FDA Issues No Objection Letter To Morinaga For GRAS Status Of BB536
Morinaga Milk Industry, a dairy company in Japan, has received a no objection letter from FDA in response to its GRAS notification for Bifidobacterium longum BB536, the company's proprietary probiotic strain. The official FDA affirmation that the ingredient is GRAS allows it to be included in functional foods.
Tohru Imamura, general manager of Morinaga's International Department, said: BB536 has been used by Morinaga in our own food products with great success for more than 30 years and has been sold as a raw material to clients overseas in more than 30 countries for use in food and supplements.
“We are very excited that its newly achieved GRAS status will allow U.S. manufacturers to bring the digestive benefits of BB536 to the American public.
The company has developed BB536, a human strain of beneficial bacteria, in the 1960s. According to the company, many published human clinical trials have found that BB536 provides a natural defense against episodic digestive upsets, including constipation, diarrhea, abdominal discomfort, gas and bloating. It also improves the bodily ratio of beneficial to harmful bacteria and decreases ammonia and putrefactive products in the digestive tract.
Morinaga Milk Industry has asserted that it has also bolstered the technical support for clients who are planning to use BB536 in their products. The company's technical staff is available to provide raw material handling advice, support in the development of strain-stable products and help navigate through the regulations of various countries in order to launch new products.
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