02/19/2019
CBD and Hemp Products in Michigan: An Update
President Trump Signs Latest “Farm Bill,” Which Legalizes the Cultivation of Hemp, a Key Source of CBD, But Legal and Regulatory Questions Still Remain
By: Seth Anderson
MAC Government Relations and Insurance Manager
This article is intended to be informational only. Legal information is not the same as legal advice, which is the application of law to an individual’s specific matter, situation, or circumstances. Legal advice may be given only on the basis of specific facts relayed by a client to an attorney. The MAC goes to great lengths to make sure our information is as accurate, useful, and up-to-date as possible. We recommend, however, that you consult an attorney if you want or need professional assurance that our information, and your interpretation of it, applies to your specific legal situation.
Additionally, the Michigan Department of Licensing and Regulatory Affairs (LARA) encourages licensees to seek legal counsel to ensure compliance with applicable law, including but not limited to the Medical Marihuana Facilities Licensing Act and associated Emergency Rules.
Key Takeaways
- The final 2018 “Farm Bill” legalizes the cultivation of hemp, a key source of cannabidiol (CBD), making it a legal agricultural commodity for the first time since the 1930s.
- FDA Response: CBD is a drug ingredient and therefore illegal to add to food or health products without approval from the FDA
- Federal/state regulatory framework in process
2018 Farm Bill
On Thursday, December 20, President Donald Trump signed into law the 2018 “Farm Bill,” the primary agricultural and food policy tool of the federal government. The new law contains language championed by Senate Majority Leader Mitch McConnell of Kentucky that legalizes hemp and its by-products. This would include products containing cannabidiol (CBD), an extract of the cannabis plant that some of our members are interested in using and/or selling in their practices for its therapeutic benefits such as pain relief and anti-inflammation, provided it is derived from hemp. The Farm Bill enjoyed large majorities in both chambers of Congress, with the U.S. Senate voting 87-13 and the U.S. House of Representatives voting 369-47 in support. These overwhelming bipartisan votes come at the end of months of infighting regarding the bill.
In relevant part, the 2018 Farm Bill:
- Broadens the definition of industrial hemp to include all parts of the cannabis plant, including seeds, derivatives, extracts, cannabinoids, etc., as long as it has a THC level of 0.3 percent or less (THC is the psychoactive ingredient in marijuana that produces the feeling of being “high”)
- Allows for the commercial cultivation, research, and development of industrial hemp, and allows for interstate commerce for hemp and hemp-derived products with less than 0.3 percent THC
- Removes hemp completely from the Controlled Substances Act and defines it as an agricultural product
- Requires states that wish to have regulatory authority for hemp farming submit a plan that meets minimum requirements to the U.S. Department of Agriculture (for Michigan’s plan, see below)
Federal/State Regulatory Framework
The Farm Bill directs the U.S. Department of Agriculture to set up a regulatory framework for industrial production of hemp, for states that don’t wish to set up their own regulations. For those that do, the bill allows each state’s department of agriculture to set up its own regulatory framework, provided it meets minimum standards.
Michigan Efforts
In early October, the Michigan House of Representatives overwhelmingly passed (106-0) a package of bills (House Bills 6330, 6331 and 6380) that would allow farmers to grow hemp and lay the regulatory groundwork for doing so in Michigan. One of these bills, HB 6331, would clarify in Michigan law that CBD oil derived from hemp should not require a medical marijuana card to possess. Like the Farm Bill, the bill package limits the THC concentrate of industrial hemp crop to .3% THC content. On December 21, the last day of the Michigan Legislature’s “lame duck” session, the Michigan Senate took up and passed the bills.
Governor Snyder signed the bills into law on December 28, 2018. Stay tuned for more information.
FDA Considerations
As CBD continues to pop up in more and more ingestible products, including supplements, coffees, teas, beers, candies, and tinctures, the opinion of the U.S. Food and Drug Administration (FDA) could be as important as that of the DEA. Does the presence of CBD in a product meant for consumption violate food and drug laws?
Because the Farm Bill does nothing to affect FDA’s authority to regulate CBD or other hemp products, the answer could still be yes. Among the FDA’s many responsibilities is protecting the public health by ensuring the safety of the nation’s food supply. Under federal law, any substance intentionally added to food is considered a “food additive” and is subject to premarket review and approval by the FDA. In a number of warning letters to companies that sell CBD-infused oils and food products, as well as a Q&A on their website, the FDA lays out their position on CBD products as follows:
“FDA has concluded based on available evidence that CBD products are excluded from the dietary supplement definition… [I]f an article (such as CBD) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.”
FDA also states: “FDA has therefore concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food… to which THC or CBD has been added.”
Just hours after the passage of the Farm Bill, FDA Commissioner Scott Gottlieb, MD, issued a statement asserting the agency’s power to regulate drugs, foods, and supplements made with hemp-derived CBD. The statement breaks CBD products into two distinct categories:
- Products with “therapeutic benefit.” These products must get FDA approval “for its intended use before it may be introduced into interstate commerce.” Furthermore, “Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk…”
- Foods, drinks, or dietary supplements. The statement notes that it is unlawful to “introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.” This is because CBD is an active ingredient in an FDA-approved drug and was the subject of substantial clinical investigations before it was marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements
The statement also said that the FDA is committed to pursuing an “efficient regulatory framework for allowing product developers that meet the requirements under our authorities” to lawfully market and sell CBD products across state lines. Commissioner Gottlieb also states:
“Given the substantial public interest in this topic and the clear interest of Congress in fostering the development of appropriate hemp products, we intend to hold a public meeting in the near future for stakeholders to share their experiences and challenges with these products, including information and views related to the safety of such products… We’ll use this meeting to gather additional input relevant to the lawful pathways by which products containing cannabis or cannabis-derived compounds can be marketed, and how we can make these legal pathways more predictable and efficient. We’ll also solicit input relevant to our regulatory strategy related to existing products, while we continue to evaluate and take action against products that are being unlawfully marketed and create risks for consumers.”
To read the full statement from the FDA, go to: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628988.htm.
So, until the FDA adopts their “regulatory framework,” the agency will continue to enforce current restrictions around cannabis products. To this point, however, the above-mentioned warning letters to producers of CBD products over the past few years are the only enforcement action taken by the FDA. But their position is still a potential factor to consider prior to selling any CBD products in a chiropractic practice. This issue could be resolved if (more likely when) the CBD industry petitions the FDA to permit CBD to be marketed as a food ingredient. Stay tuned.
Conclusion
Until further clarification from the DEA, FDA, Michigan Department of Licensing and Regulatory Affairs, and other state and/or federal stakeholders, the MAC as an organization still has questions regarding the legality of our members selling CBD products in their offices, and we continue to urge caution. As soon as we have any additional updates, we will keep you informed.