The new definition is part of a law passed by the state to set up a fund to promote industrial hemp production within Virginia. In the definitions section of that law there are these statements:
- "Industrial hemp extract" means an extract (i) of a Cannabis sativa plant that has a concentration of tetrahydrocannabinol that is no greater than that allowed for hemp by federal law and (ii) that is intended for human consumption.
- An industrial hemp extract is a food and is subject to the requirements of this chapter and regulations adopted pursuant to this chapter.
Virginia law seen as a first
There are a number of states in which medical marijuana products have been approved, and a smaller number in which full recreational cannabis use is allowed. The market for hemp/CBD extracts is thriving in these locations, and CBD products marketed as dietary supplements, while technically illegal on the federal level, seem to be available throughout the country, either online or in brick and mortar outlets.
But Virginia is, according to the Natural Products Association, the first state to have gone so far to approve hemp extracts as foods. That’s a double-edged sword in NPA’s view. It legitimizes the thousands of products for sale in the state while at the same time setting the stage for a potential blizzard of such laws in other jurisdictions.
“While we commend the State of Virginia for taking the initiative to regulate products, we are concerned that a patchwork of state laws could confuse consumers and fail to provide all of the necessary federal safeguards, including setting a safe level of daily consumption for CBD. Unfortunately, this is another example of the states filling a vacuum created by the federal government’s inaction. We have promised to work with policymakers in Virginia and across the country to make real progress on regulating the growing CBD marketplace,” said Daniel Fabricant, PhD, president and CEO of NPA.
On March 8, 2020 the US Food and Drug Administration reopened its docket seeking more safety and manufacturing information as it wrestles with the question of the best way to craft a legal pathway to market for CBD products. The new docket procedures reportedly include a mechanism by which companies can submit information to the agency while at the same time protecting trade secrets.
It is to be hoped that FDA will get more of the information it seeks with this protection in place. The agency went on the record saying it was disappointed in the response to its call for information after the meeting it convened on the subject on May 31, 2019. Nevertheless, many industry observers have been disappointed with the pace of federal regulatory action on the issue. The combined effect of the coronavirus crisis and a presidential election in fall means a final resolution on the issue will probably have to wait until 2022.
Moving the federal needle
Steve Hoffman is a principal in the firm Compass Natural Marketing. He has worked on getting state hemp laws passed via ballot initiatives and is allied with the NoCo Hemp Expo trade show in Colorado. Hoffman said he hopes Virginia’s action can help move the federal process along faster than it has.
“While the new law presumably will apply only to products meant to be produced and consumed within Virginia, it is landmark legislation. The use of hemp-derived cannabidiol extract (CBD) in foods and beverages is still technically prohibited in interstate commerce, because the FDA has so far refused to recognize CBD as a safe food ingredient. Hopefully, this will move the needle. Humans have been consuming hemp and hemp-derived products since paleolithic times. Especially in these stressful times when it’s important to boost immunity and nutrition, there are great benefits we can derive from hemp as a superfood, and as a functional botanical ingredient,” Hoffman said.
Jane Wilson, director of program development for the American Herbal Products Association, also voiced concern about the patchwork quilt issue. AHPA convened an internal cannabis committee a number of years ago to work on questions surrounding these ingredients.
“This new law defining hemp extracts as food provides much needed clarity to the Virginia hemp industry, especially during the current period of economic uncertainty. At the same time, it highlights the inefficiency and inconsistency of a state by state approach, which is filling the void of federal inaction. AHPA continues to advocate for FDA to define a rational regulatory pathway for these products that will provide a 50 state solution,” she said.
Marc Ullman, an attorney of counsel with the firm Rivkin Radler, said the Virginia law might be a laudable effort, but seems a bit weak in its definitions
“Is a CBD extract or isolate the same thing as a ‘hemp extract?’ There is also no discussion of extraction methods or anything like that,” he said.
Agricultural flexibility
One thing that Ullman did find interesting was a note further down in the bill’s text that says that farmers will be deemed to be growing a compliant crop if the THC level is below 1% by dry weight. Finished extracts still need to come in at the 0.3% THC level or below. As agricultural experience with the plant grows many farmers are starting to observe that it can be very difficult to ensure that a crop, even with the right genetics, will always be below the 0.3% level enshrined in federal law. THC is one of the chemicals expressed by the plant in response to stress, so an inopportune heat wave, to use one example, could ruin a whole season’s worth of work, they say.
“It can be very difficult to make sure that at no point in the growing or extraction process that you go over this level. We have seen stories of inspections by various state authorities where they will test products and cite companies when they are in the middle of their manufacturing process and whole lots of material have had to be destroyed,” Ullman said.
