Reclassifying Cannabidiol as a Dietary Supplement – The Requirements

Dietary supplements in human medicine

As defined by the U.S. Drug Supplement Health and Education Act of 1994, dietary supplements are products (other than tobacco) containing one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, any other substance used to supplement the diet by increasing total dietary intake, or a concentrate, metabolite, constituent extract, or combination of any of the above. The elaborate definition is needed to confer a legal distinction on dietary supplements and differentiate it from natural products, drugs, controlled substances, and, most importantly, nutraceuticals. 

The dietary supplement market is rapidly expanding with market analysts expecting the global dietary market size to reach USD 230.73 billion by 2027, and it is projected to expand at CAGR of 8.2% during the forecast period. With a growing concern for global health indices, fitness awareness, and increased demand for nutritional intake in emerging markets are expected to drive the global dietary supplement market. The nutritional benefits of dietary supplements, as suggested by different research reports, are far-reaching. 

The components in each packaged product supply the nutrients required to augment daily food intake and promote overall health. Individuals with hectic schedules and professionals aiming to keep fit are considered the primary consumers of these products. Recently, there are new lines of dietary supplements with plant and animal-derived origins. Based on anecdotal evidence and the increased use of cannabis-derived products, cannabidiol-infused supplements are becoming increasingly popular.  

Current regulation on cannabidiol as a dietary supplement

In the United States, the founding principles of the Food and Drug Administration (FDA) are based on substance control with regulations that unambiguously differentiate drugs from food products. Regulation of dietary supplements is the legal responsibility of the Office of Dietary Supplements Program under the Center for Food Safety and Applied Nutrition domiciled in the FDA’s Office of Food and Veterinary Medicine. Dietary supplements are considered to be manufactured for nutritional purposes only and, as such, require no preliminary approval prior to marketing. However, the FDA monitors the manufacturing of dietary supplements and routinely inspects manufacturing companies to evaluate their adherence to good manufacturing practices. 

Currently, under the provisions of the Federal Food, Drugs and Cosmetics Act (FD&C Act), products containing delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) are excluded from the FDA’s list of dietary supplements. The agency has also denied the existence of any product marketed as a “dietary supplement” and containing THC or CBD in trace quantities prior to subjection to substantial clinical investigations. Although the FD&C Act provides the legal definition of constituents in a dietary supplements package, the Dietary Supplement and Education Act of 1994 (DSHEA) provides the basis for content disclosure. This Act prohibits dietary supplement companies from implying, insinuating, or stating that their products can diagnose, treat, or prevent human disease.

This regulation has also affected CBD-derived dietary supplement production and marketing since these products are mostly marketed for their purported therapeutic benefits to the human biological system. This is perhaps the biggest roadblock to the labeling of CBD-infused products as “dietary supplements.” The introduction of the Agriculture Improvement Act (Farm Bill) of 2018 revolutionized the CBD industry and opened up more opportunities for the CBD commerce; however, provisions of this bill included no new directive on CBD and dietary supplements. To clear the speculations on this subject, the then-commissioner of the FDA, Scott Gottlieb, issued a directive reaffirming the FDA’s stance on CBD and criminalizing CBD or THC’s inclusion in dietary supplements. 

Requirements needed to allow CBD’s use as a dietary supplement

The existence of different medical reports supporting the use of cannabis-derive products has fueled a wild demand for the inclusion of CBD and other beneficial cannabinoids in dietary supplements. These agitations have generated different opinions and expert analysis on the requirements to be fulfilled before CBD can be legally allowed in food products and dietary supplements. Since the ban on CBD’s inclusion as a dietary supplement is a legal directive, amending different sections of the FD&C Act that concern CBD is considered the first step in achieving this goal.  

In the United Kingdom, the Foods Standards Agency has issued new guidance in relation to CBD in products meant for nutritional purposes. This directive allows businesses and nutritional product companies to submit novel food authorization applications by March 31, 2021. This advanced policy is expected to improve the regulation of CBD-derived products in the UK.

Allowing the inclusion of CBD in dietary supplements is also a question of science. For safety reasons, the FDA has consistently directed that all approval proposals for drug products be backed with a conclusive research evidence detailing the safety profile on the constituents in the human subject. Although there are many reports of therapeutic benefits of CBD based on trials in animal models, there exist only a few studies conducted in a large population of human subjects. Clinical investigations into the safety and potency of CBD for intended indications are expected to influence the stance of the FDA on CBD’s inclusion in drugs and dietary supplements. An amended Act, the introduction of a new bill, and the presentation of conclusive evidence detailing CBD’s safety profile in humans are factors expected to change the current stance of the FDA on CBD’s inclusion in dietary products.  

In January 2020, the HR 5587 Act was introduced to amend the FD&C Act with respect to the regulation of cannabidiol-containing products. The provisions of this Act aim to redefine “dietary supplements” and create a legal framework for the use of CBD for nutritional purposes and its subsequent inclusion in dietary supplement packages. Provisions included in the bill also create a legal basis for the marketing of CBD-contained products across state boundaries, and as it stands, the bill has been referred to the Subcommittee on Biotechnology, Horticulture, and Research. If finally passed, the bill is expected to secure an important milestone achievement for the CBD industry.

REFERENCES

• https://www.grandviewresearch.com/press-release/global-dietary-supplements-market
• https://www.congress.gov/bill/116th-congress/house-bill/2287/text
• https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-derived-products-including-cannabidiol-cbd
• https://www.jdsupra.com/legalnews/cbd-as-a-dietary-supplement-a-potential-95784/
• https://www.nccih.nih.gov/health/using-dietary-supplements-wisely
• https://www.fda.gov/food/dietary-supplements