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Senator
Durbin to Reintroduce
Supplement Bill
June 19, 2013
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 FDA9asking 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?
As reported by Forbes:10, 11
“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 - http://www.house.gov/) 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.
