Reagan and Carter Were Both Right About Washington

The infant formula crisis is just the latest example of a crisis exacerbated by a federal agency. The FDA appears to have other priorities. Read on for an delicious example.

It was a cloudless winter day in Washington, DC, on January 20, 1981, when Ronald Reagan, having just been sworn in as the nation’s 40th president, uttered these oft-quoted words from his historic inaugural address on the Capitol’s west front.

“In this present crisis, government is not the solution to our problem; government is the problem. From time to time we’ve been tempted to believe that society has become too complex to be managed by self-rule, that government by an elite group is superior to government for, by, and of the people. But if no one among us is capable of governing himself, then who among us has the capacity to govern someone else?”

It was a stinging rebuke of the President he had just succeeded, Jimmy Carter, who just 18 months before had attributed a myriad of problems from gasoline shortages, national security failures in the Middle East, economic stagflation, and other maladies to a “crisis of confidence” by the public. He thought he could stir America with a speech to the nation.

Voters had another idea. They responded less than 16 months later by giving Reagan one of the most significant electoral college landslide victories in American history, especially against an incumbent president.

Carter was right, however, about one thing in his July 15, 1979 “malaise” speech that is also remarkably relevant today:

“Looking for a way out of this crisis, our people have turned to the Federal Government and found it isolated from the mainstream of our nation’s life. Washington, D.C., has become an island. The gap between our citizens and our government has never been so wide. The people are looking for honest answers, not easy answers; clear leadership, not false claims and evasiveness and politics as usual.”

Fast forward to 2022. False claims, evasiveness, and politics as usual dominate a federal government that is not only isolated from the mainstream of our nation’s life but often from reality itself. The self-proclaimed “party of science” espouses that biology is bigotry and doesn’t tolerate deviations from its Orwellian ideology. And sadly, it has infected a few state capitals, as evidenced by reactions to the pandemic in cities like Harrisburg, Albany, Lansing, Sacramento, and Trenton.

As in 1980, when Americans gave Republicans control of the US Senate and a net 35-seat gain in the US House, watch for a reprise of those political sentiments in November.

The latest examples of false claims, evasiveness, and politics as usual from our government betters are too long to mention, but a recent one will suffice: Babies and Formula.

The party that pushed legislation last week to make it easier to terminate unborn children is now endangering infants. Or, as the Washington Examiner succinctly put it, Senate Democrats spent last week “fiddling about with legislation that would kill babies rather than feed them…”

The source of the well-publicized shortage of baby formula is increasingly focused not on post-pandemic supply chain concerns but on the Food and Drug Administration. The FDA is slow-walking opening of the nation’s largest baby formula factory in Sturgis, Michigan, owned by Abbott Laboratories. The good news is that the sclerotic agency last night finally agreed on a plan to restart production.

To be clear, the FDA doesn’t “approve” the manufacture of infant formulas. However, manufacturers must meet specific standards to register with the agency, which the FDA can revoke. That’s akin to pulling your license to operate. Try making formula without an FDA registration. Enjoy the media coverage and product recalls, not to mention possible federal prosecution.

“A whistleblower identified concerns to the FDA in October, but the FDA didn’t inspect the plant until January,” reported RedState.com. “In February, after four babies were hospitalized and two died, the plant was shut down out of contamination concerns. Since then, there seems to have been no rush to facilitate a process for reopening safely. It’s now May, and the plant still isn’t open. Abbott is the largest producer and is responsible for almost half the supply of formula produced in the country.”

But after an exhaustive investigation, there is no evidence that the Sturgis-made formula resulted in death from a rather ubiquitous pathogen. But that didn’t stop White House press secretary Jen Psaki from asserting that there were “babies who died as a result of taking this formula” on her last day before joining the Russia collusion hoaxers at MSNBC.

Credit Abbott for pushing back with the facts. Yep, Psaki is ready for the cameras at MSNBC. Psaki blamed Abbott, not the FDA, for formula shortages.

The largest purchaser of infant formula is the US Department of Agriculture for its Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). How that program works for infant formula manufacturers, awarding monopoly contracts in exchange for significant discounts (rebates) by state WIC affiliates, is a story for another day. Infant formula sales topped $6 billion in the US last year.

Meanwhile, immigrants crossing the Rio Grande into the US appear to have no such infant formula supply issues. US Rep. Kat Cammack, R-FL, has evidence.

Abbott isn’t the only company being falsely maligned by the White House. Just ask energy companies. President Biden blames energy companies for price gouging. At the same time as gas prices reached new zeniths, the White House canceled Alaskan oil leases last week, claiming a lack of interest by oil companies. Oil companies pushed back.

A visit two weeks ago to a rural French pharmacy for a Covid test - still required for air travel back to the USA - revealed shelves brimming with infant formula. Why not import infant formula from countries with equivalent safety and nutritional standards to ours? Reason.com gives us two reasons:

“…imports of infant formula are subject to tariff-rate quotas of 17.5 percent after certain thresholds are met. As the name suggests, tariff-rate quotas are meant to be set high enough that they effectively block additional imports by making it unprofitable to pay the tariff. In a year like this one, when domestic supplies are flagging and more formula is needed, that creates a serious impediment for suppliers.

“But even if importers and consumers were willing to swallow those higher costs right now, they might be prohibited from having that choice. Last year, for example, the FDA forced a recall of approximately 76,000 units of infant formula manufactured in Germany and imported into the United States. The formula wasn't a health or safety risk to babies but merely failed to meet the FDA's labeling standards. In this case, the products were banned for not informing parents that they contained less than 1 milligram of iron per 100 calories.”

The Biden Administration claims they are going to facilitate imports. We’ll see. Meanwhile, as it slowly agrees to reopen the Sturgis facility, the FDA wasted no time in a letter dated April 22nd affirming a new “medical device.” From the New York Post:

“A first for undies, the US Food and Drug Administration has authorized prophylactic panties for oral sexually transmitted infections.

“The ultrathin, synthetic, flavored underwear from Lorals prevents your lover from biting off more than they can chew, so to speak, by not leaving you or them with an STI.

“‘Oral sex is not totally risk-free,’ Dr. Jeanne Marrazzo, director of the division of infectious diseases at the University of Alabama at Birmingham, told the New York Times.

“There is an increased need for extensive protection, especially as “teenagers are initiating their first sexual activity with oral sex,” Marrazzo explained. But even for sexually active people of all ages, using protection can “reduce anxiety and increase pleasure.”

Priorities.

No, the issues are not directly related. Yes, medical devices are approved by a different part of the FDA under laws and regulations other than baby formula, which is highly regulated by the Center for Food Safety and Nutrition (CFSAN). FDA’s third major branch is the Center for Drug Evaluation and Research (CDER). But America’s puzzlement over the agency’s modus operandi is justified as we read these two stories last week.

The House Energy and Commerce Committee is now “investigating” the crisis, between visits to the new liquor store in the Rayburn House Office Building and free Peloton workouts. At least some staff will soon collect bigger paychecks as they are considering joining a union.

And just to confirm how out of touch the Nancy Pelosi-run House has become with “kitchen table” concerns, US Rep. Andre Carson (D-Indianapolis) today is chairing a hearing of the House Intelligence Committee’s subcommittee on counterterrorism, counterintelligence and counterproliferation, on . . . wait for it . . . UFOs. Remember that the next time you fill-up with gas or go looking for infant formula. Maybe our alien friends could help with that.

Perhaps the juxtaposition of FDA indecision in Sturgis and fast action concerning ultra-thin, cookie-flavored (thin mint? chocolate chip? Inquiring minds want to know!) latex undies is just an example of bad timing, a coincidence. But that doesn’t excuse the agency (or Congress) from its role in the current infant formula supply crisis. It is long overdue to consider the organization and management of the food regulatory agencies and systems, including merging all food inspectors under a single, more agile, and responsive agency, as most developed western nations have, especially Canada. And that is just for starters.