The U.S. Food and Drug Administration (FDA) has issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA also published a revised Consumer Update detailing safety concerns about CBD products more broadly.
CBD Products to be Legally Marketed
The FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed. This includes ongoing work to obtain and evaluate information to address outstanding questions related to the safety of CBD products, while maintaining the agency’s rigorous public health standards.
The FDA plans to provide an update on its progress regarding the agency’s approach to these products in the coming weeks.
Safety Concerns Related to CBD Products
Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD. The revised Consumer Update outlines specific safety concerns related to CBD products, 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. Questions also remain about cumulative use of CBD and about CBD’s impacts on vulnerable populations such as children and pregnant or breastfeeding women.
CBD Marketed in Lotions and Creams
CBD is marketed in a variety of product types, such as topical lotions, creams and food items. The companies receiving the warning letters are using product webpages, online stores and social media to market CBD products in interstate commerce in ways that violate the FD&C Act.
The companies that have been issued warning letters are:
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Natural Native LLC, of Norman, Oklahoma
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Infinite Product Company LLLP, doing business as Infinite CBD, of Lakewood, Colorado
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Apex Hemp Oil LLC, of Redmond, Oregon
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Sunflora Inc., of Tampa, Florida/Your CBD Store, of Bradenton, Florida
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Healthy Hemp Strategies LLC, doing business as Curapure, of Concord, California
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Private I Salon LLC, of Charlotte, North Carolina
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Daddy Burt LLC, doing business as Daddy Burt Hemp Co., of Lexington, Kentucky
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Koi CBD LLC, of Norwalk, California
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Pink Collections Inc., of Beverly Hills, California
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Noli Oil, of Southlake, Texas
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Whole Leaf Organics LLC, of Sherman Oaks, California
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Bella Rose Labs, of Brooklyn, New York
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Organix Industries Inc., doing business as Plant Organix, of San Bernardino, California
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Red Pill Medical Inc., of Phoenix, Arizona
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Sabai Ventures Ltd., of Los Angeles, California
The FDA has requested responses from the companies within 15 working days stating how they will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure or injunction.
The organization encourages human and animal health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.
Source: FDA