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Why Do Dietary Supplement Manufacturers Need to Know about Food Label Changes?

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by Betty Campbell -

The conventional food industry is abuzz with talk of what’s going to happen to the Nutrition Facts label. FDA is planning to announce proposed changes soon. The agency plans show the proposal on the schedule for publication in 2013, even though publication is more likely to be in 2014. 

FDA plans to make major changes to the nutrition label for the first time since it was first established 20 years ago, and the changes will affect all food labels. The dietary supplement industry isn’t buzzing yet, but at least some manufacturers need to be paying close attention. 

The anticipated changes will directly affect those dietary supplements that declare the “food type nutrients” in the top portion of the Supplement Facts box. FDA has stated that it is considering changes to which nutrients would be mandatory for declaration. For example, should potassium be added to the list? Should calories from fat be deleted? The National Academies of Science (NAS) has developed new advice on daily intake recommendations for vitamins, minerals, fiber and other nutrients, and FDA is studying how it should change the Daily Values (DV) used in Nutrition Facts and Supplement Facts based on these new recommendations. If a DV is changed, the declaration of % DV will change and so will any claims based on that DV. Some of the differences in the NAS recommendations include decreased DV for vitamin A and increased DV for vitamin C.

In the years since Supplement Facts was established in 1997, the world of nutrition labeling has moved ahead while FDA’s regulations have not. The requirement of trans fat in the nutrition label is the only update since the original design of Nutrition Facts in 1993. Several developed-country governments have established definitions for carbohydrates to distinguish available carbohydrate from unavailable carbohydrates, or fiber. Governments have also defined fiber differently from FDA’s current definition. The NAS recommends defining total fiber as the sum of Dietary Fiber, which consists of non-digestible carbohydrates and lignin that are intrinsic and intact in plants, and Added Fiber, which consists of isolated, non-digestible carbohydrates that have beneficial physiological effects in humans.

FDA has stated that it intends to bring its policy into conformance with current science, so we can expect something along these lines to be included in the proposed changes. How will it affect your labels? How much fiber do you declare today and how much will you be able to declare under the new definition? Which “excellent source” of vitamins claims will you be able to retain? How will you know if you don’t keep up with what’s about to happen?

FDA published an Advance Notice of Proposed Rulemaking in 2007 that discussed some of the issues it will address in a proposed regulation. (See http://www.gpo.gov/fdsys/pkg/FR-2007-11-02/pdf/07-5440.pdf.) Once the proposal is published there will be a comment period followed by a final regulation. To be aware of whether your product labels would be affected by the proposed changes you need to access the proposal or seek advice from your trade associations or outside advisors on whether and how to submit comments. Once the final regulation is published, there will be at least a year, probably more, for you to bring labels into compliance with the changes.

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