FDA Registration and Hemp CBD Processing
As a pioneer in the Hemp and CBD industry, and as the first vertically integrated CBD company to gain USDA Organic certification, it was important for us to set the standard with our brand. Since CBD regulations are still a work in progress, Palmetto Harmony decided to lead by example and to set industry standards through transparency, quality control, public health, and safety. Transparency is so very important at this time as there are very many companies popping up in the space that may or may not be following Current Good Manufacturing Practices (CGMP). FDA registration of a business shows the public that it has been inspected and is following these guidelines; taking important steps in providing the safest consumer products possible.
Palmetto Harmony began the registration process shortly after the 2018 farm bill was passed as it was not possible to register prior to that due to the federal Schedule I status of all cannabis. Part of this process involved having a third-party FDA approved inspector come to inspect our farm and processing facility. The result of this inspection allowed us to continue forward and receive our official FDA registration number. Our doors are open to the FDA to inspect our hemp processing facility at any time in order to verify that we are doing all that we are able to do to provide safe products for our customers.
Virtually all cannabis (which includes CBD derived from industrial hemp) was previously considered a Schedule I controlled substance under the federal Controlled Substances Act. A federal, Schedule I status, significantly limits research and use because it specifies that the substance has no medicinal value and is overseen by the Drug Enforcement Agency (DEA). The tides turned for hemp in December of last year, with the passage of the Agriculture Improvement Act of 2018 (Farm Bill).
The Farm Bill changed how hemp is treated and defined. The Farm Bill removed significant restrictions under the CSA on the growth, production, distribution, and use of hemp and hemp products. Hemp was distinguished as separate from marijuana and clarified that it is no longer an illegal controlled substance under federal law. This has contributed to the recent explosion of interest in such products, including cannabidiol, or CBD.
The FDA and Hemp
FDA is a federal agency within the Department of Health and Human Services charged with protecting and promoting public health through oversight of a broad range of products. The Farm Bill preserved the FDA’s authorities and removed restrictions for industrial hemp, thereby making the FDA much more relevant to stakeholders.
The FDA currently states that they treat cannabis and cannabis derivatives (classified as marijuana or hemp) the same as they do any other substance. “FDA is a science-based public health agency. Our mission is both to protect and to promote public health in a science and data-driven manner.” LINK With the passage of the Farm Bill, Congress officially recognized the FDA’s important public health role with respect to all the products it regulates, including products containing cannabis or cannabis-derived compounds.
The Law Regarding Hemp Processing
U.S. FDA food facility registration is required for all companies that manufacture, process, pack, or store food, beverages, or dietary supplements that may be consumed in the United States. CBD companies who are not registered are not following the law and are putting their customers at unnecessary risk. The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). This amendment required that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit additional registration information to FDA.
When an organization receives its registration number, the FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. They will inspect at any time to ensure that the facility is following CGMP. CGMP are the FDA’s formal regulations regarding the design, monitoring, control, and maintenance of manufacturing processes and facilities. Food facilities must renew such registrations every other year, and it also provides FDA with the authority to suspend the registration of a food facility in certain circumstances. Hemp processors are subject to the same requirements as other non-cannabis plant-based consumer product companies.