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  • Food additives are not automatically required to get premarket approval by the US Food and Drug Administration (FDA)
  • Items that fall under the “generally recognized as safe” (GRAS) designation are exempt from the approval process; food manufacturers use this loophole to add novel ingredients without FDA oversight
  • Four consumer protection groups say 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

Flawed “GRAS” System Lets Novel Chemicals into Food Supply Without FDA Safety Review

April 29, 2015 | 157,478 views

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Outdated Law Lets Unsafe Ingredients into the Food Supply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.

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 awry is artificial trans fat, which was originally considered GRAS. Faced with a mountain of evidence, the FDA has now deemed trans fats dangerous, saying they cause as many as 7,000 deaths from heart disease each year. There is little question in my mind that you will see the same reversal on GMO foods. Thankfully you don't you have to wait decades for the FDA, as you can avoid being harmed by them now by refusing to purchase them at the store or in a restaurant.

Another example is lupin—a legume related to peanuts—which can be found in many processed foods and gluten-free items. The FDA originally denied the GRAS notification for lupin,13 because it poses dangers to those with peanut allergies. Any food containing lupin would have to have a peanut allergy warning label. In response, the GRAS notification was withdrawn, and lupin is now added to foods without FDA oversight. Nor do such items have warning labels for those with potentially lethal peanut allergies...

The meat substitute known as quorn—a fungus-based mycoprotein—is another hazardous ingredient in our food supply that has been deemed GRAS. This ingredient appears to have been responsible for the death of a young boy in 2013 who was allergic to mold. His parents recently filed a wrongful death suit against the manufacturers,14,15 charging them with product liability design defects, failure to warn, and false and misleading advertising.

When Used in Combination, Food Additive Hazards Are Amplified

What little risk assessment is done is typically done on individual chemicals in isolation, and mounting research now suggests that when you consume multiple additives in combination, the health effects may be more serious than previously imagined. A recent assessment16 done by the National Food Institute at the Technical University of Denmark found that even small amounts of chemicals can amplify each other's adverse effects when combined. As reported by the Institute:

"A recently completed, four-year research project on cocktail effects in foods... has established that when two or more chemicals appear together, they often have an additive effect. This means that cocktail effects can be predicted based on information from single chemicals, but also that small amounts of chemicals when present together can have significant negative effects.

'Our research shows that indeed, little strokes fell great oaks also when it comes to chemical exposure. Going forward this insight has a profound impact on the way we should assess the risk posed by chemicals we are exposed to through the foods we eat,' Professor Anne Marie Vinggaard from the National Food Institute says."

Dietary Toxins Likely Account for 90 Percent of Diseases

Food additives are becoming of increasing concern these days. Health statistics suggest the toxic burden is becoming too great for children and adults alike, and while environmental toxins such as pollution are clearly a concern, toxins in our food simply cannot be ignored any longer. According to Joseph E. Pizzorno,17 founding president of Bastyr University, co-author of the Encyclopedia of Natural Medicine and The Clinician's Handbook of Natural Medicine, and former advisor to President Clinton on complementary and alternative medicines, toxins in the modern food supply are now "a major contributor to, and in some cases the cause of, virtually all chronic diseases."

Dr. David Bellinger, a professor of Neurology at Harvard Medical School has expressed similar concerns. According to his estimates, Americans have lost a total of 16.9 million IQ points due to exposure to organophosphate pesticides.18 Pizzorno believes pesticides may also play a significant role in the worldwide obesity epidemic, saying: "Researchers are now finding such a strong connection between the body load of these chemicals [contaminating the food supply] and diabetes and obesity that they are being called 'diabetogens' and 'obesogens'."

Pizzorno also points out that our modern food supply (most of which is heavily processed) also hampers your body's detoxification process as a result of being deficient in key nutrients. An interesting admission and change of thought expressed on the Centers for Disease Control and Prevention's (CDC) webpage on exposomics19 is the fact that, conversely to what researchers originally thought, the vast majority of diseases do NOT appear to have a genetic origin. According to the CDC:

"One of the promises of the human genome project was that it could revolutionize our understanding of the underlying causes of disease and aid in the development of preventions and cures for more diseases. Unfortunately, genetics has been found to account for only about 10% of diseases, and the remaining causes appear to be from environmental causes. So to understand the causes and eventually the prevention of disease, environmental causes need to be studied."

Glyphosate Residues in Food May Also Be a Significant Health Threat

Americans in particular also have to contend with the fact that a vast majority of our processed foods contain unlabeled genetically engineered ingredients that tend to be heavily contaminated with the toxic herbicide glyphosate (the active ingredient in Monsanto's Roundup). Experts like Dr. Don Huber strongly believe that glyphosate is actually more toxic than DDT, and the International Agency for Research on Cancer (IARC) recently reclassified glyphosate as a class 2 A carcinogen.20,21,22

The US EPA has now announced23 that US regulators may start testing for glyphosate residues on food in the near future to quell consumer concerns. But while that's good news, it's also worth noting that the EPA raised the allowable limits for glyphosate in food in 2013, and the allowable levels may now be too high to protect human health, based on mounting research.24,25

The Saturated Fat Myth in Action...

While many hazardous ingredients are given a free pass, the FDA is cracking down on food manufacturers advertising high saturated fat items as "healthy." This is yet another misguided action based on flawed science. Conventional advice calls for keeping your saturated fat intake below 10 percent a day, while mounting research indicates most people need far more than that—those with insulin resistance may need more than 50 percent of their daily calories from healthy fat. As reported by Philly.com:26

"The word 'healthy' should be removed from the labels of four types of Kind granola bars because they contain higher levels of saturated fat than is acceptable under regulatory standards for the term, the U.S. Food and Drug Administration says... In a statement on its website, Kind said it is changing the labeling for the four products...

However, the company said the fat content in nuts, one of the main ingredients in the bars, isn't unhealthy... 'This is similar to other foods that do not meet the standard for use of the term healthy, but are generally considered to be good for you like avocados, salmon, and eggs,' according to Kind."

Where to Find the Most Wholesome Food

As a general rule, a diet that promotes health is high in healthy fats and very, very low in sugar and non-vegetable carbohydrates, along with a moderate amount of high-quality protein. For more specifics, please review my free optimized nutrition plan, which also includes exercise recommendations, starting at the beginner's level and going all the way up to advanced. Organic foods are generally preferable, as this also cuts down on your pesticide and GMO exposure. If you're unsure of where to find wholesome local food, the following organizations can help:

  • Local Harvest -- This Web site will help you find farmers' markets, family farms, and other sources of sustainably grown food in your area where you can buy produce, grass-fed meats, and many other goodies.
  • Eat Wild: With more than 1,400 pasture-based farms, Eatwild's Directory of Farms is one of the most comprehensive sources for grass-fed meat and dairy products in the United States and Canada.
  • Farmers' Markets -- A national listing of farmers' markets.
  • Eat Well Guide: Wherever you are, Eat Well -- The Guide is a free online directory of more than 25,000 restaurants, farms, stores, farmers' markets, CSAs, and other sources of local, sustainably produced food throughout the US.
  • FoodRoutes -- The FoodRoutes "Find Good Food" map can help you connect with local farmers to find the freshest, tastiest food possible. On their interactive map, you can find a listing for local farmers, CSAs, and markets near you.

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