Seraphina Therapeutics’ fatty acid powder gains GRAS status

Dive Brief:

• Seraphina Therapeutics Inc. has received generally recognized as safe status from the Food and Drug Administration for its FA15 essential fatty acid powder. FA15 can be used in quantities of up to 50 milligrams per serving as an ingredient or fortifier in products such as plant-based milks and meats and nutrition bars.
• FA15 is the pure powder, free fatty acid form of pentadecanoic acid, also known as C15. This is an odd-chain saturated fatty acid (OCFA) found in butter and whole fat milk, as well as some fish and plants. The company says it is the first essential fatty acid discovered in 90 years. Seraphina has been selling FA15 as a direct-to-consumer supplement, Fatty15.
• As people have reduced their intake of full-fat dairy, the global population has developed a deficiency in C15, according to Seraphina Therapeutics. The company correlates this with the rise of chronic diseases, including diabetes, heart disease and nonalcoholic fatty liver disease, citing medical research. Plant-based foods, which tend to be deficient in the fatty acid, are a target market for the new ingredient.

Dive Insight:

Seraphina’s discovery of C15 and its potential benefits in the human diet began with an observation about dolphins.

Company founders Stephanie Venn-Watson, a veterinary epidemiologist, and Eric Venn-Watson, a military physician, were researching a group of 100 bottlenose dolphins owned by the U.S. Navy and living in two pods in California and Florida.

“Because they get such great care, they live about 50% longer than dolphins in the wild,” CEO Stephanie Venn-Watson said in an interview. The couple discovered that the California dolphins were more likely to be afflicted by aging-associated conditions such as high cholesterol and chronic inflammation, while the Florida pod had fewer of these issues. The researchers determined that the Florida dolphins were eating fish with higher C15 levels. 

The Venn-Watsons see a similar experiment playing out among humans, but on a much wider scale. They blame this on dietary guidance by the U.S. government in the late 1970s advising people to avoid saturated fats. The advice led to a four-fold decrease in the consumption of whole-fat milk in 20 years, according to the company, and with it, a decline in the wider population’s C15 levels. Besides age-related afflictions, Seraphina connects consumers’ shift toward low-fat dairy to a rise in childhood obesity, Type 2 diabetes and cardiovascular disease in children.

Stephanie Venn-Watson co-wrote a research paper published in Nature in May 2020 that connected higher dietary intake of C15 and OCFA C17 with lower mortality. The paper pointed to a long-term study of 14,000 people spanning 14 years that found lower mortality among people with a higher dietary intake of OCFAs. The Venn-Watsons said it is not known what percentage of people are deficient in C15, but pointed to a 2018 longitudinal study showing levels of the fatty acid have decreased over 13 years in a sample population. 

Seraphina has been selling a synthesized form of C15 in its Fatty15 supplements, which it says support heart, liver and red blood cell health, as well as a healthy metabolism and immune system. It currently has a clinical trial underway. 

The company sought to use C15 as an ingredient partly to have a wider impact on global health. Seraphina is targeting foods that are naturally deficient in the fatty acid, said Eric Venn-Watson.

“If you think about omega-3s in fortified foods, we would be similar to that,” he said. He noted the clear to pure white FA15 powder has no taste or smell, giving it an advantage for product formulators over omega-3 fatty acids, which are often fish oils. 

Stephanie Venn-Watson said Seraphina has had “very exciting conversations with folks in the industry” about using FA15 as an ingredient in foods or beverages. The company cannot share specific names now under a nondisclosure agreement.

“FA15 would make a lot of sense with regard to being part of grocery staples, and as an easily added food ingredient across a lot of plant-based products to include milks and plant-based meats, there’s been some interest there as well,” she said.

Next year, Seraphina will have the ability to produce 10 tons of FA15, Eric Venn-Watson said.