CBD products: you may have seen them at your local grocery store, convenience store, or chiropractor’s office in the form of gummies, brownies, sodas, and cookies. CBD is one of many cannabinoids found in the cannabis plant. Unlike THC, which gives users a “high,” CBD contains little to no psychoactive properties, but comes with many benefits. CBD is being heavily studied and is showing great promise as a nutritional and wellness supplement. CBD products are currently being used to treat pain, inflammation, stress, and symptoms resulting from a wide range of medical conditions, such as epilepsy, multiple sclerosis, arthritis, anxiety, and chronic pain. CBD binds to the body’s cannabinoid receptors to induce feelings of calmness and pain relief. It has been hailed as a safer, more natural alternative to opioids and other addictive drugs.
While the CBD craze has resulted in an influx of CBD products hitting the market, the CBD market remains unregulated and susceptible to abuse and deceptive practices. The Food and Drug Administration (FDA) seized various CBD products from store shelves across the country after health claims relating to products which are not approved by the FDA, but suggest they are approved and/or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases like cancer and Alzheimer’s disease. After the passage of the Agricultural Improvement Act (the “Farm Bill”), which legalized the cultivation, processing, and sale of hemp and hemp products, the FDA Commissioner reaffirmed that CBD, regardless of whether or not it is derived from hemp, cannot be lawfully marketed with a claim of therapeutic benefit without prior FDA approval.
The FDA urged that CBD-infused products, whether derived from cannabis or hemp, are still considered drugs and must complete the FDA’s drug approval process before they are marketed in the U.S for sale as capable of being used in the diagnosis, cure, mitigation, treatment, or prevention of diseases. Lastly, the Commissioner reiterated the illegality of introducing food containing CBD or THC into interstate commerce regardless of whether the substances are hemp or marijuana-derived.
It is important to note that the FDA’s stance does not apply to CBD sold as part of a state’s medical marijuana program, which provides regulation and oversight including testing of products to ensure purity and cannabinoid percentage accuracy.
FDA enforcement efforts have been springing up across the country. A smoke shop owner in Arizona reported the FDA seized a variety of CBD products from his shelves with instruction to anticipate follow-up paperwork. This was a few days after the FDA had visited the shop and asked what products were intended for humans. On the day of the seizure, FDA officials informed the owner that CBD could not be sold for human consumption.
In New York City, various businesses ranging from bakeries to bars received visits from the New York City Department of Health, which confiscated CBD-infused foods and drinks and classified them as “embargoed,” meaning that the goods are identified, itemized, and removed. The Department of Health has not yet issued a public statement or additional information, but some health inspectors explained to business owners that CBD cannot be used as a “food additive.”
In New Jersey, there have not been reports of FDA seizures or other action letters regarding the sale of CBD-infused food and beverage products, but some municipalities have moved to ban cannabis before it is legalized for recreational purposes in the state. William Patterson University in New Jersey formed a Cannabis Institute to advise local and state officials on cannabis policy. Pennsylvania has also not yet reported any seizures of CBD-infused products, but the Governor announced last month that there would be a series of town hall-style sessions to discuss legalizing recreational marijuana in the state.
In Maine, a state that has legalized marijuana for recreational purposes, the Department of Health and Human Services has informed various businesses that they must remove all CBD-infused foods, tinctures, and capsules form their shelves per an internal report from the state’s Attorney General’s Office. Other states, like Ohio, have banned certain CBD-infused products from local stores.
In contrast, California Assembly Member Cecilia Aguiar-Curry introduced a piece of hemp legislation that would add two provisions to the California Health and Safety Code. The proposed bill narrowly targets California regulators’ abilities to penalize companies for selling hemp-derived CBD beverages or foods on the ground that they are “adulterated” under California law.
There is also a movement to regulate CBD-infused foods outside of the United States. The European equivalent of the FDA—the European Food Safety Authority—recently changed its guidance on cannabinoids and declared that all new food products infused with the plant or its derivatives are classified under the “novel food” catalogue and must receive pre-market approval under the EU’s “novel food” regulation. Per Regulation 2015-2283, foods containing hemp extracts with CBD levels not higher than naturally occurring in European industrial hemp have been and are regarded as traditional food (not novel) by food business operators. The new guidance drastically expands the categories of cannabinoids that would require pre-market approval; however, hemp seeds, flour and seed oil remain traditional foods not subject to pre-market approval which can take up to three years. This certainly complicates U.S. CBD companies’ ability to export their products overseas and presents risks of seizure by Customs and Border Protection enforcement.
The FDA, however, has yet to release guidelines on shipping CBD products to other countries. Customs agents likely do not have a sophisticated understanding of the difference between hemp and marijuana, and therefore, could end up seizing a legal hemp-derived CBD shipment, which is permissible under both EU and US laws. The FDA understands the need for regulation and standards and has set out to re-examine its current policy toward hemp and cannabis derived CBD to provide clarity. In the meantime, stakeholders with an interest in consumer-based CBD products as well as in developing other hemp-derived cannabinoid compounds for the market may wish to consider an FDA engagement strategy as part of their business development plans.