The GRAS conclusions can apply to ingredients for human food marketed by other companies, if they are manufactured in a way that is consistent with the notices and they meet the listed specifications. Some of the intended uses for these ingredients include adding them as 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. Products that contain any of these hemp seed-derived ingredients must declare them by name on the ingredient list.
A. No. There are no other FDA-approved drug products that contain CBD. We are aware that some firms are marketing CBD products to treat diseases or for other therapeutic uses , and we have issued several warning letters to such firms. 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.
10. Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added?
A. Information for patients on Right to Try (RTT) is available on our website. RTT is designed to facilitate access to certain investigational drugs through direct interactions between patients, their physicians and drug sponsors – FDA is not involved in these decisions. Sponsors developing drugs for life-threatening conditions are responsible for determining whether to make their products available to patients who qualify for access under RTT. If you are interested in RTT, you should discuss this pathway with your licensed physician. Companies who develop drugs and biologics, also known as sponsors, can provide information about whether their drug/biologic is considered an eligible investigational drug under RTT and if they are able to provide the drug/biologic under the RTT Act.
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.
After the 2018 Farm Bill, as per federal law, CBD is considered legal in the 50 states. With that being said, since the law is still relatively new, some states haven’t fully embraced CBD. States are grouped into four varying jurisdictional categories .
1937: The Marihuana Tax Act of 1937 was passed, banning the cultivation of marijuana and hemp in the United States, despite their varying effects and uses.
Now, we’re not surprised about your confusion. CBD is a cannabinoid extracted from cannabis plants. And marijuana, which is a federally-controlled substance, is also a member of the cannabis family. So, it’s easy to get confused about CBD’s legality. But here’s the thing: CBD is just one of hundreds of cannabinoids concentrated in cannabis plants. Tetrahydrocannabinol (THC) is another. In fact, THC is the cannabinoid responsible for that euphoric high you experience with marijuana products.
Given CBD’s 2018 status change, most people falsely assume that CBD or any cannabidiol supplements can be legally marketed anywhere in the United States. Well, that is wrong: CBD marketing and use is still tightly regulated. Here’s a comprehensive guide to assist you in understanding precisely where CBD is legal, and under which specific circumstances.
Early 20th Century: In the early 1900s, increased Mexican immigration to America introduced marijuana to locals, as they used it for calming and medicinal benefits. But the THC in marijuana produced psychoactive effects and, due to public health concerns, politics, and prejudice, all cannabis products, including hemp, became suspect.
The Farm Bill allows the FDA to regulate products containing cannabis and cannabis-derived compounds, including CBD, under the Public Health Service Act, and the Federal Food, Drug, and Cosmetic Act.
These jurisdictions include Connecticut, Florida, Minnesota, Mississippi, Nebraska, Delaware, Arkansas, Idaho, Georgia, Iowa, Massachusetts, Maine, Louisiana, New Jersey, New Hampshire, Washington, Virginia, and Pennsylvania.