This blog post provides an update to our previous post, “VDACS Okays Manufacture of CBD Products Intended for Human Consumption”; please see that post for additional information regarding the manufacture of CBD products in Virginia.
Following its July 15th letter to Virginia Industrial Hemp Processors (“Processors”) notifying them of Governor Ralph Northam’s recent directive regarding the manufacture of CBD in Virginia, the VDACS Food Safety Program (the “FSP”) sent a letter to Processors on Friday, July 26th setting forth guidelines for Processors to follow when manufacturing cannabidiol (“CBD”) products intended for human consumption (the “Food Safety Letter”).
What are the requirements?
The Food Safety Letter describes several requirements that Processors must meet when manufacturing CBD products intended for human consumption (“CBD Products”). A few important requirements are summarized below.
Processors must comply with federal and state food manufacturing laws and regulations.
According to the Food Safety Letter, Processors who wish to manufacture CBD Products in Virginia must comply with Virginia laws and regulations pertaining to food manufacturing as well as federal Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (“GMP”). The federal and state requirements are largely similar, but Processors should have a good understanding of each prior to manufacturing CBD products.
The requirements also apply to Processors who wish to market their CBD Products as dietary supplements, but these Processors should note that there are specific provisions within both state and federal law that govern the manufacture of such products. Importantly, the FDA has stated in numerous warning letters that CBD Products are not dietary supplements under the Food, Drug, & Cosmetic Act (FD&C Act), and Processors should be careful to avoid implicating the FD&C Act by introducing their products into interstate commerce.
2. CBD Products cannot be marketed as supporting human health or as a treatment for a medical condition.
Similar to the FDA’s position in the warning letters mentioned above, VDACS will not allow Processors to market certain CBD Products as supporting human health or as treatment for a medical condition. This requirement can be applied to a Processor’s website, product labels, social media pages, and other marketing materials, including customer testimonials and product descriptions. Processors should closely review these materials to ensure they do not make impermissible health claims about their products.
3. Processors can source legal extracts from outside of Virginia.
The Food Safety Letter states that VDACS will deem as an approved source out of state manufacturers that manufacture hemp extracts in compliance with the food laws and regulations in their state. However, not all states require CBD manufacturers to comply with state food laws, so retailers and Processors interested in sourcing CBD Products or raw CBD extracts from vendors in another state should properly vet those potential vendors to ensure they are approved sources under the Food Safety Letter.
NOTE: Sourcing materials or products from another state could constitute “interstate commerce” under the FD&C Act. For more information on what this means, please see our previous post.
4. CBD Products must meet standards set forth by the Virginia Board of Pharmacy.
The Virginia Board of Pharmacy regulates licensed medical cannabis processors in Virginia, and as such, has developed strict limits on the presence of Microbiologicals, Mycotoxins, Heavy Metals, and Residual Solvents in medical cannabis products. The Food Safety Letter requires that hemp-derived CBD Products in Virginia adhere to those same requirements. Thus, Processors should implement testing to ensure their products comply, and individuals or businesses sourcing CBD Products from out of state should ensure the products they source meet those requirements as well.
For more information on the specific requirements contained in the Board of Pharmacy regulations, contact Nixon Law Group.
What does this mean for Processors and businesses interested in manufacturing or selling CBD?
The FSP administers the requirements contained in the Food Safety Letter, and businesses or individuals that wish to manufacture CBD Products, including dietary supplements, will need to register with VDACS as an Industrial Hemp Processor and submit an application to manufacture Industrial Hemp-Derived Extracts Intended for Human Consumption to the FSP. This requirement applies to food retail establishments that wish to add CBD to their existing products or to new products.
If and when both applications are approved, the FSP will have the authority to inspect your facility for compliance with the requirements set forth in the Food Safety Letter and all applicable laws and regulations. This inspection usually takes place within the first 60 days after an application is submitted and must be completed prior to commencing manufacturing operations.
Prior to submitting any application, individuals and businesses should review applicable laws and regulations to understand how they may apply to your proposed business. Nixon Law Group can help with this understanding and provide you with the tools you need to succeed in this newly-regulated industry. Contact us today!