Supplements Set to Become Illegal in 2012 under FDA

The Fascist Drug Addicts are at it hot and heavy right now, criminalizing supplements that have been safely on the market for years. Contact your government reps and let them know you will not stand for this:

By Garret Wood
Advanced Bionutritionals

The FDA has issued new rules that, if enacted, will enable them to ban many of the supplements you are now taking.

Think I’m exaggerating? Then please listen to the full story …

Back in the early 1990s, the FDA tried to make many supplements illegal.  Consumers were so alarmed by the FDA’s bullying that they staged a massive revolt. The result was that Congress passed the Dietary Supplement Health and Education Act (DSHEA). That law protected supplements from the FDA unless the FDA could prove a supplement wasn’t safe.

There was, however, a loophole in the 1994 law. The FDA was given the authority to regulate new ingredients introduced after October 15, 1994.

So what happened?  Nothing at first.  For 17 years, the FDA took no action, gave no guidance, and launched no enforcement of these “New Dietary Ingredients.”

And that’s been a good thing.  Because for 17 years, the dietary supplement industry has enjoyed tremendous innovation. These innovations have allowed us to extract and concentrate the most effective natural ingredients. As a result, millions of consumers have benefitted. They’ve protected their hearts and arteries … found relief from their joint pain … boosted their memory … and more.

And during this time, supplements have enjoyed a remarkable safety record.  Statistics show that supplements are safer than prescription drugs, cosmetics, medical devices, and even food!

According to the Poison Control Centers, there were zero deaths due to supplements in 2008. In 2009, there was one.

Meanwhile, pathogens like E. coli in food kill at least 2,000 people each year. Acetaminophen in drugs like Tylenol kills 450 people every year. And more powerful prescription drugs kill many more.  Even the FDA now says Vioxx likely killed over 26,000 people before they finally took it off the market!

Supplements the FDA Wants to Ban

But now the FDA wants to act like the last 17 years never happened.  The agency has drafted a proposal to regulate what it calls New Dietary Ingredients.  If this proposal is implemented, some of the most effective nutrients you take will be pulled from the market. Nutrients like resveratrol … ubiquinol CoQ10 … bacopa … strontium … and more.

But that’s not all. Under these guidelines, the FDA can define almost anything as a “new” dietary ingredient.   For example:

  • If a supplement includes more of an ingredient than was used 17 years ago — even something like vitamin C — it’s “new.”
  • If an ingredient uses a different extraction process — like baking or fermentation — it’s “new.”
  • If a supplement uses an ingredient at a different “life stage” — such as using ripe rather than non-ripe apples — it’s “new.”
  • If a supplement duplicates an ingredient in a laboratory rather than extracting it from the food — even though it’s chemically identical — it’s “new.”
  • And if a probiotic formula includes a strain of bacteria that wasn’t found in yogurt 17 years ago, it’s “new.”

So what would happen to all these “new” ingredients? The manufacturers would have to take them off the market until they could prove the ingredients are safe — even if those ingredients have been safely used for 17 years!

Why It’s Nearly Impossible to Comply

What kind of proof is the FDA demanding? According to the guidelines, many companies would have to conduct animal studies using a dosage that’s 1,000 times the typical dose.

I’m not kidding you.  It’s right there in black and white on the FDA’s website.  The FDA wants vitamin makers to do studies for a full year, at 1,000 times the typical dose.

So a fish-oil manufacturer would have to conduct a one-year study where animals are force-fed the human equivalent of 240,000 milligrams of fish-oil each and every day!  This outlandish dose would injure the animals and give the FDA an excuse to outlaw the product.

But wait, it gets even better. If one fish-oil manufacturer performs such a study and it passes, it doesn’t mean the other fish-oil makers can use the same data.  No sir.  They are still required to go out and do their own studies before they’re allowed to sell their product.

And these studies are very expensive. A study like the one above typically costs about $100,000-$200,000 to perform. Multiply that by several ingredients in several products, and you get an idea of the cost.

Say a company carries 6 products containing 6 ingredients each. It would cost between $3.6 and $7.2 million in studies before that company could even offer the products for sale. For a larger company offering 50 products or more, the costs would be astronomical.

Few supplement makers will be able to afford these studies, and many will be put out of business. And the ones that remain would still be at the mercy of the FDA’s whim. That’s because there are no requirements for the FDA to approve anything.  They can approve or reject anything they want. And in the past, they have rejected the majority of ingredients submitted to them.

That means most of the nutrients you buy today will be pulled from the market and never return.  Those that do return will be a lot more expensive — or may only be available as prescription drugs!

A Blatant Abuse of Power

This is a blatant abuse of power. What the FDA is doing here is performing an end-run around the existing law. According to the law, the FDA has to prove a dietary supplement is unsafe for it to be taken off the market. These new guidelines turn that on its head. They are clearly not what Congress intended.

Fortunately, these FDA guidelines have not yet been finalized. All federal agencies are required to give the public an opportunity to comment on a draft before it is made final. In this case, the FDA has given interested parties until December 1st to comment on the draft. That means there’s a small window of opportunity for you to voice your disapproval.

Frankly, I wouldn’t bother commenting to the FDA. The process is cumbersome, and those unelected bureaucrats don’t care what you think anyway.

What You Can Do

The best way to defeat these new rules is to talk to the people you do elect — your congressman and your two U.S. senators. They have the power to reign in the FDA — and they have done so in the past when enough voters complained.

Back in the 1970s, the FDA tried to require “warning labels” on vitamins. Angry voters called and wrote letters, and Congress responded with the Proxmire Amendments which limited the FDA’s power.

Then in the 1990s, the FDA went on the warpath again. When voters complained, Congress passed the Dietary Health Supplement Education Act, which once again limited the FDA’s power.

But like a monster killed in a horror movie, the FDA keeps coming back. And so once again, it’s time for us to step up and call the folks who rely on our votes.

Here’s what you need to do:

Go to http://www.usa.gov/Contact/Elected.shtml and look up the phone numbers of your U.S. Senators and your Representative (congressman).  Then give them a call.

Don’t be shy and don’t worry.  No one is going to bite you, no one is going to argue with you, and no one is going to quiz you to see how well you know the issues. The job of the staffers who answer is to listen politely and to relay what you say to their boss. So please do call. And please be polite and respectful of the staffers’ time.

Here are some talking points to use when you call:

  • Hello, my name is [name] and I am a constituent of [name of Senator or Representative].
  • I am very concerned about the new FDA draft guidance on dietary supplements and new dietary ingredients.
  • [Feel free to tell them about the supplements you take and/or the benefits you get from those supplements.  Then feel free to make as many of the following points as you like:]
  1. Supplements have an unrivaled safety record.  Statistics show they’re safer than drugs, safer than medical devices, safer than cosmetics, and even safer than food.
  2. The FDA cannot define New Dietary Ingredients so broadly. According to these guidelines, almost everything is a New Dietary Ingredient.  This will strangle innovation and deprive consumers of the supplements they depend on for their health.
  3. The FDA did nothing about new dietary ingredients for 17 years.  Now they want to wipe out 17 years’ worth of innovation and 17 years’ worth of benefits to the consumer.
  4. When the Dietary Health Supplement Education Act was passed, Congress intended a simple notification process for new dietary ingredients.  The FDA is turning this into a pre-approval scheme, which goes against the intent of the law.
  5. The FDA already has ample regulatory authority to take action against a product if it’s unsafe. They don’t need to have this pre-approval power, too.
  6. These could be disastrous to public health. At a time when preventative measures are even more important to health care costs, the FDA is limiting access to preventative health care.
  7. The cost of complying with these guidelines would be astronomical.  Experts estimate that the studies required would cost between $100,000 and $200,000 per ingredient notification. That adds up to millions of dollars per supplement company. Smaller companies would not be able to afford this and would go out of business.

    The economy is already hurting and we have high unemployment.  Experts estimate that this could cost the economy tens of billions of dollars and result in the loss of tens of thousands of jobs.

  8. The government’s resources are already stretched.  We have record budget deficits and record debt. Why enact more regulations when there are no safety issues here?
  • I request that Congress direct the FDA to carefully review their draft guidance.  If they do not amend the guidance to reflect my concerns, I request that Congress call hearings at the end of the review process.  I also call on Congress to write legislation that would “grandfather” all supplements currently on the market.
  • Thank you for your time.

After the phone call, send a letter to your senators and reps, making the same points.  Make sure the letter is in your own words (form letters tend not to work as well).  You can find the e-mail and physical addresses at the same website, http://www.usa.gov/Contact/Elected.shtml.

Then send the same letter to President Obama. (His address and phone number are on the website, too.)

Please, please, please don’t make the mistake of thinking that the FDA won’t take your supplements away. Similar regulations were passed in other countries, and the result was disastrous. Many supplements were taken off the market forever.  In some instances, the entire supplement industry was decimated. Don’t let that happen here.

Take action now! You only have a small window of opportunity to make your voice heard. Get started by going to http://www.usa.gov/Contact/Elected.shtml.

25 responses to “Supplements Set to Become Illegal in 2012 under FDA

  1. I hope that we who use supplements INSTEAD of drugs will follow the good advice re contacting our legislators. The FDA has done a poor job re the establishment of new drugs. What makes them think they are knowledgeable in this area which has succeeded without them?

  2. What ticks me off the most is that the FDA doesn’t require prescription drug companies to “prove” a drug is safe before it is allowed on the market. Why the double standard??

    • because they’re bed partners and until the people demand a divorce, they’re going to keep at it. they make tons for the RX. the CDC is a partner too. how often do people at CDC get jobs at the RX companies? a lot.

  3. Agree with Heorija & Lesli.

  4. Prescription drug deaths now outnumber traffic fatalities in U.S., data show
    September 1, 2011, Los Angeles Times
    http://www.latimes.com/news/local/la-me-drugs-epidemic-20110918,0,5517691.story

    Propelled by an increase in prescription narcotic overdoses, drug deaths now outnumber traffic fatalities in the United States, a Times analysis of government data has found. Drugs exceeded motor vehicle accidents as a cause of death in 2009, killing at least 37,485 people nationwide, according to preliminary data from the U.S. Centers for Disease Control and Prevention. While most major causes of preventable death are declining, drugs are an exception. The death toll has doubled in the last decade, now claiming a life every 14 minutes. By contrast, traffic accidents have been dropping for decades because of huge investments in auto safety. Public health experts have used the comparison to draw attention to the nation’s growing prescription drug problem, which they characterize as an epidemic. This is the first time that drugs have accounted for more fatalities than traffic accidents since the government started tracking drug-induced deaths in 1979. Fueling the surge in deaths are prescription pain and anxiety drugs that are potent, highly addictive and especially dangerous when combined with one another or with other drugs or alcohol. Such drugs now cause more deaths than heroin and cocaine combined.

    Prescription drug abuse destroys millions of lives
    April 21, 2010, Baltimore Sun
    http://articles.baltimoresun.com/2010-04-21/news/bs-ed-prescription-drug-abuse

    There isn’t much attention paid to prescription drug abuse, except perhaps when a Hollywood star dies from an overdose. However, it is estimated that nearly one in five Americans has used prescription drugs for nonmedicinal reasons, and 15 percent may be abusing prescription drugs. This silent epidemic has become the leading cause of addiction. The dangers of prescription drug abuse are growing at an exponential rate. Between 1992 and 2002, the number of prescriptions written increased by 61 percent, but the number of prescriptions written for opiates increased by almost 400 percent. Opiates reflect three-quarters of all prescription drugs abused. According to a report this month by the Centers for Disease Control and Prevention, hospitalizations for poisoning by prescription opioids, sedatives and tranquilizers jumped 65 percent from 1999 to 2006. One-third of new addicts report that their first drug experience was with prescription drugs. More and more teenagers are turning away from street drugs and using prescription drugs to get high.

    Note: For key reports from reliable sources on important health issues, click here: http://www.wanttoknow.info/healthnewsarticles

  5. Pingback: Supplements Set to Become Illegal in 2012 under FDA | Philosophers stone

  6. because the FDA and the drug companies are married and people don’t care and don’t demand their divorce, drug deaths are #1. RX meds are a HUGE business and vitamin supplements are a threat to them. how many times has a drug had to be recalled??! too many to count. call your senators. reign in the FDA.

  7. Thanks for the heads up on this matter.

  8. Really it is a wonderful blog post It is a informative to every visitors on the site.

    Pharma Dossier

  9. FDA is a joke and a waste of tax dollars at this point.

  10. The number one lobbing group by dollar amount in 2008 was the pharmaceutical/health products industry. ~ opensecrets.org

  11. Mitchell Drummen

    Supplements are safer by far than the other products! That’s because they don’t do anything.

  12. “I’m not kidding you. It’s right there in black and white on the FDA’s website. The FDA wants vitamin makers to do studies for a full year, at 1,000 times the typical dose.

    So a fish-oil manufacturer would have to conduct a one-year study where animals are force-fed the human equivalent of 240,000 milligrams of fish-oil each and every day! This outlandish dose would injure the animals and give the FDA an excuse to outlaw the product.”

    Could someone please provide a link for the FDA page mentioned in the first paragraph? Also, what happens in 2012 exactly–is there a new law or regulation that goes into effect? If so, which one(s)?

    Thanks,

    Jim

  13. Thanks for covering this story! The Foundation for Natural Solutions has set up an “action item” whereby you can easily email your congress-critters, the FDA and White House to “educate decision makers” about this FDA power abuse. Please use this link: http://tinyurl.com/FDApowerabuse

  14. Jim, the link to the FDA guideline is at http://tinyurl.com/FDApowerabuse — but you need to know some more background to understand that FDA is engaging in an end-run around DSHEA and that the guideline is carefully constructed to obscure this fact.

    To start with, in 2007, when Ted Kennedy gave his final gift of power to FDA, we fought to keep the DSHEA exclusion in that bill. Although the protection language was in the law, within a year FDA had banned a form of B6 at the “petition” of a drug company that wanted to get rid of natural competition. They got around the protection clause by noting that no commenter had proven that this form of B6 was “grandfathered” under DSHEA (no one knew that was ever an issue!) and the fact that this form of B6 was listing in the 1994 “old Ingredients List” posted on the FDA site was not proof! Since 90% of the industry did not exist in 1994, and those companies that did probably don’t have records that old, NOBODY can actually “prove” any dietary ingredient is “grandfathered.” Thus this very serious threat to supplements.

  15. Pingback: Food, the FDA, and all that stuff | Earth Friendly Design

  16. “Nutrients like resveratrol … ubiquinol CoQ10 ” –these are the nutrients that my wife is taking to cure her thyroid cancer. If this law passes, and she cannot get these vitamins, she will die.

    • Hi basspig

      I was wondering what other supplements your wife was using since I too have thyroid cancer and haven’t come accross anyone that was knowledgable in that field. Please e-mail me at forestdancers@yahoo.ca if you get this message. Thanks

  17. Reblogged this on Truth Matters and commented:
    So Vita Plus has FDA certification, and I sent samples to California and Milwaukee without any problems with shipping or customs. However, here’s a point of concern: This year, food supplements like First Vita Plus will be declared illegal by the FDA. Why? Read on!

  18. Pingback: We are Entering a Post-Antibiotic Era. Are you ready? — Everything Birth's Blog on Midwifery, Attachment Parenting, Cloth Diapers and More

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