Burdock Group’s Work With BioTech Startup Captozyme Results in Successful GRAS Determination o

After working with the Burdock Group to recently obtain a successful self-contained GRAS (Generally Recognized As Safe) determination for its oxalate-reducing enzyme, biotechnology company Captozyme licensed the rights for commercialization to Entring LLC, which will make it available for purchase this fall as a food ingredient. Consumers seeking a low-oxalate diet can add the virtually tasteless, odorless powder to a variety of oxalate-packed foods and beverages to help reduce the presence of the anti-nutrient.

Although the naturally occurring chemical oxalate serves important growth and regulatory functions in plants, it becomes an anti-nutrient in humans when ingested through foods packed with oxalate (e.g. greens, nuts, beans and grains), ending up as a waste product disposed of through the kidneys and urinary tract. When there’s too much oxalate in the body, it can bind with essential nutrients, such as calcium for example, to form crystals and prevent the calcium from being absorbed into the body. If this binding occurs in the body after calcium absorption, it may form a crystal that is very difficult to excrete via the kidneys. The presence of an oxalate-reducing enzyme in food allows for increased free calcium by breaking the oxalate down into its harmless constituent parts, carbon dioxide and formate.

The enzyme, developed by Captozyme, is the result of nearly a decade of intensive research and development, with funding support from the National Institute of Health. Getting such a product to market recognized as a safe (GRAS) food ingredient is not an easy task — nor should it be. And why Captozyme, founded by two scientists, understood the significance of obtaining a self-contained GRAS determination before making the enzyme available to consumers as a food ingredient.

“It’s very important to scrutinize compounds that may end up in consumer products and to do that type of evaluation requires a lot of knowledge and experience,“ says Captozyme CEO Helena Cowley.

Cowley goes on to explain that when the Gainesville-based company began its search for a consultant to assist them in obtaining the self-contained GRAS determination, it did not take them very long before contracting with Orlando-based Burdock Group.

“While researching peer-reviewed literature for similar products that related to industry, Dr. George Burdock’s name came up repeatedly,” recalls Cowley. “Then, when we realized that so many other things aligned with what we were seeking in a consultant, such as proximity and the Burdock Group’s experience with other vendors we were using, it was an easy decision.”

“As scientists, it was clearly important to the company that they could contribute to the scientific work necessary to meet regulatory requirements,” says Burdock Group Project Leader Carrie Kennedy. “Knowing this, we were able to customize the architecture of the project so that they could participate and stay informed from beginning to end.”

Each of Burdock Group’s experts in toxicology, nutrition, food science, project management and regulatory affairs plays a crucial role when working with companies to obtain a substantive, successful GRAS determination.

A SUCCESSFUL GRAS DOSSIER

“Any successful GRAS dossier to an Expert Panel or submission to FDA is more than a collation of documents and a narrative describing why the petitioner would like a favorable response; it also includes a rationale on why the ingredient is safe for the intended use and use level,” explains Dr. Burdock.

In addition, although Captozyme contracted with Burdock Group prior to FDA announcing its new final rule for the GRAS process, the consulting group’s constant interaction with FDA and regular involvement in the peer review journal process allowed them to anticipate that FDA would eventually require publication of the entire GRAS dossier, including manufacturing and consumption data. As such, they were able to advise Captozyme on how to best proceed so it could be ahead of the game and able to meet the new documentation requirements.

“We felt these new requirements were justified and decided to take the extra time to address the change so we could submit a GRAS dossier that would ensure compliance,” says Cowley.

And further indicate to FDA the company’s confidence in its product’s safety and efficacy. The proof is in the GRAS. Captozyme is on track not only to make its product available for purchase online and at independent food and health stores in Florida, but also has plans in place to grow its in-store availability to consumers throughout the southeast and nationally, and to sell it to food and beverage manufacturers to use to reduce oxalate during processing.

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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.

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