Is The FDA Plagued By Inadequate Funding?
By Laurel Maloy, contributing writer, Food Online
In the month of March, only 29 FDA warning letters were sent to the nation’s more than 30,000 food processing facilities
The Food and Drug Administration (FDA) issued a total of 29 food-related warning letters from March 3 through March 28, 2014. Ranging in severity, these letters were issued as the result of inspections occurring from last December through early-March 2014.There were also two letters addressing inadequate corrective actions and responses to warning letters issued as far back as last September. The bulk of the letters were for violations of Hazard Analysis and Control Point (HACCP) and Current Good Manufacturing Practices for Foods (cGMP) at Seafood facilities. As a whole, these same letters also cited adulterated food and unsanitary conditions.
cGMPs are fully defined in Title 21, Code of Federal Regulations, Part 110 (21CFR Part 110) with related regulation in section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). HACCP regulation and guidance can be found here.
None of the FDA warning letters addressed noncompliance at large food producers, manufacturers, or dairies. In fact, none were for Fortune 500 companies or any of the top 100 Food Processors in the U.S. This may be an indication that, in fact, the smaller food processing companies will have a much greater distance to travel in terms of aligning with the Food Safety Modernization Act (FSMA).
Or it may be the fact that inadequate funding limits the number inspections the FDA is able to perform. It is a reasonable assumption that the largest companies have the means and the impetus to comply with current regulations, leaving the FDA inspectors to concentrate on those that may not. However, some of the most large-scale and more recent foodborne illness recalls, involved Tyson and ConAgra.
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One has to wonder how the FDA can possibly keep up with the enormous number of food processing facilities in the U.S. According to the most recent comprehensive Census Bureau data in the 2007 Economic Census, there are approximately 30,000 establishments owned by 24,500 companies or individuals.
The FDA’s FSMA means sweeping changes to a broadly defined and impossible to administer system for protecting the American consumer from foodborne illnesses. Recently, the Center For Science In The Public Interest (CSPI) published its Outbreak Alert! 2014 and mentioned Congress’ failure to fund the FDA’s efforts to bring FSMA to fruition here. President Obama has given the nod to the necessity for better food safety regulation, but Congress has not put their money where the President’s mouth is. The FY2015 budget barely mentioned the FDA and FSMA.