The FDA has issued a proposed mandate that represents the greatest threat to dietary supplements since 1994. Back in the early 1990s, consumers were so alarmed by FDA bullying that they staged a massive revolt. The result was that Congress passed a law prohibiting the FDA from banning popular nutrients (as the agency had threatened to do).
There was, however, a loophole in the 1994 law. The FDA was given authority to regulate ingredients introduced after October 15, 1994.
It has been 17 years, but the FDA just issued draconian proposals as to how it intends to regulate what it now calls "new dietary ingredients". You can find the FDA Draft Guidance on New Dietary Ingredients (NDI's) here. If implemented, some of the most effective nutrients you are taking will be removed from the market. This includes many fish oil formulas and natural plant extracts. A detailed analysis of the FDA Draft Guidance is available here.
These oppressive rules are exactly what the 1994 law (DSHEA) sought to prevent. The FDA is using its authority in direct violation of Congressional intent.
In order for these ingredients you are using today to return to the market, 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.
The FDA defines dietary supplements as being "new" if they were introduced after October 15, 1994. That means that even certain nutrients that have been safely used over the course of three decades will be subject to the FDA's oppressive policies that mandate costly animal testing.
The FDA Views Supplements in Same Light as Synthetic Food Preservatives
According to the new guidelines, the FDA believes that "new dietary supplements" must be regulated similarly to synthetic food preservatives. The FDA guidelines have modeled the outrageous safety thresholds after those in place for food additives. This appears to be in direct violation of DSHEA, the law enacted in 1994 to protect consumer access to dietary supplements, which classifies dietary supplements as foods, not food additives.
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 which 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.
The FDA's new guidelines are so flawed that even nutrients shown to be completely safe in hundreds of human clinical studies would fail to accommodate the unreasonable safety margins.
To give you an example, each manufacturer of certain fish oils would have to conduct a one year study where animals would have to consume the human equivalent of 240,000 milligrams each day of fish oil.
Another option under the FDA's proposed mandates is to conduct a 90-day, 1,000 – fold safety margin study in which two species of animals, one being non-rodent – likely young beagle dogs, will theoretically consume the equivalent of 2.4 million milligrams of fish oil daily. We know of virtually no species can tolerate this high dose, so by default, FDA guidelines will make it impossible for certain omega-3 supplements to be sold. (Note typical dose of EPA/DHA people take each day is around 2,400 mg—100 times less than what the FDA proposes must be tested.)
Since these are not patented drugs, no supplement maker 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.
Pharmaceutical Industry Profit Threatened By Low Cost Supplements
It appears that the FDA is claiming that dietary supplements are unsafe, and 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 studies showing supplements are far safer than drugs.
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.
There is, however, a massive economic benefit for the drug industry if the proposed guidelines are enforced by the FDA. Health conscious Americans who properly supplement slash their risk of degenerative disease. The FDA's new rules, if enacted, will force the price of many supplements to surge upwards, while removing many effective ones altogether. That means that more aging people will have to rely on side effect laden prescription drugs to treat the degenerative diseases they will contract because they will be denied access to health-promoting nutrients.
What You Can Do to Stop this Impending Carnage!
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 proposals pose a direct threat to our health and longevity.
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 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, DC
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 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.