Breakthrough protein ingredient considered GRAS

Breakthrough protein ingredient considered GRAS

Tamarack Biotics, an emerging leader in specialty protein ingredients, announced it has received “Generally Recognized as Safe” (GRAS) approval for TruActive™ NF, the company’s breakthrough milk-based protein ingredient. The GRAS approval gives Tamarack Biotics the right to sell its milk-based protein ingredients to sports nutrition, elderly and early childhood nutrition producers. Tamarack Biotics is currently conducting or planning three clinical trials to demonstrate the nutritional benefits for elderly vaccine response, therapeutic effects on asthma and for reducing childhood allergy development.

While raw milk is rich in immune active proteins, there is a safety challenge when trying to provide its benefits to the public. The traditional method of pasteurizing milk through heating destroys most of the immune active proteins that scientists believe responsible for preventing asthma, eczema or food allergies in children, stimulating immune systems in the elderly and aiding muscle synthesis and recovery following exercise. Consuming raw milk, which contains a very diverse range of immune active proteins, invites significant risks from foodborne illnesses like Salmonella, E. Coli and Listeria. Tamarack believes it is the first company worldwide to gain approval for an alternative to pasteurization of milk.

Ultraviolet (UV) technology has been used in the water industry for years to effectively and rapidly disinfect water without the use of heat or chemical additives. The challenge has been how to apply a UV purification process to an opaque liquid like milk. Tamarack Biotics has solved this problem using SurePure’s patented Turbulator™ technology for which it has the sole rights for its use with milk. Using this breakthrough process, milk is spun into turbulence around a UV lamp, enabling pathogen reduction to the same safety levels as thermal pasteurization — without destroying the unique immune active proteins.

Tamarack Biotics just cleared a significant regulatory hurdle, receiving GRAS approval, which is the FDA designation that a chemical or substance added to food is considered safe and legal to sell to U.S. consumers. The company has already reached agreements with several leading nutrition companies, who will shortly launch products that contain TruActive.

“The GRAS approval for TruActive™ is an important milestone for Tamarack Biotics, the protein ingredient market and most importantly, people’s health,” said Bob Comstock, Tamarack Biotics’ founder and CEO. “Our patent-pending process enables TruActive™ products to retain more of the natural compounds found in raw milk than was previously possible, and research has clearly demonstrated that these compounds provide valuable benefits for sports and human nutrition.”

Tamarack Biotics is also in the middle of two clinical trials to demonstrate TruActive’s nutritional benefits. The trials include:

  • Elderly Vaccine Response. Elderly people’s immune systems become less active and able to respond to a vaccine or illness. This double-blind study of 50 patients, conducted with the University of California, Davis, is investigating TruActive’s effect on Pertussis vaccine response. The trial, which began in August 2016, is expected to be completed in mid-2017.
  • Mouse-Model Therapeutic Effect on Asthma. This study, which started in January 2017, is being conducted in Switzerland to determine if a therapeutic effect is observed on asthmatic mice who consume TruActive.

In addition to these two studies, an extensive study of TruActive’s ability to reduce allergy development in children is planned by researchers in early 2018 at the University Hospital Munich. This 3,000 post-weaning infant study will investigate asthma, atopic dermatitis and food allergy development along with respiratory infections over a five-year period after three years of TruActive consumption.

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