This June, at the Aspen Ideas Festival, six former FDA commissioners agreed that the agency has been hobbled by red tape, special interests, partisan politics, and its own flawed structure. The FDA receives funding from USDA, but reports to the Department of Health and Human Services, which like many agencies tends to make a 180-degree turn every four or eight years. “The micromanagement from on top has probably gotten to the point where an independent agency is necessary,” former FDA chief David Kessler said in Aspen, speaking for his colleagues as well as himself.
“But when you really count there 150 people between us, commissioner and that President, and they all think they are your boss and that’s the problem.”
Another problem is the influence that private interests have in the evaluation process for new foods and drugs. The FDA curates a list of food additives that it generally recognizes as safe (GRAS). The GRAS list is supposed to help protect the public’s food safety, but Kessler bluntly called it “a joke,” because industry often gets to decide which substances get, and stay, on the GRAS list.
This process, so convenient for industry, is one reason why the joke might be on the consumer. There is a long list of substances that are legal in the U.S., despite being illegal in other countries. To be fair, just because something is banned somewhere doesn’t immediately mean that the non-banning countries have it wrong. But when the watch dog is stuck in the dog house, what choice to we have but to be a little skeptical?
Some of the entries on the the legal here, banned there list sound scary. One, azodicarbonamide, can even be found in yoga mats. But weirdness does not equal toxicity. And there some cases, like the three discussed here, that make you wonder if maybe those former commissioners might be onto something about their former agency.
Olestra
Perhaps the most fitting example of FDA constipation can be found in the story of olestra-brand name Olean-the product of a $200 million investment by Proctor and Gamble into the development of a zero-calorie, fat-like polymer that tastes like fat but isn’t digested. Instead it passes through you.
Oh did it ever pass through you.
Soon after the product came to market in 1996, problems were evident. the coming years brought nearly 4,000 complaints filed to FDA, most of which for something the agency and company already knew. Kessler’s FDA was at least able to affix a label to olestra-containing products that stated: “This product contains olestra. Olestra may cause abdominal cramping and loose stools. Olestra inhibits the absorption of some vitamins and other nutrients.”
This carefully crafted statement was the result of a tedious push-pull between FDA and P&G. Two key words that didn’t ultimately make the cut were “anal” and “leakage.”
But even as the complaints piled up confirming this warning, the agency chose to drop the labeling requirement in 2003. While still illegal in Canada, the European Union and many other parts of the world, olestra continues to be used in some products like Frito-Lay Light chips. In 2006, the Center for Science in the Public Interest threatened a lawsuit against P&G. They settled when the company agreed to re-label its olestra-containing products.
David Kresser, the FDA commissioner who complained of having 150 bosses, declined to comment on olestra, which passed under his watch. But it’s worth noting that it was finally approved one day before B&G’s patent was set to expire.
That olestra remains on the GRAS list, despite its known side effects, speaks to the inertia that Kresser complained about. Unwashable & Indestructible Ass Grease remains available for your consumption in Frito Lay Light potato chips.
Artificial dyes
While Olestra was something of a sputtering flash in the pan, artificial dyes have been around for decades. This broad category is composed of several families of chemicals, some of which are more benign than others. But unlike olestra, even the worst of these can lurk silently in your body for years before any effects may be felt. Azo-dyes Yellow #6 and Red #40, for example, which are made from coal tar, break down in your body into aromatic amines. Aromatic amines have long been known to be carcinogenic-25 percent of bladder cancers are thought to result from occupational exposure to these goodies.
These very same dyes can be found in Starburst candy, assuming it was purchased in the U.S. But in the E.U., on the other hand, those bright squares would be tinted with natural dyes like carotenes, because Azo-dyes are banned.
This discrepancy points to a subtle, but massive, difference between how potentially dangerous ingredients are regulated in Europe compared to the U.S. Across the pond, a rule of thumb called the precautionary principle guides the approval process. It basically means if something might be dangerous, take action.
In the U.S., on the other hand, the approval process is guided by what could stand up in court as proof of guilt. According to former FDA chief Dave Kessler, most decisions at the agency are put off until a lawsuit comes around to break the logjam.
The precautionary principle, in all likelihood, keeps certain things out of the food supply that probably wouldn’t have harmed anyone. The U.S. litigation-driven process, meanwhile, probably allows certain unsavory elements into our food that shouldn’t be there.
In the face of mounting evidence against artificial dyes, FDA still isn’t forcing food processors to find less toxic alternatives. Luckily for consumers, the companies themselves are realizing just how bad some of these dyes are, and are switching to natural dies, on their own. It’s as if we suddenly inhabit some free-market utopia where benevolent companies take action proactively to make their products safer, at their own expense, out of deep concern for their customers.
Or perhaps they just don’t want to get sued.
There is just so much evidence out there, not just for cancer but organ damage, birth defects hyperactivity (which is ironic, given we’re talking about candy) that companies like Nestle, Hershey’s and Starburst parent company M&M/Mars are leading the charge of confection companies away from artificial colors, because the writing is on the wall, even if FDA is too impotent to do anything about it. And because, wouldn’t you know it, there are natural alternatives to most of those artificial colors.
Luke Haffenden, a flavor chemist in Montreal, doesn’t have an innate fear of hard-to-pronounce ingredients. But he’s well-aware of the potential issues with fake dyes, and hesitates to let his own kids consume products that contain them. Many others in the industry quietly feel the same way, he told me. A dye, by its very nature, he explained, is designed to attach to things and permanently change them.
“In the food industry, in the last couple of years…you go to any of these huge conventions, and a significant portion of companies are manufacturing, selling and or distributing natural color options,” Haffenden explained. “Some of these companies are making lots of noise because they think that it will be a marketing advantage. And some are quietly reformulating and hoping nobody notices.”
Ractopamine
This food additive, which has been dubbed "FDA approved pork roids," is banned in Russia and China, but not here. All told the additive, which helps animals pack on lean muscle mass in their final weeks, is illegal in 160 countries.
For those who swing toward the precautionary principle end of the spectrum in their personal consumption decisions, the snubs from Russia and China might be reason enough to avoid ractopamine-fed meat.
Of course, it’s entirely possible that the Chinese, being astute connoisseurs of fine pork, simply want nothing to do with lean pigs. But Russia? They certainly don’t seem to have a problem with steroids.
All kidding aside, most of the studies on which FDA has based its approval of ractopamine were done by Elanco, the drug’s maker. The majority of these studies focused on its efficacy in promoting lean gains, not safety. The safety data that does exist primarily focuses on the impact ractopamine has on the animals themselves, and finds that yes, it causes problems. Studies on the impacts of ractopamine on humans, meanwhile, are virtually nonexistent. Instead, safety concerns were apparently outsourced to Canada, as an FDA link brings us to a Health Canada web page.
Health Canada extrapolates that ractopamine-fed meat is safe for humans because it accumulates in very low levels in the animal parts that humans typically consume.
The E.U. meanwhile, as expected, chooses to err on the side of caution. But U.S. pork eaters don’t have that choice.
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