This past week, the Food and Drug Administration released 17 letters of warning to food manufacturers whose product claims don't adhere to federal labeling rules. FDA Commissioner Margaret Hamburg, MD, also sent an open letter to the industry, encouraging food makers to rid their labels of misleading and downright bogus claims, and be part of the effort to make food labels a tool consumers can use to improve their nutrition and make healthier choices. (She of course said it in a much nicer way.)
The letters targeted mainly companies making unauthorized health claims and nutrient-content claims.
Please bear with me while we go through the different types of label claims; I promise it’s going to make you a more informed consumer:
• A health claim describes a relationship between a food or food component and a disease, and it must be pre-approved by the FDA. There are currently slightly more than a dozen of these approved claims.
Health claims must be phrased in the specific language the FDA requires. The claim must also indicate that the disease may be caused by a variety of causes, and must state that the food should be consumed as part of a healthy diet. The appearance of a health claim means a food meets certain nutritional requirements.
The POM Wonderful complaint is an example of misuse of health claims: POM was criticized for claiming its juice will treat, prevent or cure diseases, including hypertension, diabetes and cancer. These types of health claims are drug claims and are not allowed on food products. They are allowed on drugs only after extensive and rigorous testing.
• A nutrient claim is a statement that establishes the quantity of a particular ingredient, such as fat, cholesterol and fiber. Statements such as "low sodium," "high fiber" and "fat-free" are examples of nutrient claims. These statements can be included on the label only if the food product meets specifications established by the FDA.
Nestle’s Juicy Juice was criticized for an inaccurate nutrient claim: its labels implied that the products are 100% juice when they are actually juice blends with added flavors.
The giant loophole
Although Commissioner Hamburg’s actions are good news, I’m afraid the misleading label claim party isn’t over yet. There’s a giant loophole in the FDA’s rules, and many of the most misleading and absurd claims fall into a category that’s practically as regulated as the Wild West.
That loophole is the structure/function claim.
Structure/function claims describe a role of a nutrient or substance in a food or a food supplement in affecting the normal structure or function in the body. Unlike a health claim, it doesn’t relate to a disease or a health-related condition. The verbs “support,” “improve,” “boost” and “maintain” are often a telltale sign of a structure/function claim.
Nestle’s Juicy Juice Brain Development Fruit Juice was reproached for a nutrient claim—"no sugar added" isn’t allowed on products intended for kids under 2 years of age—yet the more glaring claim on the box is “Helps Support Brain Development”. I don’t think the FDA believes this juice develops young brains, but there’s no legal action it can take against such structure/function claims.
A structure/function claim requires no FDA pre-certification. It can be attached to any food, including junk food. There are no overarching nutritional requirements for structure/function claims. They can be phrased in many ways that are at the discretion of the manufacturer. While the claim “must be truthful and not misleading”, there’s no specification about how much evidence is needed to make the claim. It doesn’t require significant scientific agreement, unlike a health claim.
Those food labels luring us with endless promises to protect our joints, boost our brain and support our immunity make structure/function claims.
Unfortunately most consumers can’t tell the difference between a health claim and a structure/function claim. “Calcium builds strong bones” and "fiber maintains bowel regularity”—both structure/function claims—sound quite the same as “calcium reduces the risk of osteoporosis” and “fiber may reduce the risk of some cancers,” which are regulated health claims.
The structure/function claim has been a boon to food manufacturers. Since there are so few limitations on its use and the trusting public can’t easily distinguish between the different types of claims, structure/function claims have proliferated. Market research shows these structure/function claims really help with sales, putting great pressure on companies that don’t have claims to consider them, just to level the playing field. This is an arms race in which the consumer loses.
And until the FDA takes care of structure/function claims, food labeling won’t get any clearer.
In a recent commentary in the Journal of the American Medical Association, two of the most respected and independent nutrition and obesity experts, Marion Nestle, PhD, MPH, and David Ludwig, MD, PhD, explain why claims are inherently misleading: Few if any claims can be verified. Hyping the benefit of a select component of a food doesn’t give the whole picture. “Healthier” is not necessarily healthy. Junk food with a little less fat or sugar is still junk. Allowing claims poses an inherent conflict of interest—food companies want to sell more, while the label’s public health purpose is to educate consumers.
Their suggestion is very simple: do away with all health claims:
“If health claims are allowed on food packages, they should be regulated more strictly according to rigorous, evidence-based national standards. Because such standards are inevitably arbitrary and subject to manipulation, consideration should be given to an outright ban on all front-of package claims. Doing so would aid educational efforts to encourage the public to eat whole or minimally processed foods and to read the ingredient lists on processed foods.”
Kudus to Dr. Hamburg for taking on this difficult and important issue! I hope one of the next steps includes creating regulatory standards for structure/function claims, or following Nestle and Ludwig’s suggestion and get rid of them all.
Further reading: The Center for Science in the Public Interest’s excellent Food Labeling Chaos
Full disclosure: I’m vice president of product development for Herbal Water, where we make organic herb-infused waters that have zero calories and no sugar or artificial ingredients. I’m also a pediatrician and have been promoting good nutrition and healthy lifestyle for many years.
Related post: Are “functional” foods healthy foods?
Reposted as part of Food Renegate's Fight Back Fridays--go join the food fight!