If you want proof that our food system is corporate-friendly rather than consumer-friendly, putting consumer health at unnecessary risk, take a look at the FDA’s Final Rule on Substances Generally Recognized as Safe (GRAS), which was released last Friday. It’s a doozy.
The agency announced it will continue to allow food manufacturers to decide whether new food additives that preserve, flavor, blend or add texture to food can be safely added to processed food or drink. Yes, you read that correctly. The food company, which may have a financial interest in using the food additive, gets to decide its safety while the FDA does not have to do a review.
If that isn’t alarming enough, food manufacturers aren’t even required to tell the FDA about any GRAS determinations they make. However, “the FDA strongly encourages companies to inform the agency of GRAS conclusions through the notification procedure finalized with (Friday’s) rule” because “the notification procedure yields important information that aids the agency’s food safety monitoring efforts.” If it yields important information to keep consumers safe, why wouldn’t the FDA make notification mandatory?
When Congress passed the Food Additives Amendment of 1958, which allowed manufacturers to make GRAS decisions, a common food additive was vinegar or vegetable oil, rather than the complex chemicals found in our modern food supply. Today, when a manufacturer needs a GRAS determination, it can convene an expert panel, go to a standing expert panel (such as the FEMA panel sponsored by the Flavor and Extract Manufacturers Association), hire a GRAS consulting firm, or use one of its own employees to make the determination.
But, as Jessica Almy, Deputy Director of Nutrition Policy for the Center for Science in the Public Interest, explains, in a statement, the FDA’s ruling will continue to produce potentially biased and secretive determinations:
Today’s rule gives (food) companies a green light to make decisions about which substances are GRAS and can be added to foods—without even informing the FDA. The new rule also fails to ensure that the experts that make these decisions do not have conflicts of interest.
Conflict of interest (COI) is a serious concern and can taint the results of the determination. When a food company asks an employee to evaluate whether a substance it wants to use is GRAS, that’s classic COI. However, as NYU nutrition professor Marion Nestle points out on her blog, a 2013 study revealed that even expert panels and consultants tend to be compromised.
Commenting in JAMA Internal Medicine in 2013 on the study titled, “Conflicts of Interest in Approvals of Additives to Food Determined to Be Generally Recognized as Safe,” Nestle wrote:
(The study) findings are alarming. An astonishing 100 percent of the members of 290 expert panels included in their review worked directly or indirectly for the companies that manufactured the additive in question. Even more alarming, the experts on these panels form a tight professional cadre. Although 850 people served on the panels, 10 experts served on 27 panels or more, and one of these ten participated in three-quarters of the panels.
Some substances that have previously been determined as GRAS have later been found to damage human health. Artificial trans fats (partially hydrogenated oils) had their GRAS determination withdrawn in 2015, after being linked to up to 100,000 premature deaths from heart disease each year in the United States. Industry fought their removal because partially hydrogenated oils are inexpensive, produce attractive, flaky baked goods and have a longer shelf life.
And other GRAS substances continue to be found in food and drink even though significant questions have been raised about their safety. For example, the state of California considers the chemical o-phenylphenol (used on fresh fruit and vegetables as a post-harvest fungicide) a carcinogen, although FEMA declared it to be GRAS. Trans, trans-2,4-hexadienal is GRAS for use as flavoring, even though it has been found to be a carcinogen by the International Association for Research on Cancer.
Another GRAS substance, 4-methylimidazole (4-Mel), which gives cola a caramel color, has been identified as a potential carcinogen. California requires a warning label on any cola that contains a high level of the chemical.
Senator Ed Markey (D-MA) criticized the new FDA rule on GRAS as “a self-graded take home exam that industry doesn’t even have to hand in.” The Senator said he “plan(s) to explore whether a legislative remedy is needed to ensure the safety of our food supply.”
In the meantime, Nestle called the FDA’s final ruling “a loss for public health,” and said that “it constitutes yet another reason not to eat products with long lists of additive ingredients.”
And don’t forget to scrub the o-phenylphenol off of your fresh fruit and vegetables – unless you're lucky enough to live in California.
