Want to get a good sense of just how utterly screwed up the Food and Drug Administration is when it comes to regulating all those unpronounceable ingredients on the labels of so many processed foods? Just check out the much ballyhooed announcement from the Grocery Manufacturers Association, the trade group that represents most of the processed-food industry, of its newfound openness about food additives. The association has launched a “five-part initiative to help modernize the process” of evaluating whether additives should be considered safe, including establishing a “GMA-sponsored database” that will provide the FDA and “other stakeholders” access to the food industry’s safety assessments of its own products.
Hold up a minute: The FDA doesn’t already have its hands on the data food companies have been using to determine whether the additives they’re putting into the food we eat are safe for human consumption?
In a word, nope.
Oh you poor, silly, naive American consumer. Did you really think that the FDA was poring over reams of scientific data before it gave the green light to an additive like epigallocatechin-3-gallate or gamma-aminobutyric acid? Not only does the agency not require food makers to submit scientific studies to back up claims that the additives they’re using are safe for humans to eat (that is, “generally recognized as safe,” or “GRAS,” in bureaucratic-speak), but the agency basically allows food companies to make that determination themselves. No FDA stamp of approval is necessary, and it’s pretty much been that way for the last 17 years.
I’m no great fan of flow charts, but this one devised by the nonprofit public watchdog group Center for Science in the Public Interest succinctly sums up what you otherwise might think should be an involved and deliberate process. After all, we’re talking about nothing less than ensuring the food in our grocery stores is safe to eat for crying out loud.
As you may have surmised from the chart, the FDA doesn’t even know all the additives that the food industry has deemed safe, which is why the Grocery Manufactures Association thinks it’s being so progressive and transparent by providing that information to the very agency most Americans believe is on top of making sure harmful stuff doesn’t make its way into our food.
“Today the food industry is congratulating itself for sharing a database of its food additive safety studies with regulators at the Food and Drug Administration,” Laura MacCleery, chief regulatory affairs attorney for CSPI, said in a statement. “That this is seen as a step forward neatly illustrates the dysfunction built into the current system. It is outrageous that FDA doesn’t already have the identity, much less the safety data, of all substances added to the nation’s food supply.”
How did it come to this? Well, for starters, the law intended to govern the safety of food additives dates to the Eisenhower administration, when there were only about 800 additives in all. Today there are an estimated 10,000, manufactured by companies with names such as FutureCeuticals, Hamari Chemicals, and ChromaDex.
But in the original law, GRAS was limited in scope. It covered ingredients that had been used in food since time immemorial, such as oil and vinegar. By 1997, feeling understaffed and overburdened, the FDA began allowing food makers themselves to determine whether their newfangled additives were safe, often based solely on the evaluation of a company’s employees or consultants it hired.
Plenty of independent public health watchdogs have been crying foul about this for years, among them CSPI, the Pew Charitable Trusts, and, more recently, the Natural Resources Defense Council. In a comprehensive three-year study of the issue released last year, Pew determined that the “FDA has not reviewed the safety of about 3,000 of the 10,000 additives allowed in food.” That includes 1,000 that food makers have “self-affirmed as GRAS”—meaning “safe” additives that the FDA theoretically doesn’t even know exist.
For its part, NRDC has taken to calling GRAS “generally recognized as secret,” and in its own report, published in April, provided four enlightening—or terrifying, take your pick—case studies of new additives for which companies had sought GRAS status, only to quietly withdraw their notices in the face of the FDA’s scrutiny.
That would sound like the FDA was doing its job, right? Well, sorta. The NRDC report notes that “the FDA does carefully review the notifications [from companies seeking GRAS approval] and asks tough questions.” But because companies can just skip out of the review process altogether with no consequence and bring their additives to market anyway, what does it matter?
Indeed, that’s just what appears to have happened with the four additives spotlighted here, according to the NRDC:
• Epigallocatechin-3-gallate “A Japanese company declared this chemical to be GRAS for use in beverages, including teas, sport drinks, and juices despite evidence it may cause leukemia in fetuses based on studies using newborn and adult human cells grown on a dish. Moreover, the company did not address a short-term study on rats showing it affected thyroid, testis, spleen, pituitary, liver, and gastrointestinal tract.” Number of products on the market with ECGC (per NRDC): 25
• Gamma-amino butyric acid “A Japanese company declared this neurotransmitter to be GRAS for use in beverages, chewing gum, coffee, tea, and candy. It did so despite having estimated exposure well in excess of what the company considered safe, relying on unpublished safety studies, providing the specifications in Japanese, and failing to consider existing exposures.” Number of produces on the market with GABA (per NRDC): 5 (including bottled tea and nutrition bars)
• Sweet lupin protein, fiber, and flour “An Australian firm declared these chemicals to be GRAS for use in baked goods, dairy products, gelatin, meats, and candy despite concerns that the chemicals would cause allergic reactions in those with peanut allergies.” Number of products on the market with this additive (per NRDC): more than 20, none of which carry allergy warning labels
• Theobromine “A U.S. firm declared it to be GRAS for use in bread, cereal, beverages, chewing gum, tea, soy milk, gelatin, candy, and yogurt and fruit smoothies despite having an estimated consumption rate more than five times the safe consumption level reported by the company’s consultant. In addition, the manufacturer did not provide convincing explanations for the testicular degeneration in rats and rabbits and delayed bone formation in rats that were seen in animal studies of theobromine.” Number of products on the market with this additive (per NRDC): more than 20 (including isotonic waters, nutrition bars, and diet foods)
So is the new industry-sponsored database likely to make the concerns of public health advocates go away? Don’t count on it. As MacCleery puts it: “Whether these companies’ evaluations are submitted on paper, assembled in a new database, or gift-wrapped with a bow tied around it, it’s no substitute for having independent and rigorous evaluations of suspect additives used in our food.”