Dive Brief: 

• Tamarack Biotics has completed its self-affirmed Generally Recognized as Safe (GRAS) process for a patent-pending raw milk product, TruActive NF, according to a company release. 

• The ingredient is treated at low temperatures and retains about 71% of the immune active proteins found in raw milk, while pasteurized milk retains about 8% of these proteins. According to the company, its product achieves the same safety standards as traditionally pasteurized products.

• The company said it will take the ingredient into clinical trials, aiming to prove its benefits for elderly vaccine response, allergy prevention and asthma therapy.

Dive Insight:

For the past 25 years, the Food and Drug Administration has banned the sale and interstate distribution of raw milk products due to food safety concerns, although states can adopt their own laws on raw milk sales. Despite the FDA’s assertion that pasteurization does not reduce milk’s nutritional value, raw milk advocates argue that it contains more vitamins, minerals, and beneficial proteins, enzymes and bacteria.

Tamarack Biotics aims to tap the potential benefits of raw milk without the safety concerns by using a process that avoids pasteurization and spray drying. The products are never heated above 53°C, but the company claims it achieves the same safety standards of other milk products.

Demand for raw milk products may be part of a broader trend, as more consumers aim to eat foods as close to their natural form as possible. Although milk consumption has been in steady decline since the 1970s, consumers are drinking more whole milk, perhaps driven by recent findings that milk fat may be more beneficial to health than previously thought. Organic milk sales are also up.

Tamarack Biotics’ product has achieved self-affirmed GRAS status, a process involving independent expert safety checks. It requires the company to be prepared to defend the safety of its product, but is not systematically checked by the FDA, as is the case with FDA-approved GRAS status.

The company also intends to target the lucrative sports nutrition market with its new product, for improved performance and recovery. The sector grew 12% last year alone, according to Euromonitor International.