Why The FDA Takes So Long To Regulate Harmful Substances

On Thursday, Wrigley announced that it would be pulling its controversial new “Alert Energy” gum — each stick of which contains as much caffeine as half a cup of coffee — from the market out of “respect” for the U.S. Food and Drug Administration (FDA) as the agency investigates the public health risks associated with pumping caffeine into everyday foods and drink. With energy products and other potentially harmful foods high in sugar, salt, and fat increasingly under public scrutiny, it’s worth asking: why can’t the FDA do more to crack down on these additives? And why does it take so long to get food makers to comply with regulations when they do?

Answering that requires a brief foray into the history of the American food safety regimen. 1958 was a seminal year for food oversight, seeing the passage of the Food Additives Amendment to the Food, Drug, and Cosmetic Act, and the creation of the Generally Recognized As Safe (GRAS) List. Under the Food Additives Amendment, “any substance intentionally added to food is a food additive and is subject to pre-market approval by FDA unless the use of the substance is generally recognized as safe (GRAS).” So if a substance is on the GRAS exemption list, then food makers can use it to their heart’s content without proving its safety, unless specifically prevented from doing so by an FDA regulation.

The GRAS list contains over 700 items, many which have been there since 1958 — and taking an item off the GRAS list once it’s on is difficult. GRAS items are specifically defined as substances that are “generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of [their] intended use.” Consequently, revoking a substance’s GRAS designation requires considerable expert consensus that an item is not safe for its intended use.

One might ask how salts, sugars, trans fats, and caffeine don’t fit that bill considering widespread evidence that those substances increase the risk of heart disease, stroke, obesity, hypertension, and diabetes, thereby harming public wellness and increasing U.S. health care costs. In fact, government watchdogs and medical groups such as the Government Accountability Office (GAO) and the American Medical Association (AMA) have issued several calls for the FDA to crack down on those very ingredients.


But an outright ban on any of those substances (other than trans fats) is impossible — and undesirable — since the majority of food items require them in at least some amount. Rather, it’s excess consumption that makes the substances potentially dangerous. That’s where the FDA can step in by issuing regulatory rules that either set targets or impose reductions in harmful food content. But that’s also where they meet their greatest obstacle: the powerful food lobby.

“It’s corporate power,” said Dr. Michael Jacobson, executive director of the Center for Science in the Public Interest (CSPI), in an interview with ThinkProgress. “For something like salt, or partially hydrogenated oil (trans fat), or sugar, there’s huge industries behind those substances. First there’s the manufacturers themselves, and then there’s the food companies that use their products. All those companies would be discomfited by an FDA ban or regulation, so they can then go to Congress and say, ‘Look at what the FDA is trying to do! It’s killing our business.’” Congress can then put pressure on the FDA by “cutting [its] appropriations or putting a rider in an FDA bill preventing it from imposing certain regulations,” according to Dr. Jacobson.

That sort of arm-twisting tends to work — even when an FDA action is simply advisory and lacks enforcement power. For instance, Dr. Jacobson explained to ThinkProgress that in the 1990s, “[t]he government came up with draft voluntary guidelines for foods marketed to young children. And the Grocery Manufacturers Association said its highest priority was to kill the voluntary guidelines –- and this wasn’t even a regulation, just guidelines!” Congress ended up siding with the grocery manufacturers over the children. “The public health becomes a side issue,” said Dr. Jacobson.

And even when the FDA succeeds in taking regulatory action, it can get held up for years — and even decades — by lawsuits and lobbying campaigns launched by Big Food companies, as well as bureaucratic red tape. In fact, that’s exactly what happened in the case of partially hydrogenated oils and trans fats. Organizations such as CSPI had been lobbying the FDA to require food labels for products using the harmful substance since 1994. After an initial proposed regulation in the early 2000s, a public comment period (which included protestations from food makers), and revisions to the proposed rules, a watered-down mandate was eventually finalized — in 2006.

Considering how much trouble the FDA had just requiring labels for trans fats, it isn’t surprising that efforts to limit sugar, caffeine, and salt are even more challenging due to their widespread use. In the 1970s, the FDA responded to a CSPI request that the agency begin cracking down on food sodium content by encouraging manufacturers to voluntarily limit their salt use. That effort was a complete failure — in fact, food companies ended up increasing their use of salt. A 2010 report by the Institute of Medicine then called for targeted reductions in food sodium in light of the failed effort — and the FDA has initiated a regulatory rule to do just that. But yet again, bureaucratic gridlock has stymied meaningful action. “The FDA has wanted to make an announcement, but it’s stalled at the White House. Is it just a traffic jam, or are there political considerations? I don’t know,” said Dr. Jacobson.


But even if the FDA’s efforts on salt eventually take hold, they certainly won’t take effect overnight, giving food corporations plenty of time to fight FDA action through Congress and the courts. That’s unfortunate, since studies have shown that even the mild labeling requirements imposed on hydrogenated oils has reduced trans fatty acid levels in Americans’ blood by over 50 percent. So as the FDA’s 1,000-person strong food safety work force takes on its own agency’s bureaucracy and the power of lobbied interests to eventually crack down on salt, sugar, and caffeine, Americans will continue being exposed to substances that kill them by the hundreds of thousands every year.