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CBD Oil Update

CBD Oil Legal Questions Answered

The Indiana Legislature passed Senate Enrolled Act No. 52, which was subsequently signed into law by Governor Holcomb. This legislation amended several sections of the Indiana Criminal Code related to the sale of products including CBD. SEA 52 amended the Indiana Code to add I.C. 24-4-21-1 et seq. This new chapter to the Indiana Code regulates the distribution of low THC hemp extract.
Because of these legislative changes, IVMA consulted with our legal counsel for guidance. The following analysis is provided, but as always, consult with your own legal counsel for specific questions and situations.

Analysis

It appears inadvisable for Indiana veterinarians to sell cannabidiol (CBD) products or to recommend their use for animal patients. According to American Veterinary Medical Association, while marijuana products and CBD are being marketed to treat diseases in animals, the FDA has not approved the use of marijuana or hemp in any form in animals, and the FDA takes the position that it cannot ensure the safety or effectiveness of such products. The FDA and AVMA caution pet owners against the use of such products. Many of these products are marketed as CBD oil or chews, and despite this marketing, the AVMA believes that these products, despite contrary claims, are illegal for use in pets.

Recently, the FDA has approved Epidolex , which contains a purified drug substance cannabidiol, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. It is the FDA’s position that products that contain THC or CBD cannot be sold as dietary supplements. According to the FDA, THC and CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act. According to the FDA, it is illegal to sell food or other products to which CDB has been added in interstate commerce. According to the FDA, it is illegal to introduce or deliver for introduction into interstate commerce any food product including animal food or feed to which CBD has been added. The FDA is aware of some marijuana based products being marketed to treat diseases in animals. The FDA has not approved marijuana or CDB for use in animals, and the FDA cautions pet owners against the use of any such products. The FDA cautions against such use citing the fact that further study is necessary to assess the safety and effectiveness for medical use in animals. According to the FDA, they are currently collecting information about marijuana and marijuana-derived products being marketed toward animals, but the FDA advises consumers that the products have not been evaluated by the FDA for safety and effectiveness.

Marijuana and marijuana derivatives remain Schedule I drugs under the Schedule of Controlled substances. In 2016 the DEA issued a rule clarification that CBD and other extracts were covered by the general Schedule I classification for cannabis. The 9th Circuit Court of Appeals in Hemp Industries Association v. US Drug Enforcement Administration denied a petition challenging the classification.  Indiana Law allows veterinarians to apply for authorization for Schedules II through V, although it appears that veterinarians may apply for authorization for Schedule I for research purposes.  Considering that CBD currently remains a Schedule I substance, it would appear that under federal law and under Indiana CSR regulations veterinarians would not be authorized to prescribe or dispense CBD.  This clearly creates a confusing grey area considering clients can go to any number of retail locations throughout the state and purchase CBD over the counter.  Until the Indiana legislature takes further action with respect to CBD to more clearly define where and by whom CBD may be sold or until CBD is reclassified, it would appear that the prescription or distribution of CBD at a veterinary office would potentially be a DEA license and Indiana CSR license violation.  Whether a veterinarian might consider recommending that a client purchase CBD from another location for use for the animal patient falls into a different grey area. The new Indiana Code sections regulating the sale of CBD oil appear to relate only to the retail sale of the product. There does not appear to be any regulations regarding the prescription or administration of CBD oil, and thus the appropriateness of the use of CBD oil in the practice of veterinary medicine would appear to be left to the professional discretion of the licensed veterinarians. The new Indiana Code sections do not regulate for what purpose CBD oil may be sold. The new sections further do not regulate for whom the CBD oil is intended and do not specifically regulate whether CBD oil may be given to animals. Despite this, recommending these products to veterinary patients appears inadvisable considering the AVMA and FDA positions discussed above. Given that the products are not approved by the FDA for use in animals and that the use of CBD products in animals has not been studied, recommending their use to veterinary patients has the potential to expose veterinarians to civil liability. Further, considering the relative grey market that these products exist in and the lack of FDA approval of any CBD products other than Epidolex, the purity and contents of other over the counter CBD products chosen by veterinary-clients at random retailers cannot be guaranteed, and veterinary clients risk exposing their animals to unknown
contaminants.