The Food and Drug Administration (FDA) is looking to award a contract to help study CBD as the agency develops regulations for products containing the non-intoxicating cannabinoid.
In a notice published on Thursday, FDA said the chosen company will provide support with “collecting samples and assessing the quantities of CBD and related cannabinoids, as well as potential associated contaminants such as toxic elements, pesticides, industrial chemicals, processing solvents and microbial contaminants, in foods and cosmetics through surveys of these commodities.”
FDA said that the results of the studies “will not only be reported to Congress, but will also be used to guide the development of future policy” and will help to “develop a better understanding of the quantities of CBD and associated cannabinoids and their distribution.”
“The goal will be to collect and analyze a statistically relevant number of samples, between 1000-3000. The reliability of the results will be supported by specified quality assurance/quality control processes within the study. The types of samples to be collected for these studies will include food and cosmetic products from across the United States, mainly including CBD-containing packaged and processed foods such as beverages, water, candy, baked goods, oils and tinctures that can be added to human or animal foods, including pills, capsules, gel caps, gummies and other forms.”
This announcement comes one month after FDA submitted a report to Congress on the state of the CBD marketplace, outlining studies the agency has performed on the contents and quality of cannabis-derived products that it has tested over the past six years.
The report, which was responsive to a mandate attached to congressional appropriations legislation last year, showed significant inconsistencies between cannabinoids concentrations that are listed on labels and what the products actually contain. At the same time, it found negligible evidence that dangerous metals and minerals are added to these products.
In the new notice on the General Services Administration’s business opportunities site, FDA laid out specific goals for the contractor it seeks to hire.
They will be charged with obtaining 1,000-3,000 samples of CBD-infused baked goods, chocolates, candy, oils, concentrates, tinctures, capsules, beverages, cosmetics and other products for both human and pet use from a variety of regions across the country.
Those preparations will be analyzed for CBD, CBDA, THC, THCA and other cannabinoid content using specified methodologies such as liquid and gas chromatography. The contractor will also be tasked with assessing toxic elements, pesticides, residual solvents and microbiological contaminants such as salmonella.
“In addition, this task order will be used to collect cosmetic samples for shipment to a third party for analysis. The purpose of these studies will be to develop a better understanding of the quantities of CBD and associated cannabinoids and their distribution. The goal will be to collect and analyze a statistically relevant number of samples. The reliability of the results will be supported by specified quality assurance/quality control processes within the study.”
Applications to become FDA’s contractor for CBD research are due by August 31.
FDA has been hard at work developing regulations for CBD since hemp and its derivatives were federally legalized under the 2018 Farm Bill.
Last month, for example, it submitted draft CBD enforcement guidance to the White House Office of Management and Budget for review.
The agency was mandated under appropriations legislation passed late last year to provide an update on its regulatory approach to CBD, and it did so in March. The update stated that “FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions.”
FDA released separate guidance last month on conducting research into cannabis for drug development purposes. That document also went through the process of being reviewed by the White House before it could be published.
The agency has continued to issue warnings to cannabis businesses in certain cases—such as instances in which companies claimed CBD could treat or cure coronavirus—and provide public notices about recalls.
Also last month, a spending bill for FDA was released that includes a provision providing “funding to develop a framework for regulating CBD products.”
Photo by Kimzy Nanney.