The Food and Drug Administration sent letters to Johnson & Johnson, CVS Corp., and Walgreen Co., warning the companies to stop making claims that their mouth rinse products effectively remove plaque above the gum line or promote healthy gums. “These claims suggest the products are effective in preventing gum disease when no such benefit has been demonstrated,” the letters said.
The letters, sent September 27, cautioned the manufacturers that their products are used to prevent or mitigate disease by resisting cavities and removing plaque.
Johnson & Johnson’s Listerine Total Care Anticavity Mouthwash, for example, claims on its label that it “Strengthens Teeth, Restores Minerals to Enamel, Fights Unsightly Plaque Above the Gum Line, Helps Prevents Cavities, Kills Bad Breath Germs, and Freshens Breath.” Those claims, combined with the “Total Care” name, “suggests that the product is comprehensive in function, and will provide benefits, including antigingivitis and antiplaque benefits. We are not aware of any support for the antiplaque/antigingivitis claims or other statements suggesting that the product is comprehensive in function, providing benefits beyond those related to prevention of cavities. Thus, the product’s labeling claim that it will provide all of the benefits listed, is misleading and accordingly makes it misbranded,” the letter said.
In another case of implied claims, the makers of Log Cabin Syrup decided to “tweak” the ingredients of the syrup after a federal legislator and a state trade group complained. Pinnacle Foods Group LLC had updated the syrup’s label, calling it “all natural” and changing the product packaging to a beige plastic jug.
In response, the New Hampshire Maple Producers Association called the new labeling “deceptive.” Vermont legislator Peter Welch (D-Vt.) also chimed in. “By continuing to market its product with jug-like packaging and ‘all-natural’ labeling, Pinnacle leaves consumers with the impression that Log Cabin table syrup and Vermont maple syrup are one and the same,” he said. “As Vermonters know, they’re not even close. It’s time for Pinnacle to stop misleading customers and stop imitating the Vermont maple industry.”
Rep. Welch also sent a letter to the Food and Drug Administration, asking the agency to investigate whether the Log Cabin syrup violated federal law by marketing itself as a natural product when it contains ingredients like caramel coloring. In light of the controversy, Pinnacle agreed to tweak its recipe. “Although this product does not pose any health or food safety issues, we are changing our recipe to remove caramel color immediately. With regard to the other ingredients, xanthan gum and citric acid are natural plant-derived ingredients,” the company said in a statement.
To read the FDA’s warning letter to Johnson & Johnson, click here.
Why it matters: In the absence of an express claim, implied claims based on words or product packaging could be objectionable. Advertisers should be especially careful of using the term “natural,” which has recently been the subject of several lawsuits filed against food and beverage makers. While the FDA has not defined the term, it must be used in a truthful, nonmisleading manner.