Hemp-derived CBD is legal, but not unregulated: the FDA weighs in

Hemp-derived CBD is legal, but not unregulated: the FDA weighs in

On December 20, President Trump signed the Agriculture Improvement Act of 2018. The new law removes hemp from the Controlled Substances Act. This means hemp is no longer an illegal substance, according to federal law. (Hemp is legally defined as cannabis sativa with less than 0.3% THC. Hemp cannot get you stoned.) That doesn’t mean the sale of hemp-derived products will be unregulated.  The Food and Drug Administration (FDA) will have the authority to regulate products containing cannabis and cannabis-derived compounds.

“The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices,” says the FDA statement released on December 20. “The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”

That doesn’t mean anyone can start hawking hemp-derived products as medicine or as supplements, FDA commissioner Dr. Scott Gottlieb said.

“Just as important for the FDA and our commitment to protect and promote the public health is what the law didn’t change: Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act and section 351 of the Public Health Service Act,” Gottlieb said in a statement.

“We’re aware of the growing public interest in cannabis and cannabis-derived products, including cannabidiol (CBD),” he added.

“In short, we treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of the source of the substance, including whether the substance is derived from a plant that is classified as hemp under the Agriculture Improvement Act.”


FDA Asserts Authority Over Products Containing Cannabis & Cannabis-Derived Compounds

Photo: Dyllyn Greenwood

In the past, the FDA has already sent warning letters to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. With so many of these products currently entering the market all at once, many of the companies are in violation of the FD&C Act because they were marketed as dietary supplements, or because they involved the addition of CBD to food.


This post originally appeared at www.respectmyregion.com.