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Nutritional Supplements

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  • 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
 

Senator Durbin to Reintroduce Supplement Bill

June 19, 2013 | 210,545 views
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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 Dr. 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?

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) 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.

 

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