DolCas BioTech, LLC, a leading cultivator and developer of botanical extracts, has announced its receipt of a ‘No Questions’ response letter from the U.S. Food and Drug Administration (FDA), signifying the completed safety review of its BCM-95® ingredient. BCM-95®, a registered trademark of DolCas BioTech, is comprised of a 100 percent pure extract of turmeric, packing it with powerful health benefits.
In 2016, BCM-95® was granted self-affirmed GRAS (Generally Recognized As Safe) status by an expert panel of scientists, for its use in medical foods at a dose of 500 mg, twice a day. DolCas BioTech is one of only a few organizations in the supplement industry to receive a FDA ‘No Questions’ response letter, after previously undergoing safety and quality evaluations.
“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.”
While safety and quality are of great importance, the more than 25 studies performed on the BCM-95 ingredient have provided a third tier of confidence as it relates to proving efficacy. One such study, published in the journal Scientific Reports, found that the specific combination of curcuminoids and essential oils found in BCM-95 more significantly modulated various attributes of disease activity in a murine model of colitis than did a standalone curcumin ingredient or placebo. Similar to the statement made by BCM’s successful journey through the rarely approached path of FDA GRAS evaluation, this hallmark study further emphasizes that not all curcumin ingredients are created equal.
The transparency of regulatory status and insight allows consumers to make informed and confident purchasing decisions. DolCas BioTech’s high regard for safety and efficacy is reflected within its well-researched ingredients and mission to continue providing consumers with the highest quality of ingredients possible.