Seven days prior to press time, a U.S.-based manufacturer called ABC Croutons Company* received a telephone call from a staff reporter of a high-profile American newspaper with national and international distribution. The call was followed up with an email message confirming the conversation.
A special interest group called Every Calorie Counts Group (Calorie Group)* provided the journalist with the results of nutrient analyses conducted of an on-pack claim on three national brands of croutons, one of which was ABC’s. The analytical results concluded that the on-pack claim was inaccurate and fraudulent. The journalist gave ABC five working days to either refute Calorie Group’s findings, or, be served notice that the story was to run the following Wednesday; the daily edition most North American newspapers dedicate to food-related coverage.
U.S. regulatons require the serving size on a Nutrition Facts Panel (NFP) to be the legislated reference amount of the food, stated in either weight or volume, and, in an equivalent household measure.
The reference amount for croutons is seven grams, which, for these croutons, occupies three tablespoons. ABC’s on-pack claim of “10 calories per tablespoon” was derived from the NFP serving size, which provided 30 calories. Conversely, Calorie Group reported a three tablespoon weight of nine grams and a caloric value of 46, which results in 15.33 calories per tablespoon, and a more than 50 per cent increase over ABC’s on-pack calorie claim. To add to the confusion, Calorie Group reported a Standard Deviation (S.D.), which is a statistical term that measures variation from the average value. This imbued the Calorie Group’s findings with a degree of scientific validity.
Where to start? Where is the source of variance between the two sets of data? There were three parameters to investigate: the caloric value of the croutons, the weight of the croutons, and the volume measure in tablespoons of a seven-gram portion of croutons. Tackling calories first, ABC had used a nutrient software program to generate the nutrients and calories to declare in the NFP. The program assigns the Atwater values of nine calories per gram of fat, four calories per gram of protein, and four calories per gram of carbohydrate to calculate caloric value, as provided in the footer of America’s NFP. In addition, the U.S. food regulations allocate zero calories per gram of insoluble fibre. Accordingly, the software program reduced the calories from carbohydrate by a factor of four calories per gram of fibre. (Note: in Canada, dietary fibre is allocated 2 kcal/gram). Turning their attention to verification of the weight of the croutons, ABC’s technical team scrutinized their internal Standard Operating Procedure (SOP) used to assign weight to all foods they manufacture. The SOP protocol was found to be scientifically sound and defensible on all but one aspect – the sampling procedure. It was pointed out that, whereas regulatory authorities such as the FDA, USDA and the CFIA implement a sampling procedure that requires random selection of representative samples from different lots of production, ABC’s SOP required random samples from only one production lot. Accordingly, they gathered eight randomly selected samples (each batch coded) from a minimum of three production lots, and sent the 24 coded packages of croutons to a certified laboratory for weight determination and nutrient analysis, the results of which were to be verified by a signed Certificate of Analysis.
On Monday of the following week, two days prior to press time, the laboratory reported a crouton weight of 2.35 grams per tablespoon, or 7.05 grams per three tablespoon serving, which verified ABC’s Nutrition Facts Panel declaration of a serving size. The nutrient analysis for all nutrients except dietary fibre was made available at the same time. Measurement of dietary fibre entails gravimetric and chemical analysis, a slow process of about two weeks’ duration in which gravity separates the dietary fibre from other carbohydrates in the food. Nevertheless, with no allowance made for zero calories per gram of dietary fibre, the caloric value of the croutons was reported to be 28.91 calories per 7 gram/three tablespoon serving, resulting in slightly less than the on-pack claim of “10 calories per tablespoon”.
The laboratory results, which exonerated ABC and validated the on-pack calorie claim, were provided to the reporter, who incidentally, is a high-profile journalist with many awards to her credit. Not one to be easily fooled, she fired back with a number of very good questions. Had ABC used this laboratory before, or, was this a one-off to impede the story? Why is the laboratory’s caloric value of these croutons less than what is reported in the USDA nutrient database? Why do Calorie Group’s values differ by such a large amount?
Yes, ABC had used the laboratory for weight analysis from time to time to verify the validity of their internal SOP. The USDA nutrient database provides a general, average value of generic and branded foods. These croutons are a niche-market product, different from the generic croutons in the USDA database. Here’s where Calorie Group went astray: Firstly, they measured only three tablespoons of croutons from one package, which fails to account for at least four factors: size variation within a product such as croutons; settling of such a food within a unit of measure; variation within a lot or production; and, lastly, variation from lot to lot. As for caloric value, Calorie Group applied the Atwater values shown in the footer of the NFP without allocating 0/kcal per gram of fibre. It remains unknown the purpose of the S.D. employed by Calorie Group.
The journalist did not run the story.
It has been estimated that nutrients declared in a NFP may differ from laboratory values by as much as 30 per cent due to three sources of variation: natural (can account for a 20 per cent variation, such as that Mother Nature does not put the same exact amount of dietary fibre into each wheat kernel); production lot (within and from batch-to-batch); and methodology (traceable to various methods of measuring the same nutrient, which is why regulators identify the analytical methodologies they recognize). Many manufacturers, and perhaps rightly so, find compliance with food regulations an expensive and daunting task. While regulatory authorities know about sources of variation, sampling procedures, tolerances and the like, consumers do not. The Court of Public Opinion exerts a much more difficult trial.
*The story is actual and recent to 2014. The names of the organizations and the product are fictitious to protect the identity of the companies and individuals.
Carol Culhane, PHEc and MBA, is the resident of International Food Focus Ltd.(www.foodfocus.on.ca), a regulatory compliance and market assessment firm serving Canada, the U.S. and the EU. In addition to forging commercialization pathways for clients, Carol serves as a member of the editorial board for Food in Canada, as a food science communicator for the Chicago-based Institute of Food Technology, and chair of the Functional Food Division of the Canadian Institute of Food Science & Technology.
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