yakult usa self-affirmed gras press release

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Yakult’s Probiotic Lactobacillus casei strain Shirota is Self-affirmed as GRAS April 17, 2012 - (Torrance, CA) Yakult Honsha Co., Ltd. (President and COO; Takashige Negishi, Tokyo) announces the acquisition of self-affirmed GRAS (Generally Recognized as Safe) status for its exclusive probiotic strain, Lactobacillus casei strain Shirota in the United States. Lactobacillus casei strain Shirota was isolated by Dr. Minoru Shirota in 1930. This probiotic strain is found in Yakult’s products, such as Yakult® (cultured probiotic drink with dairy), which are sold in a growing number of U.S. stores. An independent panel of U.S. experts in toxicology, nutrition and molecular biology has rigorously evaluated research studies and toxicology data on Lactobacillus casei strain Shirota, and concluded that this strain is safe for use as a food ingredient. As a result of the panel’s analysis, Yakult Honsha obtained self-affirmed GRAS status for Lactobacillus casei strain Shirota. This strain has been safely used in Japan as a food ingredient for over 75 years, and self-affirmed GRAS status is further confirmation of its safety. Yakult Honsha will subsequently notify FDA of this GRAS status. Yakult U.S.A. Inc., a subsidiary of Tokyo-based Yakult Honsha, started selling Yakult® in the U.S. in 1999, and sales have steadily increased since then. “Yakult will accelerate our activities to penetrate our brand not only in the U.S., but also all over the world, by increasing the recognition of the safety of Lactobacillus casei strain Shirota,” commented Michio Shimizu, President and CEO of Yakult U.S.A. Inc. About Self-affirmed GRAS Food and food ingredients designated as self-affirmed GRAS are generally recognized among qualified experts as having been adequately shown to be safe under the conditions of their intended use. FDA initiated the self-affirmed GRAS notification system in 1997.

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Yakult is the world's leading probiotic beverage created in Japan in 1935. It is produced by Yakult Honsha Co., Ltd - the world's pioneer in probiotics. Today, Yakult is sold in more than 30 countries and regions around the world. Our company's portfolio includes a range of consumer, cosmetic and pharmaceutical products. Visit us at http://www.yakultusa.com.

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Page 1: Yakult USA Self-affirmed GRAS Press Release

Yakult’s Probiotic Lactobacillus casei strain Shirota

is Self-affirmed as GRAS

April 17, 2012 - (Torrance, CA) Yakult Honsha Co., Ltd. (President and COO; Takashige

Negishi, Tokyo) announces the acquisition of self-affirmed GRAS (Generally Recognized as

Safe) status for its exclusive probiotic strain, Lactobacillus casei strain Shirota in the United

States. Lactobacillus casei strain Shirota was isolated by Dr. Minoru Shirota in 1930. This

probiotic strain is found in  Yakult’s  products,  such  as  Yakult®  (cultured probiotic drink with dairy),

which are sold in a growing number of U.S. stores.

An independent panel of U.S. experts in toxicology, nutrition and molecular biology has

rigorously evaluated research studies and toxicology data on Lactobacillus casei strain Shirota,

and concluded that this strain is safe for use as a food ingredient. As a result of  the  panel’s  

analysis, Yakult Honsha obtained self-affirmed GRAS status for Lactobacillus casei strain

Shirota. This strain has been safely used in Japan as a food ingredient for over 75 years, and

self-affirmed GRAS status is further confirmation of its safety. Yakult Honsha will subsequently

notify FDA of this GRAS status.

Yakult U.S.A. Inc., a subsidiary of Tokyo-based Yakult Honsha, started selling Yakult® in the

U.S. in 1999, and sales have steadily increased since then. “Yakult  will  accelerate  our  activities  

to penetrate our brand not only in the U.S., but also all over the world, by increasing the

recognition of the safety of Lactobacillus casei strain  Shirota,”  commented Michio Shimizu,

President and CEO of Yakult U.S.A. Inc.

About Self-affirmed GRAS

Food and food ingredients designated as self-affirmed GRAS are generally recognized among

qualified experts as having been adequately shown to be safe under the conditions of their

intended use. FDA initiated the self-affirmed GRAS notification system in 1997.

Page 2: Yakult USA Self-affirmed GRAS Press Release

About Yakult Honsha Co., Ltd.

Yakult Honsha Co., Ltd. retains its commitment to improve human health worldwide and

proactively promotes its international business. Currently Yakult's network extends through Asia,

Oceania, the Americas and Europe, and our products are sold through 28 overseas operations

and consumed  in  32  countries.  Global  consumption  of  Yakult’s  dairy  products  is  approximately  

29 million every day. Yakult will continue striving to deepen the understanding of probiotics, and

support good health for all. Yakult Honsha Co., Ltd. was established in 1955 and is regarded as

the  world’s  pioneer  of  probiotics.  Yakult U.S.A. Inc., a subsidiary of Yakult Honsha Co., Ltd. is

located in Torrance, CA,  and  supports  Yakult’s  business  in  the  United  States  and  Canada. For

more information, please visit www.yakultusa.com and www.yakult.co.jp/english.

Contact:

Hideyuki Shibata, Ph.D.

[email protected]

(310) 542-7065