What a Frozen Cherry Pie Says About FDA Regulatory Foot-Dragging

It took 15 years for the agency to decide that consumers didn’t actually need to be protected from the threat of substandard fruit desserts.

American cherry pie manufacturers may soon be able to decide for themselves how many cherries their frozen pies should have, free of burdensome federal regulations.

Former Food and Drug Administration (FDA) head Scott Gottlieb tweeted out praise that his former staff have successfully arranged to deregulate the contents of cherry pies after—no kidding—two years of hard work (and he's actually understating it, but I'll get to that):

https://twitter.com/ScottGottliebMD/status/1339577143332900867

So, is this now federal pie anarchy? No. (Unfortunately.) In 1971, the FDA established regulations imposing particular standards for frozen cherry pies. The lengthy regulations (read them here) determine not just how much of the pie must be made of cherries (25 percent by weight) and how many of the cherries may be "blemished," or have scabs, or be of less than stellar quality (under 15 percent, even though pies are a great place to put blemished fruit to keep it from going to waste), but also establishes complicated rules for determining compliance.

While the FDA has been granted the power by Congress to regulate frozen foods and fruits, including pies, it's very important to explain that these regulations were only implemented for cherry pies. There are no other similar regulations for other types of fruit pies. And there are no similar regulations for fresh pies to control the number and quality of the cherries in them. Just frozen pies, and only the cherry ones.

And so under Gottlieb and by request of the American Bakers Association (ABA), a trade association and lobbying organization, the FDA began rethinking this rule. The ABA argued that consumers, not the federal government, should decide whether they want to shell out more money for pies with more fruit in them or spend less money on lower-quality pies, if that's what they can afford.

Ultimately the FDA agreed with the ABA, because, they note in the proposed rule change, there has been no push to regulate any other similar types of fruit pies:

We are not aware of any evidence suggesting that consumers have different expectations for unbaked, frozen cherry pies than for other cherry pies. At the same time, no other cherry pies are subject to a standard of identity or a standard of quality, and we are aware of no evidence indicating that such standards are necessary to promote honesty and fair dealing in the interest of consumers or to ensure that those cherry pies meet consumer expectations. Similarly, other fruit pies are not subject to standards of identity or quality, and we are aware of no evidence indicating that such standards are necessary to promote honesty and fair dealing in the interest of consumers or to ensure that the pies meet consumer expectations.

The agency also notes that the regulations forbid the use of artificial sweeteners in unbaked frozen cherry pies, and only those pies and no other types of pies (including unfrozen cherry pies). So the feds are forbidding bakers from creating lower-sugar options, even if that's what consumers are asking for.

This is actually a notification of the rule change and not the rule change itself, so Gottlieb's celebration is possibly a little premature. There's a 90-day commenting process that ends in March, under the leadership of President-elect Joe Biden.

Does this mean that we're suddenly going to get cherry pies full of all sorts of awful garbage? Well, no. Who would buy them? Your local grocer's freezers are likely full of frozen blackberry, blueberry, and apple pies as well that don't have these regulations. Are they all terrible? No. You might not even know because your grocer's bakery probably offers remarkably cheap fresh pies, including cherry pies, that don't fall under these regulations anyway, and you might just pick up one of those and save time.

The reality is that it's not 1971 anymore, and innovations in both agriculture and food preparation have given Americans more options and competition, such that people don't actually have to settle for crappy frozen cherry pies. But the federal government implemented regulations that added additional costs to enforce compliance. The FDA study notes that there are currently 40 distinct frozen cherry pies produced by 20 different companies. That's a lot of competition for your pie money forcing companies to be honest.

It seems like a silly thing for Gottlieb to celebrate, but it was a silly thing for the federal government to regulate in the first place. And it took years for the government to reconsider it. Yet even now, people responding to Gottlieb's tweet think that food companies just can't wait to fill their cherry pies full of crappy, rotten fruit and filler, even though they haven't been doing that all along to the pies that weren't being regulated.

What's amazing about all of this, and very relevant given all the horrible foot-dragging we've seen from the FDA in responding to the COVID-19 pandemic, is that the petition from the ABA was submitted to the FDA in 2005. It has taken 15 years and an FDA head who was actually interested in deregulation to get rid of an obsolete rule that didn't really serve any valuable role in protecting consumers.

The FDA's terrible management of America's attempts to innovate solutions for the COVID-19 pandemic put its dysfunctional bureaucracy into the spotlight. Thousands of people are now dying every day. The drawn-out effort to get rid of completely unnecessary frozen cherry pie regulations shows how poorly the agency is able to evaluate and react to risks and harms.