March 30, 2022

President's FY23 Budget Includes Substantial Increase for FDA's Food Safety Activities

Holland & Knight Alert
Peter Tabor

President Joe Biden released his fiscal year 2023 (FY23) budget on March 28, 2022, which amounts to the administration's wish list for the executive branch in the fiscal year starting on Oct. 1, 2022. Included in the budget is $8.4 billion for the U.S. Food and Drug Administration (FDA), a nearly 34 percent increase over fiscal year 2022 (FY22) appropriated funding. The mix of funds via budget authority ($3.7 billion), user fees ($3 billion) and mandatory funding ($1.6 billion) is a clear sign of the Biden Administration's focus on ensuring food, drug and medical device safety, as well as using lessons learned from the COVID-19 pandemic to prepare for future pandemics.

In his statement accompanying the release of the Biden Administration's FY23 budget, FDA Commissioner Robert M. Califf stated, "The FDA has focused our budget request on some of today's most urgent needs such as human and animal food safety, medical device security and e-cigarette oversight." For makers of human and animal food intended to be sold and consumed in the United States, the president's budget request for the FDA is a clear indication of the Biden Administration's intent to enhance FDA's surveillance and compliance efforts, improve its cooperation with state and foreign government agencies to conduct these activities and to increase its utilization of new technologies to identify and address instances of food safety lapses.

The FDA proposed budget requests $76 million in additional funding to enhance food safety efforts. The agency states that its food safety efforts will continue to "use the latest technologies to identify foodborne illnesses, prevent them from reoccurring, and remove implicated products from the market." Coupled with the FDA's proactive food safety efforts under the updated provisions (enacted under the FDA Food Safety Modernization Act, or FSMA) of the Food, Drug and Cosmetic Act (FD&CA), domestic and foreign produce, packaged food and ingredient makers of both human and animal food should be aware of and prepared for continued and vigilant regulatory oversight by the FDA and entities with which it has contracts or cooperative agreements. Such entities include state agencies and, in the case of foreign foods, foreign government agencies and private entities authorized to conduct FDA inspections. The FDA estimates that well over half – and up to two-thirds – of FSMA compliance and enforcement activities will be conducted by state officials acting pursuant to a contract or cooperative agreement with the agency.

From recognizing the limits of FDA authority under existing regulations to appreciating the new technologies FDA has at its disposal to address and prevent foodborne illness, clients should take a strategic approach to understanding and influencing FDA's policy and regulatory agenda as the FY23 budget process gets underway.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.

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