Animal Health Solutions

28 Covetrus | ph: 855.724.3461 | fx: 888.329.3861 | northamerica.covetrus.com A trifecta of regulatory requirements Think of regulatory requirements as a triangle split into three horizontal sections, e.g. a base, middle and top). Federal regulations form the base because they are a baseline set of requirements that all state and local laws are required to follow, at minimum. In the middle are state laws, which while unable to enact any laws that violate baselines set by federal law, have the power to impose more stringent (strict) regulatory requirements above what the federal government requires. Local laws sit at the top. Like state law, local laws may not enact any regulations that violate federal law. Local laws additionally may not enact any laws violating state law; therefore, any local ordinances may only be even more stringent that the laws of the state within which it exists. Federal regulations December 20, 2018 was a landmark date when the Agriculture Improvement Act of 2018 (Farm Bill) was signed into federal law. Part of the Farm Bill included legalization of hemp-derived CBD in the United States. FDA has repeatedly stated that CBD may not be used in food or dietary supplements sold across state lines. Currently, there is only one FDA- approved CBD product available on the human market which is available via a valid medical prescription. The product, Epidiolex ® , contains a purified form of CBD and is prescribed primarily for treating seizures in patients two years of age and older. State regulations To varying degrees, each state has their own way of doing things. As long as state law does not violate baseline federal regulatory requirements, federal law cannot pre-empt state laws. If a state chooses to enact regulations that are more strict than federal requirements, they have the power to do so. Below are several examples showing how widely state regulations on CBD can vary: While hemp-derived CBD is now federally legal in all 50 states, there are some states, such as Idaho, that consider the federal definition of hemp-derived CBD to still be illegal. Idaho The Farm Bill legalized hemp-derived CBD with less than .03% THC; however, Idaho requires residents to only use and/or buy CBD products containing 0% THC. This law therefore precludes the use of full-spectrum CBD products in Idaho which naturally contain small amounts of THC. If you live and/or practice in Idaho, your CBD options are going to be limited. Isolate products wherein the CBD cannabinoid is completely "isolated" out and removed from other full-spectrum cannabinoids and cannabis compounds like terpenes and flavonoids; resulting in a THC-free product. Hemp-derived CBD Hemp-derived CBD is sourced from industrial hemp plants, grown primarily for their fiber and seeds. According to federal regulations, the government classifies "hemp" as any plant of the cannabis family that contains less than 0.3% THC, and "marijuana" as any plant of the cannabis family that contains greater than 0.3% THC. Under U.S. law, hemp-derived CBD is legal. Below is a summary of regulations in the Farm Bill concerning hemp-derived CBD: • It is federally legal to purchase and consume hemp-derived CBD in all 50 states. • It is federally legal to buy hemp- derived CBD online and ship it. • Even if a CBD product meets the definition of "hemp-derived" under the Farm Bill, it still must comply with all other applicable federal laws, including the FDA FD&C Act. • It is not federally legal to distribute any CBD food, beverage, or supplement product via interstate commerce without FDA approval. • Under section 301(ll) of the FD&C Act [21 U.S.C. § 331(ll)], the FDA prohibits the introduction or delivery for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355]. FDA = more gray While the purchase and consumption of hemp-derived CBD is now legal at the federal level, anything that involves food and dietary products falls under the authority of the FDA, and the LOCAL STATE FEDERAL

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