The uncertain future of probiotics in the United States

by Donna Berry
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As of Dec. 14, 2012, the term “probiotic” may no longer appear on food labels in many European Union (E.U.) countries. How this will affect the future of probiotics in the United States is still uncertain, but the U.S. industry may certainly learn from the process abroad.

There were many confounding factors contributing to the current state of affairs in the E.U., said Mary Ellen Sanders, Ph.D., a principal in the consulting firm Dairy & Food Technologies, Centennial, Colo. “First, there was a lack of clear direction from the European Food Safety Authority panel regarding what research was required to get a claim approved,” she said. “Then, in E.F.S.A.’s review of the research that was submitted, the panel excluded many well-conducted studies on probiotics because the studies were on patient (not healthy) populations or disease outcomes. Such studies — although clearly demonstrating a positive role of probiotics on health — are considered not appropriate for food claims.

“Finally, the high standard of evidence required by E.U. authorities may be unrealistic for foods,” Dr. Sanders said. “However, as regulatory expectations become clearer and as assessors become more knowledgeable, I expect that specific probiotic claims are likely to be approved in the E.U. Nonetheless, until this time, even the word probiotic is restricted in most of the E.U.”

Accepting the definition

In 2001, the Food and Agriculture Organization of the United Nations/World Health Organization (F.A.O./W.H.O.) defined probiotic as a live microorganism, which when administered in adequate amounts, confers a health benefit on the host. Dr. Sanders said if you accept this definition of a probiotic, then it is internally logical that only microbes with proven health benefits should be able to be called probiotic.

“There is little doubt about the physiological effects of many probiotics, which leads one to consider if adequate quantities of certain well-tested, live genera and species — even in the absence of human studies on specific strains — should at least be allowed to be called probiotic,” she said. “More specific claims would require more convincing evidence.”

The E.U.’s Yoghurt and Live Fermented Milks Association (Y.L.F.A.) is working with E.F.S.A. to get the term probiotic back on appropriate foods. It is not that probiotics have been removed from dairy foods. They are still part of many formulations. But the only way a consumer knows this is by reading the Latin name in the ingredient legend. According to the Y.L.F.A., because probiotics’ effects are strain-specific, the term probiotic is not making a health claim, and should be allowed as a generic descriptor of products.

Dr. Sanders said use of the term probiotic as a general descriptor is a real possibility.

“There are active discussions among some stakeholders on this right now,” she said. “But if I understand correctly, the E.U. is involved in general discussions of the rules for the category of ‘general descriptors,’ and only after those are developed will they address if the term probiotic is appropriate as a general descriptor. So I don’t expect that a ruling on such use is imminent.”

Category innovation continues

Since the E.U.’s ban of the term probiotic, numerous new probiotic dairy foods have been introduced in the United States. For example, Wallaby Yogurt Co., Napa Valley, Calif., now offers Organic Lowfat Kefir. The company said kefir is a probiotic milk beverage containing a variety of live and active cultures and long has been associated with different health benefits.

Lifeway Foods Inc., Morton Grove, Ill., reformulated its Helios Kefir to now be “Greek.” The fermented probiotic milk beverage received a boost of extra protein, going from 12 grams to 16 grams per one-cup serving. Earlier this year, the company added five new products to its Lifeway line, all containing the probiotic power of its namesake kefir, according to the company.

For children, ProBugs Bites are tiny freeze-dried kefir melts that quickly dissolve in a baby’s mouth for safe and easy self-feeding. The product is packaged in shelf-stable, non-perishable pouches, and freeze drying is said to keep the probiotic cultures alive and thriving.

For more mature palates, there’s now a lowfat honey fig kefir, the 14th flavor in the Lifeway low-fat kefir collection. It comes in 32-oz multi-serving bottles. In the freezer, frozen kefir bars are low-fat indulgences in coconut, green tea raspberry, pear and vanilla flavors.

“These new products reinforce the message we’ve been sending for years: healthy snacks don’t have to be boring,” said Julie Smolyansky, president and chief executive officer of Lifeway. “The success of products like our ProBugs and frozen kefir lines proves that millions of consumers are hungry for better pick-me-up options than ice cream and candy bars, and we continue to expand our product portfolio to meet that demand.”

ProYo, Santa Barbara, Calif., introduced what it calls an “anytime frozen treat.” Crafted from a combination of creamy probiotic yogurt, protein and fruit, each ProYo Frozen Yogurt 4-oz squeeze tube contains 20 grams of milk protein, live active probiotic cultures, added fiber and only 160 calories. It comes in four varieties: banana vanilla, blueberry pomegranate, Dutch chocolate and vanilla bean.

On the food service side, Red Mango, Dallas, a frozen yogurt chain, expanded its menu this summer with 22 new probiotic smoothies in four lifestyle-centered categories. Body Balance is a line of functional yogurt smoothies formulated with beneficial boosts, such as immune system health and fat reduction.

All Fruit Harmony smoothies contain only fruit, juice and ice and come in offerings such as The Berry Medley Hibiscus and The Strawberry Sonata. The Twisted Fruits line starts with the company’s signature yogurt smoothie recipe, to which new and innovative fruit-forward flavors are added. Just Kidd’n, as the name suggests, is a line of snack-size fruit and yogurt smoothies blended just for children.

“At Red Mango, we fortify all of our frozen yogurt and yogurt-based smoothies with a special type of probiotics called Super Biotics (Bacillus coagulans GBI-30, 6086),” said Dan Kim, founder and chief concept officer. “They’re super because unlike the extremely fragile probiotics in most ordinary yogurt, Super Biotics have been clinically proven to survive the strong acids in our stomachs so that they can actually do their job keeping our digestive and immune systems healthy when we eat right and exercise, too.”

Sugar Creek Foods International Inc., Russellville, Ark., a supplier of food service frozen yogurt mix sold under the private label brand of Honey Hill Farms, recently added three probiotic strains (Lactobacillus acidophilus LAFTI L10, Bifidobacterium LAFTI B94 and Lactobacillus casei LAFTI L26) to its recipe. The probiotic strains were specially selected to provide digestive benefits and assist in strengthening the body’s immune system.

Such health claims should only be made on products when specific strains of probiotics are used and the specific strains have been clinically proven to provide the benefit being claimed. Dr. Sanders said the Federal Trade Commission is cracking down on what it considers to be unsubstantiated claims on probiotic products in the U.S. market. The good news is industry is seeking guidance on how to conduct the needed human research to substantiate the benefits of their foods and supplements, and at the same time not have the Food and Drug Administration interpret their products as drugs.

The distinction between food/supplement and drug is critical and was a topic of discussion on June 12 when scientists gathered in New York City at the “Probiotics, prebiotics and the host microbiome: The science of translation” conference, which was sponsored by the Sackler Institute of Nutrition Sciences, the New York Academy of Sciences and the International Scientific Association for Probiotics and Prebiotics. One of the speakers, Fred Degnan, an attorney with King & Spalding, Washington, said that as a general rule, the degree of F.D.A. regulation of a clinical trial depends on the purpose for which a given probiotic is being investigated. Well-designed studies should incorporate desired food endpoints and avoid non-food disease related endpoints.

“Consumers, scientists, industry and regulatory bodies benefit when well-designed research on probiotics proceeds,” Dr. Sanders said.

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