FDA v. CBD & THC - 2017 to 2023
The following press releases and statements of policy on CBD and cannabinoids follows the agency pronouncements on needed research, regulatory pathways and the Jan. 2023 notice saying the FDA had no mechanism for setting CD regulatory standards.
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Research by Steve Courneyer doi--
January 2023
January 2023
FDA Issues Response to Three Citizen Petitions related to CBD and Dietary Supplements
November 2022
FDA Warns Companies for Illegally Selling Food and Beverage Products that Contain CBD ---
May 2022
FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products ----
FDA News Release
March 2021
FDA Warns Companies Illegally Selling Over-the-Counter CBD Products for Pain Relief
FDA News Release
December 2020
FDA Warns Companies Illegally Selling CBD Products
FDA News Release
July 2020
FDA Approves New Indication for Drug Containing an Active Ingredient Derived from Cannabis to Treat Seizures in Rare Genetic Disease https://www.fda.gov/news-events/press-announcements/fda-approves-new-indication-drug-containing-active-ingredient-derived-cannabis-treat-seizures-rare
FDA News Release
April 2020
FDA Warns Companies Illegally Selling CBD Products to Treat Medical Conditions, Opioid Addiction
3/5/2020 – Statement:
What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD
The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.
Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is the component that produces the “high” associated with marijuana use. Much interest has been seen around CBD and its potential related to health benefits.
Marijuana is different from CBD. CBD is a single compound in the cannabis plant, and marijuana is a type of cannabis plant or plant material that contains many naturally occurring compounds, including CBD and THC.
The FDA has approved only one CBD product, a prescription drug product to treat seizures associated with Lennox Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in people one year of age and older.
It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.
The FDA has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason.
Some CBD products are being marketed with unproven medical claims and are of unknown quality.
The FDA will continue to update the public as it learns more about CBD.
Potential harm, side effects and unknowns
CBD has the potential to harm you, and harm can happen even before you become aware of it.
CBD can cause liver injury.
CBD can affect how other drugs you are taking work, potentially causing serious side effects.
Use of CBD with alcohol or other drugs that slow brain activity, such as those used to treat anxiety, panic, stress, or sleep disorders, increases the risk of sedation and drowsiness, which can lead to injuries.
Male reproductive toxicity, or damage to fertility in males or male offspring of females who have been exposed, has been reported in studies of animals exposed to CBD.
CBD can cause side effects that you might notice. These side effects should improve when CBD is stopped or when the amount used is reduced.
Changes in alertness, most commonly experienced as somnolence (drowsiness or sleepiness).
Gastrointestinal distress, most commonly experienced as diarrhea and/or decreased appetite.
Changes in mood, most commonly experienced as irritability and agitation.
There are many important aspects about CBD that we just don’t know, such as:
What happens if you take CBD daily for sustained periods of time?
What level of intake triggers the known risks associated with CBD?
How do different methods of consumption affect intake (e.g., oral consumption, topical , smoking or vaping)?
What is the effect of CBD on the developing brain (such as on children who take CBD)?
What are the effects of CBD on the developing fetus or breastfed newborn?
How does CBD interact with herbs and other plant materials?
Does CBD cause male reproductive toxicity in humans, as has been reported in studies of animals?
3/5/20:
FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity
July 2019
FDA News Release
July 2019
FDA is Committed to Sound, Science-based Policy on CBD
https://www.fda.gov/news-events/fda-voices/fda-committed-sound-science-based-policy-cbd
FDA Voices
April 2019
FDA Statement
December 2018
FDA Statement
June 2018
FDA Statement
June 2018
FDA News Release
April 2019 Departing FDA Head Brings "Concern", Hope to CBD "Mass Market" Rules
by Lloyd Covens, Editor, West420 www.CHemp7.com
In a whirl-wind of activity, outgoing Food and Drug Administration commissioner Scott Gottlieb delivered headlines--and industry heartburn-- with actions and comments on CBD marketing claims
November 1, 2017
FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer
Press Releases at the FDA
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