When Southeastern Reduction Company (SRC) contracted with Burdock Group to submit a GRAS dossier to the FDA for the company’s pecan shell fiber as a food ingredient source of dietary fiber and antioxidants, it was confident that the consultant group’s experience would lead to a successful GRAS determination for certain foods. But SRC was pleasantly surprised when that experience also helped determine the product could be used in those foods — including baked goods and baking mixes, grain products and pastas, and meal replacements to name a few — in amounts of up to 10 percent.
“The Burdock Group team advised us to conduct a tolerance and dietary toxicity study to test its levels of use in foods before entering into the GRAS work,” explains John Nizio, president of SRC. “In addition to the levels, the study also revealed a 50 percent higher NOAEL than corn bran, barley and beet fiber — both outcomes were even better than we had expected.”
And that additional information was incorporated into the GRAS dossier.
“Because of our in-depth understanding and knowledge of the food industry and working with clients ranging from global food manufacturing companies to startups, we’re able to identify trends, and one of those trends is to replace the chemical synthetic product in food with naturals,” says Dr. George Burdock. “As such, we were able to advise SRC accordingly on how to successfully present that information for their product.”
The company has been selling ground pecan shell product, also known as Lignoflex, for commercial agricultural and industrial uses for decades. But because pecan shell fiber is a very clean raw material produced entirely from ground shells of pecan nuts according to current Good Manufacturing Practice (cGMP) with no additional substances added during processing, SRC saw the opportunity to explore and expand its use as a food ingredient.
In 2006, it received a FEMA GRAS for pecan shell fiber (also called pecan shell flour) as a natural flavor complex. Two years later it received an FDA CVM letter of no-object for use in all animal applications (e.g. pet food and animal feeds). And when studies indicated that diets with pecan shells for cattle showed a dramatic decrease in abscess growth in livers, SRC had research conducted and documented on the product’s potential antioxidant capability.
Indeed, the company learned that pecan shell flour has much higher levels of antioxidants than berry products including, blueberries, cranberries and strawberries — in some cases double or triple the values.
“At that point, we were confident we had an ingredient that could benefit the food industry,” recalls Nizio.
Benefits of GRAS & Compliance
But despite it being a clean product, SRC understood that this use for pecan shell flour was something new and wanted to justify it properly with thorough analysis and testing data to help achieve GRAS determination upon first petition.
“We saw the importance of working with a consultant that had the necessary technical expertise and could demonstrate a track record of approvals. Burdock Group had that,” explains Nizio. “And the team was very knowledgeable and active in bringing forth questions that needed to be addressed throughout the process and in navigating each ‘fork in the road.’”
SRC recognized the importance of establishing a solid compliance foundation upstream instead of waiting until just prior to launching their product. Engaging a compliance team to walk alongside your research and development team early on allows for maximizing product development, in many cases even beyond what was originally thought.
“The GRAS status is opening doors for this innovative ingredient,” says Nizio.
As a result, SRC is in its first year of promoting the pecan shell flour as a healthy product that can be added to foods such as baking mixes and smoothies to increase fiber and antioxidant values.
Burdock Group is an international scientific and regulatory compliance consulting firm. To learn more about how we can assist your company with customized solutions for your compliance needs, contact us today at 407-802-1400 or visit burdockgroup.com for more information.Tags: antioxidants, FDA, fiber, food ingredients, food safety, GRAS