Fixing What's Broken At the FDA, Part I
It's not a partisan issue, but it will take focus and creative leadership, two things both the Biden Administration and Congress lack. Here's where to start.
Which federal agency is most intimately involved in your life (that you’re not working for)? The answer may surprise you. If you’re reading this from a federal prison or court bench or sitting across from an IRS auditor (I’m sorry), you’d understandably answer otherwise.
It’s the Food and Drug Administration (FDA). Everybody eats - including your pets - and drugs and dietary supplements are ubiquitous. Except for nearly all meat and poultry - those fall under the US Department of Agriculture - the FDA regulates and/or inspects every food and beverage product you (and many pets) consume, domestic and imported. There is an exception or two, such as “open-faced sandwiches” or egg products (both USDA). And they both regulate what companies include or claims they make on labels, including a list of approved synonyms.
Maybe you’re beginning to see the problem.
And sometimes the FDA and the USDA fight over which will regulate emerging new product categories, like cell-cultured products. They both regulate that new industry (the new industry had asked for just the FDA). Which means they’ll probably strangle it. And don’t get me started on the regulation and labeling of genetically modified foods (or, the government’s preferred term of art, “engineered”).
We are the only developed nation in the world with such a bifurcated food safety system. Eighty percent of our foods are regulated by an agency - the FDA - which receives about 20 percent of all federal resources dedicated to food safety. The other 80 percent mostly goes to the USDA, which inspects and regulates about 20 percent of our food supply. Food safety outbreaks are just as prevalent among the FDA regulated as they are with USDA products, if not more so. No one seems to agree on just how many federal agencies are involved in food safety, in total. The best guesses are at least a dozen.
And the underlying “science-based” systems used by each agency are radically different. Under laws passed by Congress during the Great Depression, the USDA “continuously” inspects every meat or poultry product. Imagine a USDA inspector watching a line of processed chickens speeding atop a conveyor belt. A USDA inspector is there to eyeball each one, every shift, as they’ve done since before World War II. But a potato chip factory? Also under a separate Depression-era law, FDA has no such requirement. An FDA inspector - often a state health or agriculture department inspector on behalf of the FDA - shows up to inspect that facility once every five years or so, depending on how much food safety “risk” may exist. Potato chips aren’t very hazardous. Except maybe to your waistline. USDA inspectors who work at some 6,000 facilities outnumber their FDA counterparts, who regulate a universe of about 53,000 factories and farms about 10-1.
And then there are the facilities that process both FDA and USDA-regulated products. Like frozen pizza, or soup. The USDA inspector probably has a dedicated parking space out front of the factory. They’ll focus on how pepperoni pizza is being processed, or a line of canned beef chili. But if the plant is making cheddar cheese soup or cheese pizza on the next line? Not my job, the USDA inspector will say.
Ask any plant food safety or quality official which agency they’d rather have inspect such dual-jurisdiction plants, and they’ll often say, “USDA.” Why? Because they’re always there, they know them and they’ve learned to work with (and trust) each other. The FDA inspectors that show up every few months (or years) are too frequently first-time visitors who put employees through all kinds of hoops and are sometimes hostile. “Just give me one agency to work with,” food quality workers have occasionally volunteered to me.
This brings us to infant formula, which actually does have one agency in charge. You know about that crisis, especially if you have been nervously driving from store to store to find a special formula for your infant. It’s been hard to find this year.
America is the only nation experiencing such a problem today. Why is that? You can thank the FDA in large part, for three primary reasons.
First, the FDA was slow to act on whistleblower reports about maintenance issues at an Abbott Laboratory facility in Sturgis, Michigan. One of the nation’s largest manufacturers of infant formula (think Similac). When they did finally act, they took months to work with Abbott and the plant to investigate and resolve issues. FDA took public shots at Abbott, which fired right back. The plant finally reopened weeks ago, only to close again after severe storms caused drainage systems to back up into the plant. It quietly reopened again about a week ago.
Second, FDA shut down routine inspections of most food plants during the pandemic.
Third, FDA, until very recently, rejected imports of perfectly safe and acceptable infant formula, especially from the European Union. I’ll let the CATO Institute describe the problem, which also includes tariffs to protect the US dairy industry:
Making matters even worse, infant formula is subject to onerous U.S. regulatory (“non‐tariff”) barriers. For example, the FDA requires specific ingredients, labeling requirements, and mandates retailers wait at least 90 days before marketing a new infant formula. Therefore, if U.S. retailers wanted to source more formula from established trading partners like Mexico or Canada, the needs of parents cannot be quickly met because of these wait times. Businesses also have little incentive to go through the onerous regulatory process to sell to American retailers, given the aforementioned tariffs and the relatively short duration of the current crisis.
The European Union (EU) is especially noteworthy in this regard. Many parents demand formula from the EU not only because of the current scarcity but because European formula meets other preferences, including a perceived higher quality, and more varieties like goat’s‑milk-based formula. Technically, it is illegal to import baby formula from the EU for commercial purposes, but parents can (and do) import it for personal use. Recently, the FDA recalled some European infant formula because it did not comply with FDA labeling requirements. It is agreed by many medical experts that the differences between American and European formula are minor and are not worth the expense imposed by these regulations.
Except the federal government can and has confiscated your EU-made formula because it violates nutrition labeling rules. Nothing to do with safety or quality. Except now they are using “enforcement discretion” to allow such formulas into the US unmolested. For now.
The FDA is taking well-deserved hits for its inept and sclerotic handling of the infant formula issue. The FDA often does take hits from consumer activists and others when they fail to act or make mistakes, especially on food safety and labeling rules and actions. And when they do, here comes the FDA’s predictable response - more power and money, please. FDA Commissioner Robert Califf mentioned precisely that in a recent speech to the Food & Drug Law Institute (emphasis added):
I want to be clear: the infant formula shortage on our shelves was multifactorial, including loss of focus on quality by a major company, market concentration, supply chain resilience issues, and inadequate federal authorities to assure vital supply chains. However, the crisis also reveals shortcomings at the FDA, including structural and organizational deficiencies, process insufficiencies, communication barriers, technological inadequacies, chronic underfunding, and in some cases a lack of congressional authority to allow us to do what is needed to assure an adequate supply of safe and nutritious infant formula.
The FDA and the USDA already have enormous power. Much of it comes from the biggest expansion of the FDA’s powers since its creation with the enactment of the Food Safety Modernization Act of 2011. In the face of several foodborne illness outbreaks and food safety enforcement concerns, the FDA persuaded the food industry (I was a food lobbyist at the time) that they needed the same broad powers enjoyed by the USDA. They won the power to require all food manufacturers involved in interstate commerce to register with the FDA. They won mandatory recall authority, even though you could count the number of recall demands refused by companies on a single hand with fingers left over. Nearly every company that experiences a problem initiates its own recalls and then informs the FDA. Refuse a recall request by the FDA? All the FDA needs to do is issue a press release warning consumers about company A and its product B. There go sales and reputations. The trial lawyers representing any harmed consumers are never far behind.
The fact is, and remains, that food makers have the most incentive to produce safe foods. Taking shortcuts and risks with food safety is Russian Roullette and an invitation to serious jail time.
The legislation launched a series of seven major regulatory rules to change the FDA’s food safety focus from responding to outbreaks to preventing them. That may appear admirable, but it meant the FDA spreading its tentacles throughout the food supply chain to regulate things in farms and factories that they know little about. The food industry - to whom the FDA turned to help write those rules - was concerned about two things: food safety issues at often smaller companies that lacked the internal safety protocols used by larger brand-name companies, and a growing lack of consumer confidence in the FDA. The agency saw its budget and staffing increase, but guess what didn’t go down, at least since the law was passed?
Talk to almost anyone involved in food issues - whether in industry or a consumer advocacy group - and they all say the same thing: if we sat down to design a food safety regulatory system, it would not look like the current one. But to paraphrase Winston Churchill, America’s food safety system is the world’s worst, except for all the others. And for a lot of people at the agencies, their regulated industries, and especially the lawyers and lobbyists who work with them, they’re happy to keep it that way.
Our patchwork and over-layered system is still based on those Depression-era laws, with periodic expansions and billions more dollars. Very few in Congress - I can think of only two, maybe three - who have any real interest in, much less knowledge of the FDA’s food regulatory system (drug regulations and approvals, the sexy part of FDA, is a whole other can of worms).
The good news is that except for incidences of FDA ineptness demonstrated by the infant formula crisis, our system mostly still works. Most Americans trust our food safety system, for all its flaws, over any other country’s. But avoidable incidences, such as what occurred in Sturgis, Michigan, will continue to happen without structural changes if not a reinvention of food safety regulation and enforcement. And dozens of commissions and studies have been recommending them since the famous first Hoover Commission on the organization of the Executive Branch of government that concluded in 1949.
Part II will talk about the first major step: creating a single food safety inspection agency.