CBD: One of the Fastest Growing Food Ingredients Isn’t Entirely Legal
CBD is now in all types of food yet remains a federally controlled substance
Some 33 states and the District of Columbia have legalized the sale of marijuana for medicinal purposes. But what many people don’t know is that the thousands of foods, beverages, topical lotions, and other products sold with CBD — the substance derived from cannabis plants hemp and marijuana — are still not legal in the United States and many other countries.
Officially called cannabidiol, CBD is a popular ingredient found in oils and tinctures, water, sodas, candy, beer, dietary supplements, and dog food. Two major U.S. drug store chains — Walgreens and CVS — have recently announced plans to sell topical lotions and creams with CBD. The grocery chain Kroger has announced plans to sell CBD topicals on the west coast. In April, Carl Jr’s, a national fast-food chain, began test marketing a CBD-infused burger at a Denver store.
All of these products are in the murky legal and regulatory territory because the state laws passed to legalize marijuana and CBD for medicinal and recreational purposes are at odds with federal legislation. “Under current law, CBD and THC [delta-9-tetrahydrocannabinol — another active ingredient in marijuana] cannot lawfully be added to a food or marketed as a dietary supplement,” said acting FDA Commissioner Norman E. Sharpless at a packed hearing on CBD products held on May 31, 2019.
Nonetheless, legal and regulatory uncertainties have not dampened consumer demand for CBD products. A 2018 Consumer Reports (CR) survey of more than 1,000 nationally representative U.S. adults found that three quarters favored legalizing the medicinal use of marijuana while half favored legalizing recreational use.
A 2019 CR survey of consumers who use marijuana or products containing CBD turn to it to relieve stress, cut joint pain and improve sleep. Future sales of CBD products are projected to reach $22 billion annually in the next five years.
The 2018 Farm Bill has also helped open the gate to more CBD products by removing hemp from the list of controlled substances in the United States. Hemp, which has been cultivated for thousands of years to make rope, clothing and other commonly used goods, is a cannabis plant. Unlike marijuana, which is also a cannabis plant, hemp, contains minimal amounts of THC –the active ingredient in cannabis that makes people feel “high.” By comparison, marijuana has 0.3 percent or more of THC.
Removing hemp from the list of controlled substances gives scientists greater latitude to study hemp-derived CBD since it eases restrictions on acquiring it. Having fewer regulatory restrictions on hemp-derived CBD is also expected to help verify — and perhaps disprove — the myriad of health claims that make the CBD product landscape look like the Wild West.
The Farm Bill underscored that the federal CBD product regulatory responsibility remains with the FDA which works closely with the Drug Enforcement Agency and the Federal Trade Commission to regulate these and other products.
To date, the FDA has approved several prescription drugs that contain cannabis compounds. They are Epidiolex, which treats seizures in children, and Marinol and Syndros, used to treat anorexia in AIDS patients. Three other hemp seed derived substances have also come to market under a provision known as Generally Recognized as Safe (GRAS). But, the FDA has also sent three warning letters this year alone to makers of CBD products: Advanced Spine and Pain, LLC; Nutra Pure LLC and PotNetwork Holding, Inc. for selling CBD products that the agency classifies as drugs, asking them to correct alleged violations and comply with federal laws and regulations or face legal consequences.
Legal experts warn that CBD product manufacturers risk violating federal laws if they transport their products across state lines, even if those products are made in a state that has legalized marijuana use. Consumers who carry CBD products across state lines can also be at legal risk.
Elsewhere, CBD products have generated increased consumer interest and regulatory scrutiny. In January, the World Health Organization Expert Committee on Drug Dependence recommended that pure CBD not be listed in the International Drug Control Conventions. The UN Commission on Narcotic Drugs was slated to vote on the recommendation in March, but the vote was postponed to give member states more time to consider possible consequences of this proposed change. A new meeting date has not yet been scheduled.
The Cannabis Act, which legalizes the sale of cannabis oil, fresh cannabis, dried cannabis, cannabis plant seeds, and cannabis plants went into effect in Canada on Oct. 17, 2018. According to this new law, cannabis edible products and concentrates will be legal for sale no later than Oct. 17, 2019 — one year after the Cannabis Act came into force.
In the European Union, new CBD products fall under the Novel Food regulations. To be marketed, these products must be shown to be safe, not nutritionally disadvantageous and can’t mislead consumers in their purported benefits. But the EU Commission’s Working Group of Novel Foods also noted that some products derived from the cannabis plant or its parts including seeds and oil have a long history of consumption in the EU and therefore are not considered novel foods. Among them: hemp seed flour and defatted hemp seed. Even so, the EU noted that country laws may still prohibit some of these ingredients. So it advised manufacturers to check with appropriate country regulatory bodies.[SS(1]
What’s ahead? More scientific research to better understand the potential benefits and health risks of cannabis-derived substances.
Also likely: A continued push to de-schedule all cannabis from the Controlled Substances Act — a move that legal experts say could have unintended consequences.
Here’s why: cannabis-derived compounds CBD and THC have already been studied and approved as drugs. Under the existing Food, Drug and Cosmetic Act, these and other substances will be prohibited from being used as ingredients in drugs or food for humans or animals if products containing them are sold across state lines in the United States. Federal law already prohibits the sale of dietary supplements with CBD.
Plus, any medical claims about cannabis would require the seller to complete a rigorous, time-consuming and expensive new drug approval process with the FDA, as law professors Sean M. O’Connor and Erika Lietzan note in a recent issue of the American University Law Review. They also write that under current federal law, there is no legal pathway forward for conventional foods containing cannabis-derived ingredients, with the possible exception of hemp.
The FDA is accepting public comments about CBD products until July 2, 2019.
For new business inquiries, please contact Ellen DeMunter, EDeMunter@powelltate.com
Article edited by Jillian Nystedt, Jennifer Shang & Lexi Mondot
