Food and Drug Administration’s 2013 Budget Proposal Could Increase Food Manufacturer Fees, if passed
In an effort to ensure the safety of the United States’ food supply, the Food and Drug Administration (FDA) plans to increase the number of inspections and enact other safety measures to test the quality of foods and beverages exported into the United States. Each year the Department of Health and Human Services (HHS) proposes a budget for Congress to approve. This budget details how much the department is going to need for each of its agencies. As part of the budget for Fiscal Year 2013, the HHS requests $4.5 billion for the FDA. This number constitutes a 17 percent increase over the 2012 budget.
One of the main reasons for the large increase in the proposed budget is the new Food Safety Modernization Act (FSMA) enacted in 2011. FSMA largely escalates the responsibilities of the FDA—increasing the number of yearly inspections, granting FDA food recall power and other services to protect the public. In fact, FSMA spells out the number of domestic and foreign food facility inspections the FDA must perform every year for the next five years (see table). FSMA demanded the FDA inspect at least 600 foreign facilities in 2011 and double the quantity each year until 2016. This increase in inspections, along with other increases in FDA services, will result in a greater demand of the FDA’s funds. The Agency hopes to meet this need with an increase in personnel and resources.
FDA plans to acquire part of the additional financing for their 2013 budget by issuing two new user fees to be paid by food manufacturers (in addition to the re-inspection fees issued in 2011). The FDA will acquire 220 million dollars of the budget from new food registration and inspection fees (Source). These fees will be similar to current medical device registration fees paid by medical device manufacturers.
So what do these fees mean for your food company? The answer is nothing yet. Food manufacturers should note that these fees are just in phase one of the legislative process. They are not set or required as of now. This budget proposal must be approved by Congress before any fees are issued. If Congress passes the FDA budget, the legislation will include detailed instructions as to how the fees will be collected. Like with FSMA, the FDA will likely issue a guidance documents for these fees if they are approved.
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For questions related to U.S. FDA fees or any U.S. FDA regulation, you can contact Registrar Corp 24/7 at www.registrarcorp.com/livehelp or call us at +1-757-224-0177.