Tamarack Biotics Announces Filing of US FDA Notification for Approval of UV Pasteurization

Fresno, Calif. – January 23, 2025 – Tamarack Biotics announced the filing of a 403(h) Notification to gain US FDA approval for the company’s UV treatment as an alternative to heat for pasteurizing milk. The FDA has 120 days in which to respond to the Notification. After several false starts, Tamarack and the FDA jointly developed an approval plan that Tamarack has now completed. Extensive experimentation demonstrated that Tamarack’s UV treatment eliminates all pathogens, likely to be found in milk, far more effectively than heat.

“Tamarack’s TruActive® products utilize proprietary UV treatment and low temperature drying to retain more of raw milk’s immune active proteins and enzymes than any other product available today,” said Bob Comstock, Chief Executive Officer of Tamarack Biotics. “These immune active proteins offer health benefits to everyone, but particularly young children, sports enthusiasts, and the elderly.”

A University of California Davis-led clinical trial proved that TruActive® restored immune function in an elderly population. Raw milk proteins positively impact gut health, and the non-denatured proteins have significantly higher bioavailability. Additionally, the taste, smell, and dissolution are far superior to existing thermally pasteurized products.
Tamarack has also started a mouse-model allergy prevention clinical trial which will evaluate TruActive®’s ability to reduce asthma and food allergy development in children. Additionally, multiple European Commission funded allergy studies demonstrated that children who consume raw milk early in life suffer vastly fewer allergies. Researchers believe bioactive proteins provide this protective effect, and TruActive® retains these same proteins.

Tamarack Biotics Featured on Dairy Dialog podcast

On August 18th, Tamarack Biotics was featured on the Dairy Dialog podcast. Listen to the podcast, https://www.dairyreporter.com/News/Manufacturers/Dairy-Dialog-podcast-146-Arla-Cheer-Pack-Tamarack-Biotics

 

Immunosenescence Clinical Trial Paper Published

An immunosenescence clinical trial using TruActive MPC 85 was published this week in Frontiers in Immunology. Read “Use of UV Treated Milk Powder to Increase Vaccine Efficacy in the Elderly”.

“We are very excited that such an esteemed publication chose to publish our groundbreaking study of immune response improvement from consuming the immune active proteins contained in our TruActive MPC 85 product,” said Bob Comstock, CEO of Tamarack Biotics.  “As you likely know, immune systems weaken as we age, and TruActive strengthens immune response in the elderly.  The scientific evidence leads us to believe TruActive will keep elderly people well.”

Tamarack Biotics Announces TruActive Clinical Trial

Tamarack Biotics announces the initiation of a clinical trial to determine TruActive’s benefits in restoring immune health to patients undergoing chemotherapy. TruActive should strengthen immune function and keep people well. Additionally, it has been hypothesized that TruActive may reduce toxicity and potentially increase the efficacy of the new class of immune modulating cancer drugs.

We are very excited to participate in this exciting research.

Science, Sweeteners, & Safe Raw Milk

Consumer and health trends force some products to decline, and others to ascend. But in the face of these trends, new innovations in food science are still playing with long-accepted formulas, trying to keep markets open and expanding. Researchers and innovators in the lab working on functional ingredients and sweeteners keep finding ways to further disrupt and stretch outt established categories.

While the dairy industry has frequently touted its nutritional superiority to dairy alternatives, raw milk is an area of unrealized potential in the category. In sweeteners, sugar replacements have frequently struggled to prove themselves superior in flavor. But breakthroughs are made every day, and there’s a new set of ingredients with the potential to shape the future of beverage. Read the full article here.

TruActive MPC 85 elicits high antibody response in people over 60

[Mary Ellen Shoup, Dairy Reporter] Preliminary clinical trial results have revealed that Tamarack Biotics’ milk-based TruActive MPC 85 ingredient has more than double the antibody response compared to soy protein sample in individuals over the age of 60, the company said. Read the full article here.

New protein ingredient made of non-pasteurized milk is ‘biggest nutritional advance in the last 100 years,’ says founder

[Adi Menayang, Nutra Ingredients USA] Rich with lactoferrin and immunoglobulins, a new product on the market will bring finished product makers a protein powder that is nutritionally closest to raw milk, its maker claims. Read the full article here.

Tamarack Biotics Announces GRAS Status for TruActive MPC 85

Fresno, CA, September 20, 2017 – Tamarack Biotics LLC today announced the completion of a self-affirmed “Generally Recognized as Safe” (GRAS) review of its TruActive MPC 85 product. This approval enables Tamarack to begin sales of the world’s first milk protein concentrate that contains more immune active proteins than any other product available today.

Generally recognized as safe (GRAS) is an American Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements.

Tamarack Biotics announces results from two clinical trials

Fresno, CA – September 15, 2017 – Tamarack Biotics announced the results from two clinical trials, which tested TruActive’s ability to stimulate elderly immune systems and to reduce asthma symptoms in a mouse-model experiment. TruActive is the world’s first dairy product to gain regulatory approval for an alternative to pasteurization.

Immune systems weaken with age, and until now, there has been no known way to stimulate and strengthen them. This condition is known as Immunosenescence. In cooperation with UC Davis, Tamarack completed a double-blind, placebo-controlled Tetanus vaccine response clinical trial on 35 adults over 60 years of age. Twice a day for 4 weeks, the subjects consumed 7.5 grams of TruActive or a soy protein comparator and then were administered a Tetanus vaccine. After four more weeks of consumption, blood tests confirmed the level of antibodies produced by each subject. The subjects who consumed TruActive MPC 85 averaged a 12.7-fold Tetanus antibody increase, while the subjects who consumed the soy protein only experienced a 5.8-fold increase. A similar trial conducted by UC Davis in 2010 showed only a slightly statistically significant increase in whey protein consumption compared to the same soy protein.

Bob Comstock, Tamarack Biotics’ CEO stated “The Immunosenescence clinical trial proves that TruActive MPC 85 invigorates elderly immune systems and should help keep people well. The health benefits provided by a more than doubling in vaccine response are astounding. We, and our research partners at UC Davis, were pleasantly surprised by this result and we look forward to developing retail products with our partners. ”

Additionally, a study in Switzerland investigated TruActive’s ability to reduce asthma symptoms in a mouse model experiment. Six mice in each group were fed increasing levels of UHT milk, raw milk or TruActive MPC 85 for 6 weeks. During the final two weeks, the mice were exposed to house dust mite extract 3 times per week. Asthma symptom severity was measured by airway Eosinophil concentration and the study proved TruActive MPC 85 reduced Eosinophil concentration by 20% compared to UHT milk. Mr. Comstock clarified, “Asthma represents an enormous and growing problem globally. Multiple studies demonstrate that raw milk consumption, particularly early in life, reduces the number of people who develop allergies, including asthma. The scientific community believes immune active proteins provide this protective effect. The Swiss study highlights TruActive’s ability to deliver immune active proteins in a safe and effective product, which should not only protect children from developing allergies but also provide a therapeutic effect that reduces asthma symptoms.”

TruActive MPC 85 Recognized by Dairy Foods Magazine

Tamarack Biotics’ TruActive MPC 85 product was recently recognized by Dairy Foods Magazine as a new milk-based protein today to be used in foods and beverages in the sports, early childhood and elderly nutrition categories.

The article describes the ultraviolet technology used to produce TruActive, as well as outlining our current trials.

Read the article here.