On December 20, 2018, the Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill) was signed into law. The law primarily deals with agriculture, but it also dictates certain federal authorities relating to the production and marketing of hemp and any part of that plant. According to the FDA, the law dictates that the parts are inclusive of “seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” With these changes, hemp was removed from the CSA, which means that “cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under federal law.”
The FDA treats products containing cannabis or cannabis-derived compounds with the same authorities and requirements as other FDA-regulated products containing any other substance; the inclusion or not in the 2018 Farm Bill holds no stance to how the FDA views hemp.
Given that, the FDA has not actually approved of any marketing applications for cannabis in the use for treatment of any disease or condition.The agency, however, has approved of a cannabis-derived and three cannabis-related drug products that are only available with a prescription from a licensed healthcare provider.
- Epidiolex: contains a purified form of CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.
- Marinol and Syndros: intended for therapeutic use in the United States; also can be used for the treatment of anorexia associated with weight loss in AIDS patients; includes the active ingredient dronabinol, which is considered the psychoactive component of cannabis.
- Cesamet: contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived.
Other than the previous three, there are no other FDA-approved CBD products.
“Under the FD&C Act, any product intended to have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. Drugs must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a ‘monograph’ for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review. CBD was not an ingredient considered under the OTC drug review. An unapproved new drug cannot be distributed or sold in interstate commerce.”
With the rise in popularity of CBD use, the FDA is continuously concerned at how products are marketed, specifically when they assert that they’re for therapeutic or medical use without the approval of the FDA. Not only is it not legal, but it also puts the user at risk when quantity, proper usage, interaction with other drugs, or possible side effects and safety concerns haven’t been properly researched. This doesn’t mean that CBD should be disregarded as a potential therapeutic option. Rather, the Center for Drug Evaluation and Research (CDER) “is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug (IND) and drug approval process.”
Cannabis and cannabis-derived compounds are continuously being tested. “FDA relies on applicants and scientific investigators to conduct research. The agency’s role, as laid out in the FD&C Act, is to review data submitted to the FDA in an application for approval to ensure that the drug product meets the statutory standards for approval.” In December 2016, the Guidance for Industry: Botanical Drug Development was published by the FDA and it provides specific recommendations on submitting INDs for botanical drug products. Additional information concerning research on the medical use of cannabis can be found through the National Cancer Institute (NCI) and the National Institute on Drug Abuse (NIDA).
Regardless of what state laws are, the FDA still feels that it is imperative to conduct medical research on the use, safetiness, and effectiveness of cannabis or cannabis-based products in clinical trials. CBD products for sale still must comply with all applicable laws, like the FD&C Act, even if it’s determined to classify as “hemp” under the 2018 Farm Bill. The FDA is continuously working with state and local authorities to bring clarity to the legality of CBD and the proper channels for safe distribution.
One clarification that the FDA has provided, however, is that THC or CBD products can not be sold as a dietary supplement, based on available evidence.
“FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)]. Under that provision, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement. FDA considers a substance to be ‘authorized for investigation as a new drug’ if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.”
However, ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of this exclusion, and therefore might be able to be marketed as dietary supplements. Nonetheless, all products marketed as dietary supplements must comply with all applicable laws and regulations governing dietary supplement products.
“Manufacturers and distributors who wish to market dietary supplements that contain ‘new dietary ingredients’ (i.e., dietary ingredients that were not marketed in the United States in a dietary supplement before October 15, 1994) generally must notify FDA about these ingredients (see section 413(d) of the FD&C Act [21 U.S.C. § 350b(d)]). Generally, the notification must include information demonstrating that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. A dietary supplement is adulterated if it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury (see section 402(f)(1)(B) of the FD&C Act [21 U.S.C. 342(f)(1)(B)]).”
Additional information about these regulations and rules can be found in Current Good Manufacturing Practices (CGMPs) or on the FDA’s website.
Around the same time the Farm Bill came into effect, the FDA completed its evaluation of three generally recognized as safe (GRAS) notices for the following hemp seed-derived food ingredients: hulled hemp seed, hemp seed protein powder, and hemp seed oil. The FDA has confirmed that these products can be legally marketed for human consumption in food and food products for the uses described in the notices as long as the companies making the products also followed the other requirements. Even though these notices are allowed for human food marketing, the FDA has not received any GRAS notices for the use of hemp-derived ingredients in animal food.
According to the FDA, hemp seeds are the seeds of the Cannabis sativa plant and don’t naturally contain THC or CBD. These ingredients have been marketed as a source of “protein, carbohydrates, oil, and other nutrients to beverages (juices, smoothies, protein drinks, plant-based alternatives to dairy products), soups, dips, spreads, sauces, dressings, plant-based alternatives to meat products, desserts, baked goods, cereals, snacks, and nutrition bars.” Regardless, the inclusion of these ingredients must be clearly printed on the label and don’t affect the FDA’s viewpoint on CBD and THC’s role in food.
In cosmetics, on the other hand, hemp or hemp byproducts still must comply with all applicable requirements, even though cosmetic products and ingredients aren’t subject to premarket approval by the FDA. Clear branding and labeling still must be adhered and the cannabis or cannabis-derived ingredient must not be adulterated in any way. “If a product is intended to affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease, it is a drug, or possibly both a cosmetic and a drug, even if it affects the appearance.”