Seraphina Therapeutics Hits Significant Regulatory Milestone, Earning GRAS Status for FA15™

SAN DIEGO--(BUSINESS WIRE)-- Seraphina Therapeutics, Inc., a health and wellness company dedicated to advancing global health through the discovery and development of beneficial essential fatty acids and micronutrients, today announced that it has achieved Generally Recognized as Safe (GRAS) status for its revolutionary FA15™ ingredient. FA15™ has been approved as a food ingredient that can be used daily, up to 245 mg per day. This includes consumption of FA15™ as an ingredient or fortifier in plant-based milks, plant-based meats and nutritional bars.

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With GRAS status, FA15™ can be used as a food ingredient for the first time. It can help address C15:0 deficiencies, strengthen cells, enhance mitochondrial function and nutritionally guard against age-related breakdown, now in either capsule or ingredient form. (Photo: Business Wire)

Seraphina Therapeutics was the first to discover pentadecanoic acid, also referred to as C15:0 (pronounced see-fifteen), as an active dietary saturated fat demonstrating evidence of broad health benefits across multiple studies. A growing body of global evidence supports that C15:0, a trace odd-chain saturated fatty acid found in butter and whole fat milk, is the first essential fatty acid to be discovered in 90 years, demonstrating promotion of cellular integrity and function in human cell systems and in vivo models.

In addition to its demonstrated long-term benefits that support health and wellness with aging, FA15™ naturally targets PPAR ɑ/δ receptors throughout our bodies and brains that regulate immunity, metabolism, mood, appetite, and sleep. Seraphina Therapeutics’ proprietary pure, vegan-friendly, and free fatty acid C15:0 powder, FA15™, has been made available to consumers in its pure state via a capsule supplement, sold as fatty15, but it was previously unavailable for use in other products.

“Many people have moved away from dairy-based milks and now use plant-based milks. Unfortunately, these plant-based milks are deficient in C15:0, an important fat that large population-based and ongoing clinical studies support as being beneficial to our health,” said Dr. Nicholas Schork, Professor at the Translational Genomics Research Institute, Scientific Director of the Government-funded Longevity Consortium, and Seraphina’s Senior Scientist. “Having FA15 deemed safe as a vegan-friendly food ingredient could help fortify foods, like plant-based milks, with C15:0 to help ensure that consumers can still get this essential nutrient through their diets.”

With GRAS status, FA15™ can be used as a food ingredient for the first time. It can help address C15:0 deficiencies, strengthen cells, enhance mitochondrial function and nutritionally guard against age-related breakdown, now in either capsule or ingredient form.

“GRAS approval marks a significant milestone for FA15,” said Dr. Stephanie Venn-Watson, CEO and co-founder of Seraphina Therapeutics. “Now, in addition to offering supplements directly to consumers via fatty15, companies can include this powerful ingredient as a fortifier to their products, helping far more people make up for nutritional deficiencies and take charge of their health. This is particularly exciting news for children, pregnant women and nursing mothers who may not get enough C15:0 from diet alone. For the population as a whole, in lieu of relying upon dairy products as our primary source of C15:0, FA15 offers a great way to get C15:0, minus the cows or calories.”

GRAS is an FDA (Food and Drug Administration) designation embedded in the US Code of Federal Regulations.

To learn more about C15:0, the associated studies and potential health benefits and use cases, please visit www.seraphinatherapeutics.com. To learn more about FA15™ and fatty15, please visit www.fatty15.com.

About Seraphina Therapeutics, Inc.

Seraphina Therapeutics, Inc. is a health and wellness company dedicated to advancing global health through the discovery of essential fatty acids and micronutrient therapeutics. Through rigorous breakthrough science, the company develops fatty acid supplements, food fortifiers and nutritional interventions to strengthen cells, keep mitochondria working and advance cellular homeostasis to counter age-related breakdown. With its team of industry-leading scientists, Seraphina Therapeutics challenges long held approaches to nutrition, enabling the creation of novel health products designed to support quality of life. The company is a spinout of Epitracker, Inc. and headquartered in San Diego. For more information, please visit www.seraphinatherapeutics.com and www.fatty15.com.

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