2206-HealthClaim-Cover-HERO

Making Health Claims: Follow the Science, Not the Hype

June 2, 2022
It takes a lot to convince the FDA of a food/ingredient-health connection.

The connection between health and diet has been clear for decades, so it’s no surprise that food manufacturers often want to tout the health benefits of their products. After all, if the granola you’re selling will reduce heart disease, why not brag about it?

The truth is that making a health claim on a label is closely regulated by the FDA. There are only a dozen “authorized” health claims that can be legally put on a label and another 30 or so “qualified” health claims. Even if a food product can rightfully be connected to one of those claims, exactly how the claim is stated on the label is carefully prescribed.

“The biggest importance of these regulations is so consumers can make informed choices,” explains Kimberly Baker, team director of the Food Systems and Safety Program at Clemson University’s Cooperative Extension. “The rules are pretty cut and dried. You have to make sure that everything is stated so the consumer can understand it.”

The regulations about making health claims on food labels date back to The Nutrition Labeling and Education Act of 1990. Prior to that act, putting a health claim on a food label was simply prohibited, notes Neal Fortin, professor and director of the Institute for Food Laws & Regulations at Michigan State University.

“Before the 1990 labeling act, drugs were drugs and foods were foods and you weren’t allowed to make health claims on food,” Fortin says. “Then Kellogg’s wanted to make claims about diet and health on their cereal boxes, and the knowledge and research about those connections were growing, so Congress decided to open it up."

Authorized and qualified

Most consumers take for granted that diet is connected to health. Someone with digestive problems may start eating food with more fiber to move things along, and someone who commutes to work on a crowded train may drink pomegranate juice because they think it improves immunity.

But the FDA doesn’t take anything for granted. When a manufacturer wants to make a health claim, the FDA thoroughly examines the science behind that claim. For the 12 authorized health claims, the FDA determined there is “significant scientific agreement” regarding the claim, which means it is backed by the “totality of publicly available scientific evidence for a substance/disease relationship,” according to the FDA web site.

What are these golden dozen claims? Each makes a connection between a food or nutrient and a disease:

  • Calcium, vitamin D and osteoporosis
  • Dietary lipids (fat) and cancer
  • Dietary saturated fat and cholesterol and risk of coronary heart disease
  • Dietary non-cariogenic carbohydrate sweeteners and dental caries
  • Fiber-containing grain products, fruits and vegetables and cancer
  • Folic acid and neural tube defects
  • Fruits and vegetables and cancer
  • Fruits, vegetables and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease
  • Sodium and hypertension
  • Soluble fiber from certain foods and risk of coronary heart disease
  • Soy protein and risk of coronary heart disease (caveat: the FDA has proposed revoking this one)
  • Stanols/sterols and risk of coronary heart disease

These 12 food/disease connections are the only claims that the FDA has determined, in the 32 years of the labeling act, to be truly backed by “the totality” of scientific evidence.

While those 12 are the only authorized health claims, there is another category of health claims called “qualified.” The science behind a qualified claim is not as strong as that behind an authorized claim, but there is still good reason to believe the claim is valid. The FDA began allowing qualified claims in 2003, after several court decisions, based on First Amendment grounds, that the FDA couldn’t prohibit claims that have credible evidence backing them.

As the phrase implies, qualified health claims require some kind of disclaimer or other qualification in their wording. Here’s an example of a qualified health claim from the FDA website: “Scientific evidence suggests, but does not prove, that whole grains (three servings or 48 grams per day), as part of a low saturated fat, low cholesterol diet, may reduce the risk of diabetes mellitus type 2.”

When the FDA determines that a health claim is qualified but not authorized, it doesn’t issue a regulation regarding the claim, as it does with authorized claims. Instead, it issues a “letter of enforcement discretion,” which outlines the evidence backing the claim.

Health claim approvals are initiated three ways: when the FDA initiates the process itself; when a food manufacturer or other interested citizen submits a petition to the FDA about it; or when a manufacturer submits a “notification of a health claim or nutrient content claim based on an authoritative statement of a scientific body,” according to the FDA web site.

This means, for instance, if the National Institutes of Health says some nutrient helps prevent some disease, a food manufacturer can ask the FDA to allow them to use that claim on a label. Either way, the FDA goes through a complicated approval process.

The bottom line is that it’s difficult for someone to get a claim approved, either at the top level – authorized – or qualified. And that’s because the FDA follows the science.

“Science has only shown a limited number of things that are substantiated enough to make a claim,” Fortin says. “The FDA gets blamed for being the gatekeeper, but it’s really the science that dictates when a claim can be made. It’s hard, scientifically, to demonstrate the health benefit of a food.”

Rules regarding labeling

The FDA does not just approve health claims; it also dictates how those claims can be stated on labels. For example, manufacturers can make a claim “associating substances in diets low in fat and high in fruits and vegetables with reduced risk of cancer,” per FDA guidance, but only if the claim follows 10 specific rules, ranging from the use of the words “may” or “might” to the addition of the fact that the development of cancer depends on many factors.

Naturally, a qualified health claim also must follow the rules, and the resulting claim is generally somewhat weaker than that for an authorized claim. For example, stating that green tea reduces the risk of cancer is an approved qualified health claim, but the FDA requires the claim to be written like this: “Green tea may reduce the risk of breast or prostate cancer although the FDA has concluded that there is very little scientific evidence for this claim.”

The idea behind the rule is to ensure that consumers get the most accurate information. If a manufacturer tries to write something stronger on a label, it risks getting in trouble with the FDA.

Finally, it goes without saying that in order for a food manufacturer to make a health claim, the product must meet the nutritional requirements spelled out by the FDA, and that often includes the quantity of the nutrient and what other nutrient requirements go along with it.

“There are little pieces here and there that the manufacturer has to understand about making each health claim,” Baker says.

Enforcement

How does the FDA enforce its labeling regulations? The first level is through the label approval process. The labels on foods that are going to be wholesaled in more than one state have to be approved by the FDA; if the food is sold only in one state, that state’s department of agriculture handles approval.

If a manufacturer is making a health claim on the label, the approving body makes sure it meets the requirements of that claim from a nutritional standpoint, and the agency also makes sure that the claim on the label is done correctly.

Product labels are also inspected after the food hits the market, so a manufacturer can’t add a claim after a label has been approved.

Fortin says the main generator of enforcement action is when a label exaggerates the effect of the food.

“There are certain red flags. There is no cure for cancer, for example, so if you say the food is going to treat cancer, that will catch the FDA’s eye and you’ll be in trouble,” Fortin says.

The FDA prioritizes enforcement on claims that could lead to real harm. “If a consumer eats something that claimed that it could cure cancer instead of getting treatment for cancer, the consumer hasn’t just lost money," he adds. "So the FDA targets reviews on issues that will really harm consumers.”

Enforcement actions are sometimes initiated by competitors, Fortin says.

“Frankly, the industry knows what’s going on. If some company does very well because they’re making a misleading claim, and they start to take market share from someone else, it will catch their attention,” he says. “So they are like the eyes and ears of the agency.”

Once the FDA decides a label is misleading, enforcement begins with a letter that gives the manufacturer time to make the correction. Penalties escalate if the manufacturer does not fix the label or falsifies the ingredients in the product.

Getting help

Making health claims on food labels can get complicated. Even though the number of authorized and qualified claims is limited, and the FDA spells out the appropriate language, there are still subtleties that can be difficult to grasp.

“Larger manufacturers have staff and legal counsel that keep up with the changes and have the educational background to understand the terminology,” Baker says. “Here at Clemson we work with small and beginning entrepreneurs and up to larger companies, but they are usually new to the business and struggle with the requirements. They come to us and say, ‘This is the claim we want to make.’”

In addition to university cooperative extensions, several other organizations help food manufacturers make correct health claims. The NSF (formerly the National Sanitation Foundation), for example, helps manufacturers in that way.

“NSF can assist your company by ensuring your food meets the criteria required to make each claim and that the claim is declared in a compliant way,” says Carol Zweep, consulting and technical service manager for NSF. “NSF can review desired claims to help ensure nothing has been missed, whether it is in the product development stage, before the labels are created, or as a final artwork check prior to printing.”

The bottom line: Making health claims on labels is a complicated process that requires careful attention. But help exists to make sure manufacturers get it right.

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