What exactly constitutes a health claim on a food label? It’s a contentious topic that can be a source of problems and expenses for the unwitting producer.
“We want to communicate accurately and effectively to consumers in a way that’s truthful and not misleading. There needs to be a body of evidence that supports health claims,” said Josephine Wee, PhD, an assistant professor of food science at Penn State (and member of TFA’s Science Advisors). “The bottom line: health claims are complicated.”
Wee unpacked what is and isn’t a health claim during the FERMENTATION 2021 conference. Similar topics into the regulation of fermented foods will be addressed at TFA’s August conference, FERMENTATION 2022.
Wee questioned: does the fermentation community require health claims on certain fermented foods? Today, terms like gut health, probiotics and improved immunity dominate the language of fermented foods. But words and definitions matter, Wee stressed.
Defining Health Claims
When putting health claims on a food label, website or marketing material, information must be truthful and transparent. Remember:
– The FDA has approved only 12 health claims. In the U.S., food labels can legally only include health claims that meet FDA requirements. There must be “significant scientific agreement among qualified experts that these claims are factual and truthful,” Wee said. FDA approval is based on the amount of publicly available, scientific evidence from reputable studies.
– A health claim is not a nutrient claim. Food producers cannot link the effect of a nutrient or food to a disease or health condition (other than in the rare case that there is supporting scientific evidence). Nutrient claims are defined by the FDA to “describe the level of a nutrient in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite.”
– A health benefit cannot be used interchangeably with a health claim. A health claim must pass a two-part test: first, contain the characterization of the type of food/food component and, second, state its relationship to a disease. For example: “A good source of calcium and vitamin D. Reduces risk of osteoporosis.”
“The reason for these standards is that it provides a high level of confidence to validate the substance and disease relationship,” Wee said.
What is Not a Health Claim?
Wee said producers must be careful not to mislead consumers with an inaccurate health claim.
She shared the International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on fermented foods. In it, the authors write: “Although consumers have become increasingly interested in fermented foods, it is unfortunate that, in our opinion, much information available on fermented foods in popular press magazines, websites and social media is exaggerated or inaccurate.”
Here are four health-related claims that are not health claims.
1. Description of well-being from consumption of a food. These claims do not mention a disease or disease-related condition. For example, “Multivitamins contribute to general good health.”
2. Structure-function claims. A structure-function claim describes the role of an ingredient in affecting or maintaining normal structure or function in humans. “There is this presence of this food and food ingredient, but it doesn’t really talk about disease,” Wee explained. For example, “Calcium builds strong bones.”
3. Dietary guidance. A dietary label addresses the role of good health in general dietary patterns. For example, “Five servings of fruits and vegetables a day are recommended for good health.”
4. Nutrient content claim. These characterize the level of nutrients in food. For example, “Good source of fiber.”
“These four health-related claims are sometimes mistaken for health claims,” Wee said, “but they’re actually not health claims by the definition of regulatory agencies such as the FDA.”
Where Can Producers Get Into Trouble?
Securing FDA approval for a new health claim can be arduous. Under the Nutrition Labeling Education Act of 1990 (NLEA), a company can petition the FDA to consider a new health claim. But the process is typically lengthy (240-540 days) and costly.
Often, it is a competitor that challenges a producer’s health claim.In 2010, Dannon was ordered to pay $45 million in a class-action lawsuit brought against them by Activia yogurt. Dannon’s ads claimed their yogurt was clinically and scientifically proven to regulate digestion and boost immune systems, but were deemed to be false advertising.
In the past few years, kombucha brands have been particularly vigilant in monitoring health claims in their industry. Tortilla Factory (parent of Kombucha Dog) sued Trader Joe’s, Better Booch, Makana Beverages and Rowdy Mermaid Kombucha for supposedly violating the law by exceeding the 0.5% abv threshold.
“I think as fermented foods become more mainstream…over time consumers will become more educated and understand what these labels mean,” Wee noted.