A panel of experts recognized by the Food and Drug Administration (FDA) has unanimously found that white adipose tissue activator cyclophilin A peptide (trade name Pep19™), a naturally occurring decapeptide, can be safely added to food. Pep19 works as a food additive to prevent and reverse the accumulation of body fat. It works by triggering a metabolic process also triggered by cold.
 The expert panel, working under guidelines from the FDA, awarded Pep19 certification under the Generally Recognized as Safe (GRAS) program. The panel examined analyses of peptide synthesized in keeping with food and pharma regulation. Certification clears the path for its inclusion as a functional ingredient in various forms of food and beverage, such as baked goods, flavored drinks, and candy.
The determination by the expert panel was made on the basis of a comprehensive dossier that included results from a range of third-party assays. These included assays that found that the peptide is highly purified, not allergenic, and free of microbes, metals, and other contaminants. Assays showed that Pep19 has no mutagenic effects or organ toxicity. The results reviewed by the panel are consistent with pre-clinical work that showed that Pep19 has no effect on the brain, heart, pancreas, and skeletal muscle.
 “The expert panel’s finding caps years of research and development,” said a visibly pleased Chief Technology Officer Andrea Heimann, PhD, who discovered Pep19. "It means that unattached experts have agreed with our conclusions on safety. We can with greater confidence offer the food and beverage industry a very exciting new functional ingredient with which to tackle excess body fat.
The water soluble Pep19 is stable in conditions common to food preparation, such as boiling and baking. It can safely power a number of functional formulations that aim to improve body composition and metabolic health. Pep19 is in clinical trials in adults with excess body fat and is available to research and commercialization partners.
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