FDA Set to Ban Your Supplements

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 You can find the FDA Draft Guidance on New Dietary Ingredients (NDI’s) here.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 A detailed analysis of the FDA Draft Guidance is available here.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:

Tell Congress the FDA’s Draft Guidance on Supplements is Bad for Americans TODAY

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.


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:

1. 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.

2. 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.


City______________________ST____ Zip___________


Jackson Z.
Jackson Z6 years ago

Why is it that when the subject of regulating something like organic food comes up you guys are all for it, but when somebody finally talks about regulating the woefully unregulated industry that is nutritional supplements people suddenly talk about how terrible it is?

I'm not anti-supplement. I take supplements. They're great if you have good medical guidance. But they aren't a substitute for actual medical care or prescription meds, and they aren't even more natural either!

I am on a weekly prescription shot... I know so many people who are trying to get the same effects by using ten, fifteen nutritional supplements. It's expensive, tedious, and has just as many if not more side effects as the prescription drug, and to make matters worse, most of them don't even go to a doctor to see if this is an appropriate fit for them. All of that because they somehow think popping eight pills with every meal is "more natural" than a shot once a week.

Also, take anything Dr. Mercola says with a grain of salt, he is famous for presenting the crap he sells on his website as the only good version of anything. He's probably just worried the FDA will reveal that he's selling crap.

Nelson Baker
Nelson Baker6 years ago

I take no prescription medications. I believe they are dangerous. You hear of all the damage they do after being on the market for several years. The FDA seems OK with that. I do take vitamins and supplements which I believe is keeping me in good health. I believe the FDA is taking a negative position on supplements due to being aligned with the drug companies who want to take over control of the supplement market and charge us exorbitant prices for what we are now buying.

Andrea G.
Past Member 6 years ago

So let me see if I have this right. I will no longer be allowed to choose what I put into my body, but there's no problem having things I DON'T want put into me by way of GMO's?

Carol, I have to disagree with you about the FDA not getting involved w/o problems. The problem is where the money is coming from. Monsanto and Cargill have lots, and so do the pharaceutical companies. Anything with health benefits that isn't prescribable (not sure if that's a word but I think you know what I mean *lol*) isn't even allowed to advertise as such. Cherries are a good example. The FDA sent letters to cherry marketing companies, threatening them with legal action. They were told they should remove scientific information from their websites, describing health benefits of the natural medicine found in cherries. They claimed that when cherry growers give out scientific information on health benefits, such as anthocyanins (found in cherries) which reduce inflammation, they are declaring cherries to be drugs. Therefore, if cherries are drugs, they need FDA approval to be sold in the USA. And that is the ignorance of the US Government.

Don S.
Don S6 years ago

They want to ban supplements why? Because they have not been tested enough? Then why does the FDA allow gm foods to be on the market with no labeling? My guess is that the FDA is just another arm of big business. Also, if all of our life spans are shortend, the social securiety problem is not as large of a problem. "Mother should I trust the government?".........Hell No!!! They are not there for us and probably never were.

Carl Nielsen
Carl Nielsen6 years ago

If food doesnt supply everything your body needs, then how did humans survive the about 200.000 years before the invention of supplements? No species ever has evolved a need for anything it cannot find and eat in nature.

A company not being in for profit - what a hoot! Any company not in it for profit is going to end as a failure as a comercial enterprise.

And that people in Denmark who everything else consume supplements have significantly higher mortality rates than those who dont is a fact.

Marie G.
Marie G6 years ago

All these 32 comments are just "opinions". People should always make valued judgments based on actual results. Everything said in the world is 90% Opinion, 10% Fact, and actual results are Facts. You have to find the right supplements, from the right company. 60 milliion people and I are living proof of the effectiveness of good supplements from a company that is not just seeking profit - they insist that everything must work, otherwise they don't supply it! So the only warning is, don't just buy anything - do your own research and you will find the good stuff! Just do this, because your food will not supply 100% of what your body needs.

New G.
W. C6 years ago

Thank you.

Deborah D.
Deborah D6 years ago

This is ourageous. I am tired of paying ouut big bucks for prescription mdications that have a long list of serious side effects. I do take a RX, but am very informed about its effects and side effects.
I prefer to go "natural" if I believe that is the better road to take.
We all should have that right and choice.
I am taking action. Thank you, Dr. Mercola.

aj M.
aj E6 years ago


Joe R.
Joe R6 years ago