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FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)

https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd

On this page:

Consumer Information

FDA Communications

Regulatory Resources

Questions and Answers

There is a significant interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD). FDA recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer and acknowledges the significant interest in these possibilities. However, FDA is aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act) and that may put the health and safety of consumers at risk. The agency is committed to protecting the public health while also taking steps to improve the efficiency of regulatory pathways for the lawful marketing of appropriate cannabis and cannabis-derived products. FDA has a number of resources available that address cannabis and cannabis-derived products, such as CBD, and the agency wants to ensure that consumers and other stakeholders have access to these resources in a centralized location.

Consumer Information

What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD
What You Should Know About Using Cannabis, Including CBD, When Pregnant or Breastfeeding
Some Medicines and Driving Don’t Mix
FDA Communications

FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity
Congressional Testimony: Cannabis Policies for the New Decade
Archived VideoExternal Link Disclaimer
FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns
Remarks at the Council for Responsible Nutrition Conference
Remarks at the National Industrial Hemp Council 2019 Hemp Business Summit
FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease
Congressional Testimony: Hemp Production and the 2018 Farm Bill
Archived Video
FDA is Committed to Sound, Science-based Policy on CBD
Remarks at the FDA Public Hearing on Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds
Statement on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products
Statement on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds
Statement on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components
FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy
Regulatory Resources

Information on CBD Data Collection and Submission
FDA and Cannabis: Research and Drug Approval Process
FDA Regulation of Dietary Supplement & Conventional Food Products Containing Cannabis and Cannabis-Derived Compounds
Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing
Federal Register Notice
Public Hearing Page
Public Docket
Warning Letters and Test Results for Cannabidiol-Related Products
State, Local, Tribal, Territorial (SLTT) Regulatory Officials: FDA is committed to working with our SLTT public health regulatory partners as developments occur in the regulatory landscape. Please contact the Intergovernmental Affairs team with any questions at [e-mail].
Questions and Answers

Below are a number of frequently asked questions and answers on this topic.

What are cannabis and marijuana?
How does the 2018 Farm Bill define hemp? What does it mean for FDA-regulated products?
Has FDA approved any medical products containing cannabis or cannabis-derived compounds such as CBD?
Aside from Epidiolex, are there other CBD drug products that are FDA-approved? What about the products I’ve seen in stores or online?
Why hasn’t FDA approved more products containing cannabis or cannabis-derived compounds for medical uses?
What is FDA’s reaction to states that are allowing cannabis to be sold for medical uses without the FDA’s approval?
Has the agency received any adverse event reports associated with cannabis use for medical conditions?
Is it legal for me to sell CBD products?
Can THC or CBD products be sold as dietary supplements?
Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added?
In making the two previous determinations about THC, why did FDA conclude that THC is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act? In making the two previous determinations about CBD, why did FDA determine that substantial clinical investigations have been authorized for and/or instituted, and that the existence of such investigations has been made public?
Can hulled hemp seed, hemp seed protein powder, and hemp seed oil be used in human food?
What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?
Will FDA take action against cannabis or cannabis-related products that are in violation of the FD&C Act?
Can I import or export cannabis-containing or cannabis-derived products?
What is FDA’s role when it comes to the investigation of cannabis and cannabis-derived products for medical use?
Does the FDA object to the clinical investigation of cannabis for medical use?
How can patients gain access to cannabis or cannabis-derived products for medical use through expanded access?
Can patients gain access to cannabis or cannabis-derived products for medical use through Right to Try?
Does the FDA have concerns about administering a cannabis product to children?
Does the FDA have concerns about administering a cannabis product to pregnant and lactating women?
What does the FDA think about making CBD available to children with epilepsy?
What should I do if my child eats something containing cannabis?
I’ve seen cannabis products being marketed for pets. Are they safe?
Can hemp be added to animal food?
Can approved human drugs containing CBD or synthetic THC be used extralabel in animals?