HP Ingredients announces independent conclusion of GRAS for its bergamot extract

Bergamot trees. Photo © AdobeStock.com/Polonio Video

HP Ingredients (Bradenton, FL) has announced an independent conclusion of GRAS (generally recognized as safe) for its Bergamonte bergamot extract. The conclusion was based on an extensive body of published scientific literature, including pre-clinical and human studies, detailing the safety, as well as cardiovascular and cardiometabolic benefits of the bergamot extract.

“Obtaining self-affirmed GRAS for Bergamonte was years in the making,” said Annie Eng, CEO of HP Ingredients, in a press release. “We have been able to prove its safety and its efficacy for the claims on the ingredient, and now with self-affirmed GRAS status, our brand partners and their consumers can enjoy knowing that Bergamonte is, without a doubt, safe for consumption.”

According to Food Drug & Cosmetics Act, manufacturers can either submit a GRAS notification petition to the Food and Drug Administration (FDA) or make their own determination using an independent panel and publishing the report so that it is publicly available. “Our FDA experts found that the data on the extensive use of Bergamot in food in large populations in numerous areas fully satisfies this requirement,” Eng explained.

The report's authors conclude: “In sum, this extensive review by the company, based on outside expert analysis and experience, strongly affirms the long history of use of Bergamot in food, beverages and supplements in widespread populations; and the reasonable certainty of safety for its intended use, thus fully supporting an Independent Conclusion of GRAS Status.”