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Welcome to PSR's Environmental Health Policy Institute, where we ask questions -- then we ask the experts to answer them. Join us as physicians, health professionals, and environmental health experts share their ideas, inspiration, and analysis about toxic chemicals and environmental health policy.


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Dinner with a Side of Financial Conflicts of Interest

Posted on September 22, 2014

By Tom Neltner and Maricel Maffini

Before 2010, when we thought about chemical exposures, food was near the bottom of our lists.  We knew we had choices and could read the ingredient list on the labels.  Plus we had faith in the Food and Drug Administration (FDA) and knew that the safety standard for chemicals added to food or food packaging was higher than for other chemical uses.  That standard said that a chemical may not be used in food or food packaging unless there is a reasonable certainty of no harm from its use after considering the cumulative of effect of the chemical as well as other chemicals in the diet with similar biological effects. 

For three years, we slowly peeled back the layers of system like an onion.  And like an onion, the smell grew worse the deeper we got. 

We published our analyses in six peer-reviewed science journals including four in the food industry’s professional society journal.  Our main finding was that the root of the problem is an exemption in the Food Additives Amendment of 1958 for “generally recognized as safe” (GRAS) additives.  The exemption from formal FDA review was intended for common food ingredients, but has been stretched by industry, with FDA’s acquiescence, to such an extent that today most new chemicals added to food pass through this loophole.  As a result, all too often companies determine in secret that a chemical added to our food is safe without ever notifying FDA or the public as long as the toxicity, but not necessarily exposure, data is published in some publication, however obscure.  

In our 2013 article in JAMA Internal Medicine, we showed that these GRAS determinations were made despite ubiquitous financial conflicts of interest surrounding the scientists involved in the assessment. This was especially egregious when a company’s hand-picked employee or consultant made the safety decision. Our analysis was based on the GRAS notifications submitted to FDA and found in the agency’s website. Although we didn’t judge the quality of the safety decisions, consider this: when companies voluntarily notify FDA, the agency finds flaws  in one in every five proposals to utilize an additive. The outcome would likely be worse for those additives the agency doesn’t review.

In a later article in Reproductive Toxicology, we demonstrated that safety decisions rely heavily on professional judgment rather than animal studies.  We found that less than 38% of FDA-regulated additives have a published feeding study. For chemicals directly added to food (excluding chemicals migrating into food from packaging), 21.6% have feeding studies necessary to estimate a safe level of exposure and only 6.7% have reproductive or developmental toxicity data in FDA’s database.  The combination of overreliance on professional judgment in the absence of actual data and ubiquitous conflicts of interest means that any industry assurance that chemicals added to food are safe cannot be trusted.

As Mike Taylor, FDA’s Deputy Commissioner for Food, said in a front-page Washington Post article, “We simply do not have the information to vouch for the safety of many of these chemicals.”

In November 2013, The Pew Charitable Trusts published a report concluding that:

“[w]ith more than 10,000 additives allowed in food, our research found the FDA regulatory system is plagued with systemic problems that prevent the agency from ensuring their use is safe. If one of these chemicals was causing health problems short of immediate serious injury, it is unlikely that FDA would detect the problem unless the food industry alerted the agency. When new research raises doubts about the safety of an additive that is already on the market, FDA’s limited resources and authorities leave the agency heavily dependent on industry’s voluntary cooperation with its requests and on public education. In practice, FDA may have to prove actual harm before it can restrict use of an additive in the food supply—even though Congress mandated that no additive is allowed in food unless there is a reasonable certainty that the intended use would not result in harm to consumers.”

Food safety is essential.  FDA needs to be able to vouch for the safety of all chemicals added to food.  The loophole needs to be closed.  Until Congress fixes the law, FDA needs to strictly limit conflicts of interest, require that all relevant safety data on a chemical’s exposure and toxicity be published, modernize its science, and reassess the safety of chemicals approved decades ago as well as those that passed through the loophole.


Karen Glaub said ..

We need requirements that a company must prove by a set standard of tests that an additive is safe before it can be added to our food. If those standardized tests exist, they must not be strict enough. Also, children's weights should be the guage safety is measured by..... not an adult..

September 23, 2014
Tross Dodge said ..

The FDA is just a feckless pr deception for the chemical additive corporations. Members ride the revolving door of conflict of interest. That is a real shame, sham. I wonder why people don't trust corporations and colluding government agencies?

September 22, 2014

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