Acceptable immunity claims differ by country

by Jeff Gelski
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Food and beverage comp-anies may want to know and feel confident about scientific research related to products they promote for immunity benefits. They also may want to be aware of what claims are accepted in specific areas.

The United States, Canada and the United Kingdom all have their own health claim definitions, said Ashley Roberts, Ph.D., senior vice-president, food and nutrition group for Intertek, which tests, inspects and certifies products. He spoke June 27 on a session about immunity at the Institute of Food Technologists’ annual meeting and food exposition in Las Vegas.

In the United States, immunity claims are accepted only in the form of structure/function claims, which actually are not considered health claims since they cannot claim an association with a disease or health-related condition, Dr. Roberts said.

“Supports the immune system” may be acceptable in the United States since it is a vague claim that does not necessarily imply an effect on disease treatment or prevention, he said. Unacceptable claims include “supports the body’s antiviral capabilities,” “supports the body to resist infection,” and “enhances disease-fighting functions of the body.”

The U.S. Federal Trade Commission once took action against Nestle Healthcare Nutrition Inc. for how it promoted a children’s drink called Boost Kid Essentials, Dr. Roberts said. The F.T.C. had problems with the claims “reduces absences from day care or school due to illness” and “reduces the duration of acute diarrhea in children up to the age of 13” and “L. reuteri protectis has been clinically shown to help strengthen the immune system when consumed daily.”

The F.T.C. generally expects companies to have two adequate and well-controlled human clinical studies on the product, or of an essentially equivalent product, conducted by different researchers independently of each other. Well-controlled human clinical studies may mean randomized, double-blind and placebo-controlled, Dr. Roberts said.

The need for two randomized, double-blind and placebo-controlled tests was called into question on May 17. As part of a ruling on an F.T.C. complaint against POM Wonderful advertisements, D. Michael Chappell, a chief administrative law judge, said double-blind, randomized, placebo-controlled
clinical trials are not required for claims for a food or food-derived product that is safe and not being offered as a substitute for medical treatment.

Be more specific in Canada

While the F.T.C. may accept the claim “supports a healthy immune system,” the claim will not work in Canada because it is too general and non-specific, Dr. Roberts said. A claim’s wording must be aligned with and reflect the “specific and measurable outcome.” For example, “reduces risk of infectious diarrhea” would make a statement more directly.

In Europe, the European Commission has approved 11 immune health claims, all related
to vitamins and minerals. According to the European Union, changes in immune markers alone cannot be used to substantiate immune health claims. The European Food Safety Authority said the evidence does not establish that stimulation of immune markers is in itself a beneficial physiological effect.

Companies should know the geography and regulatory agency where it plans to submit an immunity claim, said Donald Cox, Ph.D., vice-president, R.&D. and business development for Biothera, Eagan, Minn.
A reasonable timeline for achieving an immunity claim, including research, is more than seven years, he said. Biothera has done such research on its Wellmune WGP ingredient, a natural beta 1,3/1,6 gluco polysaccharide. The research has brought reward this year as products with Wellmune WGP appeared in more retail outlets.

In April, Wal-Mart Stores, Inc., Bentonville, Ark., began selling Praeventia cookies made with Wellmune WGP at 500 stores in 43 U.S. states. Groupe Biscuits Leclerc, based in Saint-Augustin-de-Desmaures, Que., makes Praeventia cookies, which also include polyphenols, fiber and whole grains as well as inulin to support digestive health.

In June, the Metro, Inc. food store chain began selling private label artisan bread with Wellmune WGP at stores in Quebec and Ontario. The bread belongs to the Immuno Smart category of baked foods within Metro’s Life Smart Irresistibles line of products.

Two studies on Wellmune WGP have been published this year.

In a double-blind study published on-line in the June issue of Nutrition, fourth-year medical students at Southampton University Medical School in the United Kingdom took Wellmune WGP for 90 days and reported fewer days of cold/flu symptoms than classmates who consumed placebos. Another study published on-line in the British Journal of Nutrition found Wellmune WGP may help recreational and elite athletes achieve training and performance goals by minimizing “down time” associated with immune suppression. The randomized, double-blind, placebo-controlled study involved 60 athletes.

Biothera also seeks out collaborators for scientific research. They have included the University of Houston, the University of Montana, Miami Research Center, The Mayo Clinic and U.S. National Institutes of Health.

“Publish your research,” Dr. Cox said. “The more published you are, the more credible you’re going to be.”

Health claim definitions by region

The United States, Canada and the European Union all have their own health claim definitions.

United States:
“Any claim ... that ... expressly or by implication ... characterizes the relationship of any substance to a disease or health-related condition.”

“A statement or representation that states, suggests or implies that a relation exists between a food or component of that food and health.”

European Union:
“Any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health.”

Source: Ashley Roberts, Ph.D., senior vice-president, food and nutrition group for Intertek.

Probiotics show effects on immunity

Known more for their beneficial effects on digestion, probiotic strains are being associated with immunity, too.

Last year researchers from Griffith University in Queensland, Australia, and the Australian Institute of Sport in Canberra found health benefits in probiotic strain Bifidobacterium lactis BI-04, a Danisco probiotic strain. DuPont Nutrition & Health now owns the Danisco branded ingredients.

This year in March, Chr. Hansen won a “2012 Beverage Innovation Functional Drinks Award” in London for its L. casei 431 Juice. The probiotic was developed to survive in low pH environments such as chilled fruit beverages. It contains Lactobacillus paracasei 431, a probiotic strain that has been associated with immunity benefits in scientific studies.

Immunity at I.F.T.

Product prototypes promoted for immunity benefits were on display during the Institute of Food Technologists’ annual meeting and food exposition June 25-28 in Las Vegas.

Wild Flavors, Erlanger, Ky., offered an ImmuniTea with Immunel, a branded ingredient that is a fat-free, lactose-reduced extract from colostrum whey. Compounds in colostrum whey trigger immune defense mechanisms to help eliminate bacteria and viruses.

The Wright Group, Crowley, La., offered a tropical fruit-flavored immunity drink. The premix contained a blend of immunity-enhancing vitamins as well as antioxidants in the form of a green tea extract.

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