Watching Product Label Claims

In late February, the FDA issued official warning letters to 18 manufacturers notifying them that labeling for 22 products violate the Federal Food, Drug, and Cosmetic Act requiring labels to be truthful and not misleading. The violations include unauthorized health claims, unauthorized nutrient-content claims and the unauthorized use of terms such as “healthy” that have strict, regulatory definitions on packages and other formats, such as company websites.

The warning salvo for the scrutiny of labeling regulations was fired in Oct. 2009, when Dr. Margaret Hamburg, FDA commissioner, encouraged companies to review product labels to ascertain they met FDA regulations, saying: “It is important to note that nutrition-related FOP (front of package) and shelf labeling, while currently voluntary, is subject to the provisions of the Federal Food, Drug, and Cosmetic Act that prohibit false or misleading claims and restrict nutrient-content claims to those defined in FDA regulations. Therefore, FOP and shelf labeling that is used in a manner that is false or misleading misbrands the products it accompanies. Similarly, a food that bears FOP or shelf labeling with a nutrient-content claim that does not comply with the regulatory criteria for the claim as defined in Title 21 Code of Federal Regulations 101.13 and Subpart D of 101 is misbranded. We will consider enforcement actions against clear violations of these established labeling requirements.”

The February warning letters run the gamut: from the aforementioned misuse of health-claim terms; to pictures of fruit of the named flavor, but that are not used at 100% levels; to unauthorized claims for foods intended for infants and children under two; to “disease-related claims” for conditions on websites that FDA says  render them drugs (statements that say the foods are intended for use in “the cure, mitigation, treatment or prevention of disease”) under section 201 of the Federal Food, Drug, and Cosmetic Act.

Some concepts are pretty obvious. Regulations for claims such as “cholesterol free” have limitations on the product’s amount and type of fat, for example. Any implication that a vegetable oil might contain cholesterol seems destined to further confuse consumers whose nutritional knowledge is sketchy at best. However, highlighting health-related studies seems verboten, or perhaps not if the manufacturers don’t summarize the studies, or if an actual disease isn’t mentioned—“might help”–type language notwithstanding. But that’s just my interpretation from looking at specific examples in the warning letters—the websites seem to have removed the offending statements at the FDA’s behest. These will likely be contested. (One of the companies, POM Wonderful, says it “look(s) forward to working with the FDA to resolve these issues and to continued clear and honest communications with consumers” about product health benefits.)

What is clear is that it’s time to reread the regulations and err on the side of caution—and to hope that your interpretation of the somewhat-murky language is the same as the FDA’s.

    -Lynn A. Kuntz