By Dr. Mercola
Imagine making a trip to your favorite nutrition store, and instead of finding a cornucopia of supplements of every possible kind, finding nothing but empty shelves. Maybe a handwritten sign taped to the shelf saying, "Unavailable until further notice."
There is one United States Senator spearheading legislation engineered to bring about such a nightmare. Illinois Senator Richard Durbin launched a "sneak attack" on supplements that would have slipped under the radar were it not for the watchful eye of organizations such as the Alliance for Natural Health (ANH), who send out alerts whenever something like this occurs.
When it comes to your healthcare freedom, Senator Durbin may be the most dangerous politician in Washington, and I am sorry to say he is from my home state of Illinois.
On Tuesday, May 22, 2012, Durbin's Amendment No. 2127 was piggybacked onto a bill that was set for a vote the next day (Wednesday, May 23, 2012). The bill was 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 was defeated—for now. (It was tabled for later discussion.)
Senate offices were flooded with nearly 90,000 emails and phone calls within 24 hours in response to the announcement of the proposed amendment, applying pressure to local representatives and successfully preventing the amendment's passage. This is proof once again that when you make your voice heard, legislators listen. But we can't stop fighting yet.
Senator Orrin Hatch Steps Up in Your Defense
The tabled amendment would have required supplement companies to register supplements with the U.S. FDA within 30 days, a nearly impossible task and one designed to put them out of business. Supplement companies are already required to register with the FDA under Title III of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 1 (aka "the Bioterrorism Act"), so this new piece of legislation is redundant, pointless, and nothing more than an underhanded blow to the natural health movement.
Utah Senator Orrin Hatch2, staunch defender of the supplement industry, calls out Durbin's hidden agenda for Amendment No 2127:
"The FDA already has a tremendous amount of regulatory oversight and enforcement tools when it comes to dietary supplements… Instead of urging FDA to use its current enforcement authority to find and punish those companies that are not following the law, Senator Durbin's amendment serves to punish all responsible companies with its overreaching mandates."
Hatch added that 150 million Americans use dietary supplements regularly, and that multiple previous FDA commissioners feel DSHEA (the dietary supplement law passed in 1994) provides the appropriate level of responsible oversight.
This is NOT the first time Senator Durbin has declared war on supplements or natural foods. In 2011, Durbin sponsored the S 1310 Dietary Supplement Labeling Act of 20113, a bill that threatened the dietary supplement industry by giving FDA power to regulate vitamins and other supplement as if they were drugs. The act was his reaction to a scandal surrounding Lazy Cakes, cupcakes with added melatonin to help adults fight insomnia. Some adults who purchased the cakes fed them to toddlers, and the toddlers subsequently became ill4.
Senator Durbin Misinforms and Misleads Fellow Legislators
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One of the more disgusting aspects about this latest legislative tactic is the blatant misinformation Senator Durbin dispersed to his fellow legislators. In Senator Durbin's speech on the Senate floor on May 23, 2012, Durbin says5:
"No one tests dietary supplements...companies may test them if they wish...there's no requirement under law that they test them, and there's no agency of government that tests dietary supplements."
This is completely untrue. As ANH writes:
"Supplement companies, by law, must comply with the Dietary Supplement Current Good Manufacturing Practices (CGMPs) and must conduct testing throughout the production process as well as testing the finished product for quality control. As with the pharmaceutical industry, the burden is on supplement companies to test their own products, because in the end they are liable should FDA choose to take enforcement action against them."
In 1994, Congress passed the Dietary Supplement Health Education Act (DSHEA)6. This act established standards for dietary ingredients, from defining what is a dietary supplement and identification of ingredients, to labeling. The act gave the FDA authority over dietary supplements to include developing Good Manufacturing Practices (GMP) under Title 21 Code of Federal Regulation.7
The bottom line is, there is no need for further legislation related to the manufacturing, ingredients, labeling or use of natural supplements. If anything needs to be more regulated, it would be drugs, which are far more likely to kill you than your vitamins.
The Slippery Slope Toward Loss of Health Freedom
One reason I am so concerned about legislation like Senator Durbin's is that it's clearly intended to put us on a slippery slope toward a supplement pre-approval system, similar to the one being used by the European Union. In the EU, only certain "approved" vitamins and minerals may be used in food supplements, and only in very limited amounts.
You may not realize you have far greater freedom of choice about your dietary supplements than do Europeans—at least for now. In Europe, dietary supplements are considered prescription drugs, and are regulated as such. Many overseas tourists visiting America purchase thousands of dollars of dietary supplements to bring home with them, because their access at home is so limited.
If our supplement industry is captured by big business, you can expect legislation that will force you to obtain a prescription for natural remedies, which is what Senators like Richard Durbin want. This sort of restriction places the pharmaceutical industry in complete control of supplements, in terms of access and price, which is the LAST thing you should want if you value natural, non-pharmaceutical healthcare options. Are vitamins so dangerous that you need a physician to dole them out? Not if you examine the statistics.
Supplements Don't Kill—But Drugs Do
Supplements have a FAR better safety record than drugs or vaccines, as the following statistics8 reveal. In 2008, the adverse events reported for supplements versus drugs were as follows:
- The reported number of adverse events for prescription drugs and "therapeutic biologics" was 526,527, of which 275,421 had "serious outcomes"
- The reported number of adverse events for vaccines was 26,517, of which 3,923 were considered serious
- The reported number of adverse events for supplements was 1,080, of which 672 were considered serious
The above figures should be interpreted with caution, however. Adverse events for drugs are defined differently than adverse events for supplements. If an FDA-approved drug lists on the label that it can cause fainting or nausea, or even chest pains or seizures, then it's considered to be within the range of expected outcomes. In this case, the adverse event should be reported, but the report is not considered "urgent" and may be delayed for up to a year.
Not so for supplements. What the FDA considers an adverse event from a supplement can be anything from a concern that a supplement "isn't working" to a serious illness that follows consumption. But even with this statistical comparison unfavorably weighted against supplements, there are 487 times more official reports of adverse events related to drugs than to supplements, and 409 times more serious events related to drugs than to supplements. And according to a CDC report9, there was not one single death associated with a dietary supplement in 2010!
If you're interested in sidestepping health problems, the odds are certainly more in your favor with supplements. So, if unfathomable danger is not lurking in every vitamin bottle, then why are politicians like Dick Durbin so determined to destroy them? One must begin to ask whom these politicians are really working for and what agenda they really serve.
Keep Your Friends Close and Your Enemies Closer
It appears Senator Durbin receives a good deal of funding10 from the medical and pharmaceutical industries, which have vested interests in eliminating natural healthcare options. Drug companies are increasingly buying up supplement manufacturers11. This is a predictable takeover, given the following facts:
- Supplements are yielding greater sales growth than the overall American economy and represent the greatest threat to drug company profits (the supplement industry is slated to grow by nine percent per year between 2011 and 2015, as compared to the US economy's dwindling growth rate of two percent per year)
- Drug patents are set to expire soon, by the masses (including Lipitor and Plavix), forcing pharmaceutical companies to find replacements for their top moneymaking drugs
- Pharmaceutical companies can snuff out their competition by paying off politicians to write legislation, such as this latest amendment, that makes it too difficult for small competitors (i.e., supplement companies) to survive
- One of the drug industry's "BFFs" is the FDA, which has stacked the deck against the supplement industry in order to secure its continued financial support from drug manufacturers
Also understand that the drug companies aren't stupid. They KNOW your supplements work! But it doesn't serve their bottom line to admit it. Eventually, they can't hide the science from you. For example, look what's happened with vitamin D. There's no hiding the plethora of positive scientific studies now published about the health benefits of vitamin D. But it took quite a number of years for those studies to finally make it past the ire of the medical industry, which tried everything in their power to discredit them.
So drug companies figure, why not turn supplements into drugs?
Supplements cannot typically be patented, but drugs can. No ordinary supplement company can afford to take a non-patentable substance through a drug approval process that on average costs a billion dollars (which, incidentally, pays FDA salaries). If supplements are treated like drugs, there simply won't be any supplements unless the drug companies take them over and control them completely. It's the perfect one-two punch: arrange legislation to bankrupt the supplement industry, and then step in to overtake it.
If You Want to Keep Your Supplements, Get Involved NOW!
We must remain vigilant, as this fight is not over. There will always be legislators like Senator Durbin who will make arguments that sound good to most listeners at first blush, but are really stepping stones to ending your free choice. Senators Orrin Hatch and Tom Harken deserve our gratitude and support for the great work they did in defeating Amendment No 2127. If you wish to express your thanks, you can send a message by clicking here.
But don't stop with your thank you note!
There is still work to be done to prevent passage of S 1310, Dietary Supplement Labeling Act, introduced by Durbin June of 2011. Contact your representatives and demand the FDA immediately withdraw these proposed guidelines. You can easily do this by logging onto the Life Extension Legislative Action Center.
If you live in Illinois, contact Senator Durbin.
Tell him—or whomever your representative is—to stop this overreach of power, and that the FDA's draft guidance guidelines12 fly in the face of the original 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.
Legislators can be very sneaky in their attempts to slip legislation through that fulfills their agenda, as this latest amendment demonstrates. The time to get involved is NOW. You are the best one to decide what's best for your health, and the government has no right to stand in your way.