FDA Issues 2018 Strategic Policy Roadmap

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The Food and Drug Administration (FDA) issued its 2018 Strategic Policy Roadmap (the Policy Roadmap) in an effort to provide the public with insight into select key priorities of the FDA for 2018.  While the document is not meant to serve as an exhaustive list of the policies that the FDA will implement in 2018, the Policy Roadmap highlights different actions the FDA intends to take (e.g. finalizing policies, launching public campaigns and establishing regulatory frameworks) across various areas including Opioid abuse, combustible cigarettes, generic drug competition, food safety and nutrition.

One of the key initiatives highlighted in the Policy Roadmap is the FDA’s Nutrition Action Plan which consists of numerous actions to be taken by the FDA including issuing guidance and launching a public education campaign regarding the menu labeling regulations and updates to the Nutrition Facts label as well as revising requirements for select label claims including the contested “healthy” nutrient content claim.  The FDA’s goal of the Nutrition Action Plan is to provide consumers with the information needed in order to assist consumers in their food making choices.

Over a year ago the FDA had requested comments in connection with their redefinition of the claim “healthy” on conventional food products. Current interim guidance on the subject matter provides that the FDA would use enforcement discretion on the use of “healthy” claims for food products that do not meet the definition of the current regulation but meet certain other criteria with a focus on types of fat as opposed to amount of fat. More settled guidance from the FDA is eagerly anticipated by the industry.

The FDA also intends to update certain Standards of Identity for food products (i.e. requirements that determine what needs to be in a conventional food product in order for such product to be marketed under a specific name – such as milk or yogurt).  Due to innovations such as plant-based dairy products (e.g. vegan cheese) many manufacturers and consumers are looking to the FDA for further guidance.

Although the Policy Roadmap does not provide a timeline within which the actions will be taken, nor is it a complete list of the initiatives to be taken in 2018, it serves to highlight certain issues which remain of focus for the FDA.

You can read the FDA 2018 Strategic Policy Roadmap for details on these and other initiatives.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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