Over 60 Billion Doses a Year and Not ONE Death, But Still Not Safe?
April 23 2012
By Dr. Mercola
Vitamins, minerals and herbal supplements have a tremendously safe track record, yet they are often singled out as being potentially dangerous by government agencies like the U.S. Food and Drug Administration (FDA).
This – the notion that dietary supplements are unsafe -- is the premise behind the FDA's Draft Guidance on New Dietary Ingredients, which would require the supplement industry to prove the safety of natural ingredients that, in many cases, have been on the market and used safely for decades.
As new research from the American Association of Poison Control Centers' National Poison Data System reveals, there were zero deaths linked to nutritional supplements in 2010, the most current data available.
Zero Deaths Linked to Vitamin Supplements
However, in the FDA's new Draft Guidance, the FDA is essentially claiming that dietary supplements are unsafe, and implying that in order to "protect consumers" the agency must place a stranglehold on the dietary supplement industry by requesting exorbitant safety testing.
These ludicrous safety thresholds are in excess of those required by pharmaceutical drugs -- despite extensive toxicological data showing supplements are far safer than drugs.
The most recent data comes from the U.S. National Poison Data System's annual report, which tracked data from 57 U.S. poison centers and showed vitamin and mineral supplements caused zero deaths in 2010.i
As noted by Orthomolecular Medicine News Service, Americans easily take more than 60 billion doses of nutritional supplements every year, and with zero related deaths this is an outstanding safety record:
"Well over half of the U.S. population takes daily nutritional supplements. Even if each of those people took only one single tablet daily, that makes 165,000,000 individual doses per day, for a total of over 60 billion doses annually. Since many persons take far more than just one single vitamin or mineral tablet, actual consumption is considerably higher, and the safety of nutritional supplements is all the more remarkable.
Over 60 billion doses of vitamin and mineral supplements per year in the USA, and not a single fatality. Not one. If vitamin and mineral supplements are allegedly so "dangerous," as the FDA and news media so often claim, then where are the bodies?"
In striking contrast, drugs are known to cause well over 125,000 deaths per year when taken correctly as prescribed – yet the FDA allows "fast-track" approvals and countless new additions to the marketplace. So why are dietary supplements on the chopping block?
Why is the FDA Attacking Dietary Supplements That Have Been Used Safely for Decades?
Back in the early 1990s, the FDA threatened the availability of dietary supplements to the point that consumers staged a massive revolt, which resulted in the Dietary Supplement Health and Education Act of 1994 (DSHEA).
The law specifically protects your access to dietary supplements by classifying them as foods, not food additives or drugs, and it grand-fathered in dietary supplements that were already in use as of 1994. Only novel ingredients introduced after October 15, 1994 are required to seek FDA approval.
The FDA's new proposed mandates directly contradict what DSHEA sought to prevent, and the FDA is using its authority in direct violation of Congressional intent. As explained in an article by Alliance for Natural Health, the proposed regulations turn what was clearly supposed to be a pre-market notification system into a pre-approval system, just like that of drugs.ii
As a result, dietary supplements that have been freely available for nearly two decades can now be forced off the market until they receive New Dietary Ingredient (NDI) approval. And the NDI approval process is a lengthy affair that may take months or years to complete, and cost a small fortune. Bringing a drug from the pre-clinical (or discovery phase) all the way to market can easily take more than a decade and cost significantly more than $1 billion! This despite the fact that contrary to drugs, fatalities from vitamins and other supplements are minuscule.
According to the 2001 report of the American Association of Poison Control Centers (AAPCC), of the substances implicated in fatal poisonings in 2001, 84.6 percent were pharmaceutical drugs, with analgesics being implicated as the primary cause of death in 32 percent of fatalities or 341 deaths. This compares with 0.8 percent for all dietary supplements combined, even including substances such as dinitrophenol, a dangerous (and illegal) substance banned in 1938, as well as the central nervous system stimulant Ma Huang (Ephedra). Interestingly, the anti-asthma drug theophylline alone was responsible for 15 deaths, 66 percent more than all the available dietary supplements combined.
What might make an "old" ingredient "new," under the new regulation?
The methods of production and extraction, for example … As bizarre as that sounds, the mere fact that a product is being extracted or produced by improved means compared to methods used in the past, could reclassify any grandfathered nutrient as an NDI that would now have to undergo the same type of safety testing and approval process as a drug.
FDA Seeking Outrageous Safety Studies from Tried and True Supplements
In some cases, the FDA will require manufacturers to conduct outrageously expensive studies using absurdly high doses, in some situations multiplied by a "safety factor" up to 2,000-times the recommended dosage on a per product basis. Further, the FDA proposes that new dietary supplement ingredients should adhere to aggressive safety margins, which are typically reserved for chemical compounds known to be dangerous in all but the most miniscule concentrations.
Since food additives or preservatives such as aspartame, monosodium glutamate, and sodium nitrate are known to cause cancer or other severe health problems, the FDA has implemented safety guidelines that limit allowable concentrations of these food additives to levels that are supposed to be physiologically inert.
The fact that the FDA is trying to impose the same limits upon dietary supplements seems to be arbitrary and completely unfounded. In fact, when someone takes a dietary supplement, their intent is to positively affect the structure or function of their bodies in some way -- limiting dosages of dietary supplements to physiologically inert levels defeats the entire purpose of supplementation with health-sustaining nutrients.
And, since supplements are not patented drugs, virtually no supplement manufacturers will be able to afford these "safety" studies, which means that many of the nutrients you now purchase at low prices will convert into high-priced drugs, or simply disappear from the market entirely.
The Drug Industry is the Real Safety Threat
While the U.S. National Poison Data System's annual report showed zero deaths from nutritional supplements, this was not the case for prescription and over-the-counter drugs. The top categories associated with the largest number of fatalities were ALL medications, including:
Analgesics, sedatives, hypnotics, and antipsychotics
Slightly lower down on the list were more drugs, including muscle relaxants, anti-inflammatory drugs, hormones, antacids, anticoagulants, antihistamines and more. Out of a total 1,366 reported fatalities, pharmaceuticals were involved in over 1,100 of these deaths (again, compared to zero for supplements). Keep in mind that this is not an estimate of all the deaths attributed to pharmaceuticals in the U.S., only those reported to 57 poison control centers. The total figure is closer to 125,000 deaths from pharmaceuticals per year. iii
If you extrapolate this number out over 30 years this is well in excess of 3 million people who died from taking appropriately prescribed legal drugs. It is simply incomprehensible that any rational approach would seek to vilify supplements over drugs when the data in no way, shape or form supports it. The most likely motive for this position is financial greed that can put your life in jeopardy.
Defend Your Right to Continue Taking Safe Supplements
No one can sit on the sidelines with an emergency of this magnitude about to befall everyone who depends on dietary supplements. As citizens, we have the constitutional right to petition the government to redress our grievances. In this case, the FDA NDI proposals pose a direct threat to our health and longevity by threatening free access to dietary supplements with exemplary safety records.
We therefore have to take extraordinary measures to defend our right to continue using supplements that our very lives depend on, and to gain access to new natural ingredients that demonstrate efficacy in scientific studies. I ask each one of you to contact your representatives by following this link:
Recall how consumers revolted back in 1994 and the result was a glorious victory over FDA tyranny! Let your voice be heard by exercising your right to petition the government against these serious violations of the law and scientific principle. Please be sure to call, fax, or send a certified letter to your representative -- emails can be easily dismissed. Here is a set of talking points for your consideration:
My name is [Name] and I am a constituent of [Congress Member's name].
I am very concerned about the new FDA draft guidance on dietary supplements and new dietary ingredients.
I request that Congress hold hearings and take action to review the FDA's draft guidance and stop their overreach of power.
The FDA's draft guidance flies in the face of the original congressional intent of the Dietary Supplement Health Education Act: The guidance turns what was meant to be a simple notification system for new dietary ingredients into a preapproval scheme that Congress did not intend to create.
Congress recognized that dietary supplements are natural ingredients and therefore inherently safer than drugs and chemical food ingredients. It did not intend that the FDA would have the power to approve or reject dietary supplements.
The FDA's draft guidance creates unnecessary regulations that limit my access to dietary supplements I rely on. The expensive and burdensome process will force between 20,000 and 42,000 dietary supplements to be removed from the market and will increase the cost of those supplements that remain.
The draft guidance hurts our economy. Expert analyses show that this guidance will cause a total economic loss of $21.2 billion to $39.8 billion annually.
Thank you for your time.
Be courteous and respectful.
Keep your comments brief and focused on the facts.
Always thank the staff member for their time taking your call.
SAMPLE LETTER TO CONGRESS:
The Honorable _________________________ Washington, D.C.
In direct violation of the law, the FDA is threatening to ban my access to new dietary supplements.
The FDA defines dietary supplements as being "new" if they were introduced after October 15, 1994. That means that nutrients that I have been safely using over the course of three decades will be subject to the FDA's oppressive policies that mandate costly animal testing, which translates into forced withdrawal from the market, and higher prices for me if the supplement is ever allowed to be sold again.
The Dietary Supplement Health and Education Act of 1994 states that:
"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."
It says that Congress finds that:
"dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare."
And it says that:
"legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness."
This draft guidance does the exact opposite of what Congress intended. It imposes unreasonable barriers that limit and slow the flow of safe products and accurate information to consumers. I call upon Congress to:
Uphold the landmark legislation it passed seventeen years ago, and to direct the FDA to revise its New Dietary Ingredient draft guidelines to reflect DSHEA's (and Congress's) stated values and goals.
Vote against the newly introduced Dietary Supplement Labeling Act as this would give the FDA even greater arbitrary powers to remove safe dietary supplements from the market, and will profoundly impact this nations' health in a negative way.
All of these proposals result in wasteful federal spending, while at the same time impose a massive new "regulatory tax" on consumers and the vitamin industry.
Kindly let me know what actions you are taking in response to the urgent issues raised in this letter.
i 2010 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS): 28th Annual Report
ii Alliance for Natural Health July 12, 2011
iii U.S. Centers for Disease Control and Prevention Poisoning Factsheet
Source: Orthomolecular December 28, 2011