Quality Control Critical to FDA Approval of CBD Products

CBD in the Spotlight

Cannabidiol (CBD) holds significant promise as a new functional ingredient. But in order to win FDA approval, the industry needs to prove its safety. While this includes developing a strong body of clinical and analytical research—which is in progress, with several examples cited in the August issue of Cannabis Products—developers of CBD-infused foods and beverages also need to perform their due diligence through quality assurance and control (QA/QC).

Based on recent FDA analysis, this is an area of concern.

In December 2019, the Further Consolidated Appropriations Act of 2020 directed FDA to conduct a sampling study of the current CBD marketplace, including foods and beverages, to determine the extent to which products are mislabeled or adulterated. On July 8, FDA submitted its report.

During 2019, FDA tested 31 products for cannabinoids. Of those, 21 products specified an amount of CBD in the product. However, only seven of them contained a CBD level within 20 percent of the amount indicated on the label. Also, of the 10 products that did not indicate the amount of CBD included in the product, six contained CBD and four did not contain any CBD. In addition, nearly half—15 of the 31 products—contained tetrahydrocannabinol (THC) above the limit of quantitation (LOQ). FDA did not specify whether the measured levels of THC were above, at, or below the 0.3 percent THC level permitted in hemp.

FDA then ran another series of tests this year on 147 products. Of those, 138 products contained CBD. Of the 102 products that indicated a specific amount of CBD on the label, only 46 of them contained CBD levels within 20 percent of the amount indicated on the label. About half of the products again contained THC or THCA levels above the LOQ.

FDA will continue testing CBD products on an ongoing basis to evaluate marketplace mislabeling and/or adulteration issues.

The cannabis industry clearly needs to get a better handle on QA/QC for stated cannabinoid levels in products—not just to avoid incurring FDA’s wrath, but to win public trust and long-term customer approval. This will require better strategies for dosage control, including use of verified process controls for homogenous distribution of cannabinoids across the product matrix.

CBD and other cannabinoids collectively form the most-promising new category of beneficial ingredients we have seen in the food and beverage industry in years. But we have to ensure that we are delivering what the label claims in order to earn consumer confidence.

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Douglas J. Peckenpaugh is Group Editorial Director of Snack, Bakery, Cannabis, Meat, Candy and Food Safety for BNP Media. He has over two decades of publishing experience following the food industry from farm to fork, covering agriculture, ingredient processing, CPG and foodservice R&D, retail and restaurant menu trends, and retail grocery branding. He is a member of the Research Chefs Association and the International Foodservice Editorial Council. Doug studied Professional and Creative Writing at Purdue University.