A health claim expresses or implies the relationship between a substance in a food and a disease or health-related condition. These claims can be in the form of a statement on a label, a symbol, a third-party reference or a vignette. FDA allows three main types of health claims that food companies can make on packaging: authorized claims, qualified health claims and FDA Modernization Act of 1997 (FDAMA) claims.
Authorized and qualified health claims must undergo the evaluation-based review system, which involves FDA examining all available science-based literature submitted by the company on the relationship between an ingredient and a disease or health condition. Not only are the findings evaluated, but FDA judges the methodology of each study to discern the strength of the science behind each claim.
In 2003, the FDA issued the Consumer Health Information for Better Nutrition Initiative, which allows qualified health claims to be made on conventional foods. The initiative was intended to provide more information to consumers concerning their diets and health. Qualified health claims still must be supported by publicly available evidence reviewed by FDA, but the evidence doesn’t need to be as strong as that supporting authorized health claims. The wording of these health claims must come with a disclaimer letting the consumer know that the strength of the science backing up the claim isn’t conclusive.
According to a health claim expert at FDA, if the agency establishes a health claim relationship and verifies the scientific evidence once, then any company can use that health claim on a product that meets the claim’s requirements. No notifications, petitions or reviews are necessary. A list of these claims can be found on FDA’s website, www.fda.gov. If a company wishes to use a claim that hasn’t been reviewed, the company must petition FDA and submit all the science-based literature supporting the claim to undergo the evaluation-based review system, which can take the agency months.
FDAMA claims are statements that resemble health claims and are supported by an authoritative report such as the Dietary Guidelines for Americans. A company must notify FDA of its intention to use an FDAMA claim and submit the authoritative report that supports it, said an FDA health claim expert who spoke with Baking & Snack under the condition of anonymity. FDA then reviews the report and issues a response that dictates the exact wording that must be used when making the claim.
LOST IN TRANSLATION.
Although some health claims have become more available for food companies, most gravitate toward nutrient content claims over health claims. According to Elaine Meloan, director, food labeling, AIB International, Manhattan, KS, a nutrient content claim such as “fat free” is easier for consumers to grasp than the complex wording required for health claim statements.
For instance, a claim about walnuts cannot simply say on the packaging, “Walnuts may reduce the risk of coronary heart disease.” According to FDA, the claim’s wording must be exact. Because the evidence supporting qualitative health claims is limited, the statement must be qualified with a disclaimer to prevent misleading consumers.
In the case of walnuts, the qualified health claim on a package must read, “Supportive but not conclusive research shows that eating 1.5 oz per day of walnuts, as part of a low-saturated-fat and low-cholesterol diet and not resulting in increased caloric intake, may reduce the risk of coronary heart disease. See nutrition information for fat [and calorie] content.” While this wording may not misinform consumers, it won’t get them excited about the health implications of a product either.
Despite tougher requirements governing authorized health claims, the wording of the claim on the package doesn’t have to be exact. According to Ms. Meloan, authorized claims have recommended wording and certain elements that must be included in the label, but the final wording of the claim is more flexible.
“There are many popular health claims, but you don’t see them on a lot of products, and I think that’s because of the cumbersome language required,” said Lee Sanders, senior vice-president, government relations and public affairs, American Bakers Association. “For example, folic acid is a great message and a great opportunity, but the language that you have to put on your label is hard to fit on.”
Simplifying the language of health claims, however, is a task that falls on FDA. Bakers, snack producers and their organizations can only suggest to FDA that this change be made.
“I think if we were able to streamline the language and shorten it, make it more concise and consumer-friendly, then it would encourage bakers to have more of those types of claims on their products,” Ms. Sanders said. She added that companies producing foods with enriched or whole-wheat flour should take advantage of any opportunity to the tout health claims that come naturally for their products.
WORTH THE RISK.
The requirements and challenge of fitting a health claim on a label may seem daunting and not worth the risk of an FDA warning letter, but Ms. Sanders said she believes companies have a lot to gain from pursuing health claim labels.
“I think consumers look for those messages,” she said. “When they’re looking for a specific product and they see those descriptors on the packages, then it helps them make a choice.”
With today’s tightening budgets, she added, consumers are looking for their groceries to do more for them nutritionally, and including health claims on packaging helps them make informed choices to meet their families’ nutritional needs.
Foods that make health claims must also qualify as containing low levels of negative nutrients such as fat, saturated fat, cholesterol and sodium and high levels of a positive nutrient such as certain vitamins or minerals, protein, or fiber.
“Some of the current health claims are not that hard to meet if you truly have a healthy food,” Ms. Meloan said. “If your food meets the requirements for ‘low fat,’ you already meet the health claim concerning dietary lipids and cancer, and you can make a statement such as, ‘Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers.’”
The amount of information on label claims — health claims and nutrient content claims — can be overwhelming, and it is easy to get lost in the maze of online resources. For links to all information regarding regulations, petitions and a list of existing health claims, visit www.fda.gov/Food/LabelingNutrition/LabelClaims/default.htm. The Grocery Manufacturers Association offers seminars, conferences and resources to help food manufacturers break down food labeling at www.gmaonline.org/resources/gma-claims-prgram. AIB International also offers seminars and guidance on labeling, and if a company is still stuck, AIB has food labeling experts to assist with specific labeling needs. For more information, visit www.aibonline.org/researchandtechnical/services/foodlabeling.???