GRAS for probiotics seen as step toward market acceptance

by Jeff Gelski
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Probiotic ingredient suppliers hope receiving a letter from the Food and Drug Administration may add credibility in conversations with customers.

The biggest consumer product companies, such as the top 25 food companies, will not work with a probiotic ingredient unless the F.D.A. has sent a letter saying it has no objection to the Generally Recognized As Safe (GRAS) status of the ingredient, said Mike Bush, vice-president of business development for Ganeden Biotech, Cleveland.

Ganeden in August said it received such a no-objection letter for its GanedenBC30 (Bacillus coagulans GBI-30, 6086) probiotic ingredient for use in such product categories as grain-based foods, confectionery items, beverages and dairy items.

“It’s one more step toward the credibility that we need to work with the big C.P.G. companies,” Mr. Bush said.

Under the F.D.A. GRAS system, companies may have experts study whether an ingredient is safe for use in certain food and beverage categories (Ganeden Biotech did such for GanedenBC30). The company then voluntarily may submit a notice of its findings to the F.D.A., which will evaluate whether each submitted notice provides a sufficient basis for a GRAS determination. Ganeden Biotech submitted its GRAS notice to the F.D.A. in 2011 under the guidance of AIBMR Life Sciences, Inc., a nutraceutical products consulting company based in Puyallup, Wash.

GanedenBC30, a spore-forming probiotic strain, already is finding success in new product applications. In June, Tipton Mills said it would use GanedenBC30 in private label and direct-to-consumer instant chai lattes, lattes, cappuccinos and teas.

“A lot of our products are heat-sensitive,” said Tim Sheehy, chief executive officer of Tipton Mills. “This particular product, GanedenBC30, thrives in a heated environment.”

Also in June, GanedenBC30 was added to Uncle Wally’s Smart Portion Muffin Tops, which are sold in New York and New England retail outlets. In July, GanedenBC30 began appearing in the entire Frozen Naked Pizza line.

Denver-based Frozen NP, L.L.C., launched the brand in October of 2011. The pizzas are available in the western part of the United States.

More GanedenBC30 launches may be on the way.

“We should have a launch a month, at least for the foreseeable future, at least through next summer,” Mr. Bush said. “It’s across the board, from food, beverage, animal health, livestock —across the board.”

Montreal-based Micropharma, Ltd. currently is seeking an F.D.A. no-objection letter. The company in July of 2011 achieved self-affirmed GRAS for its Cardioviva brand probiotic strain (Lactobacillus reuteri NCIMB 30242). On Aug. 16, 2012, Micropharma sent a GRAS filing to the F.D.A. for the ingredient’s use in multiple food and beverage categories.

Lallemand Health Solutions in February of this year announced it had achieved self-affirmed GRAS status for its Bacillus subtilis R0179 for use in food and food supplements. The probiotic strain is resistant to high stress conditions such as heat, acid, pressure and lack of nutrients. Potential applications include baked foods such as muffins and bread and beverages such as shelf-stable juices.

Lallemand Health Solutions has not yet made a GRAS filing with the F.D.A.

Studies focus on probiotic benefits

• A clinical trial in Australia involved Howaru Protect (Lb. acidophilus and Bif. lactis), which are probiotic strains from DuPont Nutrition & Health. The Australian Institute of Sport and Griffith University conducted the study in which 263 adults received Howaru Protect or a placebo for 150 days. People who took Howaru Protect saw a significant reduction in the number of days experiencing cold-associated and flu-associated symptoms.

Howaru Protect is available for use in North America in such applications as beverages, confectionery, dairy, frozen desserts, nutritional bars, nutritional drinks and milk powder formulas, said Peggy Steele, global business director, food and beverage probiotics, for DuPont Nutrition & Health, and based in Madison, Wis.

• Recent research has shown Lallemand’s Probio’Stick (L. helveticus R052 and B. longum R175) may reduce physiological symptoms associated with chronic stress, including abdominal pain and nausea, and it also may reduce signs of anxiety and depression.

• The British Journal of Nutrition soon will publish a study on probiotic strains BB-12 (Bifidobacterium animalis ssp. lactis) and LGG (Lactobacillus rhamnosus GG) from Chr. Hansen. In the study at Framingham State University in Framingham, Mass., 198 college students took either a placebo or a powder blend containing the two probiotic strains. The median duration of upper respiratory infections was shorter by 2 days with probiotics versus placebo. More modest, the probiotics group missed 0.2 fewer school days compared to the placebo group.

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