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Does the FDA Regulate CBD?

September 05, 2022 5 min read

Does the FDA Regulate CBD?

Does the FDA Regulate CBD?

After hemp derived products were federally legalized due to the 2018 Farm Bill, the FDA has ensured its efficacy and safety. Herein you learn; the understanding of CBD, overview of CBD products regulation, the 2018 Farm Bill legislative changes, and whether FDA regulates CBD.

The Food and Drug Administration (FDA) is a body under the Department of Health and Human Services responsible for safeguarding public health. FDA regulates food safety, dietary supplements, vaccines, over-the-counter medications, and the quality of medical devices. FDA-approved products mean it has ascertained that the products' benefits outweigh their potential risks making them safe for human consumption. The demand for CBD products has increased recently due to their various benefits. Consequently, the number of CBD products on the drug shelves has increased, posing a significant health risk. FDA's weak regulations (or non-existent regulations) on CBD products have prompted many states to enact laws to help consumers.

Understanding CBD

According to Burstein &Sumner (2015),CBD is a non-intoxicating cannabinoid available in the cannabis plant. Despite limited evidence to support these claims, it is famous for treating various medical conditions ranging from mental health disorders and inflammation to seizures. In the U.S., it is marketed in cosmetics, food and beverages. CBD is also available in an FDA-approved drug known as Epidolex.Casajuana et al. (2018) noted that CBD does not provide the high effects due to the absence of the psychoactive THC.

Overview of CBD Products Regulation

Since hemp and marijuana are different, they are subjected to various regulatory requirements. The controlled substance act allows the use of marijuana. It is also Drug Enforcement Administration (DEA) regulated. However, its unauthorized distribution, manufacture, and possession are highly prohibited. On the Federal level, marijuana-extracted cannabidiol is forbidden except as an active ingredient in the Epidolex drug used for seizure treatment. Despite marijuana-derived CBD being prohibited at the federal level and not FDA-approved, it is available in various states that have allowed its medical and recreational use. Some states only allow the purchase of CBD if the individual has a legit cannabis prescription. For others, CBD products are sold at licensed dispensaries solely.Coit &Marne (2018) noted that due to the passing of the 2018 Farm Bill, hemp-derived cannabidiol products are not subjected to control at the federal level.

The 2018 Farm Bill Legislative Changes

After the Farm Bill approved hemp-derived products, its market skyrocketed, and more opportunities were available in the hemp market. The Bill only allowed all hemp cannabinoids, isomers, derivatives, and extracts that did not have more than 0.3 percent of THC. All the federal restrictions made on hemp cultivation were removed; hence it was no longer subjected to control by the DEA. It now falls under the regulation of the USDA (U.S. Department of Agriculture). Various stakeholders expected the changes would abolish one primary concern: hemp products production and marketing, including cannabidiol. Unfortunately, the 2018 farm bill left that to FDA. Since the farm bill did not interfere with FDA's authorities on hemp and its derived products, they are treated similarly to other FDA-regulated products. They have to follow each of its regulations.

Does the FDA Regulate CBD?

White et al. (2019) noted that the FDA regulates various cannabis-derived products, including CBD. Hemp-derived cannabidiol is sold as an active ingredient in beverages, cosmetics, foods, and dietary supplements. As aforementioned, the only FDA-approved CBD drug is Epidolex. The FDA disallows CBD use in nutritional supplements due to arioso provisions given by the FFDCA. According to the FFDCA, it is illegal to introduce food with an approved drug or if it’s medical claims have been publicized. However, there are various exceptions, such as;

  • The drug has been approved by the secretary to be used in food
  • The drug was used in food before being approved as a drug
  • The drug use enhances food safety and not therapeutic effects on individuals, and it meets the required requirements

The FDA stated that the named exceptions do not affect CBD and its products. However, other cannabis-derived products that do not have THC or CBD are not excluded. According to the FDA, various foods with low levels of CBD, like hemp seeds, can be marketed as long as they are safe. The FDA has banned the marketing of food that has CBD regardless of whether it is hemp-derived. Many companies have been warned against marketing CBD as a dietary supplement and making unsupported medical claims.

Is It Legal To Sell CBD Products?

The legality of CBD products depends on various factors, such as their intended use, marketing, and labeling. Even if a product meets the 2018 Farm Bill hemp definition, it should comply with other laws like FD&C Act. You should also beware of your state laws and confirm whether CBD products are legal in the state.

Factors to Consider While Choosing CBD Products

Below are some factors to put in mind while buying CBD products:

  • The brand: buy from a reliable and trusted brand that sells high-quality products. Ensure it provides information about the production process to help consumers make the right choice.
  • Always read other consumers’ reviews.
  • Availability of third-party lab test results: When purchasing CBD products online, ensure you go through the company's website to confirm if it has third-party lab test results. The third-party lab report provides an objective assessment of the products' quality.
  • Ingredients present: CBD products are used as safer alternative treatment for conditions such as anxiety and pain. Hence the reason consumers are cautious when it comes to ingesting them. You should read the ingredients list carefully to know what the product contains. For example, it should have high-quality base oil like MCT since it preserves the product.

Summary

The passing of the 2018 Farm Bill listed all restrictions on selling hemp-derived products, their cultivation, and processing. On the other hand, the FDA regulates various products with CBD. The cannabis derivative is available in both hemp and marijuana plant. However, only hemp-derived cannabidiol is marketed as an active ingredient in various cosmetic, food, and dietary supplement products. The FFDCA restricts the interstate commerce of foods that incorporate drugs or drugs whose medical claims have been publicized. Users should be careful while purchasing CBD products. Only buy your product from a reliable brand with assured quality.

References

Burstein, S. (2015).Cannabidiol (CBD) and its analogs: a review of their effects on inflammation. Bioorganic & medicinal chemistry, 23(7), 1377-1385.

Casajuana Kögel, C., López-Pelayo, H., Balcells-Olivero, M. M., Colom, J., & Gual, A. (2018). Psychoactive constituents of cannabis and their clinical implications: a systematic review. Adicciones, 30(2).

Coit, M. (2018). The Fate of Industrial Hemp in the 2018 Farm Bill-Will Our Collective Ambivalence Finally be Resolved. J. Food L. & Pol'y, 14, 12.

White, C. M. (2019).A review of human studies assessing cannabidiol's (CBD) therapeutic actions and potential. The Journal of Clinical Pharmacology, 59(7), 923-934.