream registered with the U.S. Food and Drug Administration (FDA).
“Having spent 30 years or so with medical device companies that worked with the FDA, I know and respect the value of the FDA, and I also know that whenever anyone uses an active ingredient, … they should be getting it registered with the FDA, but so many of them are not,” Donnelly tells Cannabis Business Times. “In our case, the active ingredient is lidocaine. We basically have a cream that contains 200 mg of CBD, some other oils that are very beneficial for quality skin, and then we have lidocaine. The lidocaine, as an active ingredient, basically opens up the highway to deliver the CBD to the point where you want it.”
Any product that contains an active ingredient can—and should—be registered with the FDA, he says, and this includes CBD products. FDA registration should not be confused with FDA approval, however; FDA registration applies to over-the-counter medication that has met certain criteria and has been granted an FDA registration number, while FDA approval applies to prescription medication that has undergone multiple studies to prove its efficacy, Donnelly says.
When a product is registered with the FDA, the agency essentially verifies its contents and ensures that it is manufactured according to FDA guidelines.
“In our case, [it’s] making sure that there is 200 mg of CBD, that there is lidocaine in it like we say, and then, equally as important, making sure what’s not in it,” Donnelly says. “Many of these CBD products are coming from places like China with microbes and pesticides and solvents in the product. By us going through the FDA registration process, we have it manufactured in an FDA-certified [facility], and that, again, is a whole differentiation. It is a facility that the FDA visits regularly and inspects, and the product is manufactured to their standards.”
AmourCBD does not own the manufacturing facility but has partnered with it to produce the product up to AmourCBD’s specifications, Donnelly says.
To register a product with the FDA, a brand must first submit written descriptions of the product, including its contents and how it is manufactured, Donnelly says. Next, a product’s labeling, including the ingredients listing, warning labels and label claims, must be submitted for review.
“All of that has to comply with FDA regulations,” Donnelly says. “For example, our product says, ‘Amour Pain Relieving Cream.’ Those words ‘pain relieving’ are critical. The only reason we can say the words ‘pain relieving’ is because we are FDA-registered.”
The FDA has indeed been cracking down on CBD brands that make unsubstantiated label claims. Just this past summer, the agency warned Curaleaf against making such claims on its labeling, and the company responded by scrubbing the claims from its marketing platforms.
In any case, once the labeling has been reviewed, companies are required to submit their final products to the FDA for validation testing, Donnelly says.
At the end of the process—which can take up to nine months—a product that meets all criteria is assigned an FDA registration number, which can be seen on over-the-counter medication at the drugstore, Donnelly says.
“If you go into Walgreens or CVS and you’re looking at cough syrup, … they will all probably be FDA-registered and there will be a number on it—the FDA registration number,” he says. “On our AmourCBD, there is an FDA number and the pharmacist or anyone else can look it up. It’s more than the good housekeeping seal of approval that the product has been developed, packaged [and] inspected to a certain degree to meet FDA guidelines.”
Right now, AmourCBD’s pain-relieving CBD topical cream is the company’s only product that can be registered with the FDA, as it is the only one that contains an active ingredient outside of the CBD itself.
“The rest of our product line—things like gummies and tinctures—cannot be FDA-registered because they do not have an active ingredient. It’s just pure CBD,” Donnelly says. “But it tells the consumer that they can trust the entire family of products, that … we’ve gone so far as investing time and money to do the cream to a … very high standard. They can trust the rest of the product line.”
This sort of trust is important, he adds, especially in the wake of the vape crisis.
“They thought vaping was limited risk, and [then] they find out that there are all these things in it that they never imagined,” Donnelly says. “We’re making sure that there are no misrepresentations in our product line. People can put their heads down on their pillow at night, knowing that we’re working with the FDA and it’s an FDA-registered product.”
And there may come a day, he adds, when all CBD products must be registered with the FDA. “I’ve worked in FDA-regulated environments. I know they can be good for the industry. I welcome their involvement, and I know it’s coming. So, I might as well be out there first. … It will be an entirely different industry in two years, five years, 10 years."