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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

FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward

https://www.fda.gov/news-events/press-announcements/fda-concludes-existing-regulatory-frameworks-foods-and-supplements-are-not-appropriate-cannabidiol

 

January 2023

FDA Issues Response to Three Citizen Petitions related to CBD and Dietary Supplements

https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-response-three-citizen-petitions-related-cbd-and-dietary-supplements

 

November 2022

FDA Warns Companies for Illegally Selling Food and Beverage Products that Contain CBD   --- 

 

https://www.fda.gov/food/cfsan-constituent-updates/fda-warns-companies-illegally-selling-food-and-beverage-products-contain-cbd

 

 

May 2022

FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products    ----

https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-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

https://www.fda.gov/news-events/press-announcements/fda-warns-companies-illegally-selling-over-counter-cbd-products-pain-relief

FDA News Release

December 2020

FDA Warns Companies Illegally Selling CBD Products

https://www.fda.gov/news-events/press-announcements/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?

 

https://www.fda.gov/news-events/press-announcements/fda-warns-companies-illegally-selling-cbd-products-treat-medical-conditions-opioid-addiction

 

 

3/5/20:

FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity

https://www.fda.gov/news-events/press-announcements/fda-advances-work-related-cannabidiol-products-focus-protecting-public-health-providing-market

 

 

July 2019

FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer's disease, opioid withdrawal, pain and pet anxiety

https://www.fda.gov/news-events/press-announcements/fda-warns-company-marketing-unapproved-cannabidiol-products-unsubstantiated-claims-treat-cancer

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

Statement on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products

 

https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-steps-advance-agencys-continued-evaluation

 

FDA Statement

 

 

 

 

December 2018

Statement on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds

   https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-signing-agriculture-improvement-act-and-agencys

FDA Statement

June 2018

 

Statement on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components

https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-importance-conducting-proper-research-prove-safe-and

 

FDA Statement

June 2018

FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy      

https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms

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

https://www.linkedin.com/pulse/departing-fda-head-brings-concern-hope-cbd-mass-market-covens?trk=article-ssr-frontend-pulse_more-articles_related-content-card

November 1, 2017

FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer

   https://www.fda.gov/news-events/press-announcements/fda-warns-companies-marketing-unproven-products-derived-marijuana-claim-treat-or-cure-cancer

Press Releases at the FDA

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