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.”
Photo courtesy of AmourCBD
AmourCBD’s pain-relieving CBD cream contains lidocaine as an active ingredient, and has been registered with the FDA.
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