On November 12, 2019, the Maine Center for Disease Control and Prevention (“CDC”) issued a notice to licensed food establishments regarding the sale of CBD-infused products. The guidance explains how to properly package and label ingestible CBD products in order to avoid issues with upcoming state inspections. Importantly, the name and address of the source of hemp from which the CBD was derived must be stated clearly on the product label. If the source CBD is imported, it must come from a state that has a 2014 Farm Bill-compliant pilot program.
The Maine agency also clarified that while CBD extract can be shipped to Maine from out of state under certain circumstances, any CBD-infused food or beverage must be produced in Maine in order to be sold in state. Put another way, ingestible products (food and/or food additives) may not be imported from out of state if they already contain CBD. That means a retail store cannot sell a CBD-infused soda manufactured by a company in California. Inspections will begin as early as January 1, 2020, and products that do not meet CDC’s standards will need to be removed from shelves. Businesses that do not comply will face fines, penalties, and potentially court-ordered sanctions.
While some may balk at the details of this new policy, it is intended to protect Maine businesses and does nothing to change existing state or federal laws. It is still federally illegal to market or sell CBD-infused food and drinks unless the U.S. Food and Drug Administration (“FDA”) approves the specific product as a drug. This is a costly process that can take years.
Maine amended its food laws in 2019 to allow hemp-derived CBD products to be sold in state, but this did not change the fact that once that product crosses state lines, the FDA has authority to take enforcement action against the businesses involved. This can include fines and even criminal penalties under certain circumstances. FDA is working on a way to effectively regulate CBD products, but it is unclear when we might see any meaningful changes to federal policy. In the interim period, states like Maine, Massachusetts, and many others are adopting laws and regulations that are intended to keep local businesses in compliance with federal law.
The Evolving Landscape of Hemp and CBD Regulation
As of 2018, hemp is no longer a controlled substance. While hemp and marijuana are different names for the same plant (cannabis sativa L.), the federal government classifies marijuana as a Schedule I controlled substance. The term “marijuana” now refers to any cannabis plant containing more than 0.3% THC by dry weight.
Cannabidiol (“CBD”) can be extracted from hemp plants and added to food, beverages, hand creams, and many other topical products. CBD can also be extracted from marijuana for the same purposes. Only CBD that is extracted from compliant hemp crops and that contains less than 0.3% THC is federally legal.
The legal framework for hemp and CBD continues to evolve. On October 31, 2019, the U.S. Department of Agriculture (“USDA”) officially launched the U.S. Domestic Hemp Production Program, implementing the hemp provisions of the 2018 Farm Bill. However, the 2014 Farm Bill provisions also remain in effect for the next year in order to cover hemp that was cultivated in 2019. Licenses under the newly established hemp program will be available in time for the 2020 growing season.
The new rule addresses issues such as ensuring that hemp crops are properly tested for compliance with the 0.3% THC limit and ensuring that proper licensing and reporting takes place. The rule focuses exclusively on hemp cultivation, and does not address extraction or manufacturing of hemp-derived products.
The FDA is still actively grappling with how it will regulate ingestible CBD products.
If you have questions about how to ensure your CBD products comply with all applicable state and federal laws, please contact a member of our Regulatory Compliance group.