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FDA Requests Input on Reducing Regulations - September 12

  • As previously reported on this blog, the White House issued Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs” on January 30, 2017. A few weeks later, on February 24, 2017, the White House issued Executive Order 13777, which directs each Agency to establish a Regulatory Reform Task Force (RRTF) to evaluate existing regulations and identify those that may merit repeal, replacement, or modification. To assist with implementation of those orders, the U.S. Food and Drug Administration (FDA) asked for input on how the Agency can “can change our regulations to achieve meaningful burden reduction while continuing to achieve our public health mission and fulfill statutory obligations.”

  • FDA’s call for public comments appeared in seven, separate Federal Register Notices published on September 8, 2017, one directed to each of the FDA Centers, as well as one applicable to general regulatory and information collection requirements that affect multiple FDA Centers. In each Notice, FDA provides a list of questions to help the public in providing comments. The questions include:

    • Is the regulation still current, or is it outdated or unnecessary in some way? (This could be due to scientific advances, duplicate regulation, etc.)

    • Have regulated entities had difficulties complying with the regulation?

    • Does the regulation impose requirements that are also provided for in voluntary or consensus standards or guidance by third party organizations (e.g., International Council for Harmonisation, International Organization for Standardization, Codex Alimentarius)?

    • Does the regulation contain redundant, outdated, or unnecessary collections of information or retention of records?

    • Could the goal of the regulation be achieved by less costly means that would provide the same level of public health protection?

    • What factors should FDA consider in selecting and prioritizing regulations and reporting requirements for reform?

  • More information, including how to submit comments (which are due by December 7, 2017), is available at the links below:

  • This is the first request by FDA on how to reduce regulations in response to the Executive Orders mentioned above. However, the Department of Commerce (DOC) asked for input on the impact burdensome Federal regulations this past March.  We discussed some of the responses from the food industry to that request on our April 4, 2017 blog. These included the compliance date for the Nutrition Facts Panel and too broad of a definition for “produce” in the FSMA Produce Safety Rule.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...