Food Labeling Unleashed

Magic cherry bullet? Don’t believe the hype.

Co-opting a timeless maxim by Hippocrates, “let food be thy medicine and medicine be thy food,” some food makers stretch the bounds of advertising rules with ads to convince consumers that their products, like medicine, will prevent, treat or mitigate disease.

The advertising claims vary from the most blatant health claims about disease fighting or prevention qualities of a product to less conspicuous “structure/function claims”, as they are known in the industry, which tend to mislead consumers. Even though the Food and Drug Administration (FDA) frowns upon such practices, some companies make such claims anyway until they are told to stop by the agency.

Some may remember the Cheerios labels that, not so long ago, promised to lower cholesterol in four to six weeks. The maker of Cheerios, General Mills, got into trouble with the FDA in 2009 for making these and other “unauthorized health claims.” The FDA told the company that not only was Cheerios misbranded but that the cereal is a “new unapproved drug” that cannot be legally sold in the United States without an approved new drug application. The company resolved these labeling snafus last year after it obtained FDA’s approval for revised labeling.

In another case several companies made incredible claims about cherries in 2005 until the FDA put a kibosh on it. Consumers were told that these cherry-containing products “help relieve the pain of arthritis, gout,” that eating cherries “is like unleashing inside your body an entire army of James Bond-type agents who are adept at neutralizing cancer-causing agents,” and that cherries “inhibit colon cancer tumors,” along with other bold affirmations.

Another company was told to stop promoting its green tea carrying many disease prevention claims, including that it provides “neuroprotection” against “Alzheimer’s disease and Parkinson’s disease,” and that “green tea may provide some of the benefits that Vioxx and Celebrex had offered to patients without their toxicities.”

It’s not just the FDA that is forced to step in. Earlier this year, the Federal Trade Commission (FTC) ruled that Pom Wonderful juice ads were misleading because they made deceptive disease prevention and treatment claims concerning heart disease, prostate cancer claims and erectile dysfunction. Although, the FDA had a thing or two to say about Pom juice labeling as well.

In case you wondered, the FTC has a broader jurisdiction to police misleading food advertisement than the FDA. To avoid overlap the two agencies have an agreement that the FTC takes the lead in policing food advertising other than product labeling. The FTC, for example, oversees ads on the internet, television and print, while the FDA’s bailiwick are claims made directly on food packages and materials accompanying food product.

One consumer advocacy organization, the Center for Science in the Public Interest (CSPI), has long complained about food labeling laws and the FDA’s regulation. CSPI says that some companies rely on the hair-splitting distinction in the food labeling rules to make misleading claims. For example, to avoid having the FDA pre-approve “health claims” on labels, which also have a higher approval hurdle, companies increasingly use “structure/function claims” which do not require the agency’s pre-approval.

Structure/function claims describe the effect that a substance has on the structure or function of the body and are not supposed to make direct reference to a disease. An example of such a claim is “Calcium builds strong bones.”  Consumers, however, find it hard to distinguish between health claims and structure/function claims.

Clamoring for change, CSPI encouraged the FDA to take action against misleading structure/function claims that “dishonestly claim to protect immunity, nourish the brain, support a healthy digestive system, or protect cartilage and joints.”

Health claims, says the FDA, are those that directly or indirectly “characterize the relationship of any substance to a disease or health-related condition.” Further, the FDA says that “health claims are limited to claims about disease risk reduction, and cannot be claims about the diagnosis, cure, mitigation, or treatment of disease.” By way of example, the FDA authorized the following health claim: “Three grams of soluble fiber from oatmeal daily in a diet low in saturated fat and cholesterol may reduce the risk of heart disease. This cereal has 2 grams per serving.”

The FDA admits that differentiating between the claims is difficult. In a Q&A guidance to the industry the agency stated that “[i]t may not be possible always to draw a bright line between structure/function and disease claims.” According to CSPI, the FDA’s own data reveals that consumers can not always tell the difference between these categories of labeling.

For example, CSPI’s survey revealed that of consumers who saw labels claiming that a certain food “help[s] support a healthy immune system,” nearly half believe that it meant the food prevents colds and the flu and nearly 23% of participants believed it helps prevent cancer.

The FDA’s regulations have not stemmed the tide of misleading food claims. It is also no secret that private litigation by consumers and organizations such as CSPI has been more active in policing claims on food labels. But even the threat of private litigation is no deterrent. Steve Garnder, a lawyer with CSPI, told me that health versus structure/function claims is a continuing problem which has gotten worse over the last couple of years.