New York, NY — On May 27, 2016, sweeping changes were made to the nutrition and supplement facts labels. Originally, compliance deadlines established required companies with more than $10 million in sales to comply by July 2018 and those below $10 million to comply by July 2019. These deadlines have since been pushed back, with the new deadlines yet to be established.
A panel at the American Conference Institute’s 5th Annual Legal, Regulatory and Compliance Forum on Dietary Supplements, in partnership with the Council for Responsible Nutrition (CRN), addressed these changes recently and the challenges they pose.
For dietary supplements, most troublesome are the changes in unit of measure for certain nutrients and the new definition of fiber. With regard to the unit change, vitamins A, D and E are now to be listed in micrograms and milligrams instead of IUs. This is challenging because while the amount may remain the same, the change in units will throw consumers off. The amount when expressed in IUs appears larger than milligrams and consumers may believe they are actually getting less when it’s actually the same. This will require manufacturers and retailers to educate their customers so they understand why their favorite products have changed.
Changes in daily recommended values (DRV) may also require manufacturers to reformulate because lower DRVs for, say, sugar or sodium may affect the claims a manufacturer can make. The issue of fiber is particularly troublesome because the U.S. Food and Drug Administration (FDA) currently recognizes only seven types of fiber, while many others are under review by FDA. One fiber consistently used by dietary supplement formulators, called inulin, is not among these seven fibers. Fibers not included on this list will fall under total carbs. The reason for this is that the FDA approves fiber for four claims: attenuation of blood glucose, energy intake, improved laxation and lowering cholesterol. Fibers under investigation need randomized controlled trials (RCTs) or non-RCTs that establish causality.
This is burdensome to suppliers who have to invest capital in proving a fiber’s effectiveness as well as manufacturers who may be forced to reformulate. It may also discourage innovation because the process of approval for a new fiber would be expensive and long.
The national mandatory GMO labeling law is also something to consider. In fact, the delay for compliance of the nutrition and supplement facts labels are seen by some as an opportunity to sync both labeling initiatives at once instead of implementing one and then doing the other, which would be costly. However, it appears that supplements were an afterthought in drafting the legislation, with the focus being on food. This means, many questions need to be answered and while FDA has two years to draft guidelines for how to comply, it will likely not make the deadline, which is 13 months away.
All these factors are important for retailers to consider because they will affect the way your customers shop in your store and they will need guidance and instruction to make informed decisions once these changes go into full effect. Not only that, these label changes and the potential for having to reformulate may also raise prices.