Food manufacturers may be increasingly leery of using a health claim or investing in the research to support a claim since the Food and Drug Administration recently stretched its regulatory arm and told General Mills, Inc. it had issue with the language on the Cheerios box suggesting the cereal reduces cholesterol.
"Health claims are authorized by existing statute, and all health claim types require premarket review and authorization by F.D.A," said Regina Hildwine, senior director for food labeling and standards at the Grocery Manufacturers Association, Washington. "It is possible the government could move to make the conditions and wording for health claims stricter, but health claims very much depend on companies requesting them, and few companies have done so recently."
With all of this considered, what exactly is the value of a health claim?
Nancy Chapman, executive director of the Soyfoods Association of North America, believes the heart health claim for foods with soy has greatly benefited this particular market.
In general, most consumers associate soy as a healthful product. But Ms. Chapman believes part of the reason consumers have come to believe this is in 1999 the F.D.A. approved a health claim for foods containing at least 6.25 grams of soy protein. The health claim states 25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease.
"The establishment of a health claim for soy protein brought about an expansion of the market that has helped increase the variety of soy products available and improved the taste and functionality of the products for consumers — making it easier for consumers to incorporate soyfoods into a plant-based, healthy lifestyle," Ms. Chapman said.
Even if consumers understand the healthfulness of the product, the question then becomes if consumers really understand what the claim means for them. According to the United Soybean Board’s 2009 Consumer Affairs Attitude’s Report, 18% of consumers mentioned foods with soy reduce the risk of heart disease and 13% mentioned soy lowers cholesterol.
In addition, Ms. Chapman said sales of foods with soy increased 41% between 1999 and 2001. She said there began to be a diversification of new products with soy around 1997 before the health claim, and this continued with strength after the health claim was approved. She said the health claim has helped develop a variety of foods.
Ms. Chapman said the company or groups of companies presenting a health claim have to show compelling evidence the substance of the claim is based on has scientific evidence that it actually makes the change claimed.
She said in the case of the soy claim, soybean farmers were the ones who initially got the ball rolling, but The Solae Co. had sponsored studies and actually brought the evidence to the F.D.A. She said others in the market got involved in the effort, too.
"Health claims are an extremely important tool, but communication is also an important piece," Ms. Chapman said.
To this end, Ms. Chapman said the soy industry is continuing to educate consumers. In addition, she said those in the market continue to gather research data and information to keep the scientific basis for the health claim up to date.
Things to keep in mind
Ms. Chapman said the value of health claims in general is to help consumers who are interested in health to find products to boost their health quickly. She said if companies really want to position themselves with consumers interested in healthy products, this is a way to boost sales.
With between $20 billion and $30 billion in sales per year, the functional food market represents about 5% of the overall food market, according to a study by PricewaterhouseCoopers. And with functional foods all marketed as having some positive benefit for a consumer’s health, it’s no surprise that according to the F.D.A. about 5% of products had health claims or qualified health claims.
In addition, the Food Label and Package Survey revealed some of the most prevalent health claims are about the relationships between a diet low in saturated fat and cholesterol and a reduced risk of coronary heart disease. Other prevalent health claims include the relationship between soluble fiber from certain foods and heart disease, the relationship between whole grains and heart disease, or whole grains and heart disease and certain cancers. The most prevalent qualified health claims describe the relationship between nuts and coronary heart disease or walnuts and heart disease, according to the F.D.A.
In general, there is a belief in the industry that no further regulation is needed for health claims.
"G.M.A. believes health claims of all types are carefully regulated and stronger regulations are not needed," Ms. Hildwine said. "G.M.A. would encourage F.D.A. to develop more consumer-friendly language for health claims, including qualified health claims."
Ms. Hildwine said consumers may have a hard time explaining the nuances in language between one health claim and another and it would be important for consumers to understand these statements about how specific foods and nutrients may reduce risk of disease have been evaluated in advance by the F.D.A.
"Companies must remember health claims require authorization from F.D.A. before they are marketed, so if a firm is thinking of using a new message about how a substance may reduce the risk of disease and F.D.A. has not authorized the message it could not be used," Ms. Hildwine said. "Health claims established by regulation have more flexibility in language than qualified health claims."
Types of Health Claims
There are several different classifications of health claims:
A regular health claim describes a relationship between a food or food component or dietary supplement ingredient and how it reduces the risk of a disease or health condition. For example, calcium helps reduce the risk of osteoporosis. One type of health claim is a qualified health claim. Qualified health claims are used when there is evidence for a relationship between a food, food component or dietary supplement and reduced risk of a disease or health-related condition. The evidence is not strong enough to meet strong scientific agreement and approval by the F.D.A., and the language reflects this. Specifically, pomegranate juice may reduce your risk of heart disease.
Other types of health claims include nutrient content claims and structure/function claims. Nutrient content claims characterize the level of a nutrient in a food that are made in accordance with F.D.A. regulations and describe the level of a nutrient using words such as free, high and low. An example would be this food is low in saturated fat. Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans. An example would include calcium builds strong bones.
This article can also be found in the digital edition of Food Business News, September 15, 2009, starting on Page 47. Click