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Cannabis-Derived Products, Including Cannabidiol


Warning to companies for illegally selling products containing CBD


What You Need to Know About Products Containing Cannabis or Cannabis-derived Compounds, Including Cannabidiol (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, but 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. Also, hemp contains higher amounts of CBD than THC.

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

The Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill) removed hemp from the definition of marijuana in the Controlled Substance Act (CSA).

This means that cannabis plants and derivatives that contain no more than 0.3 percent delta-9-tetrahydrocannabinol (THC) on a dry weight basis are no longer controlled substances under the CSA.

At the federal level, CBD derived from cannabis is considered a Schedule 1 substance in the Controlled Substance Act (CSA), and is illegal.

But, CBD derived from a hemp source containing less than .3% THC by dry weight is not illegal because hemp is not a controlled substance.

However, FDA-regulated products containing hemp must still meet applicable requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act. The Food, Drug, and Cosmetic Act states that once a substance is used as the active ingredient of a new drug that has been approved or authorized for clinical trials, food and beverages containing this ingredient cannot be introduced into interstate commerce.

Therefore, it is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement. At this time, the FDA does not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.

Moreover, FDA has warned companies to stop selling CBD products they claim are intended to prevent, diagnose, treat, mitigate, or cure serious diseases such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes.

CBD is scientifically linked to the prevention of seizures, leading the Food and Drug Administration (FDA) to approve a prescription drug, which contains CBD as an active ingredient.

The agency has approved one drug, Epidiolex, that contains a highly-purified form of CBD for the treatment of seizures associated with Lennox‑Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in people one year of age and older.

Lower Your Risk

CBD has the potential to harm you, even before you become aware of it. Is CBD bad for your heart, liver, and kidneys?

CBD can cause liver injury

In clinical studies for Epidiolex, high levels of liver enzymes were a main reason treatment had to be stopped. But Epidiolex doses are much higher than you’ll find in most over-the-counter (OTC) CBD products.

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.

Potential Side Effects
  • 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.

Seek immediate medical attention or advice if you are currently experiencing a serious or troublesome cannabis-related symptom(s).

Call your health care provider or the Poison Center at 1-800-222-1222.

Need to report an incident? You may report the following:

▪ An adverse health event which includes any troublesome or undesired medical occurrence or symptom associated with the use of a cannabis product.

▪ A concern about a cannabis business which includes businesses that sell cannabis products including unlicensed business locations, sales to a minor or consumption in unauthorized areas.

▪ Or a concern regarding a cannabis product, such as product safety, product mislabeling, product formulation or product expiration date.

CBD Legalization By State

Cannabidiol (CBD) has gone from fringe to mainstream in the world of wellness. Today, you can easily find CBD in a variety of forms including tinctures, capsules, gummies and more.

State-regulated cannabis dispensaries are good places to buy CBD. These stores usually have strict rules for testing and labeling. While hemp-based CBD is legal at a federal level, some states consider using or possessing any cannabis product illegal. Other states only allow CBD use medically.

Fully Legal

▪ Alaska

▪ Arizona

▪ California

Hemp-derived CBD edibles are not legal in the state, but cannabis-derived CBD edibles are. Legislation has been proposed to remove this restriction.

▪ Colorado

▪ Connecticut

▪ District of Columbia

▪ Illinois

▪ Maine

▪ Massachusetts

Oil with THC content exceeding 0.3% fully legal for adults age 21 and up, and for adults 18 to 20 years old with medical cannabis license.

▪ Michigan

▪ Montana

▪ Nevada

▪ New Jersey

▪ New York

▪ Oregon

▪ Vermont

▪ Virginia

▪ Washington

It’s likely that regulations surrounding CBD legality will continue to evolve and fluctuate over time. The conversation has only just begun.

The use of CBD raises safety concerns, especially with long-term use.

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