WASHINGTON -- In December 2018, the Agriculture Improvement Act of 2018 (also known as the Farm Bill) was signed into law, officially removing hemp from the Controlled Substances Act. This effectively lifted restrictions on the production and marketing of hemp products, seemingly paving the way for a legal hemp and CBD (cannabidiol) market in the United States.
The law did not, however, change the fact that the U.S. Food and Drug Administration (FDA) has oversight over all products containing cannabis or cannabis-derived compounds. And the FDA was quick to release a statement indicating that it will indeed exert authority over the growing CBD industry.
CBD is the nonpsychoactive component of cannabis and has emerged as a wellness ingredient in products such as body oils, lotions, beverages, snacks and candy.
“(The) increasing public interest in these products makes it even more important with the passage of this law for the FDA to clarify its regulatory authority,” said FDA Commissioner Scott Gottlieb in a Dec. 20 statement. “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.”
Gottlieb cited two specific areas of concern, first and foremost being any products that make a specific or general health claim without FDA approval. “This deceptive marketing of unproven treatments raises significant public health concerns, as it may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases,” he said.
He also pointed out that it’s illegal for companies to sell food products containing CBD or THC (the psychoactive compound that gets a user “high”) or market CBD or THC products as dietary supplements without first receiving FDA approval to do so.
“We’ll take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and are being marketed in violation of the FDA’s authorities,” Gottlieb said.“While products containing cannabis and cannabis-derived compounds remain subject to the FDA’s authorities and requirements, there are pathways available for those who seek to lawfully introduce these products into interstate commerce.”
Though Gottlieb’s warning may alarm retailers interested in entering the CBD space, Patrick Goggin, a senior attorney specializing in cannabis at San Francisco-based Hoban Law Group, said the agency has not asserted a position against topical CBD products.
“While the FDA maintains its position that CBD cannot be marketed as a dietary supplement and is a prohibited food additive, this position has never been ruled upon as valid by the courts,” he told CSP.
The agency plans to move forward with a public meeting “in the near future” that will allow various stakeholders to share experiences with CBD and hemp products and explore ways to make the legal pathways “more predictable and efficient.”
“We recognize the potential opportunities that cannabis or cannabis-derived compounds could offer and acknowledge the significant interest in these possibilities,” Gottlieb said. “We’re committed to pursuing an efficient regulatory framework for allowing product developers that meet the requirements under our authorities to lawfully market these types of products.”
For now, Goggins advised retailers to keep the FDA in mind as they decide what CBD products to bring into their stores.
“Ultimately, the FDA is primarily concerned about consumer safety,” Goggins said. “Thus, as the FDA considers pathways (other than drug approval) for blessing products rich in CBD, retailers should prioritize consumer safety and confirm that the products are produced with good manufacturing practices, use Farm Bill-compliant hemp, have proper labels that follow FDA guidance and do not make health claims.”