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Update on Cannabis-derived and Cannabis-related Products

1. The Farm Bill also removed tetrahydrocannabinols included in ‘hemp’ from Schedule I under the CSA. It did not, however, change the FDA’s authority to regulate drugs and food under the federal Food, Drug, and Cosmetic Act (FDCA)

2. The FDA has commented on CBD products marketed as dietary supplements stating that, “Some of the products are marketed as dietary supplements. However, CBD products cannot be dietary supplements because they do not meet the definition of a dietary supplement under the FDCA.”


3. In determining whether something is a drug, ‘intent to use’ is very important and is defined by the FDA. The FDA determines a product's ‘objective intent’ by what appears in labeling claims, advertising matter, and oral or written statements by manufacturers, sponsors, or their representatives.


4. To our knowledge, there are no long-term safety data available for the use of CBD in companion animals.


5. Results of a very small-scale study (8 dogs, 8 cats; no animals used as controls) focusing on pharmacokinetics an d safety were recently (October 19, 2019) published in Animals. The study included a preliminary safety and adverse effect assessment for the dogs and cats given CBD at a dose of 2 mg/kg for 12 weeks. Serum chemistry and CBC results showed no clinically significant alterations or did physical examinations.


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