Aegis Compliance & Ethics Center, LLP
FDA Extension of Nutrition Label Final Rule: Public Health Impact
The Food and Drug Administration (“FDA”) has extended the first compliance date for the Nutrition Facts Label Final Rule until January 1, 2020. Revisions to the Nutrition Facts Label were first announced by the Obama administration and the FDA in 2016, to take effect by July 2018. Last month, the FDA decided to extend the compliance dates to allow manufacturers more time to make the required changes. Delaying the revisions has raised concern about public health and a confusing marketplace for consumers during the transition.
Reason for the Delay
The FDA originally scheduled the mandatory compliance date for July 26, 2018 for manufacturers with $10 million or greater in annual food sales and July 26, 2019 for manufacturers with less than $10 million in annual food sales (the latter group, given one extra year to comply, makes up 90% of the industry). The 1.5-year delay for larger manufacturers is in response to food and beverage companies and other stakeholders expressing concern about their ability to implement rules and update all product labeling before the original deadline as well as the financial burden of doing so. The FDA announced that they have taken this measure to ensure manufacturers have proper guidance and are able to completely update and relabel products before compliance is expected.
Changes to the Nutrition Facts Label include important updates to ensure consumers can make informed decisions about the foods and beverages they select. The key changes to nutrition facts labels include a clearer focus on calories, updated serving sizes to accurately reflect the amount Americans eat or drink and disclosing the amount of added sugars in grams as a percent of one day’s recommended maximum intake. Labels will have larger, bolded font for calories per serving, number of servings per container and serving size. Percentage of Daily Values for nutrients have also been updated – consumers use these values to determine the amounts of nutrients in one serving of a food or beverage and how it compares to the total recommended daily amount. The revisions to the Nutrition Facts Label presents the first significant makeover in over 20 years. The FDA final rules were initially established during the last presidential administration to assist in combating public health issues associated with obesity and many feel the transparency for consumers is a critical public health necessity.
Recent data from the Centers for Disease Control and Prevention (“CDC”) reported all 50 U.S. states with obesity rates higher than 20 percent, with 25 states as well as Puerto Rico and the Virgin Islands having obesity rates of 30 percent or higher. More than 50% of American adults have one or more preventable diseases related to physical inactivity and unhealthy diets. Some of the leading causes of death in America includes Type 2 Diabetes, heart disease, stroke and certain cancers – all of which can be reduced by improved diets and weight loss. As research mounted about the prevalence of preventable diseases in Americans, the FDA recognized the need for an improved nutrition facts label to improve public health and nutrition awareness. This came to fruition in 2016 when the changes were announced.
Critics have largely responded to this extension by stating that the delay harms public health by denying consumers important information and creating an unfair marketplace as many companies have already updated and pushed out new labels (approximately 8,000 products have updated labels currently, and this is expected to rise by 15,000 additional products by the end of the year). The delay in required compliance deadlines will prevent consumers from accessing clearer information and making informed decisions about the food and beverages they eat and drink.