After extensive research into what manufacturers add to our food, the researchers report that about 1,000 additives are in the food supply without the FDA's knowledge.
And, for those additives the FDA does actually know about, fewer than 38 percent of more than 8,000 FDA-regulated additives — including those manufacturers intentionally add directly to food and materials that may come into contact with and contaminate foods — have a published feeding study. (Feeding studies comprise the basic toxicology test — the first test a scientist would do to evaluate the safety of a chemical additive.) For direct additives, added intentionally to food, only 21.6 percent of the almost 4,000 additives have undergone the feeding studies necessary for scientists to estimate a safe level of exposure, and the FDA databases contain reproductive or developmental toxicity data for only 6.7 percent.
It appears the FDA and the food industry were often making safety decisions by comparing one chemical to another rather than doing an actual toxicology study. In making such decisions, they were building a house of cards based on assumptions and unsupported extrapolations instead of direct scientific evidence.
How has the oversight of our food regulations gone so terribly wrong? The researchers have a few insights. First, many chemicals were grandfathered into the system in the 1950's, and so they are in our food supply without information on their safety. Once a chemical is cleared for use in foods, the clearance is forever, so there are no requirements or incentives for a manufacturer to support additional testing. And, under the outdated U.S. Food Additives Amendment of 1958, the FDA doesn't even have the authority to require testing if it has questions about a chemical.
Also, industry can self-determine if its chemical food-additives are Generally Recognized As Safe (GRAS), and therefore free from the usual regulatory requirements for food additives. If the industry makes a GRAS determination, it is not even required to notify FDA that it has put the new GRAS additive on the market. Allowing industry to determine the safety of the chemicals it creates is a textbook example of the fox guarding the chicken coop.
Last week, many of the same Pew researchers published a report in The Journal of the American Medical Association (JAMA) Internal Medicine showing that "financial conflicts of interest are ubiquitous" in the industry-driven process leading to determining that a chemical is GRAS. In that article, Pew reports that all — that's 100 percent — of the members of expert panels that review food additives to make GRAS determinations have financial relationships with companies that manufacture the food additives being reviewed.
Follow the money! A commentary by Marion Nestle that accompanied the JAMA article highlights the presence of obvious conflicts of interest as one of the biggest problems with chemical food-additive regulations (or lack thereof). A recent editorial in the journal Nature discusses the Pew study and highlights the problems of financial conflicts, as well.
I've spent much of my career extensively reviewing EPA determinations of safety for hazardous chemicals. It is an outrage that FDA is not even looking at many of the chemicals added to food, and that the agency doesn't even have mandatory notification when industrial chemicals come into our food supply.
I've also spent much of my career documenting the problem of chemical manufacturers testing the safety of their own products. It isn't rocket science to think that a bias and a financial conflict may lead to a misrepresentation of the potential toxicity of a chemical.
In an article in Science this past June, the authors reported similar problems in the pharmaceutical industry where financially conflicted experts were able to sway FDA drug approvals. For industrial chemicals, numerous examples of industry misrepresentation of the harm from their products have been documented in the 2008 book by David Michaels, Assistant Secretary of Labor for the Occupational Safety and Health Administration, titled "Doubt is Their Product: How Industry's Assault on Science Threatens Your Health." But, when chemicals are intentionally added to the food supply, well, things just got a lot more serious.
NRDC's health program has recently turned more attention to the FDA's food safety programs. This past spring, NRDC officially requested a copy of the FDA database of food additives that includes both the names of the chemicals and the basis for the FDA's approving them for use in food. The FDA failed to respond, so we actually had to file a lawsuit against the FDA for this public information. What is FDA hiding from the public? I can only wonder. But thanks to the Pew researchers and their collaborators, the public is starting to learn about failures in the food additives regulatory process.