The FDA may have turned a blind eye to companies like Bio Steel in the past who’ve been selling supplements containing CBD in the United States but they’re like to start issuing more warning letters when drug claims are made. With the FDA enforcement of CBD supplements being like pet supplements the FDA is concluding that the existing regulatory framework isn’t appropriate for CBD supplements.
The cannabidiol (CBD) product market has seen accelerated growth in 2022, leading FDA to take a closer look at the regulatory pathways. They’ve since concluded that a new pathway for CBD is required to balance risks and desire for CBD products. While working with Congress to adjust regulations they’ve decided to deny petitions/rulemaking for marketing CBD products as dietary supplements.
The various usages of CBD (safety concerns):
Studies have shown that long-term usage of CBD has the potential to harm your liver, and the male reproductive system and interact negatively with various medications. CBD exposure can hurt young children and pregnant women. The new impending regulatory pathway would aim to benefit consumers by providing safety measures to minimize risks. This could be carried out by; CBD content limits, measures, minimum age requirements, prevention of contaminants, etc. The current authorities have very limited tools for managing the risks of CBD products and health officials plan to change that.
CBD impact on animals (pet supplements)
CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk, and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.
What do the FDA officials have to say?
“We have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm,” FDA Principal Deputy Commissioner Janet Woodcock said.
“A new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks,” the agency said.
Although as of January 26th, 2023, the FDA said that it doesn’t intend to make any new guidance related to CBD, they may have to depend on how effective the framework proves to be once it’s created. Having mainly focused on unsubstantiated health claims of food/beverage and supplements in the past it will be interesting to see how they approach creating a regulatory framework for CBD.
The FDA has stated that the available data didn’t show how CBD products could meet the standards of safety for animal food substances and didn’t intend to provide new rules for its use in human or animal foods.
How Quality Smart Solutions can help:
Please contact our team for more information on food classification, ingredient feasibility questions, ingredient submissions, dietary supplement compliance, NHP compliance, and food labeling projects. Our specialists are here to help with the following services; Novel Food Notifications, SFCR License application, HACCP & PCP program, TMA License for Supplemented Foods, Nutrition Facts Table (NFT) Creation and label compliance!