June 17, 2018

June 15, 2018

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FDA Requests Input on Reducing Regulations

In response to Presidential Executive Orders aimed at reducing regulatory burdens, the U.S. Food and Drug Administration (FDA) is seeking comments to help the Agency “identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory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.  The Federal Register notices explain that input from the public is intended to assist the Agency in implementing Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs”), issued on January 30, 2017, and Executive Order 13777 (“Enforcing the Regulatory Reform Agenda”), issued on February 24, 2017.

In each Notice, FDA provides a list of questions to help the public in providing comments. These 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  • Is the regulation still current, or is it outdated or unnecessary in some way?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  • Does the regulation contain redundant, outdated, or unnecessary collections of information or retention of records?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, is available at the links below:

Comments are due by December 7, 2017.

© 2018 Keller and Heckman LLP


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PackagingLaw.com is the premier online resource for the global packaging industry. It provides a wide range of information on laws and regulations—both in the U.S. and other countries throughout the world—that affect packages and packaging materials. PackagingLaw.com features news articles on current issues affecting the packaging industry, in-depth features, an Ask an Attorney section, links to packaging industry and government websites, and detailed information on the U.S. Food and Drug Administration (FDA) Food Contact Notification system.