Citing FDA, Maine Takes Steps to End Sales of CBD to Public

On Friday, the Portland Press Herald reported that in the last week, the Maine Department of Health and Human Services (DHHS) has begun instructing Maine businesses that only medical marijuana dispensaries will be allowed to sell foods, tinctures, and capsules that contain CBD, and only to registered patients. DHHS is also refusing to certify commercial kitchen facilities that produce CBD products.

As Penelope Overton, Portland Press Herald staff writer clarifies, the change in Maine state policy comes directly as a result of the passage of the 2018 Farm Bill, which clarifies that hemp is legal, but also that CBD products would be regulated by the Food and Drug Administration (FDA), which currently has only one approved drug that uses CBD, and no approved foods, beverages, or dietary supplements.

“The Maine Department of Health and Human Services has determined CBD is an unapproved food additive that federal authorities do not recognize as safe.”

While mostly lost in the excitement of legalizing hemp on December 20, 2018 – the same day as the passage of the Farm Bill – FDA Commissioner Scott Gottlieb, M.D. issued a detailed statement that specifically warned that the FDA could – and would – start enforcing the regulation of unapproved CBD products (e.g. all of them except GW Pharma’s Epidiolex):

“Additionally, it’s unlawful under the FD&C Act 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 both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were 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. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug.”

What this means for the national hemp industry, or Vermont’s own exploding CBD and hemp community will remain to be seen. Ironically, the the bad news blew in from the East just one day after Vermont’s lone House member, Representative Peter Welch (D-Vermont), met with Agency of Agriculture hemp program administrators, and a group of hemp farmers and CBD processors, to discuss Vermont’s fastest-growing cannabis industry.

Heady Vermont has obtained a full copy of the letter sent to Maine CBD retailers by the Maine Department of Health and Human Services (DHHS) and transcribed it below. Maine advocates are hosting a ‘Rally for CBD and Hemp Farmer Rights‘ at the Maine Statehouse in Augusta this Tuesday.

We will continue to follow this story and update with reactions and updates from the the Vermont Agency of Agriculture, Farms, and Markets and Vermont’s Congressional Delegation.

January 25, 2019

Dear Licensee,

“Cannabidiol (“CBD” or “CBD oil”) may not be used by Health inspection Program (“HIP”) licensees in food because such use violates the Maine Food Code. the Maine Food Code specifies that, “Food may not contain unapproved Food Additives or Additives that exceed amounts specified in… Since the US Food and Drug Administration (“FDA”) has not approved CBD oil as a food additive and it is not considered generally recognized as safe (GRAS), any food that includes CBD oil has an unapproved food additive. Food containing CBD is also considered adulterated under Maine law, Maine Food Code… Any prior statements the HIP may have made with regard to allowing CBD in products sold in HIP licensed establishments were incorrect under Maine law and are rescinded and replaced with this statement effective as soon as you are notified.

Currently, the only legal way to sell (or furnish for remuneration) food containing CBD in Maine is in accordance with the Maine Medical Use of Marijuana Act, 22 MRS Chapter 558-C. People who are appropriately licensed under ‘An Act to Implement a Regulatory Structure for Adult use Marijuana” might also be able to sell such products in Maine, ut that regulatory structure is not in place yet.

Please note that prohibition against using CBD in food does not apply to certain industrial hemp products (that do not contain CBD), which are GRAS. US FDA has found hulled hemp seeds, hemp seed protein, and hemp seed oil to be GRAS…

Sincerely, Lisa Silva

Program Manager

Health Inspection Program

Division of Environmental and Community Health

Maine CDC, Department of Health and Human Services