Kyowa Hakko USA Announces GRAS Self-Affirmation for Setria® Glutathione

Kyowa Hakko USA, a wholly owned subsidiary of Kyowa Hakko Bio Co., Ltd., has completed Generally Regarded as Safe (GRAS) self-affirmation for its Setria® Glutathione ingredient.

Setria® L-Glutathione, a well-studied form of glutathione, is a tripeptide manufactured through a unique, patented process that can help replenish the body’s reserves that may be depleted through poor diet, pharmaceutical drugs and even the natural aging process.* Setria® provides intracellular antioxidant support, benefits cellular detoxification, supports a healthy immune response and supports a healthy aging process.

Found in virtually every cell of the body, glutathione plays essential roles in protein synthesis, synthesis and repair of DNA, enzyme function, transport, and cell maturation. 

Optimal levels of glutathione have been associated with physical and mental health.* Setria® helps eliminate toxins, ingested chemicals and potential carcinogens that the body has already absorbed. It also intercepts and neutralizes toxins in the gastrointestinal tract before they are absorbed.*

Setria® Glutathione is successful sold as a key skin health ingredient around the world. A clinical study conducted at Thailand has evaluated the effect of Glutathione on skin health. It is reported that the orally taken Setria® in doses of 250mg per day may decrease melanin production, lightening skin in individuals with darker skin types1

Setria® will be marketed by Kyowa Hakko USA as a food ingredient in the United States for use at levels of 5 mg/serving to 400 mg/serving in foods and beverages, including: 

  • Baked goods
  • Cereals
  • Cheeses
  • Gum
  • Coffee
  • Tea
  • Dairy products
  • Hard candy
  • Meal replacements
  • Protein bars 

“With GRAS affirmation, Setria® becomes a powerful ingredient for food and beverage manufacturers to add to their products as a way of supporting immune health,” said Dr. Danielle Citrolo, PharmD, Scientific and Regulatory Affairs Manager for Kyowa Hakko USA. “Attaining GRAS status opens the door for more people to make Setria® the master antioxidant ingredient in their diet.”

In addition to Setria® Glutathione, Kyowa is the maker of other leading branded ingredients including Cognizin® Citicoline and Sustamine® L-Alanyl-L-Glutamine. Kyowa offers manufacturers and formulators one of the industry's most extensive lines of over 50 amino acids and related compounds, as well as nucleic acids, bio-products and fine chemicals. 

About Setria® Glutathione

Setria® Glutathione, manufactured by Kyowa Hakko Bio Co., Ltd., is a clinically studied and patented form of glutathione that, when taken orally2, has been shown to replenish the body's reserves, which may be depleted as a result of poor lifestyle choices, stress or natural aging. Called the "master antioxidant," glutathione helps protect cells in the body from the damaging effects of oxidative stress and toxins. Setria® Glutathione is manufactured through a patented fermentation process to yield high purity and high quality, is vegetarian and allergen-free. For more information about Setria® Glutathione, visit

About Kyowa Hakko USA 

Kyowa Hakko USA is the North & South American office for Kyowa Hakko Bio Co. Ltd., an international health ingredients manufacturer and world leader in the development, manufacturing, and marketing of pharmaceuticals, nutraceuticals and food products. For more information visit

1. Sinee Weschawalit, MD, Siriwan Thongthip, RN, APN, Phanupong Phutrakool, Pravit Asawanonda, MD, DSc. Glutathione and Its Anti-Aging and Anti-Melanogenic Effects. Clinical, Cosmetic and Investigational Dermatology 2017, 10:147-153 DOI  
2. Richie JP Jr, Nichenametla S, Neidig W, Calcagnotto A, Haley JS, Schell TD, Muscat JE. Randomized controlled trial of oral glutathione supplementation on body stores of glutathione. European Journal of Nutrition. May 2014: 1436-6207. doi: 10.1007/s00394-014-0706-z

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