Join the Shrill Cry to Save Your Supplements
They're Threatening Your Free Access to Supplements, Putting Your Health in Jeopardy
Sixty percent of Americans take supplements.These supplements are regulated by the Food and Drug Administration (FDA) under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Supplements help people worldwide achieve good health, especially with modern farming and food processing methods that leave many individuals vulnerable to nutritional deficiencies. Even the richest of soils lack certain essential nutrients for optimal health.
A report published by two Harvard doctors in the Journal of the American Medical Association i states: "All adults should take a multivitamin every day."
Despite the benefits and tremendously safe track record of vitamins, minerals, and herbal supplements, your protected right to supplements is being threatened. URGENT ACTION ALERT!
The Enemies Have a Seat in Senate
Illinois Senator Richard Durbin first introduced the Dietary Supplement Labeling Act in 2011. This bill threatens the supplement industry by granting FDA additional powers to regulate supplements as if they are drugs, potentially driving supplement companies out of business.
Durbin's supplement bill failed miserably. In May 2012, he tried to slide his amendment (No. 2127) through by piggybacking it onto a senate bill, the Food and Drug Administration Safety and Innovation Act or S. 3187, slated for a vote the next day.
The natural health community, always on its feet, immediately took action and caused Durbin's amendment to fail once again. Only 22 out of 100 Senators supported Sen. Durbin's attempt to limit your supplement access.
SenatorsRichard Durbin (D-IL) and Senator Richard Blumenthal (D-CT)have reintroduced their Dietary Supplement Labeling Act (S. 1310).
With this supplement bill, you can expect a far more stringent regulation than what pharmaceutical drugs undergo now.
According to Sen. Durbin, his bill is designed to stop "mislabeling products and making health claims that have no scientific basis" and "marketing supplements with impure or incorrectly identified ingredients." The truth is that each of these things is already against the law, with almost all of the bill's provisions already covered by existing law.
This bill requires the FDA and the Institute of Medicine (IOM) to compile a list of dietary ingredients (supplements) that might lead to adverse events or are deemed risky, based on completely arbitrary or nonexistent standards. Watch out, because the FDA is profoundly biased against supplements and favorable of pharmaceutical interests.
S. 1310 intends to givethe FDA major new powers to curtail supplement sales – with neither it nor the IOM subjected to clear standards. The highly potential result is an arbitrary list of "bad" supplements or "bad" doses, with no scientific evidence.
Consider this bill a step closer to a full FDA pre-approval system for supplements, which would make these products ridiculously expensive and on the verge of being gone because of immense FDA approval costs.
Supplements have FAR fewer reported adverse reactions than drugs or vaccines, yet why are they considered a major threat to your safety and well-being through proposed stricter regulations?
Your Right to Supplements Is Protected by the Law – Yet They Continue to Violate It
"The Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers." - Dietary Supplement Health and Education Act of 1994 (DSHEA)
In the early 1990s, the FDA threatened the availability of dietary supplements, which prompted consumers to stage a massive revolt. This gave birth to the Dietary Supplement Health and Education Act of 1994 (DSHEA), which protects your access to dietary supplements by classifying them as foods, not food additives or drugs.
Dietary ingredients having a "history of use" in accordance with the DSHEA are NOT new dietary ingredients (NDI). This means that only novel ingredients introduced after October 15, 1994 are required to seek FDA approval.
Such is the understanding of DSHEA guiding supplement manufacturers and marketers, until:ii
"...the FDA published its controversial 'Draft Guidance for Industry: Dietary Supplements: NewDietary Ingredient Notifications and Related Issues' in July 2011. This guidance attempted to turn the language and spirit of DSHEA on its head by requiring industry to supply exhaustive documentation of safety in what has now become of a system of pre-market approval, rather than pre-market notice."
As reiterated by the campaign group Alliance for Natural Health USA (ANH-USA), the FDA's proposed mandates would turn what was clearly supposed to be a pre-market notification system into a pre-approval system, just like that of drugs.iii
The notion that dietary supplements are unsafe was the premise behind the FDA's Draft Guidance, which would require the supplement industry to prove the safety of natural ingredients that are usually on the market and used safely for decades.
What this leads to is a lengthy, costly approval process that entails exorbitant safety testing – even though zero death has been linked to these supplements!
Supplements Have a Super-Safe Track Record
Consider these data from the United Kingdom and the European Union collected by ANH-Intl:iv
|Compared to supplements:
||Adverse reactions to pharmaceutical drugs are:
|You're around 900 times more likely to die from food poisoning
||62,000 times more likely to kill you than food supplements
|You're nearly 300,000 times more likely to die from a preventable medical injury during a UK hospital stay – comparable to the individual risk of dying that active military face in Iraq or Afghanistan
||7,750 times more likely to kill you than herbal remedies
These staunch "regulators" refuse to recognize the fact that the real safety threat is not supplements, but those that are found inside your medicine cabinet.
Durbin cites the 2013 GAO Dietary Supplements report, which details adverse effects reports (AERs) linked to supplements, in hopes that statistics are a compelling case for stricter supplement regulations. This very move backfired, as the GAO report demonstrated how safe supplements are compared to vaccines and drugs.
Since 2008, the supplement industry has been required to report adverse events to the FDA's AER system. The following are 2008 statistics comparing dietary supplement AERs with drug AERs:
|1,080 dietary supplement AERs
||526,527 prescription drug AERs
||26,517 vaccine AERs
|When you do the math... There were 488 times as many adverse events from prescription drugs as from dietary supplements!
There has been an increase in supplement AERs from 400 in 2007 to 1,080 in 2008, but this stems from an increase in the number of supplements on the market and more careful reporting of AERs to the FDA. Still, as ANH-Intl points out, the number of AERs is small compared the hundreds of millions of supplement servings consumed, with more than half of Americans taking nutritional supplements.v
"...dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare." - Dietary Supplement Health and Education Act of 1994 (DSHEA)
But as Senator Durbin claims, these AERs are underreported. Are they?
The 2013 GAO report shows that there were only 20 AER compliance problems identified during supplement company inspections. This suggests that most of these companies are compliant with mandatory AER guidelines. As 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."
According to the GAO report, FDA officials said that the current regulatory framework – DSHEA – is sufficient to identify and act on safety concerns involving foods with added dietary ingredients.
There are always bad products in every industry. Overall, though, supplements appear to be one of the safest in the consumer arena. And the solution is not expanding government regulation – it's educating consumers to take further control of their health, to grow their own food, and care for their bodies the way the self-sustaining individuals of centuries ago did.
The Drug Industry Is the Real Threat to Health
Data dictate that the attention needs to be focused on drugs instead of supplements.
The U.S. National Poison Data System's annual report in 2012 showed zero deaths from nutritional supplements. The same, though, cannot be said of prescription and over-the-counter drugs.
ALL medications were the top categories linked to the largest number of fatalities, including:
- Analgesics, sedatives, hypnotics, and antipsychotics
- Cardiovascular drugs
- Acetaminophen combinations
Muscle relaxants, anti-inflammatories, hormones, antacids, anticoagulants, and antihistamines are also on the list.
Pharmaceuticals were involved in more than 1,100 of the 1,366 fatalities reported to 57 poison control centers. This is just part of the picture, as the total figure is closer to 125,000 deaths from drugs per year.vi The question is: why are legislators not concentrating their efforts on the life-threatening drug industry?
The Stakes Are High for Your Health – And Their Deep Pockets
What Durbin's legislative efforts show is his goal of making sure every supplement is approved by the FDA before it is sold on the market.
Here's the problem: the FDA is heavily biased in favor of drugs, as this agency is primarily funded by the pharmaceuticals. Supplements are seen as competition for drugs, which means that not many will be approved.
Natural health expert Dr. Joseph Mercola explains that if Durbin's supplement bill were to pass, it is likely for the FDA to demand very expensive supplement trials.vii As a result, the vast majority of recent supplements would be eliminated, since they cannot afford trial expenses. Those who will survive will probably have no choice but to increase their prices. Supplements generally cannot be patented – supplement manufacturers will never see the return on investment that drug companies see.
And this is ultimately why supplements are under attack when drugs are the one that surface in data as the much, much bigger threat to your life and health: killing the competition.
This legislation is engineered to eventually have supplements pulled out of store shelves. And there is so much at stake in eliminating natural healthcare options, given the following facts:
- Supplements are yielding greater sales growth than the overall American economy – its 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.
- Supplements represent the greatest threat to drug company profits.
- Pharmaceuticals are on the lookout to replace their top moneymaking drugs, as drug patents are set to expire soon (including Lipitor and Plavix).
- Pharmaceuticals can defeat competitors paying off politicians to write legislation, such as the supplement bill, to make it difficult for small players like supplement companies to survive.
- The FDA is more than willing and able to perform favorably to Big Pharma to secure its continued financial support.
Emergency Situation: Save Your Supplements Now
Fight this legislation that spell grave consequences to your right to essential nutrition.
Your health can pay a dear price for not taking part in this important issue: either supplements will convert into high-priced products or disappear from the market entirely because of the needless tighter regulation being proposed.
Supplements are nutrients, not drugs. They are not the dangerous elements that they are painted to be!
S.O.S. today – join the grassroots campaign to preserve your right and access to nutritional supplements. Call or write to your senator or representative, or sign the petition. Fight for your health freedom: your right to access supplements and take control of your health.