The fledgling probiotics industry has created not only market opportunity but also reason for caution for food and beverage formulators. Advertising a product’s probiotic benefits and staying within regulatory boundaries may prove complicated. Even a company known for its probiotic products, the Dannon Co., White Plains, N.Y., finds itself defending its probiotic claims in a lawsuit (see story on Page 58).
"It should be made clear that claims must be supported by data, verifiable by a third party and approved by qualified council," said Mike Bush, vice-president of business development for Ganeden Biotech, Inc., Mayfield Heights, Ohio. "As an industry that is growing quickly and under a great deal of scrutiny, the high road is always the best road to take."
Taking the path of probiotic inclusion may lead to profits.
"Price premiums vary widely, but we are seeing price premiums ranging from 20% to 400% in functional foods and beverages in general," Mr. Bush said.
James Kopp, vice-president for Lallemand Nutritional Food Ingredients, Montreal, said he has seen price premiums range from 25% to over 55% for products promoted for their probiotic content.
Mr. Kopp said most probiotic claims are either content claims or structure/function claims. Saying a product contains a certain amount of probiotic strains is an example of a content claim. "Supports a healthy immune system" and "supports a healthy digestive system" are two examples of structure/function claims.
"The highest claim available is a health claim that needs clinical data, which is really not for the average food producer," Mr. Kopp said.
Dr. Mary Ellen Sanders, executive director of the International Scientific Association for Probiotics and Prebiotics, said she would like to see more third-party certification for probiotic claims.
"Some want to whitewash this issue by proposing very generic approaches to the issue," she said of claims. "Unfortunately, the microbiology and physiology of probiotics can be so different that one method is not going to be adequate."
The United States Pharmacopeia, Rockville, Md., has the means and the experience to conduct third-party assessments, Dr. Sanders said, but that organization mostly deals with pharmaceuticals and dietary supplements instead of food.
"I think the best option right now for food products would be to engage some type of laboratory to evaluate their products and make public the results," she said. "One complicating factor for this whole effort is that a standard method for enumerating probiotics does not exist. This is because there are many different types of product formats and bacteria, and product specific issues are many."
For example, how would a company test multi-strain products? Also, laboratory tests may prove products meet their content label claims, such as having a certain amount of probiotics per serving, but that does not provide evidence of efficacy, she said.
"As more and more information about probiotics is being published," Mr. Bush said, "it is important for the food manufacturer to be accurate in their claims about probiotic survivability.
"In order for probiotics to be beneficial to consumers, the bacteria have to survive the manufacturing process, shelf life in stores and the acid in the stomach so they can colonize in the intestines. They should also be careful to identify the actual strain in the product rather than simply ‘probiotic’ as some are doing."
Ganeden Biotech uses several third-party laboratories to test inclusion rates in its clients’ products, Mr. Bush said. The company in all cases recommends its clients work on the advice of qualified Food and Drug Administration and Federal Trade Commission counsel.
Lallemand reviews information for its clients and explains what is available in the rules or scientific community, Mr. Kopp said.
"We assist but leave the claim decision with the customer," he said.
Several probiotic suppliers have scientific data to back up the beneficial effects of their strains.
Several clinical trials have demonstrated the beneficial effect of Rosell-52 (Lactobacillus acidophilus) together with Rosell-11 (Lactobacillus rhamnosus) in cases of lactose intolerance, diarrhea, constipation and meteorism, according to Montreal-based Institut Rosell, Inc., the human nutrition and health division of Lallemand, Inc.
Ganeden Biotech offers GanedenBC 30 (Bacillus Coagulans GBI-30, 6086), which the company says is a clinically-proven safe and effective healthy strain of
probiotic bacteria that has proven efficacious in numerous digestive disorders and stimulation of the immune system.
DSM Nutritional Products, Basel, Switzerland, claims scientific evidence has demonstrated the beneficial health effects of its Lafti line of probiotics in different areas of immunity, healthy digestion and vitality level. Numerous studies have proven regular consumption of Howaru probiotics, a line from Danisco, will enhance the immune system and reduce digestive disorders. Danisco offers such probiotics as Howaru Bifido (Bifodobacterium lactis HN0019), Howaru Dophilus (Lactobacillus acidophilus NCFM) and Howaru Rhamnosus (Lactobacillus rhamnosus HN001).
The credibility of probiotic claims for food and beverage products was an issue in 2005 at an American Academy for Microbiology colloquium in Baltimore. The event attracted people with knowledge in such areas as microbiology, medicine, periodontics, animal science, immunology and nutrition.
Discussion at the event led the American Academy for Microbiology to publish a 2006 report entitled "Probiotic Microbes: The Scientific Basis." It concluded much work was needed in the verification of probiotic claims in foods and beverages: "At present, the quality of probiotics available to consumers in food products around the world is unreliable, though some manufacturers have been better able to deliver high quality than others. Probiotic products that make false claims or fail to deliver promised doses of active organisms harm the reputation of valid probiotic research and stymie future work.
"Testing to ensure the identity of the organisms within probiotic products, the potency of those organisms and the purity of those products needs to be put in place."
This article can also be found in the digital edition of Food Business News, March 4, 2008, starting on Page 53. Click