DolCas gets ‘good day letter’ from FDA for GRAS status of BCM- 95 curcumin


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The US Food and Drug Administration has issued a ‘No Questions’ response letter to DolCas BioTech, LLC, for its BCM-95 turmeric extract.

This follows a self-affirmation of the GRAS (Generally Recognized As Safe) status by an expert panel of scientists last year for its use in medical foods at a dose of 500 mg, twice a day.

The submission to the FDA includes use in yogurt, nutritional bars and smoothies at a maximum dose of 60 mg/ serving.

“Not all curcumin products are the same or have gone through the most rigorous safety reviews. The additional level of review that led to the FDA’s recent response reflects our commitment to ensuring the safety of our products go above and beyond what is commonplace in the industry,”​ said Dr. Shavon Jackson Michel, ND, Medical & Scientific Affairs Advisor.

“The FDA’s response adds further credence to our expert panel’s confirmation of GRAS status. This is a rare accomplishment and distinguishes BCM-95 as a product our customers can trust.”

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