Flavor Manufacturers’ Trade Group Is
the De Facto Regulator of Flavor Additives in the US
July 20, 2015
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
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.
“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...
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.