Excessive Hopes for FDA Regulation of CBD Merchandise

The FDA regulation of CBD products faces new challenges as the market develops.

Go to Pfizer, Moderna, and Johnson & Johnson: Some cannabis product providers announced that their products offer a hip, happier cure for COVID-19.

In March 2021, the U.S. Food and Drug Administration (FDA) issued a warning letter to Cannafyl, a cannabis product company, for marketing its cannabidiol (CBD) -containing products as products that could prevent or cure COVID-19. These products are still available for purchase, but Cannafyl’s website now includes a disclaimer stating that its CBD products are “not intended to diagnose, treat, cure, or prevent” any disease.

When the landscape changes for products in the food or healthcare sectors, the FDA often decides which products are safe for Americans. However, recent developments show that markets tend to move faster than regulators, which begs the question of which products the FDA should leave freely on the market to make available to consumers.

In recent years, one of the compounds found in marijuana that is psychoactive but does not induce a “high”, CBD has been used in products as diverse as chocolate, mascara and lotions.

Some studies have concluded that CBD alleviates ailments like anxiety, insomnia, chronic pain, and addiction to substances like nicotine and heroin. However, the FDA has warned consumers that CBD can have potentially harmful side effects such as liver damage. At the very least, the harm potential of CBD seems to require weighing the costs and benefits of certain products.

Selling these products is illegal under federal law enforced by the FDA, but since the FDA is unable to prohibit any sale of any food product or supplement that contains CBD, companies continue to sell CBD products. In addition, many of these products are reported to contain dangerous ingredients or are mistakenly marketed as cures for diseases such as COVID-19.

The FDA is investigating which CBD products fit within the current regulatory framework and pose undue health and safety risks. However, the growing market for marijuana-related products creates financial opportunities that are putting pressure on Congress and states to expand the opportunities for legal sales regardless of the FDA’s findings.

In 2018, President Donald J. Trump signed the Agriculture Improvement Act of 2018 into force. Under that law, CBD products that contain less than 0.3 percent tetrahydrocannabinol, the compound that creates a “high”, are no longer classified as controlled substances, which are categorically illegal under federal law. Instead, the 2018 legislation empowers the FDA to regulate the sale of CBD products under the Federal Food, Drug, and Cosmetic Act (FDCA).

The FDCA makes it illegal to sell any food or dietary supplement that contains an “approved active ingredient” without express FDA approval. When the FDA approved Epidiolex, a CBD seizure medication, CBD became an approved active ingredient. Although this measure makes CBD illegal in most products without FDA approval, the FDA has not issued a regulation that draws clear lines between approved and unapproved uses of CBD in other products.

Although it is technically illegal to sell CBD products without FDA approval, companies continue to sell them in the emerging US CBD product market. This growth in current and potential earnings creates strong financial pressure to legalize CBD use.

The FDA has stated that its delay in prescribing CBD is necessary to investigate the side effects of CBD. It takes time to conduct research that could provide enough evidence for the FDA to decide whether a drug ingredient should be approved for use in food – and currently research on the benefits of CBD is mixed.

The FDA set up a CBD Policy Working Group in April 2019. In the following year and a half, the FDA issued some non-binding guidance documents on CBD products – but no regulations citing the need for additional research.

Restrictions on the FDA’s research budget created problems when the FDA had CBD-related issues on its list as the FDA’s resources were strained by requirements related to the COVID-19 pandemic. Even without issuing more detailed instructions on many products containing CBD, the FDA has warned some companies not to market unapproved products, claiming that the CBD ingredients in the products help treat Alzheimer’s disease or the growth of cancer cells to stop.

As the FDA is considering issues related to CBD products, some state governments are trying to replace these products with their own rules, and Congress is considering steps to reduce or lift FDA restrictions. States like California have adopted CBD-related guidelines that appear to contradict the FDCA’s ban on the use of CBD in foods and supplements. In the meantime, other states are taking steps to tackle the improper sales of CBD products. For example, the New York attorney general sent a cease and desist letter to a CBD company last April claiming its products would help fight COVID-19.

Some members of Congress have tabled bills addressing CBD products. Two bills tabled in the Senate this year, the Hemp Access and Consumer Safety Act and the Cannabis Administration and Opportunity Act, and one in the House of Representatives, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021, would vote change federal regulation of CBD products. Proponents of these bills argue that there needs to be federal law or other FDA action to clarify the treatment of CBD products under federal law.

However, it is equally evident that the emerging market for CBD products will thrive without FDA regulatory enforcement action. Those who make and sell CBD products, and those who seek access to them, will likely strive to enforce favorable changes in the law. While there are compelling reasons for the FDA to take more time to regulate these markets, delays will almost certainly create conditions that will make a careful, product-specific legality determination politically more difficult for the FDA.

In the end, time will tell if the FDA believes in the high hopes for CBD – and if so, how the FDA will change its regulatory approach.