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December 15th, 2010
05:45 PM ET
FDA cracks down on tainted dietary supplementsManufacturers who put tainted or undeclared ingredients into dietary supplements were warned Wednesday by the Food and Drug Administration that they can no longer market them as such. The FDA has received reports on well over 100 products over the last few years, a number of them detailed serious injuries, even deaths. In fact, since 2007 the agency has sent out consumer alerts about 300 adulterated products. "These tainted products can cause serious adverse effects, including strokes, organ failure and death," said FDA Commissioner Dr. Margaret Hamburg. "The manufacturers selling these tainted products are operating outside the law." Concern over the growing problem has led the agency to send a letter to five major trade associations - the Counil for Responsible Nutrition, Natural Products Assocation, United Natural Produdcts Alliance, Consumer Healthcare Products Association and American Herbal Products Association - whose member companies make dietary supplements, warning them of the problem and of "their legal obligations and their responsibility to prevent tainted products from reaching the US market." The FDA's own laboratory tests revealed a variety of undeclared active ingredients in products sold as dietary supplements like anticoagulants, drugs that prevent blood from clotting and nonsteroidal anti-inflammatory drugs or NSAIDS, that prevent inflammation and pain. They also found supplements that contained active drugs that had been taken off the market as a safety precaution. The agency is focusing on three categories where the bulk of these illegal products come from: weight loss, body building and sexual enhancement. The FDA found weight loss products that contained sibutramine, the active ingredient in the diet pill Merida, which was recently pulled off the market because it increased the risk of heart attack and stroke. Also body building products that contained anabolic steroids–a controlled substance, and sexual enhancement products like Vigor-25, Magic Power Coffee, Duro Extend Capsules for Men. These have the same active ingredient as approved drugs Viagra, Cialis and Levitra–which are available only by prescription. The FDA has launched a new RSS Feed - a feed on their website that frequently updates information and other content like photographs. They are also establishing new ways to inform consumers about dangerous products and new ways for the industry to alert the agency to contaminated products–even anonymously. Dr. Joshua Sharfstein, principal deputy commissioner, FDA says it's buyer beware. "We want consumers to be aware that there are products masquerading as dietary supplements but pose significant dangers. Warning signs include products that claim to be alternatives to FDA approved drugs, products marketed primarily in a foreign language, .marketed though mass E-mails, or sexual enhancers that boast rapid affects." The dietary supplement industry is onboard. "We fully support increased enforcement of those who put the health of consumers at risk by selling illegal spiked products and put the health of the legitimate dietary supplement industry at risk by injuring our reputation," said Steve Mister, president and CEO, Council for Responsible Nutrition. "We applaud the agency's resolve to get tough with the criminals and we will support these efforts in any way we can." "I am astonished at the growth of these intentionally spiked products," said Loren Israelsen, executive director, United Natural Products Alliance. "We join with FDA and colleagues in the dietary supplement industry to drive these pirates out of the industry and protect public safety." Manufacturers of these tainted products could face product seizure and criminal prosecution the FDA says.
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bring ephedra back!
I still think it's funny how ephedrine was banned. A baseball player took about 8 pills before a baseball practice and died... I think that was one of the leading reasons for the ban. But a person can take a bottle of Advil or Aleve and die; can drink to the point that they endanger not only themselves but others as well; and finally, can smoke till they die from lung cancer. Ephedrine was like so many other things. If used in moderation and within the confines of the recommended amounts it was fine... actually helpful. I used one supplement and only taking one pill a day (when the recommended amount was 3 pills) I lost weight and never felt healthier in my life... then ephedrine was banned. Well, at least I can legally drown my sorrows in liquor and cigarettes. Thanks for protecting the American people FDA.
Ephedrine wasn't banned because occasionally someone would kill themselves by taking too much of it. It was banned because it turned out it was a readily available supply of the main ingredient used to make crystal meth. That's the actual reason it was banned Train, not because there can be adverse effects by taking too much of it. And I have to say, comparing cigaretttes is a ridiculous argument anyway. Might as well say, "we don't ban Big Macs, why would we ban meth?!"
Train, ephedrine was banned so they added a molecule to it and called it pseudo-ephedrine. That was legal. It created one more step in the process to manufacture meth. Then they banned ephedra which comes from a plant and has been used for centuries in parts of the world. It creates an effect similar to caffeine but with less paranoia/anxiety. Recently the decriminalized ephedrine. You go into any drug store or gas station and write your name down on in a log that is picked up by a police officer every week. Your name is entered into a database. If you purchase more than the allowed amount you get witness your tax paying dollars at work. So plants = bad. Big Pharma lab concoctions = good. Glad we cleared that up.
Actually Ben, pseudoephedrine was out long before ephedrine was banned and has been marketed for years as a nasal decongestant. Both can be used to manufacture meth. Ephedrine was as lot easier to do it with. Up until the late 90's, you could buy a bottle of 1000 ephedrine tablets for under $20. Once the DEA restricted its sale to a small number of tablets at a time, people started using pseusoephedrine in meth manufacture. This is why you now have to sign for any product containing pseudoephedrine.
Ephedrine, when taken as recommended, worked well as a bronchodilator. Ephedra, a naturally occurfing form, was also known as ma huang. It was used in diet and energy pills. The problem occurred when people would take 5 to 10 times the recommended dosage and their heart would give out.
Ephedrine was not banned, it is still sold over the counter and is legal. You can still buy it, all you have to do is sign a sheet at the drug store and show your drivers license. I buy it once in a while for my sinus and allergy problems.
However, the question of which drugs should be banned and which one legalized is complicated. Cocaine was once legal, should we make that over the counter? Yet, everyday people drink themselves to death and every year people die from taking too much Tylanol (acetaphetamine). People have an extremely high risk of getting lung and other cancers if they smoke long term. Obesity kills, should we ban food?
I do not have the answers but like it or no the FDA is set to to protect people from drug misuse. I guess we could legalize every drug and see what happens. What do you think would happen?
These are the same damages you can experience from taking Tylenol
Why don't we get to vote in FDA members?? They are in control of our very lives, more so than some moronic governor of a state. The FDA is in control of what we can put in our mouths for sustenance and our bodies for health!!!!!!!!!!!!!!!!!!!!!!!!!!!
They are extremely corrupt. I predict they will outlaw all vitamins and supplements to ensure that all of America is taking prescription drugs. Don't believe me? They already have a bill that has been on the table for over a year to mandate supplements being pulled off the shelves and require a prescription under the guise of SAFETY. Meanwhile thousands upon thousands die from Vioxx, Lipitor and other CRAP!
"We fully support increased enforcement of those who put the health of consumers at risk..." +++++ Increased? I haven't heard of any of these people who've put so many at risk with already banned substances. Large campaign contributors?
The problem with "supplements" or herbal remedies is that SOME OF THEM WORK. If they actually work, then they have an active ingredient in them (unless you believe in magic!). In medicine, we don't prescribe medications unless we know what they are, how they act, what side effects they have and what interactions they have with other medications. So even the supplements which are not spiked with known medications, should not be taken. If they are effective, then they may not be safe. If they are not effective, then they may safe to take but why waste your money?
Pharmaceutical garbage is taken off the market every day. This is often after several adverse reactions up to and including death. Unfortunately, a lot of the same garbage is kept in the market because too many people stand to make too much money if done otherwise. Drugs do not create health. Great for crisis situations, but definitely over used and abused.
I think herbal medicine can complement prescriptions and even be used instead of them in some cases. There is truth to traditional folk remedies.
@Steve..."In medicine we don't prescribe medications unless we know what they are, how they react, what side effects they have with other medications." I, also, work medical field, and the truth is, as far as I am concerned is that: The new meds that come on the market are not proven, doctors only know what they are told by the pharmacutical reps over lunch. Although, I do agree with you as far as the supplements go...the majority of them are fake and can cause more damage than good. I, for one, only will take meds that have been out there for years, proven to be effective....no new supplements or new drugs for me. Common sense.
I have seen you cut and paste this comment before. Work for the medical community much?
Wow Steve, you sound a little biased there. Natural should always be first. Apparently you buy into the LIE that before modern medicine, everyone on the frickin planet was dying at the age of 30. No moron. The world does not and did not begin and end with Europe. Many native american groups used natural remedies for thousands of years, long before you white pr icks came around. The egyptians as well used natural remedies and did not die at 30. Please. Get out from under the hold of bigoted history books and learn something other than what our biased white media tells you.
Oh, BTW, I am white.
The same agency that said it's not necessary to label food as "genetically Engineered" because it might scare the public unnecessarily.
Which makes perfect sense. There is no logical reason to believe genetically modified food is more likely to cause harm than non genetically modified food.
@nepawoods. "
There is no logical reason to believe genetically modified food is more likely to cause harm than non genetically modified food."? So you think pork created by splicing human DNA into swine is no more dangerous than regular pork? No chance of causing a genetically mutated virus that resist antibiotics and is contractible by both human and swine? Especially with the prevalent use of antibiotics in our livestock. No chance of a global untreatable epidemic there. Do you really believe that corn genetically modified to secrete a toxin that kills insect does no damage to the food chain? At the very minimum, it upsets ecological balance by killing nearly every insect that comes into contact with this corn. Even supposing that toxin does no damage to the human body what-so-ever (not very likely) do you really think that humans are unaffected when entire populations of the insects that feed the higher order animals are wiped out and/or poisoned? Do your research. Some of the top biologists on the planet are warning us of that very possibility. Even if you don't research it, watch the movie "The future of food". Or you can just keep repeating the same old blah, blah, blah spewed by Fox news; the "news" organization that the government uses to placate the voting masses.
@Don:
"So you think pork created by splicing human DNA into swine is no more dangerous than regular pork?"
As far as health effects to the human consuming it are concerned, no I don't.
"No chance of causing a genetically mutated virus that resist antibiotics and is contractible by both human and swine?"
This can happen whether or not genetic engineering occurs. Do you have any evidence to suggest that the likelihood of a killer megavirus evolving is SIGNIFICANTLY GREATER, more imminent, or more deadly with genetic engineering than without? Or is it possible that the chances of such a complex, incurable, epidemic-scale strain forming are NEGLIGIBLY GREATER or even LESS LIKELY to occur if pig dna is spliced with human dna than if it isn't? I don't know for sure, and I also seriously doubt that either you or the foremost biologists in the world have the hard evidence to support any of these outcomes occurring probabilistically. It's easy to think of rhetorical doomsday scenarios that might happen for any controversial topic, but actually demonstrating that these outcomes are likely or imminent threats is a much more difficult ordeal. Your statements are akin to me saying that using your computer will destroy the human race through emission of harmful species which deplete the ozone layer and allow harmful UV radiation to fry our brains. Maybe so, but until someone can demonstrate that this is a likely outcome I don't think you will hesitate booting up anytime soon. Yes, almost anything is possible and by that token, everything that anyone does carries at least some infinitesimal probability of destroying the world. But the remote possibility that the Large Hadron Collider would generate cataclysmic black holes did not stop the people at CERN from operating it, and the field of physics is probably better off for it.
So before you say something like "no chance of a global untreatable epidemic there", maybe you should take a minute to try and actually assign a number to that chance. And if you can't, maybe the benefits realized by this new technology outweigh your rhetoric.
With that said, I think concealing information about whether food is genetically engineered to prevent "unnecessary panic" is an poor justification.
@Don and @Shane:
By its very nature, a virus is not going to be affected by antibiotics. Antibiotics only fight /bacteria/. They don't do a darn thing against viruses. Just wanted to clear that up.
Thank you sigh...
I'm glad I'm not the only one that noticed...
Anyone who really things that genetically modified food is safe is kidding themselves. I give up on the human race.
nepa: Do you know a single thing about Gm foods? I suggest you research it before spouting off your mouth.
Really? The FDA cracking down? Johnson and Johnson just keep putting out garbage with recallls on tylenol, Advil, various allergy meds. I can't keep track of all of it. A reacall means it's too late and people have injested already. Earthshaking fines might score compliance rather than recall. First clean up J and J, then the American Red Cross. That is critical NOW!! Of course herbs work. Look at pubmed under "ginko". But how do you know what's in the bottle? The Germans have tightly regulated all of this. US has the worst standards on platelet manufacturing in the world, and these cause cancer to proliferate. FDA crackdown? They are protecting their pensions.
when you cant even trust that pill in your hand, who can you? corupt politics, corrupt medications, where does the list end i ask you?
The FDA is banned from regulating dietary supplements. The only thing that allows the FDA to take action on these things is that they are intentionally spiking them with real medicines.
Now if the FDA were allowed to regulate dietary supplements, I would certainly start having a lot more faith in those pills.
But hey, the other option is to stop all that pesky government interference and let the market decide what the right amount of undeclared additives is.
Well it seems to me that the actual products that can cause serious problems and even death are some of the ones used in allopathic medicine. Why didn't they bring that out as well if the major concern is to put an end to "dangerous" ingredients. Never a day goes by without we hearing about the dangerous side-effects of this major drug or that major drug. Therefore, if the FDA truly is concerned about public safety they need to start regulating the major allopathic drugs first! You can't have your cake and eat it too drug makers. Pull the dangerous drugs out first!
They already regulate allopathic drugs. It's supplements and herbs that they give the free passes to.
Please, don't tell me from your name that you advocate homeopathic "medicine." It's sad what people will believe. No wonder this country is ranked behind Croatia in science.
The FDA is not allowed to regulate dietary supplements. The only reason they can regulate these particular supplements is that the manufacturers are putting real "allopathic" medicine into them. If they wouldn't put real meds in, the FDA would give them a free pass.
But hey, we don't want those nasty government people making sure that the pills we take actually have what the bottle says, do we?
Yes because the FDA in our country that has only been around for less than 250 years knows all. Before it, everyone on the face of the Earth died at the age of 20 and had no clue of how to treat their ailments. If you believe this Mike, you are a stone cold idiot. Get a clue and quit drinking the Kool-Aid space cadet.
The writer of this article should really try editing their work. Produdcts? Assocation?
Dr. Arthur Hull, head of the FDA overruled his own board of inquiry and approved aspartame as a dietary sweetener. Aspartame is 10% methanol. Methanol/wood alcohol is a deadly poison. Methanol is gradually released in the small intestine when the methyl group of aspartame encounters the enzyme chymotrypsin. The absorption of methanol into the body is sped up considerably when free methanol is ingested. Free methanol is created from aspartame when it is heated to above 86 Fahrenheit (30 Centigrade). Methanol breaks down into formic acid and formaldehyde in the body. Formaldehyde is a deadly neurotoxin. When Dr. Hull left the FDA under allegations of impropriety (imagine that), he took a position with Burston-Marsteller, the chief public relations firm for GD Searle, the Apartame patent holder. At the time the head of GD Searle was non other than Donald Rumsfeld. Monsanto buys GD Searle and begins to market apartame. Now, before Democrats cry fould about a Republican conspiracy, Barak Obama has appointed former Monsanto executive Michael Taylor to head the FDA! In view of this, it seems rather hypocritical to me for the FDA to pretend it gives a rat's butt about public safety. The FDA is nothing more than a pimp for corporate interest. It's not about conservatives versus liberals either. That is just smoke and mirrors to promote disagreement between the citizenry while both parties bilk the people, exchanging our health for their profit. Homework: Go online and research Monsanto and the FDA's role in dumping genetically modified hormones and food crops into the American ecology and food markets.
@Don
Aspartame does not contain 10% methanol. It is a methyl ester. Just a wintergreen is a methyl ester of salicylic acid. They both break down in the body the methanol. Methanol, like the regular drinking alcohol ethanol, is oxidized in the human liver by alcohol dehydrogenase. The rate of methanol metabolism is much slower than ethanol, about 2.5 grams per hr for a 200 pound person.
Vilifying aspartame without regards to other sources of methanol is simply uneducated and short sighted. Yes, methanol is toxic, but I'd be more concerned with the methanol load in a couple of beers or a few shots of whiskey than from a package of Nutrasweet or a Diet Coke.
oh yeah, like the FDA has a shining record. They just want their hands in everything, and a piece of the pie. Pretty soon, chewing gum will need FDA "approval". america... land of the not so free anymore
I think you've seen too many episodes of the Sopranos. The FDA isn't the mob, and it doesn't ask for protection money. It's just an agency doing what it can to make sure the stuff you eat doesn't do more harm than good.
@Jerry And each one of us has an angel that watches and protects us while we sleep. Those angels and Big Brother work together to keep us safe and happy. When Michael Taylor wakes up every morning, little bluebirds circle his head singing of their love for this wonderful servant of the people. And ostriches never get eaten because hiding their heads in the sand and not observing the world around them protects them; just as surely as Monsanto and the FDA work together to protect all of the good little boys and girls.
Having the FDA in charge of our food and drug safety is like putting poachers in charge of our wild game refuges. There is simply too much conflict of interest for it to be a successful match.
A warning is considered a "crackdown"? I have never seen the FDA actually do anything.
Two dides to every story. Dr Ko after an 11 month treatment of interferon,a form of chemo, I relapsed in 2 months. But after injections of hyalgan I am getting some pain relief. You don't know for sure but hope for the best. I get quality supplements and my Dr's give their input.
I take Milk thistle for my liver and the Mayo Clinic supported it.
I might spend sdome extra money on supplements that I feel may assist in keeping me healthier and out of pain. I also know of people that live on pain killers and alcohol. I would rather risk a natural herbal supplement.
Whoever thought Gila Monster saliva would help treat type 2 diabetes or a rooster's comb (hyalgan which are given in the doctors office) would be an alternative to knee replacement?? You can also get that hyalgan in supplements I have found out.
someone deep dseresped person energy try believe therapies treatments. power mantra therapie need nowhere nothing cure . learning recite mantra correctly recite concentration eliminate depression , practice room, seat down comfortable back stright. reciting breath deep wonders ty.
The FDA as a whole may be set up for the "right" reason(s), but unfortunately, the top brass are always political associates of whatever party is in power.....They are always corporate mongers masquerading as "protectors" of the American people, when in reality, they are there to "cash in" on whatever political & corporate interest they are involved in during the tail end of their careers.
Why can't we vote in members of the FDA? They do more damage than anyone else.
i notice ur a mscauiin, so am i im dedicated to the drums,i apparently have adhd but anxiety above all else so addaral ,ritalin was a no go for me cuz of added anxiety later on in the high of the med,meth was better sadly,anyways-im goin into a shrink to perscribe me zanex here in the army,ill see how it works ,not sayng meds are the answere , i noticed this comment b4 the vid started ill watch this vid ina sec,,sry i hav a lil buzz , alc. helps with my anxiety and adhd
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FINALLY they're doing something about it. http://razzlea.blogspot.com/
Before you take a high horse and chastise someone, you should know what you are talking about
Ephedra, the Chinese herb Ma Huang, was banned but Ephedrine, i.e. Primatine or Bronkaid, was NOT banned.
Jeez
Over 100,000 die each year in the US not counting worldwide stats from pharma drugs!!! Go back ten years how many is that?Go back another ten years,etc.And the FDA is worred about vitamins and herbs?Over a million,every year including the very young ,suffer permanent side effects for these deadly drugs that never cure anyone.All the while the pharmas are making billions.Do any of these drugs cure?NO! Do they qll cause side effects?YES!
If any other industry did this they would go out of business due to product failure!!!
Some time back I started ordering for myself dietary supplements from a website called Findrxonline, but after reading your blog I am literally stunned to discover about the test results revealed by The FDA regarding the weight loss, body building and dietary supplements. Honestly speaking I have not gained much improvement in health and feel everybody should certainly get a proper doctor’s recommendation before getting prescription drugs from online stores. Findrxonline solely provides information on hard to find narcotics and benzodiazepines for example such as xanax and valium, and on where you can buy those based on research of facts and feedback. FindRxOnline absolutely sells no prescription drugs at all, nor supplements of any kind, just subscriptions to allow access to premium website content.
You could better obtain a proper doctor’s prescription before buying any medications as they may do harm. Please be careful and don't do as I did as I learned you may never know what you get and the quality may not be as hoped for at all!
Regards
Dan Watson
http://razzlea.blogspot.com/
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Well, since the FDA only acts on executive orders, it should be no surprise to anyone that they come out against certain "herbal" remedies. Naturally, the corporate machine that /is/ America wants you to see a doctor, pay hundreds of dollars, then get hooked on /their/ drugs. Later on, the FDA turns around and claims some drugs are bad for you when they're no worse for you than the other drugs they're allowing. It's ALWAYS about money with the FDA and their actions are NEVER in your best interest. It's a corporate money-making machine - like everything else in the USA. You truly can't trust anyone.
I find it comical the "say" the reason for the crack down is for 100's of reports of adverse effects and death, which seems odd in comparison to the the millions of deaths a year from prescription pills. It would seem like the FDA needs to crack down on the industry they already have control over and stop with these bogus lies that their concerned with our health and safety when the real reason their so concerned is to try and get support for The Dietary Supplement Labeling Act of 2011 (S. 1310). They want control of the supplement industry as well as the pharmaceutical side.
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