Illinois Senator Durbin is planning to reintroduce his
supplement bill, the Dietary Supplement Labeling Act (S 1310),
which would grant more power to the FDA to regulate dietary
supplements like they were drugs; Durbin first introduced S 1310
in 2011, but it failed miserably, as have many of his other
attempts to pass laws attacking the supplement industry
Durbin’s citing of the 2013 GAO Dietary Supplements report,
which details adverse effects reports (AERs) associated with
supplements, backfires in that it demonstrates just how safe
supplements are, compared to vaccines and drugs
Based on the GAO report, there were 488 times as many adverse
reactions reported for prescription drugs as from dietary
supplements, and there is no evidence supporting the claim that
adverse reactions to supplements are underreported; data from
poison control centers confirms their safety
The financial burden created by Durbin’s proposed legislation
will likely cause many supplement companies to go under; and, as
a result, the cost of your supplements will likely skyrocket
and, more importantly, your supplement choices will be limited
Manufacturers are migrating products previously classified as
“supplements” into the category “food products” in order to
sidestep the tighter regulations imposed on supplements, and
this loophole is completely ignored by the Durbin bill
By Dr. Mercola
Make no mistake, there is a well orchestrated campaign underway
to take away your rights and access to vitamins and supplements.
You have likely witnessed the recent flurry of articles from doctors
with scary headlines like "Don't Take Your Vitamins" written by Paul
Offit. Senator Dick Durbin has taken a leading role as well.
Senator Durbin was also a sponsor for the SOPA / PIPA act, which
would give the government even more power to censor and control the
internet. You would think it would be impossible at this point to
have MORE control, considering the recent leaks regarding the NSA.
There is no satiating the hunger for more power in our federal
government. Politicians will scare you about sugary beverages loaded
with caffeine as examples of the dangerous and 'unregulated'
supplement industry.
Meanwhile, consumers load up at Starbucks and other coffee shops
- where they can easily down cups and cups of this 'dangerous'
substance. You don't see Durbin beating down the door of Starbucks
or Dunkin Donuts, even though coffee is the primary source where
most people get their caffeine fix.
When you notice this type of hypocrisy, you can usually bet there
is a serious industry influence behind the scenes. There is a
campaign push assaulting the supplement industry by those hoping to
gain control of it. Essentially, if supplements become regulated
like drugs - only the drug companies will be manufacturing them.
By setting new regulations and gaining control of the industry,
big pharma can charge higher prices and make higher profits.
Surprisingly, a newly released GAO Dietary Supplements report has
recently shown just how safe dietary supplements really
are. There are always bad products in every industry, but overall,
supplements appear to be one of the safest of all consumable
products.
Senator Durbin has been on a mission that appears, at least
superficially, to stem from concern over “your health.” However,
when scrutinized more closely, Durbin’s proposed legislation would
have precisely the opposite effect.
If Senator Durbin is genuinely concerned about “your health,”
then his focus should be on making drugs and vaccines safer, which
are the real danger — not dietary supplements.
Why Should Supplement Regulation Be More Stringent Than That for
Drugs?
Durbin first introduced the Dietary Supplement Labeling Act (S
1310) in 2011, a bill that threatens the supplement industry by
granting
FDA more power to regulate supplements as if they were drugs,
potentially putting supplement companies out of business.
In fact, under this bill, supplement regulation would be even
more stringent than for pharmaceutical drugs! The bill specifies the
following:1
Requires regulators to compile a list of dietary supplement
ingredients and proprietary blends of ingredients that are
judged capable of causing serious adverse reactions
Mandates manufacturers to submit a list of all the products
they make at a given facility and their ingredients; new
products or reformulations would require new registrations
Despite resorting to sneaky tactics and dispersing blatant
misinformation to his legislative colleagues in attempts to garner
support, Senator Durbin has had a difficult time obtaining any
support for his bill.
Therefore, in May 2012, Durbin tried to slide his amendment (No.
2127) through by piggybacking it onto a senate bill that was slated
for a vote the very next day (S 3187, the Food and Drug
Administration Safety and Innovation Act).
Because the natural health community so quickly and effectively
sprung into action, Durbin's amendment failed. Although his efforts
to pass this ridiculous legislation have been unsuccessful thus far,
his determination has not waned, misguided though it is. We must
continue our efforts to thwart this bill, which if passed into law,
could spell disastrous consequences for your health.
The Danger of Food Supplements Is VASTLY Overstated
Durbin and others would have you believe supplements are
dangerous and need further regulation. But the truth is that
supplements are already FDA-regulated and produce far fewer adverse
reactions than either drugs or vaccines. The March 2013 GAO Dietary
Supplements report,2
which Durbin hoped would paint supplements as dangerous, actually
showed how incredibly safe they really are—particularly when
compared to drugs and vaccines.
Since 2008, the supplement industry has been required to report
adverse events to the FDA’s AER system, pursuant to the 2006 Act.
Consider the following statistics comparing dietary supplement AERs
with drug AERs (from the 2013 GAO report):
From 2008 to 2011, FDA received 6,307 AERs for dietary
supplements, not including 1,000 AERs that were submitted to
poison control centers, rather than the FDA3
In 2008, 1,080 dietary supplement AERs were reported to FDA
In 2008, 526,527 prescription drug AERs were reported
In 2008, 26,517 vaccine AERs were reported
When you do the math, there were 488 times as many
adverse events reported from prescription drugs as from dietary
supplements!
Supplement AERs increased from 400 in 2007 to 1,080 in 2008, but
as the Alliance for Natural Health points out, that stems from an
increase in the number of supplements on the market and more careful
reporting of AERs to the FDA, especially since the implementation of
required good manufacturing protocols. The number of AERs is
miniscule compared to the hundreds of millions of supplement
servings consumed.4
According to a 2007 National Health Interview Survey,5
more than
half of Americans (157 million individuals) take nutritional
supplements.
Senator Durbin and company are trying to claim AERs are
underreported. However, according to the 2013 GAO report, there were
only 20 AER compliance problems identified during supplement company
inspections, suggesting most of these companies are compliant with
mandatory AER guidelines. Adverse reactions aren’t being
underreported—there just aren’t that many reactions to report. Even
the GAO report itself states:
“The greatest challenge for identifying potential safety
concerns from AERs is the small number of AERs that FDA receives
related to dietary supplements.”
Poison Control Data Supports the Safety of Nutritional Supplements
Data from the U.S. National Poison Data System’s annual report,
which tracked data from 57 U.S. poison centers, showed vitamin and
mineral supplements caused
zero deaths in 2010, whereas pharmaceuticals caused more than
1,100 of the total 1,366 reported fatalities. FDA-approved drugs
cause 80 percent of poison control fatalities each year.6
Poison control centers report 100,000 calls, 56,000 emergency room
visits, 2,600 hospitalizations and nearly 500 deaths each year
from acetaminophen (Tylenol) alone.
Data from the European Union indicate that pharmaceutical drugs
are 62,000 times as likely to kill you as
dietary supplements. You’re actually more likely to be struck
dead by lightning or drown in your bathtub than have a lethal
reaction to a dietary supplement. These figures make it quite clear
where the danger lies. If Senator Durbin really cared about
your health, his efforts would be centered on doing something to
make drugs safer, as they obviously pose a FAR greater risk to your
health.
Laws Regulating Supplements Are Already in Place
According to the GAO report:
“FDA officials told us that the current regulatory
framework is sufficient to identify and act on safety concerns
regarding foods with added dietary ingredients.”
They are referring to the Dietary Supplement Health and Education
Act of 1994 (DSHEA).7
The only deficiency, to the extent it exists, lies in the
enforcement of the current law, in terms of ensuring good
manufacturing practices and mandatory reporting of adverse events by
supplement companies. If the FDA is already well-equipped with
legislative authority to do its job, then what is Senator Durbin
really trying to accomplish?
The only answer that makes sense is that the ultimate goal of
Durbin’s bill is to make sure every supplement is approved by the
FDA before it is sold.
The hidden problem with this is that the
FDA is heavily biased in favor of drugs, as the agency is
primarily funded by the pharmaceutical industry. The FDA sees
supplements as competition for drugs, so not many will be approved.
Durbin’s bill attempts to get supplements into the clutches of our
completely dysfunctional drug approval regime, where they can be
subjected to every possible legal obstacle that will keep them off
store shelves. Less competition from supplements would also soften
the impact of decreased revenues from expiring drug patents.
Forcing Supplement Companies Out of Business Will Not Improve Your
Health
If Durbin’s bill were to pass, the FDA would demand very
expensive (on the order of hundreds of millions of dollars)
supplement trials just like drug trials which would eliminate the
vast majority of recent supplements as most manufacturers have
revenues that are only a tiny fraction of drug companies and can’t
afford these expenses. More importantly, they are simply unnecessary
as they provide virtually no benefit to the consumer. The current
reported adverse effects are simply too low to justify this
unnecessary safety requirement from a nonexistent danger. Remember,
supplements don’t kill tens to hundreds of thousands of people every
year; drugs do. Supplements don’t kill anyone.
Unlike drugs, supplements generally cannot be patented, so
manufacturers will never see the return on investment that
pharmaceutical companies see. The cost of complying with the
pre-approval process will likely put many supplement companies out
of business, and those who survive may do so only by drastically
increasing the price of their products, making them cost prohibitive
for many... particularly low-income families who need them the most.
Durbin’s bill would also impose a significant burden on federal
regulators, diverting these resources away from where they
should be focused—i.e., on the
drug industry.8
Crafty Reclassification of Products Allows Manufacturers to Dodge
Regulations
There is an additional problem that appears to be completely
ignored by Senator Durbin. Dietary supplements are already more
rigorously regulated than food products. Taking full advantage of
this, some manufacturers are migrating products previously listed as
“supplements” over to the “food products” category in order to
sidestep regulation.
Energy drinks are a prime example. Loren Israelson, executive
director of the United Natural Products Alliance, is quoted as
saying:
“I think he [Senator Durbin] misunderstands the dynamics
of the energy drinks market. There has been a significant shift
of brands going from dietary supplement labeling to food
labeling. His bill would not capture some of the products he’s
concerned about.”
Caffeine—A Ridiculous Case of Selective Regulation
In related news, the FDA is now going after caffeine to protect
your and your children’s health, in response to Senator Durbin’s
fervent outcries. Back in November 2012, Senators Durbin and Richard
Blumenthal (D-Conn.) sent a series of letters to the FDA9
asking for energy drinks to be reviewed and potentially regulated.
While caffeine can indeed have detrimental health effects, the
irony of the situation is that no attention is going toward actual
coffee, which clearly would impact major multinational
corporations like Starbucks. No, they’re only concerned with
supplement, food and beverage makers using caffeine in their
products, while the primary source of caffeine is not even part of
the discussion. Supplements are just a tiny portion of caffeine
consumption, so why not go after coffee?
“FDA Deputy Commissioner for Foods Michael Taylor spoke
out against what he called the 'unfortunate' trend [of adding
caffeine to processed foods]... Taylor specifically called out
gum maker Wrigley on a new product, and stated that while formal
regulation might be forthcoming, 'we hope this can be a turning
point for all to prevent the irresponsible addition of caffeine
to food and beverages. Together, we should be immediately
looking at what voluntary restraint can be used by industry.'
..Mr. Taylor expressed concern over the 'cumulative
amount' of caffeine available, particularly for children.
...[A]s long as FDA’s actions aren’t tethered to
standards or science, they threaten to sweep in products that
don’t merit any concern or scrutiny. During FDA’s successful
effort to drive some caffeine-infused alcoholic beverages, like
Four Loko, off the market, it also
sent warning letters to brewers whose product line featured
beers brewed with coffee. The amount of caffeine in and serving
sizes of the beer paled in comparison to Four Loko, which led
the head of a craft-brewing association to feel such letters
were 'inadvertent.' He did add, however, 'brewers should be
concerned. This could lead the FDA to question beverages that
get their caffeine from natural products like coffee, chocolate
or tea. Who’s to say where this will end?'”
Call to Action
Dick Durbin will be up for re-election in 2014. You can bet we
will be focusing very specifically on this career politician. Durbin
and others would have you believe supplements are dangerous and need
further regulation. However, supplements have far fewer reported
adverse reactions than either drugs or vaccines and are already FDA
regulated.
Durbin is reintroducing his supplement bill in hopes of forcing
dietary supplement manufacturers to pass regulations that are even
stricter than those governing pharmaceutical drugs. Legislative
tactics such as this represent part of a master plan by the drug
industry, in partnership with its best friend FDA, to eliminate the
competition by taking control of the supplement industry.
Durbin’s bill has failed miserably in the past due to lack of
support and strong opposition by health-conscious consumers. We can
do that again, but your help is needed. Please contact your
representatives and urge them to vote NO on S 1310, Dietary
Supplement Labeling Act. You can do this by signing the
Alliance for Natural Health (ANH) petition.
If you live in Illinois, as I do, I would encourage you to contact
Senator Durbin directly. Tell him (or whomever your representative is)
to stop this overreach of power, and that the proposed guidelines fly in
the face of the congressional intent of DSHEA. Congress never intended
for the FDA to control supplements, and giving them this control
jeopardizes your access to the dietary supplements you rely on, as well
as further damaging the US economy. Please be courteous and respectful,
and thank them for their time.