FDA sends warning to companies illegally selling CBD products
The Food and Drug Administration sent a letter Monday to 15 companies, warning them that they are selling cannabidiol, known as CBD, in ways that violate the Federal Food, Drug, and Cosmetic Act.
The FDA also issued a revised Consumer Update on CBD, noting that they still “cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.”
“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 in ways that raise a variety of public health concerns,” FDA Principal Deputy Commissioner Amy Abernethy said in a statement.
“In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate.
“We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’
“Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and 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. 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.”
The 15 companies which were warned are:
▪ Koi CBD LLC, of Norwalk, Calif.
▪ Pink Collections Inc., of Beverly Hills, Calif.
▪ Noli Oil, of Southlake, Texas
▪ Natural Native LLC, of Norman, Okla.
▪ Whole Leaf Organics LLC, of Sherman Oaks, Calif.
▪ Infinite Product Company LLLP, doing business as Infinite CBD, of Lakewood, Colo.
▪ Apex Hemp Oil LLC, of Redmond, Ore.
▪ Bella Rose Labs, of Brooklyn, N.Y.
▪ Sunflora Inc., of Tampa, Fla./Your CBD Store, of Bradenton, Fla.
▪ Healthy Hemp Strategies LLC, doing business as Curapure, of Concord, Calif.
▪ Private I Salon LLC, of Charlotte, N.C.
▪ Organix Industries Inc., doing business as Plant Organix, of San Bernardino, Calif.
▪ Red Pill Medical Inc., of Phoenix, Ariz.
▪ Sabai Ventures Ltd., of Los Angeles, Calif.
▪ Daddy Burt LLC, doing business as Daddy Burt Hemp Co., of Lexington, Ky.
Center for Science in the Public Interest Policy Director Laura MacCleery said, “CSPI is glad that the Food and Drug Administration has issued another tranche of warning letters to companies making illegal claims for CBD-containing products. New and notable is FDA’s announcement that it cannot conclude based on current evidence that CBD is generally recognized as safe, or GRAS, for use in human or animal food. That means just about everyone selling CBD in a food is breaking the law.”
MacCleery continued, “The agency has already concluded that CBD products ‘do not meet the definition of a dietary supplement under the [Food, Drug, and Cosmetic Act].’ If the hemp industry wants CBD to be legal in foods or supplements, it will need to affirmatively convince the FDA that it is safe. And as of now, given the gaps in the research noted by FDA, CBD makers have an uphill battle on their hands.”