The Food and Drug Administration (FDA) sent warning letters to four cannabis companies for allegedly making unauthorized claims about the medicinal benefits of CBD products they marketed to animals.
The agency said cannabis sold “illegally” are “unapproved animal medicines” and their safety or efficacy has not been evaluated. While the Food and Drug Administration has said it is concerned about the lack of research into the effects of CBD on the animals themselves, it has argued that there are also potential risks for people who consume things like milk, meat, and eggs from animals that eat hemp.
Warning letters have been sent to Free State Oils, Hope Botanicals, Plantacea LLC dba Kahm CBD, and Kingdom Harvest.
The US Food and Drug Administration (FDA) has issued warning letters to 4 companies that illegally sell unapproved and potentially unsafe CBD products for use in food-producing animals and people. https://t.co/2omk6QuCL1 pic.twitter.com/u5SLnBfNXV
– FDA CVM (FDAanimalhealth) 26 May 2022
“Although the FDA does not know the current extent of CBD use in food-producing animals, the agency is taking steps with respect to these unapproved and now potentially unsafe products to help protect animals and the safety of the food supply,” she said in a notice. Thursday.
Hemp and hemp-derived products containing no more than 0.3 percent THC by dry weight have been legalized under the 2018 Farm Act. But the Food and Drug Administration has not yet enacted regulations allowing such products to be marketed in the human or animal food supply. The slow pace of FDA rule-making on cannabis products has been a source of frustration for lawmakers and stakeholders.
At a congressional hearing last week, Food and Drug Administration Commissioner Robert Califf realized that his agency Did not take beneficial steps to regulate CBD products Over the years since hemp was legalized, but he’s also placed the onus on Congress to enable the agency to facilitate rule-making more effectively.
The FDA has taken a discretionary approach to cannabis application, singling out these companies for claims they made about the therapeutic value of CBD for “food-producing animals” in treating conditions such as anxiety, pain, and inflammation.
Companies also sell unapproved medications containing CBD and adulterated foods to people. These products include oils, creams, extracts, ointments, and chewing gum.
– FDA CVM (FDAanimalhealth) 26 May 2022
“Unapproved medications such as these CBD products have not been evaluated by the FDA to determine if they are effective for their intended use, what is the appropriate dosage, and how the products may interact with FDA approved medications.” , or whether it has serious side effects or other safety concerns.
“The FDA is concerned about CBD products for food-producing animals, not only because CBD can pose a safety risk to the animals themselves, but also because of the lack of data on the safety of human food products (meat, milk, eggs) from animals that consumed these CBD products.”
The agency said the main concern is CBD residues in animals that are milked or slaughtered after ingesting non-intoxicating cannabis. She said that because the products had not been evaluated by the Food and Drug Administration, she was unable to “determine the minimum amount of time between the last dose of a drug” when it would exit the animal’s system and go to market.
“To date, there is a lack of data on residues that may result when food-producing animals consume CBD products. There is also a lack of data on potentially safe residue levels for a person consuming foods that come from CBD-treated animals,” she said, adding that The agency has received reports of contaminated CBD products.
Furthermore, the FDA said it was concerned that people might delay seeking professional medical advice for animals with symptoms such as anxiety because they are using CBD that is marketed as a treatment option.
For what it’s worth, a recent federally funded study found that feeding hemp to livestock In fact, it reduces stress.
The notice says the companies that received warning letters “also sell unapproved new drugs containing CBD to humans and adulterated human foods.” “Some products have also been marketed as dietary supplements even though CBD-containing products do not meet the definition of a dietary supplement. These products include oils, creams, extracts, ointments, and chewing gum.”
Companies are given 15 days to respond to warning messages with information about how they intend to address the issues. Failure to respond and making changes may result in penalties, including forfeiture of products and/or orders.
Meanwhile, the Food and Drug Administration recently warned consumers Fake food products filled with marijuana Which are similar to popular brands and the dangers of accidentally taking THC, especially for children.
Agency separately It issued its first set of warnings To companies regarding the alleged illegal sale of products containing the increasingly popular delta-8 cannabinoid.
Five warning letters have been sent to companies that market products with the intoxicating compound and make what the agency says are unauthorized claims about its therapeutic potential.
The top Republican on a major congressional committee also called on the leadership this month to… Schedule an FDA Accountability Hearing For not taking action to set regulations for CBD and delta-8 THC products.