The Food and Drug Administration (FDA) is seeking out the recipient for a contract that will permit the studying of CBD products. These plans emerge in the midst of the Agency’s plans to establish a firm set of regulations for products that contain the non-psychoactive cannabinoid, of which can be derived from cannabis and hemp plants.

A public notice published by the company on Thursday, July 23, confirmed that the FDA will offer a contract that ensures the selected company provides adequate 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.”

In addition to using the study results as a method of reporting to Congress, the FDA says they will be relied on to stimulate the development of future policies surrounding CBD research. Moreover, the CBD research contract will help “develop a better understanding of the quantities of CBD and associated cannabinoids and their distribution.”

The FDA’S CBD research contract will gather thousands of samples

The primary aim of the FDA’s CBD research contract initiative is to gather and assess a “statistically relevant number of samples” that the Agency pins in the range of 1,000-3,000. A number of quality control processes and quality assurance will be implemented to ensure the results are reliable.

A range of food and cosmetic products will be collected for the studies; each sample product will be procured from the United States. According to the FDA, most CBD-enriched products will include packaged and processed foods like flavored drinks, water, candies and baked goods. In addition to this, the FDA will allow for oils and tinctures to be added to ingestible foods for humans or animals, such as pills, capsules, gel caps, gummies and other forms.”

The news emerges one month since an FDA-filed report – conjoined with congressional appropriations legislation from 2019 as a reactive mandate – was received by Congress regarding the status of the CBD market. The report honed in on studies that the agency had carried out into the quality and content of cannabis-derived products it tested over the course of the last six years.

The push for new studying of CBD products stems from the results of past studies executed by the FDA, which demonstrated inconsistencies in product labeling and the concentration of those products. Moreover, contamination in the form of harmful minerals and heavy metals was noticeable. Regulatory development has been in the works since hemp and its derivatives became federally legal following the passing of the 2018 Farm Bill. 

Various cannabinoid preparations will be analyzed under the FDA’s CBD research contract initiative 

In order to determine whether or not the CBD that circulates the U.S. marketplace really contains what it says on the label, the FDA hopes to assess preparations for their levels of active and naturally-occurring cannabinoids like CBD, CBDA, THC and THCA. How will the contract recipient accomplish this? The Agency says that specific methodologies will be utilized to glean the results, including liquid and gas chromatography. 

Aside from assessing the cannabinoid composition, the chosen contractor will need to examine the toxic elements that may be present in CBD products; e.g. pesticides, residual solvents and microbiological contaminants like 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.”

The FDA’s efforts to better regulate the CBD marketplace have blossomed from previous moves, such as the guidance that was released by the Agency last month regarding cannabis research for drug development purposes. Prior to its publishing, the document was scrutinized by the White House Office of Management and Budget. Moreover, “funding to develop a framework for regulating CBD products” was included in a spending bill for the FDA in July. 

Applicants must now submit their interest for the latest initiative before August 31. Further information pertaining to the specific goals of the FDA’s CBD research contract are listed on the General Services Administration’s site.