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Want to Study Thousands of CBD Products? The FDA is Hiring

Aug 20, 2020

Want to Study Thousands of CBD Products? The FDA is Hiring

The US Food and Drug Administration (FDA) is looking to hire a contractor to study thousands of CBD product samples to help the administration develop regulations for products containing the compound.

In the newly listed contract opportunity, the FDA says that it is seeking a contractor who can “provide support to the FDA by 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” present in a range of CBD-infused foods and cosmetics products.


Driving future policy change

As an attachment to the listing explains, there has already been a similar smaller sampling study carried out by the Center for Food Safety and Applied Nutrition that looked at around 200 samples of CBD products currently available on the market. The contract opportunity currently being offered would be a longer-term study with a much larger sample base of between 1000-3000 samples from across the US.

The results of this longer-term analysis of the CBD marketplace “will not only be reported to Congress,” the listing reads, but will also “guide the development of future policy.”

“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. The analytical methodology for this contract will be defined by the FDA and will include methods based on widely available and recognized methodology.”

The contractor will be expected to analyze each sample to determine their CBD, CBDA, THC, THCA, and other cannabinoid content, using liquid and gas chromatography techniques. They will also be required to detect any contamination or harmful elements in the sample, such as heavy metals, pesticides, residual solvents, and microbiological risks such as salmonella contamination.

Applications for this contracting role with the FDA are due by August 31, 10:00 am EDT.


The state of the American CBD marketplace

This search for a contractor comes one month after the FDA wrote a letter to Congress outlining the concerning frequency with which commercially available CBD products are being mislabeled and sold to consumers.

FDA testing of 102 labeled CBD products found that only 46 products were within 20 percent of the CBD levels advertised on the label. Shockingly, 18 products contained less than 80 percent of the expected CBD content, while a further 38 products had more than 120 percent of the advertised amount of CBD. Approximately half of the total 147 products studied in this FDA testing round were also found to contain amounts of THC or THCA above the limit of quantification.

The FDA has continued to issue warning letters to businesses selling mislabeled or misleading cannabis products in recent months. CBD product recalls have been made following the discovery of mislabeled products and product formulations that were marketed without FDA approval, and some businesses have been subject to enforcement actions after making unsubstantiated claims about the ability of CBD products to cure or prevent coronavirus.

While the agency says it has seen only limited data on CBD safety which “point to real risks that need to be considered before taking CBD”, the FDA also recognizes that there is significant interest in CBD and other cannabis-derived products and so has committed to building a new regulatory pathway for these products that will better protect public health.

Progress on this front is ongoing, with the FDA presenting draft enforcement guidance for the CBD industry to the White House Office of Management and Budget (OMB) earlier this summer. Although, the contents of this document, titled “Cannabidiol Enforcement Policy; Draft Guidance for Industry,” have yet to be made public and the document is currently still pending regulatory review.

 

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