FDA Is the Department of Homeland Security for Food and Drugs
To keep our country safe, counterterrorism efforts must be operational and effective 24/7/365. It only takes one terrorist at one specific moment to create a catastrophe.
When it comes to food and medical products, FDA is our nation’s Department of Homeland Security. FDA needs to be funded and staffed at a level that reflects our vulnerability and the potential consequences. The threat is both domestic and foreign; we need support for systems that are effective in protecting us from both sources.
Before there was a government agency that eventually became FDA, the potential for adulteration, mislabeling, and fraud was an ever-present risk at every meal and in every medical interaction. Since its founding in 1906, nearly every expansion of FDA jurisdiction and responsibilities has been in response to a national tragedy in which consumers relied upon and were harmed by fraudulent or adulterated products.
Very few Americans appreciate the challenge faced by FDA. I mentioned the 2008 Chinese milk scandal in an earlier column (column here; background here). In that scandal, an inexpensive plastic (melamine) was substituted in milk products for relatively expensive protein whey. Quality control did not pick up the switch. The problem was only detected epidemiologically because of a cluster of infants with acute kidney disease. Altogether, 300,000 children were affected worldwide.
The feedback on my column made clear that even long-time FDA-watchers don’t understand the strength of the motivation or the size of the profit that is derived from cutting corners on product quality or otherwise evading FDA regulation.
Confidence in FDA--laws, regulations, standards of identity, and inspections--enables Americans to eat safely and to trust medical products, including prescription drugs. There will always be some recalls, but the general acceptance of food and drugs as “safe” attests to the overall success of the FDA in its role of protector.
This achievement could not have been accomplished without the active participation of farmers, food companies, drug and device manufacturers, consumers and consumer advocates, food and medical product distributors, restaurants, health professionals, hospitals and clinics, as well as state and local public health departments, the USDA, and the CDC.
The large public sector portion of this endeavor is threatened by budget cuts everywhere. Notably, CDC and state and local public health departments are at risk for drastic cuts that threaten their ability to be on the frontline in protecting Americans.
For FDA, the never-quite-achievable goal of 24/7/365 protection of food, drugs, and other medical products is continually challenged by the enormity and diversity of the agency’s jurisdiction.
The agency is responsible for oversight of more than $3.9 trillion worth of food, medical products, and tobacco consumption. FDA-registered establishments total more than 129,000 domestic facilities and nearly 162,000 foreign facilities. Additionally, the agency’s regulations impact approximately 35,000 produce farms, around 300,000 restaurants and food establishments, and over 10,000 vending machine operators, as well as the entirety of medical product development, production, and distribution.[1]
Because “criminals are always identifying and exploiting new vulnerabilities...and never stop innovating,” FDA cannot sleep on its 24/7/365 responsibility for the safety of food and medical products. Here are some areas of acute concern:
Medical Product Imports. The latest report (here) from the Partnership for Safe Medicines (PSM), which tracks pharmaceutical border security, notes:
“Our analysis of large-scale commercial imports...from March to August of 2025 showed cancer drugs masquerading as antibiotics, semaglutide supposedly manufactured at a home hardware store, and over 120 kilograms of tirzepatide from unregistered facilities marked for compounding. Most of the shipments made it through U.S. ports of entry.” (emphasis added)
Low-income Consumers. Although all Americans are at risk from adulterated, fraudulent, and counterfeit food and medical products, low-income consumers are especially vulnerable.
Hungry people buy whatever sustenance they can afford from whoever can supply it. As access to government feeding support programs becomes more limited, unscrupulous manufacturers, distributors, and marketers can be expected to expand their efforts to sell cheap foods of questionable safety and value.
Likewise, individuals with significant health challenges seek relief from wherever help is offered. As the number of uninsured families and individuals increases, alternative and questionable medical providers using counterfeit, fraudulent, and unapproved products and ingredients can be expected to expand their efforts to sell less expensive products with questionable safety and effectiveness.
For food and drug products, the FDA is our nation’s Department of Homeland Security. It will never catch every bad guy or stifle every attempt to breach its protections.
However, we need to support the agency in coming as close as possible to 24/7/365 protection for the American people. Additionally, we should not make the agency’s job harder by enabling bad behaviors, lowering our standards, or undercutting FDA’s regulatory authority.
[1] These FDA facts and more are documented here; my blog column, “Behold: The Incredible Breadth, Depth, and Complexity of FDA’s Responsibilities,” is here.
--------
FDA Matters analyzes FDA policy and regulatory issues and advocates for a more effective, efficient, and fair FDA.
FDA Matters doesn't cover the news....we provide analysis of what's behind the news.
If you would like to subscribe (for free), you can do so on our website (www.fdamatters.com) or by sending a note to sgrossman@fdamatters.com. We recognize that you are busy, so we limit our content to 1-2 columns per week and ensure it is always a 5-minute read or less.