Are Cannabis Products Approved by the FDA?

Are Cannabis Products Approved by the FDA?

Published on February 8, 2022 by Kristina Willis

The cannabis industry has grown over tenfold in the past decade and shows no signs of slowing down. While there are certain benefits to increased growth, such as innovation and availability, it is also becoming progressively challenging for consumers to stay informed and discern effective and safe products.

Many products are regulated by the U.S. Food and Drug Administration (FDA), and a common way for consumers to gauge safety is through FDA approval for drugs of consideration. However, due to the rigorous application process and additional barriers to cannabis research, the number of FDA-approved cannabis products is few and far between. To date, only four cannabinoid medications have received such distinction, and all require a valid prescription.

Keep reading to learn more about the FDA’s role in public health and the cannabis industry.

What Does the FDA Do?

The FDA is a federal government agency charged with monitoring public health and upholding standards for product safety. The distribution and marketing of products that are regulated by the FDA must follow legal requirements that vary depending on the industry. They are also responsible for advancing innovations that can potentially improve lives through higher efficacy and safety.

FDA Mission Statement:

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

What Products Does the FDA Regulate?

►Human foods
►Medical devices
►Electronic products that give off radiation
►Veterinary products
►Tobacco products

What Does FDA Approved Mean?

Contrary to popular belief, FDA approval does not guarantee zero harm. When something is FDA-approved, it conveys three essential pieces of information that the agency has verified to be true:

1. The product legitimately does what it claims to do.
2. It does not place humans at unreasonable risk.
3. It follows federal manufacturing, labeling, and distribution guidelines.

Where safety is concerned, FDA approval indicates that the drug’s benefits outweigh the risks—not that it is entirely risk-free.

“Caregivers and patients can be confident that FDA-approved drugs have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they are on the market.”

U.S. Food and Drug Administration

What Is the FDA Approval Process?

To gain FDA approval, a sponsor (company, research institution, etc.) submits their lab data to the FDA’s Center for Drug Evaluation and Research (CDER) to prove the drug works and is relatively safe. They must also develop a plan for human testing and show why their method is legitimate.

Additionally, sponsors must submit an Investigational New Drug Application (IND) in order to distribute their drug across state lines for clinical testing. The following steps involve a series of controlled clinical studies that thoroughly test the product’s viability. After the necessary tests are conducted, the sponsor must submit a New Drug Application (NDA), which serves as the formal request for approval.

The FDA meets with the sponsors throughout clinical trials to facilitate the drug’s development. However, it is worth noting that the FDA does not test or develop products themselves. Instead, they only review the material submitted by sponsors seeking approval for their products. Official FDA approval can only be obtained after a thorough analysis of all the material concludes that every specification and requirement has been met.  

Are Cannabis Products Approved by the FDA?

Any cannabis products intended for clinical use and making therapeutic claims are considered drugs. Currently, over-the-counter (OTC) and general use cannabis products are by no means approved by the FDA.

All FDA-approved medical products require a prescription from a licensed healthcare provider and are subject to heavy quality control guidelines. It is important to reiterate that purchasable products found in dispensaries, retail stores, or online are not approved by the FDA. Any of these products that claim to have therapeutical benefits violate the Federal Food, Drug, and Cosmetic Act and are thus breaking the law.

Cannabinoid Medications:

1. Epidiolex
2. Marinol
3. Syndros
4. Cesamet

As of February 2022, only four cannabis medications have been approved by the FDA. Epidiolex is a treatment for a rare and severe seizure disorder and the only product derived directly from the cannabis plant. Marinol, Syndros, and Cesamet are all synthetically derived and produced in a lab.

Has the FDA Approved Any CBD Products?

Epidiolex is the only FDA-approved CBD product and contains pure CBD. Any other CBD products claiming FDA support are making unsubstantiated claims and should not be trusted.

Does the FDA Regulate CBD?

Yes, the FDA has authority over all cannabis-derived products, including CBD. Products containing CBD that make therapeutic claims are illegal under the Food, Drug, and Cosmetic Act mentioned above.

Does the FDA Regulate Hemp?

One of the major changes that came out of the 2018 Farm Bill was creating a distinction between marijuana and hemp. Cannabis classified as hemp (less than 0.3% THC content) may be used for clinical research without prior FDA approval.

Are Products That Are Not FDA-Approved Safe?

Without a doubt, FDA-approved cannabis medications adhere to a higher quality control standard. The lengthy vetting process lets consumers know that the drug has legitimate benefits and follows through on claims made on the label. It will also have a relatively good safety profile for human use. With more official testing and market regulation, consumers can rest assured that the cannabis products they use will not harm them.

However, one of the disadvantageous side-effects of the FDA’s rigorous approval process is that few manufacturers want to spend the time or money to gain the official stamp of approval. With only four FDA-approved cannabinoid medications, it is safe to say that there are many cannabis products available that are not FDA-approved but are still effective and helpful to the general public.

Unfortunately, tons of cannabis brands make illegal and unsubstantiated claims to make their products more appealing, and there is no easy method to determine their legitimacy. While the FDA monitors cannabis products and issues warnings to offending companies, plenty more fly under the radar. Until the market becomes better regulated, consumers must always research individual products they are interested in before purchasing.  

Insurances Demonstrated By FDA-Approved
Cannabinoid Medications:

► The drug has undergone rigorous testing, including placebo-controlled, publicly disclosed clinical trials. The necessary tests have been conducted to determine efficacy, safety, and, most notably, recommended dosing.

► The product’s manufacturing process is regulated to ensure batch consistency and reliability.

► It must meet FDA standards and guidelines and will be continuously monitored and regulated.

► Product labeling will be accurate and specify precise ingredients and concentrations.

“Overall, the growth of the CDP market continues to outpace the growth in the science and our understanding of the public health implications of these products.”

—FDA’s Cannabis Derived Products (CDP) Data Acceleration Plan, October 2021

Preview image by nickolette licensed under CC BY 2.0 on Wikimedia Commons.