Fortunately, FDA’s current prohibition of CBD foods and drinks is not set in stone. FDA is expected to promulgate regulations once the agency collects the necessary data and scientific research to ensure the safe regulation of CBD as an ingredient—even the new FDA commissioner recently recognized seeking to prohibit CBD products is a “fool’s errand.” In order to regulate CBD products, FDA is seeking answers to its many questions to guide the agency through the rulemaking process. Remarkably, even in the absence of federal regulations, the CBD market has exploded as a result of consumer demand, which now pushes FDA, as well as the federal government as a whole, to re-evaluate the safety of cannabis and its cannabinoids as an ingredient. As the market continues to grow, we can only expect the types of products to expand as well. What’s next will be determined by market trends and will be curbed by future FDA regulation.
CBD is the non-psychoactive cannabinoid found in Cannabis sativa L.—marijuana and hemp—and is distinct from tetrahydrocannabinol (“THC”), the primary psychoactive cannabinoid. The Agricultural Improvement Act of 2018 (“2018 Farm Bill”) removed hemp—defined as cannabis with no more than 0.3% THC on a dry weight basis—and its derivatives, including CBD, from the Controlled Substances Act (“CSA”). The 2018 Farm Bill expressly delegates to FDA regulatory authority of all finished products containing hemp-derived ingredients. The agency regulates all foods, drugs and cosmetics marketed in the U.S. under the framework of the Federal, Food, Drug and Cosmetic Act (FD&C). The FD&C provides that all foods, drugs and cosmetics produced and marketed in the U.S. must adhere to all federal law and the governing regulations throughout formulation, manufacturing, labeling and marketing.
Holistic and therapeutic products have become a popular option to improve overall health, relieve aches and pains, reduce stress and promote sleep. Some of these products have transcended traditional product forms, such as tinctures and essential oils, and have become more conventional, like sparkling waters and snacks. When shopping, consumers are met with endless options and recently have been introduced to a growing selection of products containing cannabidiol, or “CBD.” For many, CBD is novel but interesting considering the excitement surrounding the cannabinoid. As a result of this excitement, manufacturers are creating and putting to market innovative CBD products, such as CBD popcorn, water, gummies, seltzers and mints.
Compared to cosmetics and over-the-counter CBD products, CBD foods and drinks present FDA with a difficult task because there currently are no federal regulations that specifically govern the production and sale of CBD foods and drinks. In particular, FDA is most concerned with products intended for ingestion.
Full-spectrum oil contains all of the plant’s cannabinoids, terpenes and flavors. Broad-spectrum oil also includes all cannabinoids, terpenes and flavors, with the exception of measurable amounts of THC. Unfortunately, both full-spectrum and broad-spectrum oil present a common concern: taste. Unlike with isolate, the robust smell and taste of the cannabis plant is apparent in these oils and when infused into a food or drink, formulators must compensate for these aromas and tastes or otherwise embrace them. Comparatively, CBD isolate generally is tasteless and presents countless opportunities to be infused into both foods and drinks.
Although many states have legalized marijuana for either medical and/or recreational purposes, federally marijuana remains a schedule I controlled substance under the CSA. This federal status alone precludes marijuana-derived CBD from being an ingredient in any product. Since the 2018 Farm Bill removed hemp from the CSA, hemp-derived ingredients are no longer prohibited on federal status alone. FDA currently allows foods and drinks to include ingredients derived from hulled hemp seed, hemp seed protein powder and hemp seed oil. But since the 2018 Farm Bill, there has been an increase in the number of CBD-specific companies and the variety of CBD products has greatly expanded to now include CBD foods and drinks.
There are numerous techniques to infuse foods and drinks with CBD. Manufacturers have infused their hemp-derived products with either CBD isolate, full-spectrum or broad-spectrum oil. CBD isolate, containing at least 98% pure CBD, is a pure form of CBD, and a relatively easy ingredient to utilize. CBD isolate contains nominal amounts of other cannabinoids or terpenes, which makes isolate appealing because of its clean and unnoticeable taste. Unfortunately, there are regulatory obstacles with this option given the arguable comparisons to the active ingredient in the FDA-approved drug, Epidiolex.
Scientists believe that CBD reduces nerve pain by binding to glycine receptors in the brain that regulate the speed at which nerve signals pass between nerve cells.
There have also been suggestions that CBD may aid in the treatment of cannabis and nicotine addiction. Further research is needed.
Remember, because CBD oils are largely unregulated, there is no guarantee that a product is either safe or effective.
Clinical research has shown that CBD oil can trigger side effects. Severity and type can vary from one person to the next.
To use CBD oil, place one or more drops under the tongue and hold the dose there for 30 to 60 seconds without swallowing. Capsules and gummies are easier to dose, although they tend to be more costly. CBD sublingual sprays are available as well.