US states take CBD legislation into own hands as FDA dithers

11 May 2020 --- Some US states are going rogue in their regulation of hemp and cannabidiol (CBD) products as the Food and Drug Administration (FDA) continues to stall on providing clarity. Texas has released proposed regulation, which would create rules around manufacturing, distribution, testing, labeling and registration. This comes at the heels of a new Virginia law, which regulates CBD as a food product.

“This is another example of states filling the CBD vacuum created by the FDA. As more and more states take matters into their own hands, we are concerned that we are going to be left with a patchwork of state laws that could confuse consumers and fail to provide all of the necessary federal safeguards, including setting a safe level of daily consumption for CBD.

We have promised to work with policymakers and across the country to make real progress on regulating the growing CBD marketplace,” says Daniel Fabricant, President and CEO of the Natural Products Association (NPA).

The proposals have been put forward by Texas’s Department of State Health Services (DSHS) via the Executive Commissioner of the Texas Health and Human Services Commission. They include creating rules related to:

• The manufacturing, processing and distribution of consumable hemp products.

• Testing of consumable hemp products by implementing testing and sample analysis.

• Retail, possession/distribution/sale of products, packaging and labeling requirements, retail, and transportation.

• Registration for retailers and enforcement.

The DSHS states that the new proposals will positively affect local economies and pose no threats to the economics of small businesses, micro-businesses, or rural communities. Additionally, the new rules will expand economic opportunity for individuals interested in the manufacture, processing, or retail sale of consumable hemp products. 

Donna Sheppard, Chief Financial Officer at DSHS, has determined that for each year of the first five years that the rules will be in effect, there will be an estimated additional cost and revenue to the state government. However, DSHS does not anticipate a cost to local governments from the implementation of the rules. Notably, the rules’ “earliest possible date of adoption” is June 7, 2020, meaning these guidelines could be rolled out quite quickly. 

Virginia has ushered in state regulation by defining hemp extract as a food.Broader moves in regulation
This news follows an April announcement that Virginia Governor Ralph Northam had signed a bill defining hemp extract as food, thus ushering in state regulation. The bill establishes the requirements for the production of an industrial hemp extract or a food containing an extract and conditions under which a manufacturer of such extract or food can be considered an approved source.

“The bill authorizes the Board of Agriculture and Consumer Services to adopt regulations establishing contaminant tolerances, labeling requirements, and batch testing requirements, and it provides that monies collected under the chapter shall be deposited in the Virginia Industrial Hemp Fund, created by the bill. The bill directs the Secretary of Agriculture and Forestry to report by November 1, 2020, a plan for the long-term sustainability of funding for the industrial hemp program,” details Virginia’s Legislative Information System (LIS). 

Meanwhile, the NPA supports legislation passed by the US House of Representatives that provides resources so the FDA can perform a Health Hazard Evaluation (HHE) and set a safe level of CBD for consumers to use each day. The process would follow the same precedent as red yeast rice, which allows a natural product to contain a level of a drug ingredient that the FDA has determined to be safe. With the exception of Epidiolex, all CBD products in the US are considered illegal by the federal government. 

The NPA states that new CBD-related developments are providing policymakers with more urgency to act. In February, the UK’s Food Standards Agency set a deadline for the CBD industry to provide more information about CBD products and their contents. It also advised vulnerable groups not to take CBD, and healthy adults to take no more than 70 mg a day. In March, industry slammed the FDA’s reopening of the public comment window on cannabis and CBD products, as it moved to “extend it indefinitely.”

Nonetheless, the CBD space has continued to take steps forward. Last month, AOAC International approved of a liquid chromatography-diode array detection (LC-DAD) method for hemp, while Kemin Industries launched CBD in Brazil. 

Edited by Katherine Durrell