FDA Maintains Focus on Nutrition to Foster Human Health

In a speech, entitled "Reducing the Burden of Chronic Disease," delivered on March 29th by FDA Commissioner Scott Gottlieb before the National Food Policy Conference in Washington, D.C., FDA kicked-off its Nutrition Innovation Strategy.  FDA has identified several areas where it believes there is opportunity to improve public health and encourage industry innovation towards reducing preventable death and disease related to poor nutrition.  Components of the Strategy, which is evolving, presently include:

  1. Modernizing Claims

Food claims, such as nutrient content claims (express and implied) and health claims (including qualified health claims and those based on significant scientific agreement or an authoritative statement), convey quick messages for consumers about the benefits that a food or beverage may provide, and also can encourage the food industry to reformulate products to improve their nutritional qualities bearing upon health.

FDA believes that the regulatory criteria for claiming “healthy” (and related terms) are ready for an update, and that a legal definition of “natural” finally may be warranted. 

The agency also is interested in exploring claims for products that offer food groups for which American diets typically fall short of recommendations; examples include whole grains, low-fat dairy, fruits and vegetables, and healthy oils.

FDA also plans to streamline its process for reviewing health claims that it receives from industry to enhance the efficiency of the review process.  The goal would be to triage health claim petitions/notifications based on their public health significance, and prioritize those that are the most meaningful and science-based.

  1. Modernizing Ingredient Listings

FDA plans to re-evaluate the ingredients list on food packages to assess what revisions might make the information more consumer-friendly, readable, and understandable.

As an example, FDA notes that simplifying common or usual names might be helpful (e.g., use of the name “vitamin B6” instead of “pyridoxine hydrochloride” and “vitamin B12” instead of “cyanocobalamin”).

  1. Modernizing Standards of Identity

Most regulatory standards of identity (SOI) have been codified for many years.  FDA believes it important to take a fresh look at existing SOI in light of marketing trends and the latest nutritional science.  The goal would be to maintain the basic nature and nutritional integrity of standardized foods, while allowing industry flexibility for innovation to produce more healthful foods.

  1. Implementing Advances in the Nutrition Facts Panel and in Menu Labeling

FDA issued final nutrition labeling regulations in May 2016, and has issued several guidance documents on issues such as fiber, added sugars, and serving sizes to help manufacturers meet the requirements of the final rule.   FDA has a proposed rule to extend the compliance dates for the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule from July 26, 2018, to Jan. 1, 2020, for manufacturers with $10 million or more in annual food sales.  Manufacturers with less than $10 million in annual food sales would receive an extra year to comply, i.e., until Jan. 1, 2021.  Pending completion of this rulemaking, FDA intends to exercise enforcement discretion with respect to the current July 26, 2018, and July 26, 2019, compliance dates.

The menu labeling final rule becomes effective for compliance on May 7, 2018.  The agency in November 2017 issued a draft guidance document that provides flexibility on how the menu labeling requirements may be implemented, and reportedly will soon finalize the guidance.

  1. Reducing Sodium

FDA notes that excess sodium in the diet results in high blood pressure, which increases the risk of strokes and heart attacks. The agency acknowledges its committment to advancing the short-term voluntary sodium targets, and will align its approach with the Dietary Reference Intake study being conducted by the National Academies.  FDA plans to release the updated short-term targets in 2019, as well as to continue the dialogue on longer-term reduction efforts.

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FDA prospectively will provide opportunities for public input on many of these nutrition and health matters..

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