Although the 2018 Farm Bill legalized hemp, it’s not a free pass for CBD to be added to foods and beverages. That’s because the FDA’s regulatory positionÂ under the Federal Food, Drug and Cosmetic Act is thatÂ CBD can’t be legally sold in conventional foods or dietary supplements.
While hemp and marijuana are both members of the cannabis family, hemp extracts contain CBD, a non-psychoactive compound that doesn’t produce marijuana’s trademark high from tetrahydrocannabinol, or THC. Hemp does contain very low levels of THC, but hemp products legally sold in the U.S. must have no more than 0.3% of the chemical.
The FDA is particularly concerned about drug claims made for products not approved by the agency that may contain CBD or other cannabis-derived compounds, Gottlieb said. Any such products marketed as providing therapeutic benefits must be approved beforehand for their intended use, he added, just like any other human or animal drug.
“Cannabis and cannabis-derived products claiming in their marketing and promotional materials that theyâ€™re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimerâ€™s disease, psychiatric disorders and diabetes) are considered new drugs or new animal drugs and must go through the FDA drug approval process for human or animal use before they are marketed in the U.S.,” Gottlieb said.
Meanwhile, food and beverage makers aren’t waiting on the sidelines when it comes to introducing these products. Besides being used to infuse beverages such as water,Â coffee, cocktails and iced tea, CBD isÂ being added to a wide variety of other foods, including ice cream, salads, milk and even children’s cereal and pet treats. Other recent innovations containing CBD are California-based SNAAK CBD, which markets itself as optimizing sports performance â€” but is only available in California and online â€” and Spring’s line of CBD-infused sodasÂ sold in New York, Florida, Nevada and Illinois.
Large food manufacturersÂ seem to be taking a wait-and-see attitude before rushing to add CBD or hemp to their products, so these items have largely come from smaller companies.Â But as more players enter the industry and new products make their way into retail, that could quickly change.
The market for CBD and hemp-derived products is already significant, and manufacturers and marketers are gearing up to do business nationwide.Â According to the Capital Press, a New Frontier Data report found that U.S. CBD sales jumped almost 40%Â in 2017, hitting $367 million. And the total retail value of all U.S. hemp products last year â€” including food â€” was estimated at $820 million,Â according to the Agricultural Marketing Resource Center.
These sales gains will likely continue their upward trajectory. By 2022, hemp-derived CBD is projected to be a $22-billion market, according to a report from the Brightfield Group, which helps to explain why the FDA is anxious to make its regulatory oversight clear to all stakeholders as soon as possible.Â Also, with the new congressional session getting underway, there could be a move to legalize CBD in all food and drink products nationwide â€” once a revised oversight and safety framework is in place.
Moving forward, the ongoing federal government shutdown could pose at least a temporary obstacle to the FDA’s plans as far as holding a public meeting and then explaining â€” and perhaps shifting â€”Â its regulatory oversight of the interstate commerce of foods and beverages containing CBD and hemp. Still, a sense of urgency could help to overcome that since, as GottliebÂ put it, the increasing public interest in the issue “makes it even more important with the passage of this law for the FDA to clarify its regulatory authority over these products.”