The Food and Drug Administration (FDA) has broad authority, big budgets, experts, and a mission that matters. A big part of their mission is food safety – for health and national security. The current baby formula crisis, a shortage driven by contamination and slow FDA action, is a warning: the FDA is behind the curve and must be proactive. Ditto for the entire federal government.
Recent investigations suggest the FDA is – like much of the federal government – in that “good enough” mindset. Only “good enough” is not good enough. Across government, “good enough” leads to policy, program, budget, and mission failures. This is not a secret and it’s not getting better.
Having once been Chief Counsel to the U.S. House Oversight Committee’s investigative subcommittee focused on Defense, State, Justice, and NASA, my perspective is shaped by what is possible – not what passes for acceptable, not what is okay because it’s not criminal.
Taxpayer accountability is what is missing. As with oversight of baby formula supply – which now appears to have been inadequate, untimely, inconsistent, and slow to resolve – other parts of government are missing the mark.
At State, “withdrawal preparations” out of Afghanistan were “good enough,” deterrence of Russia’s invasion into Ukraine was “good enough.” At Defense, morale, readiness, and ballistic missile protection are – somewhat frighteningly – “good enough,” despite hypersonic missiles.
Closer to home, in one year, the Government Accountability Office (GAO) just added seven new “high risk areas,” where things have gotten measurably worse – on top of those already sliding. Thus, new urgency is attached to cybersecurity, the Post Office, the Environmental Protection Agency (EPA), Census, and Human Capital Management (across government), plus Health and Human Services and prison management.
These weaknesses come on top of unresolved high-risk issues at 38 other federal departments, bureaus, and agencies, from Defense, small business, surface transportation, information technology, energy sector management and Veterans’ care to the multi-agency failure in stopping exponential growth in drug abuse, addiction and overdoes (diffuse responsibility, finger pointing, loose accountability, low priority).
So, stepping back 20 paces, what we are seeing nationwide on baby formula shortages, based on a major missed cue last September, slow response, and a boatload of excuses – is not uncommon. High risk areas exist across the government, and of course the missing pieces are leadership and accountability.
So, what exactly is wrong at the FDA? And then, more broadly, how do you fix erosion of leadership and accountability? At the FDA, the issues are several and well known, just ask the non-partisan GAO. The FDA needs “leadership commitment” for starters, as “federal agencies have not developed a national plan or strategy for food safety” and “Congress has not directed the Office of Management and Budget (OMB) to develop a government-wide performance plan for food safety.”
Of course, having a plan and directing it to exist is just a start – it then must be responsibly, swiftly, and effectively implemented. What else does the GAO show missing at the FDA? Lots, such as internal capacity, action plans, program monitoring, and seriousness of remedies.
The GAO says bluntly: “The safety and quality of the U.S. food supply, both domestic and imported, are governed by a highly complex system stemming from at least 30 federal laws that are collectively administered by 15 federal agencies” and “we have long reported on the fragmented federal food safety oversight system, which has caused inconsistent oversight, ineffective coordination, and inefficient use of resources.” Boom, tick.
What does all this mean? At the FDA, it should mean get yourself in gear and move out. Is it better to nurse a baby formula crisis or prevent it? Is it better to get ahead of domestic or foreign supply contamination – let alone intentional contamination – or wait?
Obviously, since we have the ability, the goal should be 100 percent food safety. Is that not what tax dollars are for? If we cannot all run a farm, we should have an FDA that runs food safety.
You reverse poor leadership with good leaders. You assure accountability by demanding it – having Congress demand it, doing real oversight, not playing political games, and then rallying citizens to demand accountability.
In the end, the baby formula debacle was preventable – and by whom? Biden’s FDA and a Congress doing their job, namely, hands-on, real-world, and proactive government oversight.
Net-net, the shortage we face may be less about baby formula than national leadership, federal accountability, and congressional oversight…But for now, let’s just hope the FDA can end this unnecessary crisis and get the bottle back to half full or better. “Good enough” is not good enough.
While American babies go hungry (is that why there was no 2% milk at the store?…not good), biden and harris have stockpiled pallets of formula at the border to be given to illegals sneaking into the country. OMG.
I’ve made the comment before, but the obvious remedy for new mothers is to breastfeed their babies. If you can, do. This will free up some of the demand for formula for those mothers or caregivers who can’t. If you started and then quit, ask your doctor about trying again. Besides, it’s much healthier for both mothers and babies–not to mention, natural–and it doesn’t cost a penny. I heard about a nursing mother who is offering her milk for $1.00 per ounce. Never in my dreams would I have thought of this “commodity” as an entrepreneurial resource. But there you have it; these are crazy times.
… no shortage of baby formula for Biden’s bestest buddies, the Mexican Drug Cartels –
Great article. I agree wholeheartedly. I trust the FDA, CDC and all the alphabet of government agencies as far as I can throw them. What have you done for me lately? NOTHING!
The is no formula shortage except in the USA. We sent it to the border for the illegals. FYI, go to Amazon, change your status to Canada, and order it. It will come to the US. If you Dems like what is going on, keep voting for these Anti-American Dems. Otherwise, wake up and vote differently. MAGA!!
Good Enough is not good enough. That’s what the Russian and Chinese strive for and seldom achieve it. Americans need to strive for Excellence!
We need to privitize every governmental function possible. With no profit motive (and being accountable to NOBODY), incompetence
I would like to know what action has been taken since the Abbott plant was shutdown? It has been 12 weeks since closure, what has FDA and Abbott been doing?
DICTATOR Beijing biden’s FAULT ALL THE WAY.
NO MORE SNOW FLAKE EXCUSES and LIES.
Mr. Charles, I agree the “baby formula debacle was preventable” and that the FDA and Biden administration are responsible. However, I strongly disagree with your analysis of the cause and proposed remedy. Having worked in the private sector my entire career, I would like to offer an alternative view.
Despite questioning their leadership, you assumed the FDA is truthful regarding contamination of powdered infant formula (PIF) manufactured by Abbott Nutrition, a product sold domestically and internationally. Without offering any evidence to support the claim, you even imply that there was “intentional contamination,” (my emphasis).
You scold the agency for failing to act in September 2021, after receiving one (1) report of a possible infection, suggesting the FDA acted reasonably by forcing the plant to halt all manufacturing following four (4) consumer complaints, from four (4) states, over a period of four (4) months, related to Cronobacter sakazakii (or Salmonella Newport) in infants who had consumed PIF manufactured at the Sturgis facility. There is a shortage of baby formula because the FDA used a chainsaw instead of a scalpel to address a potential problem.
For historical context, in the two (2) month period of November 1, 2011, to January 13, 2012, the CDC was notified by four (4) states of four (4) infants infected with Cronobacter sakazakii, possibly related to consumption of PIC. The circumstance was eerily similar to the reported cases this year. In 2012, the CDC and FDA acted in a manner responsible to consumers and manufacturers, evaluating the products and facilities without a “presumption of guilt” forced shut down.
According to the CDC website, Cronobacter exists in the environment and “has been found in a variety of dry foods, including powdered infant formula, skimmed milk powder, herbal teas, and starches. It has also been found in wastewater.” Also per the CDC, Cronobacter infection is rare, and the CDC “typically receives reports of 2-4 infections in infants per year,” (my emphasis), indicating that, based on historical precedence, there was no cause for alarm this year. Finally, regarding the association of Cronobacter infection with PIF, the CDC states, “Since the bacteria live in the environment, it’s possible there are other sources of infection,” (my emphasis again). As anyone who conducts research knows, correlation does not equal causation.
As you and the GAO observed, the FDA is a bloated, unaccountable, redundant bureaucracy, superannuated to the food safety authority of the States. Instead of continuing to insist that the agency reform itself, it’s time to return the ultimate authority to the States and the citizens.
Maybe have a state version for oversight, federal doesn’t seem capable of handling anything right.
I think what it was which finally snuffed what little confidence I had left in America’s institutions and bureaucracies, the two Moderna jabs the policy community arm-twisted me into. One year later, I’m still bouncing back. Still, not quite 100%, I’ve never been the same guy, since.
The Federal bureaucracy is more concerned with power than service, since Obama installed political supporters in all agency management positions. Then Obama added to the power of the socialist leaning public employee unions. These vermin, like termites eating a dead tree, erode the civil rights of the citizens with a defiant arrogance. While long sentences in Federal prison would be justice, they should be allowed to retire if they leave peacefully.
This is all planned by the enemies of the USA Constitutional Republic! The tragedy is that there are many – a majority of “government employees” who just want to keep their gravy-train jobs and lifetime retirement!
If they knew about it in Feb Id say Yes
Yes, it’s reprehensible. It was completely avoidable. One plant shutting down just means the others pick up the slack. Good grief.
All part of Butthead Bidens’ plan. Just like when he made the remark ‘there’s going to be a food shortage’ and next we heard there were 20 food processing plants on fire. What a coincidence!!!!
Now what did our parents and grandparents/great grandparents do for milk for the babies? We were stationed at an outpost in Germany in 1975-1977, no “formula” in the outpost commissary, drove to Nurnberg, none there. Drove to Grafenwoer, none there. Chief Warrant Officer at outpost stated military is telling mothers with babies to buy canned PET or Carnation Evaporated milk, follow instructions given by military such as amount of water, KARO light syrup, drops of iron in bottles, shake good, and baby would be fine. When it’s time for a “cereal”, that can also be added to the bottle. When those supplies run slim, make a phone call to family in the US, they can ship a case or two of Evaporated milk to you. A recipe for the PET milk for babies can be found on google/PET milk, etc. Folks, you need to be thinking outside the box, don’t have tunnel vision. Don’t rely on our government as they are useless right now. Both of my children were raised from birth on the PET Evaporated milk recipe, they are healthy and alive, 39 and 45. Ask your doctor and pediatrician.
Contamination?!??
For the last two weeks, we’ve been led to believe that there’s incoming illegals, down at the border, receiving plenty of baby food while everywhere else in the country, it’s the supply-chain!
So, are they actually now sending contaminated baby food to the border too?