Staking out probiotic claims
September 28, 2010
by Jeff Gelski
While sales of food products promoted for their probiotic content have sailed along in recent years, the validity of probiotic claims potentially may become murkier. Mary Ellen Sanders, a consultant with Dairy & Food Culture Technologies in Centennial, Colo., said she wonders if some product claims will lead the Food and Drug Administration to consider the product a drug and not a food. Also, the National Advertising Division, a self-regulating entity within the Council of Better Business Bureaus, recently recommended the probiotic claims of a tabletop sweetener be discontinued.
Sales of food and beverage products in the U.S. promoted for their probiotic content reached $1.26 billion for the 52 weeks ended June 12, 2010, which was up from $1.2 billion for the 52 weeks ended Jun 13, 2009, and up from $1.06 billion for the 52 weeks ended June 14, 2008, according to The Nielsen Co., New York. Sales covered food stores with $2 million and over annually in sales, excluding supercenter items.
The F.D.A. has no approved health claims for products with probiotics, but structure/function claims are allowed.
“Although no preapproval is required, these claims should still be substantiated and meet the F.D.A. standard of truthful and not misleading,” Dr. Sanders said. “I don’t know how many products out there do meet this standard, as few are challenged by the F.D.A. or F.T.C. (Federal Trade Commission).
“The F.D.A. has a very narrow range of acceptable endpoints for studies documenting structure/function effects. So it is not at all clear how a responsible company can go about designing studies to support a structure/function claim. For example, a structure/function claim on ‘supports a healthy immune system’ would require some studies on immune cell biomarkers, but it would also seem reasonable to substantiate that the product reduces the incidence or severity of common infectious diseases, such as colds or diarrhea. However, the F.D.A. would deem such a study a drug study and not appropriate for food. I think the industry is looking for guidance on how to address the issue.”
Dr. Sanders is the author of an article titled “How do we know when something called ‘probiotic’ is really a probiotic? A guideline for consumers and health care professionals.” The article appeared in the spring 2009 issue of Functional Food Reviews.
Peggy Steele, Danisco Health & Nutrition, global business director, Danisco USA Inc., Madison, Wis., said examples of structure/function claims for the company’s Howaru line of probiotics include: supports good digestion, supports healthy immune function, maintains levels of beneficial microbiota, supports normal bowel function and maintains regular transit.
She said she recommends food and beverage companies add a probiotic with proven health benefits, add probiotics at the dose tested in the clinical trial (or higher) throughout shelf life of the product, ensure the claim is truthful and not misleading and have clinical data to substantiate the claim.
Alleged lack of data played a role on Sept. 1 when the National Advertising Division, New York, recommended Heartland Sweeteners, L.L.C. discontinue advertising claims that say Nevella with Probiotics, a sucralose no-calorie sweetener product, offers certain health benefits. The N.A.D. requested support for the implied claim that consumers will receive health benefits, such as improved digestive health and immune system support, by using Nevella with Probiotics.
“Product performance claims should be supported by competent and reliable evidence, with the gold standard being testing on the product itself,” the N.A.D. said.
McNeil Nutritionals, L.L.C., based in Fort Washington, Pa., and the manufacturer of Splenda No-Calorie Sweetener, challenged the claims.
Nevella with Probiotics uses GanedenBC30 probiotic strains from Ganeden Biotech, Inc., Cleveland. While Ganeden Biotech has published clinical studies to back up the efficacy of GanedenBC30, the N.A.D. said Heartland Sweeteners, Carmel, Ind., had not done any product testing to determine the efficacy of Nevella with Probiotics.
“When the substantiation in the record consists solely of evidence regarding the efficacy of ingredients in a product, but not for the product itself, the advertising must not suggest or imply that the product proved the claimed benefits,” the N.A.D. said. “The claims must be clearly expressed as ingredient claims.”
Heartland Sweeteners, in its advertiser’s statement, said it disagreed with the N.A.D. finding, but “has already undertaken to revise its packaging. Heartland will also take the decision into account in reviewing its future packaging and advertising.”
In 2009 The Dannon Co. said it would create a $35 million fund to reimburse qualified consumers up to $100 for products purchased, according to settlement terms of a class-action lawsuit involving alleged misleading advertising for the company’s Activia and DanActive yogurt products.
More strains in more products
Manufacturers of such products as nuts, fruit, yogurt, chocolate and juice added probiotic strains to their products in 2010. Tropical Nut & Fruit, Inc. in July launched a partnership with Cleveland-based Ganeden Biotech, Inc. that led to the introduction of raisins covered in yogurt with GanedenBC30 probiotic strains. In August, Agostoni Chocolate launched its Chocolate Plus Private Label, a snack program that combines GanedenBC30 probiotic strains with Italian dark chocolate. Also in August, A. Lassonde Inc. in Canada launched “10 fruits with Probiotics” fruit juice that contain the probiotic strain L. rhamnosus R0011 from Montreal-based Lallemand, Inc. The dairy-free juice has a 90-day shelf life and has been shown to provide 1 billion live probiotic bacteria per 250-ml serving at the end of its shelf life.