15 companies, most of which sell cannabidiol products for pets receive warning letters; veterinarians and other healthcare providers urged to report adverse effects.
The FDA issued warning letters this week to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic (FD&C) Act, according to a release from the agency. These companies' websites indicate that most if not all of them sell CBD products for pets as well as people.
Also this week, the FDA published a consumer update detailing safety concerns about CBD products, indicating that due to a lack of scientific information, it cannot conclude that CBD is generally recognized as safe (GRAS). Still, the FDA says it's continuing to explore potential pathways for CBD products to be lawfully marketed. This will hinge on obtaining and evaluating information related to the safety of CBD products, the agency says.
“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we'll continue to monitor the marketplace and take action as needed against companies that violate the law,” says FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, in the release. “This overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate.”
Dr. Abernathy says the FDA is concerned that people may think the many CBD products on the market have been evaluated by the FDA and determined to be safe, or simply that trying CBD “can't hurt.”
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“We want to be clear that a number of questions remain regarding CBD's safety-including reports of products containing contaminants, such as pesticides and heavy metals-and there are real risks that need to be considered,” Dr. Abernathy continues. “We recognize the significant public interest in CBD, and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”
There are many unanswered questions and data gaps regarding CBD toxicity, the FDA release states, and some of the available data raise serious concerns about potential harm. The consumer update outlines specific safety concerns, including potential liver injury, interactions with other drugs, drowsiness, diarrhea and changes in mood. In addition, studies in animals have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels and impair sexual behavior in males.
CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, food products, and topical lotions and creams. The companies that received warning letters have used web pages, online stores and social media to market CBD products in insterstate commerce in ways that violate the FD&C Act, the FDA states, including marketing CBD products to treat diseases or for other therapeutic uses for humans or animals. Other violations include marketing CBD products as dietary supplements and adding CBD to human and animal foods.
The companies that received warning letters are:
Koi CBD of Norwalk, California
Pink Collections of Beverly Hills, California
Noli Oil of Southlake, Texas
Natural Native of Norman, Oklahoma
Whole Leaf Organics of Sherman Oaks, California
Infinite Product Company, doing business as Infinite CBD, of Lakewood, Colorado
Apex Hemp Oil of Redmond, Oregon
Bella Rose Labs of Brooklyn, New York
Sunflora of Tampa, Florida/Your CBD Store of Bradenton, Florida
Healthy Hemp Strategies, doing business as Curapure, of Concord, California
Private I Salon of Charlotte, North Carolina
Organix Industries, doing business as Plant Organix, of San Bernardino, California
Red Pill Medical of Phoenix, Arizona
Sabai Ventures of Los Angeles, California
Daddy Burt, doing business as Daddy Burt Hemp, of Lexington, Kentucky.
Under the FD&C Act, any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than a food) that is intended to affect the function of the body of humans or animals, is a drug, the FDA states. The agency emphasizes that it has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy. The FDA has previously sent warning letters to other companies illegally selling CBD products.
Some of the products highlighted in the warning letters issued this week raise other legal and public health concerns, the FDA states:
Some of the products are marketed for infants and children, a population that may be at greater risk for adverse reactions.
Some of the products are foods to which CBD has been added. Under the FD&C Act, it's illegal to introduce into interstate commerce any human or animal food to which certain drug ingredients, such as CBD, have been added. In addition, the FDA is not aware of any basis to conclude that CBD is GRAS among qualified experts.
Some of the products are marketed as dietary supplements. However, CBD products cannot be dietary supplements because they don't meet the definition of a dietary supplement under the FD&C Act.
One product outlined in a warning letter to Apex Hemp Oil is intended for food-producing animals. The agency says it is concerned about the safety of human food products (e.g. meat, milk, and eggs) from animals that consume CBD, as there is a lack of data establishing safe CBD residue levels.
The FDA has requested responses from the companies within 15 working days stating how the companies will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction, the release states.
The FDA is encouraging human and animal healthcare professionals and consumers to report adverse reactions associated with CBD products to the agency's MedWatch program.