From Dr. Mercola:
By Dr. Mercola
Processed foods can contain any number of the thousands of additives used by the food industry. Many are under the mistaken belief that such additives must have gone through stringent testing to prove their safety, but that’s oftentimes not the case at all.
Shocking as it may sound, food additives are not automatically required to get premarket approval by the US Food and Drug Administration (FDA).1,2,3,4,5
As explained in the featured video, items that fall under the “generally recognized as safe” (GRAS) designation are exempt from the approval process altogether. This is a loophole stemming from the 1958 Food Additives Amendment, which excludes GRAS items from the formal FDA approval process for food additives.
You might also recognize that this is how Monsanto and other agribusinesses snuck GMO foods into our food supply, as the FDA classified them as GRAS in 1992. Steven Druker revealed in my interview with him how his lawsuit to reverse this was lost on technicalities.
Outdated Law Lets Unsafe Ingredients into the Food Supply
The problem is, the chemical concoctions used in processed foods today didn’t exist in the 1950s when the amendment was written into law. At the time, it was meant to apply to common food ingredients like vinegar and baking soda—regular cooking ingredients known through their historical use as being safe.
Nowadays however, countless manufactured ingredients end up slipping through this loophole. Another part of the problem is the fact that food companies are allowed to determine, on their own, whether an ingredient is GRAS.
A company can simply hire an industry insider to evaluate the chemical, and if that individual determines that the chemical meets federal safety standards, it can be deemed GRAS.
At that point, the company doesn’t even need to inform the FDA that the ingredient is used, and no independent third party objective evaluation is ever required.
Food additives are not automatically required to get premarket approval by the US Food and Drug Administration (FDA).
According to Center for Science in the Public Interest6,7 (CSPI), at least 1,000 ingredients are added to our food that the FDA has no knowledge of.
According to a CSPI investigation,8 these industry experts are a small tight knit group of scientists, many of whom have ties to the tobacco industry. According to Laura MacCleery, an attorney for CSPI:
“These are standing panels of industry hired guns. It is funding bias on steroids.”
As if that’s not bad enough, if a company does choose to notify the FDA, and the FDA disagrees with the company’s determination that the item is GRAS, the company can simply withdraw its GRAS notification and go ahead and use it anyway, as if no questions were ever raised.
This legal loophole allows food manufacturers to market novel chemicals in their products based on nothing but their own safety studies, and their own safety assessments—the results of which can be kept a secret.
Food Ingredient Approval Process Violates the Law
Together with the Consumers Union, the Environmental Working Group, and the Natural Resources Defense Council, CSPI has filed an 80-page long regulatory comment9 stating that the process for determining GRAS substances is in violation of the 1958 law, which requires the FDA to determine the safety of an ingredient before it can be used in food.
According to the CSPI:10,11
“That law acknowledged that the FDA need not require pre-market testing of substances that had long been used in foods or that were well-recognized as safe by scientists.
But in a rulemaking opened by the agency in 1997—but never finalized—FDA weakened the standards for what could be considered GRAS and proposed making permanent what the groups say is an illegal program of GRAS determinations by the food industry, often done in secret…
‘The FDA must provide better oversight over all of the substances that are put in our food, especially those whose safety is in question,’ said EWG Research Director Renee Sharp.
‘Any safety determination should be based on publicly available scientific data, not the opinions of ‘expert panels’ that likely have conflicts of interest with food additive regulation.’”
How Can Brand New Technologies Be GRAS?
Today we’re also contending with novel nano technologies such as taste modifying chemicals that allow the company to reduce the fat or sugar content of the food.
These additives do not even have to be listed on the label. Instead, they fall under the general category of “artificial flavors,” even though they do not actually have or add any flavor per say.
There’s absolutely no telling what these agents are, or whether or not they’re safe. As noted by Michael Hansen, a senior scientist with the Consumers Union:
“Any substance added to food created by using new science or technology, including nanomaterials, should be required to undergo a safety assessment prior to marketing and so should categorically be denied GRAS status.”
To combat this runaway situation, the groups make several recommendations they believe would bring the FDA’s proposal on GRAS in line with the 1958 food additives law. Their recommendations include:
Denying GRAS for novel chemicals and substances flagged as potentially risky by authoritative scientific bodies Denying GRAS notifications based on unpublished studies GRAS notifications must be made by experts without conflicts of interest GRAS notifications should be mandatory and public Examples of Hazardous GRAS Ingredients
As noted in a report12 by the Natural Resources Defense Council (NRDC) titled: Generally Recognized as Secret: Chemicals Added to Food in the United States:
“A chemical additive cannot be ‘generally recognized as safe’ if its identity, chemical composition, and safety determination are not publicly disclosed. If the FDA does not know the identity of these chemicals and does not have documentation showing that they are safe to use in food, it cannot do its job.”
One now “classic” example of the GRAS process gone…