• As our readers are aware, in May 2016, FDA issued final rules to implement changes to the nutrition labeling and serving size regulations. On March 1, 2018, Commissioner Scott Gottlieb, M.D. released a statement about the new Nutrition Facts label and FDA issued practical guidance documents on fiber, added sugars, and serving size declarations, in order to provide industry with the information needed to effectively implement the new version of the Nutrition Facts label.
  • Commissioner Scott Gottlieb’ statement announced that FDA is launching an educational campaign for consumers surrounding the new label. The educational campaign will allow the FDA to reach consumers directly through educational videos, social media campaigns, and user-friendly websites to help them discern the relationship between their dietary choices and the impact those choices have on their health.
  • FDA published a final guidance on dietary fiber. The May 2016 final rule established a definition for the term “dietary fiber,” which includes naturally occurring fibers, like those found in fruits, vegetables, and whole grains, and seven isolated or synthetic non-digestible carbohydrates (NDCs), each having a physiological health benefit. A party may submit a citizen petition for FDA’s consideration to add a given isolated or synthetic NDC to the FDA’s regulatory definition of “dietary fiber.” The final guidance communicates FDA’s revised standard of review of the scientific evidence that shows the NDC has a beneficial physiological effect on human health. Evaluation of whether the evidence supports a conclusion of a physiological effect will be based on the number of studies and sample sizes of each study, the dose response data, the types of foods tested, the relevance of the body of scientific evidence to the U.S. population or target subgroup, and the overall consistency of the total body of evidence
  • FDA published a draft guidance to help industry declare added sugars on the label of honey, maple syrup, and certain cranberry products. The draft guidance addresses FDA’s intent to allow manufacturers to use a symbol immediately after the added sugars daily value, directing consumers to language that provides truthful and not misleading contextual information about “added sugars” and what it means for each of these specific products.
  • The final guidance on the requirements for serving sizes provides appropriate reference amounts customarily consumed (RACC) for a variety of products to aid manufacturers in determining the appropriate serving sizes to include on the labels of their products.
  • The FDA is now working to respond to citizen petitions requesting that the agency include additional NDCs in the regulatory definition of “dietary fiber,” to finalize the rule regarding the compliance dates for the Nutrition Facts label rules, and to issue several additional technical guidance documents related to nutrition labeling.