Dangerous Loophole in Law Permits Food Companies to Market Novel Chemicals Without Safety Disclosures

Story at-a-glance -

  • Many food additives have questionable safety profiles, or none at all, as only a small percentage have ever been properly tested
  • A loophole in the 1958 Food Additives Amendment allows food companies to add chemicals to their products without sharing safety information with the US Food and Drug Administration
  • Action item: tell the FDA to put an end to food companies’ right to make chemicals’ safety decisions in secret
  • The processed food industry has dramatically altered our diet, and these changes directly affect your weight and overall health
  • Returning to a diet of locally grown, fresh whole foods is really the only way to optimize your health and normalize your weight

By Dr. Mercola

The fact that processed foods contain added ingredients that aren't necessarily food isn't secret knowledge. A simple read-through of just about any processed food label will tip you off to this fact with its listing of impossible-to-pronounce chemicals.

Many of these additives have questionable safety profiles, or none at all, since only a small percentage has ever been properly tested. This situation has become the norm courtesy of a regulatory system that favors industry profitability over public health and safety. This too is a well-known fact by many.

What may come as a complete shock, however, is that companies are allowed to add chemicals to their food without disclosing what they are to the US Food and Drug Administration (FDA), or having to prove their safety before putting them into use.

All they have to do is have their expert evaluate it on their terms. There is no independent third party objective evaluation. This is reprehensibly irresponsible on the part of governmental agencies that are assigned the task of looking out for our health. According to EcoWatch:1

"As long as a company designates a chemical as being 'generally recognized as safe,' or GRAS in regulatory parlance, according to FDA's interpretation of the law, it has no responsibility to inform the agency. FDA doesn't know about the safety of an estimated 1,000 chemicals because they aren't disclosed."

GRAS: Generally Recognized as Secret

Crazy as it may seem, food additives are not automatically required to get premarket approval by the FDA.2 Certain items that fall under the "generally recognized as safe" or GRAS designation, are exempt from the approval process.

According to the GRAS Notification Program, substances that are "generally recognized, among experts qualified by scientific training and experience to evaluate their safety as having been adequately shown... to be safe under the conditions of their intended use," are excluded, and do not require FDA approval. 

When the 1958 Food Additives Amendment was enacted, the exclusion of GRAS items from the formal FDA approval process for food additives was meant to apply to common food ingredients such as vinegar, i.e. items known through their historical use as being safe. Nowadays, however, countless manufactured ingredients end up slipping through this loophole.

A company can simply hire an industry insider—a completely conflicted "expert"—to evaluate the chemical, and if that individual determines that the chemical meets federal safety standards, it can be deemed GRAS without any involvement from the FDA. As noted in the NRDC's report,3 "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."

The Natural Resources Defense Council (NRDC)4 identified 56 food companies that rely on "undisclosed GRAS safety determinations" for 275 chemicals used in their products. Of these companies, 62 percent responded to the NRDC's request for information about the chemicals, but none of them shared their safety information.

The remainder did not respond at all.

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Loopholes Turn Food Safety Into a House of Cards

In an effort to stay on top of the situation, the FDA has created a voluntary program that asks food companies to submit their safety assessments for FDA review. If the agency cannot find any major problems with the company's argument for GRAS status, a "no questions" letter is sent to the company.

However, if questions about safety are raised by FDA scientists, the company can simply withdraw its voluntary submission, and go on using the chemical as if nothing has happened.  

This legal loophole in the law 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.

The dangers inherent in such an "honor system" are obvious, as the food industry isn't well-recognized for placing consumers' long-term health above profits. As reported by the Washington Post:5

"The FDA said that although the law allows for food manufacturers to make their own safety determinations, the agency 'encourages companies to consult with the agency when developing new ingredients.' Ultimately, the FDA said, manufacturers 'are responsible for ensuring that their food products are safe and lawful.'

NRDC said that Food Additives Amendment of 1958 was enacted, the GRAS process was meant to apply to innocuous additives like vinegar. Instead, it is commonly used for chemicals that are potentially dangerous and have never before been in the American food supply.

For example, until recently, artificial trans fats were considered GRAS but the FDA has now deemed them dangerous, saying they cause as many as 7,000 deaths from heart disease each year."

Take Action: Tell the FDA to Put an End to Secret GRAS Determinations

The NRDC has created an action page,6 asking the FDA to take appropriate action to put an end to food companies' right to make chemicals' safety decisions in secret. I encourage you to sign the petition, which will be sent to FDA Commissioner Margaret Hamburg.

"It's up to the Food and Drug Administration to protect the public's health from unsafe chemicals added to food. But as long as companies are allowed to make chemicals' safety decisions in secret, the agency cannot ensure food is safe.

Letting industry decide for themselves that chemicals are 'generally recognized as safe' (GRAS) without notifying FDA or the public is unacceptable, especially for new additives," the NRDC writes."Consumers should demand that their grocery stores and their favorite brands sell only food products with ingredients that the FDA has found safe, and ask the FDA and Congress to make the necessary changes."

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The Dangers of a Processed Food Diet Are Many

As discussed in the featured video above, the food industry has dramatically altered our diet, and these changes directly affect your weight and overall health. A large part of the problem stems from the processes used to manufacture the food, as food processing destroys valuable nutrients. It also removes much of the food's original flavor.

One example is pasteurization, which effectively sterilizes the food. Gone are all the beneficial microorganisms naturally found in raw milk, yoghurt, and cheese for example. Food irradiation is another example. Eating what amounts to a sterile diet has dramatic ramifications for your health as it alters your gut flora, allowing potentially pathogenic microorganisms to take over the terrain.

To counteract the problem of lost nutrients and flavor, synthetic nutrients and flavorings are added back into the processed food. In fact, popular junk foods owe their market shares to the complex flavor science used to optimize the addictive nature and "craveability" of these products.7 Few if any of these added chemicals serve any beneficial function in your body. On the contrary, they oftentimes tend to wreak metabolic havoc, as your body doesn't quite know what to do with them.

Another factor that makes processed foods the antithesis of a healthy diet is the excessive use of refined sugar and/or processed fructose from corn. If you become an avid label reader, you'll soon realize that virtually every processed food contains sugar—including commercial infant formula and baby food! One 2009 survey of more than 100 foods for babies and toddlers found examples that contained as much as 29 percent sugar! Others contained trans fat.

Obesity Sets the Stage for Chronic Poor Health

When your child is raised on sugar, harmful fats, and any number of synthetic chemicals, health problems are sure to follow. Obesity typically comes first, which then sets the stage for a wide variety of chronic diseases, including:

Diabetes, which can lead to a whole host of other medical issues

Congestive heart failure, a condition in which your heart can't pump enough blood to your body's other organs

Pulmonary embolism, a potentially fatal blockage of an artery

Fatty liver disease, in which large pockets of fat accumulate in your liver cells


Gout, caused by uric acid accumulation in your blood

Gallbladder disease, resulting from high blood cholesterol levels, which can cause gall stones

Cancer, particularly estrogen-sensitive cancers like breast cancer

Americans also have to contend with the fact that a vast majority of corn-based fructose is genetically engineered and 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. Compelling evidence now suggests that glyphosate residues, found in most commonly consumed foods in the Western diet courtesy of GE sugar, corn, and soy, enhance the damaging effects of other food-borne chemical residues and toxins in the environment to disrupt normal body functions and induce disease. Glyphosate also severely disrupts your gut flora, thereby further exacerbating metabolic havoc and poor health. 

Ditching Processed Foods Is the Answer

Eating fresh, whole foods is the "secret" to getting healthier, losing weight, and really enjoying your food, but many have fallen into the mistaken belief that it's next to impossible to create a meal without falling back on processed foods. Bruce Weinstein and Mark Scarbrough tackled this issue head-on in their book Real Food Has Curves: How to Get Off Processed Food, Lose Weight, and Love What You Eat.8 It's a great starting point to relearn the basics of how to prepare real food.

While you may need to invest in a good cookbook, once you get the hang of it, you'll find you can whip up a healthy meal from scratch in the same amount of time it would have taken you to drive down the street to pick up fast food. Sure, finding the time and the money to make healthy meals for your family can be challenging at first, but please don't use that as an excuse to exist on processed food.

Your health -- your energy levels, your appearance, your mood, and so many other factors -- will improve when you eat real food. Returning to a diet of locally grown, fresh whole foods is really the only way to reach optimal health. For a step-by-step guide to make this a reality in your own life, simply follow the advice in my optimized nutrition plan.

Remember, a processed food diet sets the stage for obesity and any number of chronic health issues, including asthma, allergies, and behavioral problems—from hyperactivity to aggression. In fact, many of the top diseases plaguing the United States are diet-related, including heart disease, diabetes, and cancer. The answer to these health problems lies not in a pill, but in what you eat every day.