Flawed “GRAS” System Lets Novel
Chemicals into Food Supply Without FDA Safety Review
April 29, 2015
Story at-a-glance
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
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Outdated Law Lets Unsafe Ingredients into the Food Supply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.
"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.
Eat Well
Guide: Wholesome Food from Healthy Animals --
The Eat Well Guide is a free online directory of sustainably
raised meat, poultry, dairy, and eggs from farms, stores,
restaurants, inns, and hotels, and online outlets in the
United States and Canada.
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.
Copyright 1997- 2015 Dr. Joseph Mercola. All Rights Reserved.