The FDA’s Frequently Asked Questions about the Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) – Part Two

While FDA is considering revamping its approach to regulation of CBD products in light of the proliferation of CBD products on the market, FDA continues to enforce some longstanding legal prohibitions.  Here is what you need to know about FDA’s legal do’s and don’ts if you are going to market a CBD product.

Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added?

The Food, Drug, and Cosmetic Act (section 301(ll)) prohibits introducing or delivering for introduction into interstate commerce

• “Any food (including any animal food or feed) to which has been added a substance which 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
• A drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. “

There are exceptions, including:

• “When the drug was marketed in food before the drug was approved or
• Before the substantial clinical investigations involving the drug had been instituted or
• In the case of animal feed, that the drug is a new animal drug approved for use in feed and used according to the approved labeling.”

Currently, the conclusion of the FDA is that none of these exceptions apply for THC or CBD. This means the FDA prohibits introducing or delivering any food (including feed or animal food) to which THC or CBD has been added. The FDA has no current reason to believe this evaluation will change. Further,

“When this statutory prohibition applies to a substance, it prohibits the introduction into interstate commerce of any food to which the substance has been added unless FDA, in the agency’s discretion, has issued a regulation approving the use of the substance in the food (section 301(ll)(2) of the FD&C Act [21 U.S.C. § 331(ll)(2)]).  To date, no such regulation has been issued for any substance.”

“Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of 301(ll), and therefore might be able to be added to food.  For example, certain hemp seed ingredients can be legally marketed in human food.”

“However, all food ingredients must comply with all applicable laws and regulations.  For example, by statute, any substance intentionally added to food is a food additive, and therefore subject to premarket review and approval by FDA, unless the substance is Generally Recognized As Safe (GRAS) by qualified experts under the conditions of its intended use, or the use of the substance is otherwise excepted from the definition of a food additive (sections 201(s) and 409 of the FD&C Act [21 U.S.C. §§ 321(s) and 348]).”

Except for three hemp seed cases (see the next question), to date, no other cannabis or cannabis-derived ingredients:

• Have been the subject of a food additive petition
• An evaluated GRAS notification, or
• Have otherwise been approved for use in food by FDA.

“Food companies that wish to use cannabis or cannabis-derived ingredients in their foods are subject to the relevant laws and regulations that govern all food products, including those that relate to the food additive and GRAS processes.”

Can hulled hemp seed, hemp seed protein powder, and hemp seed oil be used in human food?

“In December 2018, 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
• Hemp seed oil

“The FDA had no questions regarding the company’s conclusion that the use of such products as described in the notices is safe. Therefore, these products can be legally marketed in human foods for the uses described in the notices, provided they comply with all other requirements. These GRAS notices related only to the use of these ingredients in human food. To date, FDA has not received any GRAS notices for the use of hemp-derived ingredients in animal food.”

Negligible amounts of THC or CBD

“Hemp seeds are the seeds of the Cannabis sativa plant. The seeds of the plant do not naturally contain THC or CBD. The hemp seed-derived ingredients that are the subject of these GRAS notices contain only trace amounts of THC and CBD, which the seeds may pick up during harvesting and processing when they are in contact with other parts of the plant. Consumption of these hemp seed-derived ingredients is not capable of making consumers “high.””

FDA approval of these hemp products is only for human food and not animal food. If other companies use the ingredients, they should make their products according to the specifications of the ones that have been improved. The maker must list approved ingredients by name on the product ingredient list.

The approved ingredients are being used 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.”

“These GRAS conclusions do not affect the FDA’s position on the addition of CBD and THC to food.”

What is FDA’s role when it comes to the investigation of cannabis and cannabis-derived products for medical use?

The FDA believe that more research is needed to determine the safety and uses of CBD-based products. FDA does approve clinical research under the following guidelines:

“To conduct clinical research that can lead to an approved new drug, including research using materials from plants such as cannabis, researchers need to work with the FDA and submit an IND application to the Center for Drug Evaluation and Research (CDER).”

“The IND application process gives researchers a path to follow that includes regular interactions with the FDA to support efficient drug development while protecting the patients who are enrolled in the trials.”

“For research for use as an animal drug product, researchers would establish an investigational new animal drug (INAD) file with the Center for Veterinary Medicine to conduct their research, rather than an IND with CDER.”

The FDA anticipates that removing hemp from the Controlled Substances Act through the 2018 Farm Bill will help speed the development of new CBD based drugs.

Clinical research using cannabis-related substances that are scheduled by the DEA (now, essentially non-hemp based products) generally require that the researchers work with:

• The DEA to register their research
• The NIDA or other DEA approved sources – to obtain the cannabis for the research
• The FDA which will review the IND or INAD application and research protocols

Additional DEA requirements are generally required for Schedule I controlled substances.

The “NIDA provides research-grade cannabis for scientific study. The agency is responsible for overseeing the cultivation of cannabis for medical research and has contracted with the University of Mississippi to grow cannabis for research at a secure facility. Cannabis of varying potencies and compositions is available. DEA also may allow additional growers to register with the DEA to produce and distribute cannabis for research purposes.”

“Researchers work with the FDA and submit an IND application to the appropriate division in the Office of New Drugs in CDER depending on the therapeutic indication. Based on the results obtained in studies conducted at the IND stage, sponsors may submit a marketing application for formal approval of the drug.”

Does the FDA object to the clinical investigation of cannabis for medical use?

No. The FDA believes that scientifically valid research conducted under an IND application is the best way to determine what patients could benefit from the use of drugs derived from cannabis. The FDA supports the conduct of that research by:

• “Providing information on the process needed to conduct clinical research using cannabis.
• Providing information on the specific requirements needed to develop a drug that is derived from a plant such as cannabis. In December 2016, the FDA updated its Guidance for Industry: Botanical Drug Development, which provides sponsors with guidance on submitting IND applications for botanical drug products.
• Providing specific support for investigators interested in conducting clinical research using cannabis and its constituents as a part of the IND process through meetings and regular interactions throughout the drug development process.
• Providing general support to investigators to help them understand and follow the procedures to conduct clinical research through the FDA Center for Drug Evaluation and Research’s Small Business and Industry Assistance group.”

How can patients gain access to cannabis or cannabis-derived products for medical use through expanded access?

The FDA understands that some patients who have a life-threatening illness or condition need a pathway to try investigational medical products (drug, biologic, or medical device) to see if they work even though there are no current clinical trials and no current comparable therapies available. The FDA’s expanded access program, sometimes called “compassionate use,” may provide additional options. Manufacturers may be able to make investigational drugs available to individual patients in certain circumstances.

FDA is continually working to balance the need for new drugs and products that can benefit patients with the need to ensure the safety and effective use of these products. This is especially true with CBD products which many developers claim have beneficial medical uses. Companies that wish to make CBD products need to understand the FDA regulations and how to comply with them. The best course of action is to consult with an experienced healthcare lawyer before starting operations rather than waiting for a warning letter from the FDA.

Contact Cohen Healthcare Law Group, PC to discuss how the FDA regulations affect your CBD products. There are many pitfalls. If you claim that your products have medical uses, then FDA will likely warn you that your product is a drug. In some cases, FDA may claim it is a dietary supplement or a cosmetic. They may warn you that the product is adulterated, that is misbranded, or that the labeling is not accurate.

If you’re going to operate in any kind of venture, get the expertise that you need to develop your systems, your procedures, and your business.