FDA’s Policymaking and the Changing Compliance Landscape for ‘Healthy’ Foods
On March 9, 2017, the U.S. Food and Drug Administration (FDA) held a public meeting to seek stakeholder input on its plan to update the regulatory standards for using "healthy" as an implied nutrient content claim in human food labeling. The meeting follows FDA's announcement, during the waning days of the Obama Administration, that delayed the close of the comment period on its September 2016 Request for Information for another 90 days, until April 26 (which we discussed here).
FDA's efforts to redefine "healthy" responds, in part, to KIND LLC's December 2015 Citizen Petition, which was submitted following FDA's 2015 Warning Letter and scrutiny of the company's compliance program (see here and here). At the public meeting, KIND advocated for FDA to change the regulatory standard to focus on the health benefits of whole foods, such as salmon, nuts, and olives, rather than on their nutrient content (e.g., limits on total fat per serving, which result in none of the aforementioned foods meeting the current criteria for a "healthy" nutrient claim). Other panelists also recommended a focus on whole foods, noting that while many processed and packaged foods may bear labels claiming they are "healthy," raw, unaltered fruits and vegetables typically are not labeled at all -- but perhaps should be, given FDA's mandate to improve public health.
Clinical guidelines have changed since "healthy" was first defined in 1993. A new focus on the presence of added sugar and avoidance of allergens such as gluten has emerged, and FDA has proposed new targets for sodium content. Alternatively, some interest groups recommended that FDA create a more flexible approach with exceptions for certain types of products, suggesting that chicken livers, avocados, specialty foods processed by small enterprises, and even bottled water might qualify for exceptions. Another group of stakeholders recommended that FDA eliminate the definition of "healthy" altogether, as they believe that the term is overly broad and inflexible, and therefore meaningless, to both consumers and the food industry.
Breakout sessions at the public meeting discussed both the food-based and nutrient-based standards as potential policy options, with FDA staff apparently favoring a hybrid approach. Many details remain open for debate, including the nutrients (and quantities of them) that FDA should include in a new standard, and how best to distinguish whole foods and ingredients that are derived from whole foods (e.g., fresh apples… and dried apples? Applesauce? Apple juice? Apple pie?) Other major themes that emerged include the need to align the FDA's regulations with other government initiatives to simplify compliance, and to encourage investment in innovative products that are "healthy" but also meet consumers' preferences for taste, price, and convenience.
The decision to update the definition is not without controversy, and while there is an emerging consensus on some issues, the path forward for FDA's policy-making activity is presently unclear. FDA has released guidance stating that the Agency intends to apply enforcement discretion for foods that bear "healthy" labeling and exceed the limits for total fat, provided that mono- and polyunsaturated fats are present in larger amounts than saturated fats. FDA also plans to exercise enforcement discretion for foods rich in potassium or vitamin D, despite their absence from the current regulations.
Based on the discussion at the public meeting, it could be some time before new regulations will be proposed, and there is still ample time to influence the agency's thinking. But FDA's focus could quickly shift over the coming months with a new Commissioner. And it is reasonable to expect that drafting new regulations may be a lower priority than eliminating existing ones.
© Arnold & Porter Kaye Scholer LLP 2017 All Rights Reserved. This blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.