The U.S. Food and Drug Administration (FDA) has issued a broad request for comment to assist the agency in identifying regulations and related paperwork requirements that it could modify, repeal, or replace to reduce the regulatory burden on the public. The request is specific to products within the jurisdiction of the Center for Food Safety and Applied Nutrition (CFSAN) (i.e., human food, dietary supplements, and cosmetics) and presents a unique opportunity for industry to identify regulations and/or information collection (paperwork) requirements that are outdated, ineffective, or unnecessary; impose costs greater than their associated benefits; or limit job creation.

FDA issued the request as part of its implementation of Executive Orders (EOs) 13771 and 13777. EO 13771, entitled “Reducing Regulation and Controlling Regulatory Costs,” states that it is the policy of the executive branch to be prudent and financially responsible in the expenditure of funds from both public and private sources and to manage the costs associated with the government imposition of private expenditures required to comply with federal regulations. EO 13777, entitled “Enforcing the Regulatory Reform Agenda,” directs each agency to establish a Regulatory Reform Task Force to evaluate existing regulations and make recommendations regarding their repeal, replacement, or modification. The information the public submits in response to the request for comment will supplement FDA’s review of its regulations.

This post summarizes FDA’s requests and the specified formatting and instructions for providing comments.  Read more. 

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Photo of Joe Levitt Joe Levitt

Partner, Washington, DC

As the FDA’s former top food regulator, Joe Levitt brings a true insider’s knowledge to helping food industry clients deal effectively with the FDA. Whether influencing policy making or confronting a threatened compliance action, Joe’s 25 years of FDA experience puts clients in the best position to succeed.  In the private sector, Joe was on the ground floor when Congress developed the landmark FDA Food Safety Modernization Act (FSMA). Joe was also a leading voice for the food industry when the FDA developed regulations that all food companies must now follow. No one can help navigate the labyrinth of FDA’s FSMA regulations better than Joe and his team, and no one can better put your company in the driver’s seat when the FDA inspector knocks on your door for your first FSMA inspection.

Joe adeptly handles high visibility recalls and compliance actions. If a company finds itself in trouble with the FDA, they need someone with a deep insider’s understanding of what works and what doesn’t. Joe knows what the agency expects in the compliance arena, and the bar clients will be expected to meet. He can communicate his client’s position calmly and effectively to the FDA so the matter gets put behind them. His record of “helping startups and multinational companies… survive Food and Drug Administration investigations and avoid import bans that could shutter the companies,” led to Joe being named a Law360 Food & Beverage MVP (2016).

Joe is among the most decorated officials in FDA history, with his achievements being recognized by multiple U.S. presidents, cabinet secretaries, and FDA Commissioners. He maintains close working relationships with senior FDA officials and has served as the Board Chair of the FDA Alumni Association.

Photo of Leigh Barcham Leigh Barcham

Associate, Washington, DC

Leigh Barcham provides business-oriented legal and policy solutions to food and agriculture companies and trade associations. She advises clients on state and federal regulatory issues that may arise throughout the entire food production line from farm to table. Leigh also guides clients in consumer products industries as they navigate federal advertising laws and regulations.
When she joined Hogan Lovells, Leigh brought with her more than five years of public policy experience. A part-time student by night and a law clerk by day, Leigh worked throughout law school at a firm in Washington, D.C., focusing on legislation and federal regulation affecting the energy industry. Before law school she served as a policy analyst for international affairs and climate change at the White House Council on Environmental Quality.