Sabinsa gets FDA no objection letter for GRAS status of its Curcumin C3 Complex

15-Oct-2013 - Last updated on 16-Oct-2013 at 15:16 GMT

“With the majority of the published studies on curcumin using C3 Complex, it is no wonder it’s the preferred ingredient on the market" - Muhammed Majeed, PhD, Sabinsa’s Founder

The US Food and Drug Administration has issued a letter of no objection to Sabinsa for the Generally Recognized As Safe (GRAS) status of its Curcumin C3 Complex for use in food and beverages.

Curcumin, the natural pigment that gives the spice turmeric its yellow color, has increasingly come under the scientific spotlight in recent years, with studies investigating its potential health benefits.

As a result, curcumin has been linked to a range of health benefits, including potential protection against prostate cancer, Alzheimer’s, protection against heart failure, diabetes, and arthritis.

"Just as with omega-3's, consumer acceptance flows from a robust body of science on safety and benefits making its way into the medica community, consumers who do research into nutraceuticals, and influential health writers,” said Shaheen Majeed, Markering Director, Sabinsa. “The body of science on curcumin is quite impressive, and it is beginning to get on consumer's radar."

Sabinsa’s Curcumin C3 Complex has been self-affirmed GRAS since 2009 after a comprehensive review of safety and toxicology data by an independent panel of scientists assembled by Soni & Associates, Inc. The ingredient can be used in a variety of foods and beverages ranging from baked goods to soups, snack foods, imitation dairy products and seasonings & flavors.

“The ‘no comment’ letter from FDA was the next logical step in Sabinsa’s long history pioneering curcumin’s growth,” explained Muhammed Majeed, PhD, Sabinsa’s Founder. “With the majority of the published studies on curcumin using C3 Complex, it is no wonder it’s the preferred ingredient on the market. GRAS status expands the pool of products in which it can be used.”

Since the company’s ingredient is a patented, uniquely produced ingredient, this GRAS status does not extend to competitor’s products, said Reza Kamarei, PhD, Sabinsa’s Vice President of Science & Technology.

“This letter applies to only Sabinsa’s product, the way it is manufactured and for its specifications, and others cannot copy it. If others need to claim their product is FDA affirmed GRAS, then they will need to submit GRAS notification to FDA.”

C3 Reduct

Earlier this year, the company launched its ‘next generation’ of curcuminoids offering ‘greater potency, stability and much better bioavailability’. Curcumin C3 Reduct was launched at the Engredea show in Anaheim, and is a patented and clinically safe 95% tetrahydrocurcuminoids ingredient. It is currently only used in dietary supplements.

Shaheen Majeed told us: “C3 Reduct is going well, plenty of SKU's have come out. It is not GRAS, and we don't have plans for it yet, but perhaps sometime in the near future.

“It is performing well and we anticipate more growth as our efforts on Curcumin continue to grow.”