Flavor Manufacturers’ Trade Group Is the De Facto Regulator of Flavor Additives in the US

Story at-a-glance

  • The organization responsible for the safety of flavor additives used in foods for the American market is the Flavor and Extract Manufacturers Association (FEMA), an industry trade group
  • FEMA has the power to designate ingredients as “generally recognized as safe” (GRAS), which automatically exempts them from the FDA’s formal approval process for food additives
  • Once these industry insiders have deemed an additive GRAS, a food company doesn’t even need to inform the FDA that the ingredient is being used


This is an older article that may not reflect Dr. Mercola’s current view on this topic. Use our search engine to find Dr. Mercola’s latest position on any health topic.

By Dr. Mercola

Were it not for added flavors—be they synthetic or derived from natural substances—there would be no processed food industry, as most foods would quite simply be unpalatable.

As it stands, flavor companies develop additives that not only taste good, but that are “craveable” if not outright addictive.

The fact that processed foods contain added ingredients that aren't necessarily food isn't secret knowledge. But would it surprise you to find out that flavors added to processed foods are “regulated” by the industry itself?

This is the classic case of the fox guarding the hen house. As explained in the featured video, a legal loophole may have introduced a huge number of flavors and other additives of questionable safety into the American food supply.

Who’s Responsible for the Safety of Food Flavors in the US?

Since 1960, the organization responsible for the safety of flavor additives used in foods for the American market is the Flavor and Extract Manufacturers Association (FEMA), which in recent years has been increasingly criticized for the lack of transparency in its safety decisions.

As the name implies, this is an industry trade group, and it has the power to designate ingredients as “generally recognized as safe” (GRAS), which automatically exempts them from the Food and Drug Administration’s (FDA) formal approval process for food additives.

As noted by the Center for Public Integrity,1,2 this trade group has no in-house employees, no office, and a very small budget. It’s actually managed by Verto Solutions, a scientific consulting, communications, and government relations services firm based in Washington, D.C.

In addition to FEMA, Verto Solutions caters to other trade associations, including the International Association of Color Manufacturers, the International Organization of the Flavor Industry and Pickle Packers International.

Center for Public Integrity writes:3

“In recent years, activist groups and social media campaigns have been demanding that food companies become more accountable to consumers and transparent about what they are adding to their products.

But most Americans know as little about the decidedly low-profile Flavor and Extract Manufacturers Association and its safety assessments as they do about the more than 2,700 flavoring chemicals it has declared safe during the past five decades.

Moreover, public interest groups say the FDA’s recent response to a Freedom of Information Act request suggests that even the government may be blind to the science behind many of those flavors.

Much is at stake: The flavor industry’s system of self-policing helps it avoid government oversight, potentially saving companies significant amounts of time and money...

The flavor industry makes its safety evaluations ‘behind closed doors’ and then asks consumers to trust them, said Caroline Cox, research director for the Center for Environmental Health.

‘We just have enough experience with all kinds of toxic chemicals to know not to want to trust an evaluation if someone says, ‘Trust us, it’s all OK.’’”

The situation is quite different in Europe, where food flavors and other additives must undergo an independent safety review by the European Food Safety Authority, an agency funded by the European Union.

Outdated Law Lets Unsafe Ingredients into the US Food Supply

In 1958, the Food Additives Amendment was enacted, which excludes GRAS items from the FDA approval process. However, the chemical additives used today didn’t exist back when the law was written.

Originally, it was a common-sense amendment to exclude commonly used food ingredients like vinegar and baking soda from an unnecessarily onerous approval process.

Today, the GRAS designation has become a gigantic loophole through which thousands of synthetic chemicals are slipped into the food system without proper safety assessment. The most notorious pervasive and pernicious substance that slipped through under this loophole was glyphosate (Roundup) in 1992.

A company can simply hire an industry insider to evaluate the chemical, and if that individual determines the chemical meets federal safety standards, it can be deemed GRAS. As noted by the featured article:4

“The Flavor and Extract Manufacturers Association’s member companies—which produce 95 percent of all flavors on the market in the United States—typically forgo FDA review and instead choose to submit their flavors to the trade association for a safety review.

A standing panel of six to eight scientific experts oversees the trade group’s safety program and determines whether ingredients are generally understood to be safe by the scientific community.

These experts, who are paid by the trade association, review published and unpublished data before making a conclusion on the safety of an ingredient’s use.”

Crazy as it may seem, once this industry expert or panel of experts have deemed the additive GRAS, the company doesn’t even need to inform the FDA that the ingredient is used.

According to the Center for Science in the Public Interest5,6 (CSPI), at least 1,000 ingredients are added to our food that the FDA has no knowledge of.

But how can a chemical be “generally recognized as safe” if its safety determination is not disclosed and the FDA doesn’t know it even exists?

The Natural Resources Defense Council (NRDC) has identified 56 food companies that rely on "undisclosed GRAS safety determinations" for 275 chemicals used in their products.7

Even more shocking: 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 the ingredient anyway!

Flavor and Extract Manufacturers Association Uses Unpublished Research in Its Safety Determinations

Industry officials insist food flavors pose minimal health risks, if any, because they’re used in such small quantities. But when safety data isn’t publicly disclosed, how would one even go about identifying potential health concerns?

What’s worse, according to a Center for Public Integrity review of documents provided by the Flavor and Extract Manufacturers Association, the trade association has repeatedly relied on research that was never published, and hence unavailable for review by the public or scientific community. This seems to be out of compliance with FDA policy, and in September 2014, a number of public interest groups—including the Natural Resources Defense Council and the CSPI—argued this point in a letter to the FDA.

“To establish ingredients as ‘generally recognized as safe,’ determinations typically rely on published studies to show that qualified scientists generally agree that the ingredients won’t harm consumers. This process allows companies to avoid subjecting their ingredients to an extensive FDA-led safety review,” the featured article8 states.

“The consumer groups’ letter points to comments Michael Taylor, the FDA’s deputy commissioner for food, made to TheWashington Post last August: ‘The [GRAS] assessments need to be based on publicly available information where there is agreement among scientists...

It has got to be more than three employees in a room looking at information that is only available to them.’ But the Flavor and Extract Manufacturers Association, the public interest groups charge, doesn’t always follow such guidance.

In their letter to the FDA, they said they could find ‘no relevant published safety data’ establishing the safety of a handful of flavors declared safe by the trade group last July. ‘We asked FEMA for the published data on the four substances and it said there was none,’ the letter stated, adding that the trade group offered to make 7,000 pages of unpublished data available for a $1,000 processing fee. ‘This practice is contrary to FDA guidance … and a common sense definition of general recognition.’”

When Used in Combination, Food Additive Hazards Are Amplified

In clear opposition to industry claims that food flavors and other additives pose virtually no risk due to the minimal amounts used is recent research showing that even minuscule amounts of chemicals can amplify each other’s adverse effects when combined—a risk you can be sure is not taken into account during the safety assessment, if one is actually done.

What little risk assessment is done on the thousands of additives used in processed food is typically done on individual chemicals in isolation. The research9 in question was done by the National Food Institute at the Technical University of Denmark, and the report states, in part:

“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.”

Where’s the Data FEMA Claims to Have Given the FDA?

The Government Accountability Office (GAO) has given kudos to the Flavor and Extract Manufacturers Association (FEMA) for informing the FDA of its safety determinations—data that FEMA claims would fill about 500 boxes. Yet when the CSPI filed a Freedom of Information Act (FOIA) request with the FDA last October, asking for “all information that the Flavor and Extract Manufacturers Association (FEMA) has supplied to FDA since 1960 as support for its determinations that flavors it has evaluated are generally recognized as safe, or GRAS,” the FDA’s reply was: “We have searched our files and find no responsive information.”

As noted in the featured article: “Laura MacCleery, the attorney for the public interest group who filed the records request, said she was “shocked” that the FDA’s response appears to contradict the flavor trade group’s public statements about sharing information with the FDA.” It clearly doesn’t make sense that hundreds of boxes of information would go missing, so was such information ever actually shared with the FDA? If so, why can’t the FDA find it? Basically, their reply suggests the FDA has no data on any of the flavor additives FEMA has processed over the past 55 years.

The Food Industry Hides More Than the Safety of Its Flavors...

Download Interview Transcript

The composition and safety of food flavors is just the beginning when it comes to food industry secrets. In her exposé book, Swallow This: Serving Up the Food Industry's Darkest Secrets, Joanna Blythman dishes out a number of shocking revelations. One important consideration is that chemicals used in the course of processing do not have to be disclosed. Least of all on the label.

For example, there are at least 150 different enzymes used in food processing, and they’re rarely ever listed on the food label. The manner in which they’re used vary. As one example, when eggs are pasteurized, they lose their color. An enzyme is therefore added that brings back the color of the egg.

According to Joanna, there’s typically at least one enzyme-modified ingredient in every processed food. Breads usually have five enzyme-modified ingredients. Now, enzymes are not intrinsically toxic. They’re merely functional proteins composed of natural amino acids.

What’s so insidious about this practice is that they mask and deceive you about the underlying process, fooling you into believing you’re eating something you really aren’t. What looks like a regular egg is a colored version of a processed substance that was once a real egg...

It tricks you into thinking you’re eating “real food.” Another classic example of how enzymes are used to trick you is to create mature cheese flavor. Real cheese takes several months to mature. By adding an enzyme, they can create fake cheese flavor in a matter of days.

So you’re eating cheese flavor only—it’s NOT real cheese. Additives are also used to create butter flavor without the presence of actual butter; or in some cases they may add just enough butter to be allowed to legally proclaim “made with real butter” on the label.

What You Need to Know About the Clean Label Concept

In her book, Joanna also exposes the industry concept of “Clean Label.” In response to consumer demand, some food companies are starting to switch to more natural ingredients—or so they claim. They know many consumers avoid items with long chemical-sounding names on the ingredients list, so to avoid such “label polluters,” many food makers are replacing them with more natural-sounding ingredients. Examples include “carrot concentrate” instead of “coloring,” and rosemary extract instead of “preservative.”

In reality, these natural-sounding ingredients bear no resemblance to the real thing as they have been heavily processed, but this processing does not need to be disclosed. Extracts, for example, are often extracted from the whole food using toxic organic solvents like hexane, which you cannot remove. Those solvents remain in the ingredient. As Joanna says: “Clean Label substitutes really are additives by another name. They’re not really anymore natural. But they sound better.”

It’s important to realize that the processed food industry is primarily driven by the perception of wholesomeness—not the realization of it (which is impossible). The moment the food industry finds out that a labeled ingredient is perceived poorly, they will either rename it, or find an alternative that may be just as bad, or worse, that doesn’t have that negative association.

You MUST Avoid Processed Foods if You Ever Hope to Be Healthy

In the end, no matter how natural-sounding the ingredients on the label, if the food has been processed, your best bet is to avoid it, and this includes organic processed foods as well. I firmly believe swapping processed foods for whole, unadulterated, and ideally organic foods is one of the most important changes you can make if you want to improve your health or prevent disease. For a step-by-step guide to making wiser food choices for yourself and your family, please refer to my free optimized nutrition plan.

More than 10,000 additives are allowed in food when you factor in both the additives and the chemicals used in the packaging—such as bisphenol-A (BPA), bisphenol-S (BPS), and phthalates—which are allowed in food packaging and migrate into your food to wreak havoc with your hormones. The question is not if these will impair your health but when you will start to suffer the consequences of this chemical assault. It’s also worth remembering that many agricultural chemicals, such as glyphosate sprayed on genetically engineered plants cannot be washed off. Every cell of the plant is saturated with it, and hence it’s in the processed food as well.

Consuming pasteurized and irradiated foods will also alter your gut flora, allowing potentially pathogenic microorganisms to take over, as any and all beneficial live microbes have been killed. This in turn can have wide-ranging health consequences. If there’s any question in your mind as to the reasons for reverting to whole, minimally processed foods, I encourage you to pick up a copy of Joanna’s book, Swallow This: Serving Up the Food Industry's Darkest Secrets as it will radically increase your understanding of what you’re really eating, and boost your motivation to avoid these harmful foods. As an undercover insider, Joanna reveals details about the food processing industry that you simply cannot get anywhere else.


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