FDA is proposing significant changes to nutritional labels including redefining which carbohydrates can be declared as dietary fiber. This new definition would require proof the proposed carbohydrate demonstrates physiological benefits associated with dietary fiber. Until the carbohydrate is proven to have these benefits and is accepted by the agency, it would only be listed as a carbohydrate on the nutrition label. Once recognized by FDA as a dietary fiber, the label could then be adjusted to include this carbohydrate in the declared amount of dietary fiber.
Historically, the amount of dietary fiber declared on nutritional panels was the amount that was measured via approved AOAC analytical methods (notably 985.29, 991.43, and more recently 2009.01 and 2011.25). These methods measure the amount of carbohydrates that are not digested by enzymes found in the body.
The changing definition is not the only proposed change for dietary fiber. FDA also proposes to increase the DRV for dietary fiber from 25 to 28 g. This will mean some products will be at risk of no longer being eligible for claims. Some products may need to be reformulated to maintain current label declarations.
The combination of fewer recognized dietary fiber sources with an increased DRV could affect both label claims and nutrition panel declarations. The industry needs to evaluate current and under-development products to assess the possible effects.
In with the New, Out with the Old
Under the proposed new definition, carbohydrates are recognized as dietary fiber if they are: 1) non-digestible carbohydrates (> 3 monomeric units) and lignin that are intrinsic and intact in plants, and 2) added (isolated or synthetic) non-digestible carbohydrates (> 3 monomeric units) that have been determined by FDA to have physiological benefits. This proposed definition is consistent with the definition adopted by the CODEX Alimentarius Commission in 2009, which was based on the latest scientific knowledge about the molecular structure of dietary fiber and associated physiological benefits.
The good news is available analytical test methods do measure carbohydrates that are resistant to digestion in the small intestine, a key component of demonstrating benefit physiologically. However, for foods containing carbohydrates which are measured as fiber by these analytical methods, but have not received FDA acceptance as dietary fiber, record keeping during production would be needed to adjust the declared dietary fiber on the label.
To Claim or Not to Claim
Manufacturers concerned about the changes to the nutrition facts label have more worries to consider. With the changing definition of fiber, some will be faced with certain fiber claims on their product being at risk. If this new definition is approved, any newly isolated or manufactured “dietary fiber” would need to first undergo additional evaluations before being allowed to be claimed as dietary fiber. The current unanswered questions are, “which current carbohydrates can be included in the declared dietary fiber content?”, and “for those not yet recognized as dietary fiber, what physiological benefits must they be shown to provide?” FDA has stated they will issue guidance to the industry on how to submit proof to demonstrate physiological benefits to human health. This guidance would need to address what would be accepted as “beneficial physiological effects” and which dietary fibers would be grandfathered.
Concerning beneficial physiological effects from dietary fiber, earlier studies have listed benefits as stool bulking, laxation improvement, cholesterol lowering, glucose attenuation, and fermentation by bacteria in the bowels. It is my belief these will be the benchmark benefits that will be used to evaluate proposed dietary fibers. Of course, other benefits identified by the medical community would need to be reviewed in the future.
For carbohydrates currently listed as dietary fiber on labels, many already have associated clinical studies showing physiological benefits so will likely be grandfathered into the regulation. For carbohydrates lacking physiological studies, guidance is needed from FDA on how to conduct the studies, notably the attributes to measure, the number of studies, population, etc.
Proof is in the Pudding
What this means to ingredient suppliers and food producers is that more up-front work would be required to sell and declare the ingredient as a dietary fiber. In addition to the behavior of the fiber (taste, mouth feel, water binding, etc), studies must be done to show how the fiber behaves in our digestive system. This could delay new fiber sources being added to foods; however, when they are added, there will be definitive proof the fiber is positively contributing to the digestive system. This combined with the proposed DRV increase from 25 to 28 g needs to be evaluated for all fiber-claiming products in the market and in development.
The proposed FDA regulations are expected to be finalized sometime in mid-2016. At that time, the amount of analytical testing and clinical studies will increase to demonstrate compliance. Some manufacturers will be faced with evaluating fiber claims on their products and making decisions regarding reformulations should they desire to retain claims or make new ones. The knowledge base on the dietary fiber we ingest will then increase, a positive for us to better monitor and to improve our diets.