FDA has no objections to GRAS status of Spanish firm’s hesperidin

By Adi Menayang contact

- Last updated on GMT

Getty Images / ASIFE
Getty Images / ASIFE

Related tags: hesperidin, Orange, Cardiovascular disease, Gras, Gras status

Spanish firm Interquim SA, part of the pharmaceutical company Ferrer, announced that the FDA has no objections to the company’s Generally Recognized as Safe (GRAS) claim for its standardized orange extract.

The ingredient is standardized to preserve the isomeric structure of the flavonoid hesperidin as found in oranges, an isomeric form known as 2S.

Ferrer HealthTeach​ markets the ingredient under the brand name Cardiose. “[It] provides the same Hesperidin isomer that may be found in fresh orange or in a hand-squeezed orange juice,” ​according to a statement issued by the company.

The GRAS notice, which is still marked as ‘pending’ on FDA’s website​ (last updated Feb. 26, 2019), explains that the ingredient is for use in: “flavored milk and imitation milk drinks, dry powdered milk mixtures (not reconstituted), yogurt, coconut beverages, cookies, cereal, cereal/granola/nutrition bars, fruit/fruit flavored and vegetable juices/drinks, table fats and vegetable oils, candies (chocolate and dietetic candy), tea, carbonated soft drinks, fortified water, nutrition drinks, nutrition powders, energy drinks, and sports drinks at a level of 500 mg per serving.”

In the EU, hesperidin has already been included in the non-novel food catalogue as a dietary supplement.

The ingredient launched in the US in the form of a dietary supplement last year. “It is performing well and more growth is anticipated after the recent publication of the no objection letter,”​ according to the company.

The ingredient has been studied for its gut microbiome modulation benefits in rats​, as well as its potential cardiovascular health benefits​.

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