I spend a lot of time with labels, probably too much. Due to the number of labels I review, I have labels on the brain. I can’t go to the grocery store or pick up a drink without looking at the label to see what is right and wrong with the label. However, I’m not the only one reviewing labels. Consumers are looking at labels closer than ever before to see what they are actually putting in their body. Plaintiff lawyers are looking at labels to see what might be the basis for their next class action lawsuit. And regulators are looking at labels closer than ever. This close scrutiny of labels brings me to my topic for today – “Crooked Numbers.” Whenever I talk about labeling, I bring up the topic of “crooked numbers.” And while “crooked numbers,” in and of themselves, don’t seem terribly egregious, they can lead to other, much more serious, problems.
So, what are “crooked numbers”? The technical labeling requirements for the nutrition information that must be contained in Nutrition Facts Panels are set forth in the Code of Federal Regulations at 21 CFR 101.9; similar requirements for the information to be contained in Supplement Facts Panels are found in 21 CFR 101.36. Among the numerous requirements (anyone who suggests that the food and supplement industries are “unregulated” need only take a look at the labeling requirement in the CFR) are provisions for the identification of certain required nutrients that must appear in a Nutrition or Supplement Facts Panels. These provisions include requirements for identifying certain nutrients such as calories, total fat, and total carbohydrate, as well as certain vitamins and minerals. In addition, these provisions include certain parameters for identifying the amounts of those nutrients, including specific rounding requirements. For example, calories must be rounded to the nearest 5 calories between 5 and 50 calories and to the nearest 10 calories above 50 calories. Total fat must be expressed to the nearest 0.5 grams below 5 grams and to the nearest whole gram above 5 grams. Vitamins and minerals are to be rounded to the nearest 2% DV between 2-10%, to the nearest 5% between 10-50%, and to the nearest 10% above 50% for foods and beverages, but to nearest 1% for supplements above 2%. When numbers are not properly rounded as specified in the CFR, we get what I call the “crooked numbers.”
So, does the FDA really care about “crooked numbers?” Is the FDA really going to take action against a company because it provide potentially more accurate information and listed calories as 113 instead of 110? Probably not, although that information, even if it is accurate, technically makes the product mislabeled. However, the concern with “crooked numbers” is not so much with the FDA’s potential action over those specific labeling issues as much as the potential “yellow flag” that they create and wave to the FDA. When the FDA sees that a company has “crooked numbers,” it gets the impression that the company doesn’t really know the laws and regulations regarding labeling. And, if a company doesn’t really know the laws and regulations regarding labeling, the FDA might believe that it also probably doesn’t know what claims can be properly made or what is necessary to comply with the CGMPs. “Crooked numbers” often are the gateway to other scrutiny and regulatory action from the FDA. So, listing Calories from Fat as 12 or Total Carbohydrate as 11.7 might not seem like much of an issue, it might lead to much closer scrutiny from the FDA, when the FDA might otherwise have moved on to the next target if the product was labeled properly. More than ever, it is important that someone knowledgeable and experienced with the FDA labeling regulations reviews your labels and straightens out those crooked numbers!
About the Author
Justin J. Prochnow is an attorney and Shareholder in the Denver office of the international law firm of Greenberg Traurig LLP. His practice concentrates on legal and regulatory issues affecting the food & beverage, dietary supplement and cosmetic industries. He can be reached at (303) 572-6562 or firstname.lastname@example.org and he can be followed on Twitter at @LawguyJP.
This article is issued for informational purposes only and is not intended to be construed or used as general legal advice. The opinions expressed are those of the author exclusively.