The declassification of industrial hemp as a Schedule I drug hasn’t lessened legal complications but has created a surge in cannabidiol products and associated health claims.
Since the signing of the Agriculture Improvement Act of 2018 — commonly known as the 2018 Farm Bill — cannabidiol, or CBD, has flooded the marketplace. CBD seemingly is everywhere and in everything, from health and beauty products including bath salts, mascara, lotions and lipsticks to food and beverage items such as sparkling water, ice cream, restaurant menu items and candy. CBD has become so popular that Nielsen predicts the U.S. hemp-derived CBD market could become a $6 billion industry by 2025.
How It Started
Although a new farm bill is enacted approximately every five years, the 2018 Farm Bill was unlike its predecessors because it legalized the cultivation of industrial hemp with a license or permit and declassified it as a Drug Enforcement Administration, or DEA, Schedule I controlled substance. This declassification transferred supervision of hemp from the DEA to the U.S. Department of Agriculture’s Agricultural Marketing Service. Additionally, the bill expanded the possibilities for, and placed an increased emphasis on, industrial hemp research apart from standard market evaluations, which are done for business research purposes.
Defining the Substance
Hemp, marijuana, CBD and delta-9-tetrahydrocannabinol, or THC, all have had their share of the spotlight. While there is some relation between them, there are key differences.
In legislation, hemp is defined as the cannabis plant — the same cannabis plant that produces marijuana. However, it does not, and legally cannot, contain more than 0.3 percent THC. Before the 2018 Farm Bill, federal law did not differentiate hemp from other cannabis plants such as marijuana.
THC is the key psychoactive compound in marijuana that produces the sensation commonly referred to as being “high.” Marijuana plants contain higher concentrations of THC. CBD is found in both hemp and marijuana. But unlike THC, CBD is not a psychoactive compound and therefore does not provide the same “high” sensation as THC. Both CBD and THC have the same molecular structure, but one small difference in the arrangement of molecules is responsible for the big difference in their psychoactive or nonpsychoactive effects.
The human body produces its own cannabinoids, known as endocannabinoids, the endocannabinoid system (ECS) or endogenous cannabinoids. When THC is consumed, it interacts with endogenous cannabinoids to create the “high” sensations and effects. Researchers still are unsure of how CBD interacts with the ECS.
CBD Research
Early evidence suggests there may be benefits from CBD. In 2018, the U.S. Food and Drug Administration approved the first CBD drug, Epidiolex, to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients age 2 and older. Children with these serious forms of epilepsy typically do not respond to traditional therapies and anti-seizure medications, but clinical trials showed Epidiolex, along with other medications, was effective in reducing the frequency of seizures compared to placebo.
Among the general public, pain reduction is perhaps a more widely associated and touted benefit of CBD. While CBD is frequently promoted as being able to reduce chronic pain, medical research exploring and confirming the mechanisms is limited to mostly animal models, meaning more human research is needed. Other possible yet unsubstantiated benefits include a reduction in anxiety, treating inflammation and promoting sleep. Current claims on the benefits of CBD mostly are anecdotal, and more research is needed to confirm and understand these statements.
The benefits of CBD may be promising, but there are potential side effects: Some human pre-clinical and clinical trials on CBD for epilepsy and psychiatric disorders reported adverse effects such as CBD-induced drug interactions, liver problems, diarrhea, fatigue, vomiting, mood changes and extreme sleepiness.
Legal Confusion
The 2018 Farm Bill may have declassified industrial hemp as an illegal substance, but it also ushered in a lot of confusion. Is CBD legal? In short, it depends.
In a statement released by the FDA immediately following the signing of the bill, then commissioner Scott Gottlieb, MD, emphasized that despite the declassification, the FDA maintains its authority to regulate products that contain cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act. These regulations create complications for food and beverage manufacturers that wish to incorporate CBD into their products.
Under the FD&C Act, it is unlawful to use any active ingredients that are already in FDA-approved drugs, or any ingredients that were studied in substantial clinical investigations, in foods or dietary supplements. This means both food and dietary supplements containing added CBD or THC is unlawful, regardless of whether the substance is hemp-derived or not.
The FDA can issue a regulation to allow the use of CBD and THC in a food or dietary supplement. And while it held a public hearing in May 2019, allowing stakeholders to share feedback and scientific data related to CBD, the FDA has not issued any new regulations and says it will continue to uphold current guidelines until it can obtain enough research, data and public health input to warrant a change.
Numerous warning letters have been sent by the FDA and the Federal Trade Commission to companies selling CBD products such as food items and dietary supplements and products meant for therapeutic use, mainly those claiming to cure diseases such as Alzheimer’s, Parkinson’s or cancer. It should be noted that there are three hemp-derived substances that have been approved by the FDA as Generally Recognized as Safe (GRAS) and are therefore lawful: hulled hemp seeds, hemp seed protein powder and hemp seed oil.
The rules and regulations get even hazier considering various state laws; some states still consider CBD illegal despite the 2018 Farm Bill, and there are some states where all marijuana and cannabis (medical or recreational) are illegal. Laws fluctuate between states, and CBD oil may be legal recreationally or medically depending on the location. Some states have been more adamant about enforcing these laws including Texas, Ohio and Iowa, whose law enforcement has raided stores selling CBD products.
Implications for RDNs
Since CBD is gaining popularity, clients and patients likely will have questions about the compound. Because laws vary by state, registered dietitian nutritionists should stay abreast of their individual state laws as well as any progress in federal legislation. Keeping clients and patients aware of the legality of CBD in food and dietary supplements may be as important as educating them on the potential risks and benefits.
Many products containing CBD are being introduced without regard for the legal requirements that apply to dietary supplements, foods, drugs and cosmetics. The FDA sends warning letters after a product has been produced and sold — usually because it is either promoted as a cure for disease or due to an adverse reaction. This means some CBD products may have gone through little, insufficient or no testing before sale. Some products could contain more or less CBD or THC than advertised, which could have safety implications of a drug interaction, impairment or an occupational problem for those who are drug tested. Additionally, products could contain other harmful ingredients unknown to the buyer.
The Academy of Nutrition and Dietetics recommends consumers use caution when purchasing CBD products and food items and has taken a neutral stance regarding the use of CBD in food and beverage products. The Academy supports a “science-based, public health-driven approach to the regulation of products containing cannabis or cannabis-derived compounds, including THC and CBD.”
RDNs should monitor developing research, laws and regulations concerning CBD to best counsel and educate clients and patients.
References
Abernethy A, Schiller L. FDA is Committed to Sound, Science-based Policy on CBD. U.S. Food and Drug Administration website. Updated July 17, 2019. Accessed September 25, 2019.
Academy Provides Comments to FDA on Cannabis Products. Academy of Nutrition and Dietetics website. Published July 17, 2019. Accessed September 25, 2019.
Akpan N, Leventhal J. Is CBD legal? Here’s what you need to know, according to science. PBS NewsHour Website. Published July 12, 2019. Accessed September 25, 2019.
By 2025, the U.S. Hemp-based CBD Industry Will Be a $6 Billion Opportunity—Snack Industry Take Note. Nielsen website. Published June 6, 2019. Accessed September 25, 2019.
FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. U.S. Food and Drug Administration website. Published June 25, 2018. Accessed September 25, 2019.
FDA Clarifies Position on CBD After Passage of 2018 Farm Bill. Hall Render Law Firm website. Published January 18, 2019. Accessed September 25, 2019.
FDA Regulation of Cannabis and Cannabis-Derived Products: Q&A. U.S. Food and Drug Administration website. Updated December 31, 2019. Accessed January 2, 2020.
FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety. U.S. Food and Drug Administration website. Published July 23, 2019. Accessed September 25, 2019.
Grinspoon P. Cannabidiol (CBD) — what we know and what we don’t – Harvard Health Blog website. Updated August 27, 2019. Accessed September 25, 2019.
H.R.2 – 115th Congress (2017-2018): Agriculture Improvement Act of 2018. Congress.gov website. Published December 20, 2018. Accessed September 25, 2019.
Holland K. What’s the Difference Between CBD and THC Healthline website. Reviewed May 20, 2019. Accessed September 25, 2019.
Hudak J. The Farm Bill, hemp legalization and the status of CBD: An explainer. Brookings Institution website. Published December 14, 2018. Accessed September 25, 2019.
Huestis M, Solimini R, Pichini S, Pacifici R, Carlier J, Busardò F. Cannabidiol Adverse Effects and Toxicity. Curr Neuropharmacol. 2019;17(10):974-989.
Industrial Hemp. National Institute of Food and Agriculture website. Accessed September 25, 2019.
Johnson J. CBD oil for pain management: Effects, benefits, and uses. Medical News Today website. Reviewed July 29, 2018. Accessed September 25, 2019.
Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds. U.S. Food and Drug Administration website. Published December 20, 2018. Accessed September 25, 2019.
What to Know About Products Containing Cannabis and CBD. U.S. Food and Drug Administration website. Published November 25, 2019. Accessed September 25, 2019.
Esther L Ellis, MS, RDN, LDN, is an associate editor of Food & Nutrition Magazine.
