The main reason why is this: in the 1990s wealthy large companies paid for expensive PR campaigns that appealed to the public's paranoia, convincing many that the government was trying to take away their wonderful supplements. At the same time, the industry paid large amounts into the campaign coffers of "anti-regulation" senators and in return they got the law they wanted that prohibits the government from regulating supplements. (Details about how the industry destroyed the FDA's ability to regulate supplements can be found in this Harvard Law School publication HERE.)
As things stand now, manufacturers can sell pretty much anything they want to as long as they don't make health claims on the label and as long as their supplements don't cause enough death or disability to trigger an investigation.
What this means for you the consumer is this: supplement manufacturers can promote their wares as medicines as heavily as they want to, as long as they do not put the claim on the actual bottle they sell. They can put it on a web site. They can pay a PR person to plant articles in health magazines, and they can send brochures to self-appointed alternative medicine "practitioners." And, believe me, they do.
Supplement manufacturers often sell their extremely expensive products with the argument that the natural supplement is a better choice than a pharmaceutical drug. For example, they may tell you that soy isoflavones are better than pharmaceutical estrogen at menopause. Or that you can control your blood pressure by taking magnesium rather than blood pressure medication. As long as they don't put this false claim on the label, the FDA cannot step in. It's worthy of note that if a health claim is supported, it CAN be put on the label. But if that is the case the FDA would then be able to treat the supplement as a drug and test it to see if the bottle contains what it says it does.
In most cases, it doesn't. Which is why you will never see any health claim on supplement labels.
Every time anyone takes bottles of supplements to the lab they find that these bottles do NOT contain what they say they do. They may not contain any of the expensive herb or chemical you are paying for or they may contain an amount of that substance that is quite different from what they list on the label.
Sometimes the bottle you just paid $23.95 for contains little beyond some calcium carbonate pills. But though you are frequently not getting what you paid for, at other times the pills you buy may contain too much. And since some supplements are toxic in large doses this is a concern. Even within a single bottle, given the lax manufacturing practices in this unregulated industry, pill to pill the ingredients may vary.
And the problems with what's in that bottle go beyond fluctuating doses. The pills you buy may also contain poisons. These may occur in the form of heavy metals, industrial contaminants (solvents etc.), and the naturally occurring toxins that come from fungal or bacterial contamination.
A recent lab analysis of what was in the bottles of 12 brands of Red Yeast Rice, a supplement marketed for controlling cholesterol, makes it crystal clear why if you do find yourself needing medicinal treatment, you should avoid the use of unregulated supplements.
The study can be found here: Marked Variability of Monacolin Levels in Commercial Red Yeast Rice Products Ram Y. Gordon et al. Archives of Internal Medicine, 2010; 170 (19): 1722 DOI: 10.1001/archinternmed.2010.382
You can read a more detailed report about this study's findings here: Science Daily: Active ingredient levels vary among red yeast rice supplements.
THIS "NATURAL" STATIN REPLACEMENT CONTAINS ACTUAL STATINS
People take Red Yeast Rice to lower cholesterol instead of statins, rightly fearing the problems that statins can cause. What the supplement industry does not make clear is that the reason Red Yeast Rice may lower cholesterol is that it contains a chemical, monacolin K, which is chemically identical to the chemical marketed as the pharmaceutical drug lovastatin.
THE AMOUNT OF STATIN IN A RED YEAST RICE PILL CAN RANGE FROM ALMOST NONE TO WAY TOO MUCH
The main difference between statin in the red yeast rice pill you buy and pharmaceutical lovastatin is that the amount of lovastatin you get in the "natural" supplement is completely unknown. In the study cited above, researchers found that the concentration of lovastatin in the 12 different branded bottles varied from 0.10 to 10.09 mg per capsule. That's a significant range!
Since the size of the dose of statin you take has a lot to do with both its effectiveness and with whether it will cause the severe side effects that statins cause (including brain damage leading to mild, irreversible dementia and muscle wasting) it is extremely unwise to take your statin in a form where you have no idea how much you are getting. This study clearly shows that when you buy your statin as a "natural supplement" you may be getting almost none, some, or too much. Why play Russian Roulette with your meds?
THE NATURAL SUPPLEMENT CONTAINS ADDITIONAL TOXIC CONTAMINANTS ESPECIALLY DANGEROUS FOR PEOPLE WITH DIABETES
But that's not the only problem with Red Yeast Rice. The other problem is that because it is an unregulated "natural" product which is created by growing funguses on rice, it often contains other funguses--some of which produce poisons.
In the case of Red Yeast Rice the fungus-produced toxin that produced by the funguses that grow alongside of those that produce the statin is called citrinin. It is a toxin known to destroy the kidneys in animals.
The study cited above found "elevated levels" of citrinin in four out of twelve brands of Red Yeast Rice products it evaluated. (The phrasing suggests the researchers also may have found lower levels in other bottles.) Sadly, the researchers did not reveal to the public which brands contained this toxin. My guess is that they did this out of a fear of lawsuits brought by the companies who earn billions each year from selling you this toxic crap.
I would have to say that one of the most common questions I get in my email from readers of this blog and the Blood Sugar 101 web site is "What supplements do you recommend I take." Many of my correspondents will accompany this question with a long list of supplements they are already taking.
Sadly, many of them are taking red yeast rice in the erroneous belief that it is safer and healthier than the statins that doctors push on people with diabetes.
Since so many people with diabetes already have early kidney damage at the time they receive their diabetes diagnosis, this is disturbing news. The last thing a person with diabetes needs is to be taking a supplement that contains a chemical known to poison the kidneys.
THE SUPPLEMENT INDUSTRY ENSURES THAT THEIR TOXIC PRODUCTS WILL STAY ON THE SHELF
As things stand now, the FDA can act against a supplement only after doctors report damage to patients that is linked to their taking a specific supplement. But because doctors expect people with diabetes to develop kidney failure and may not even know their patients are taking these alternative medicine forms of statins, it is very unlikely that the damage that kidney-toxic red yeast rice may be wreaking will ever be noticed.
There are real problems with statins, but at least when you take a statin you bought at the pharmacy you can be sure that the capsule contains the dose you were told it did and that it is not contaminated with poisons.
The same is true of every other supplement you may buy. And given the amounts of money that corporations who profit from selling you dangerous crap are paying into the campaigns of candidates howling for more "deregulation" you can be sure it isn't going to change any time soon.
If you really want to protect your health, avoid all supplements. You have no way of knowing what is in any of them. Some companies claim that their supplements have been tested for purity. However, when I investigated these claims in the past, I learned that all this means is that one batch was taken to the lab, once. There is no assurance that what you buy will match the lab assay provided (and the small print that accompanies these claims of lab-proven purity is full of legal weasel-wording.)
Other potentially damaging supplements include kelp, all of which is contaminated with arsenic. When I contacted supplement companies about this I was told that finding arsenic in natural kelp it was "normal." None denied the claim that their products contained arsenic. Arsenic exposure has been implicated as a cause of diabetes. (Details HERE).
Fish oil may contain mercury. Vitamin D capsules appear to contain amounts of Vitamin D that do not correspond to the label Details HERE.
The supplement industry always responds to these kinds of reports by appealing to anti-government paranoia. "This is a plot by the FDA to take away your freedom" is the usual response.
Personally I would like to take away the freedom of a cynical multi-billion dollar industry to sell you whatever it feels like putting in a pill, slapping a label on the bottle that lies about its contents, and to ignore the fact it is charging you a fortune for toxins that can shorten your life and make what is left of it miserable.
11 comments:
The issue with nutritional supplements is that it's largely a free-for-all in terms of what you get when you buy these things. This occurred because the Senator Hatch from Utah had a lot of people who worked for the companies that sold supplements, so under his leadership, Congress voted to limit how much the FDA could regulate the industry. This is true, and most supplements sold are cheap varieties that retailers can make a large margin on. There are a handful of retailers who refuse to buy from low-cost providers for these very reason, but they are few and far between. When it comes to supplement, my rule has always been let the buyer beware.
Wow. This is giving me a lot to think about. I hope it's okay if I write a rather long comment, especially as I don't know anything about Red Yeast Rice. I do absolutely agree with your message of BUYER BEWARE!
On the other hand, I think that some of the preference for "natural" products may be backlash in the face of a system that prefers synthetics. Many people have had more success with natural thyroid drugs than with synthetic ones, but it would seem that the synthetic thyroid manufacturers would really like to eliminate that competition. It's much harder to corner the market for a harvested natural product than for a patentable laboratory creation. I don't know if profitability is also a factor when it comes to bioidentical hormones (progesterone vs. progestin, and so forth). There may be good scientific reasons to prefer the synthetic, at least for some patients. I just wouldn't put it past a pharmaceutical company to promote and produce a more profitable drug instead of a safer and more effective one.
One of the supplements which used to be illegal was tryptophan (due to one case of contamination in the 80's). Some people felt that tryptophan was completely removed from the market partly to reduce competition for SSRIs, since tryptophan supplementation can also improve serotonin levels. I don't know if that's a conspiracy theory or what, but an amino acid seems, on the face of it, a far safer approach to lowish serotonin levels than an SSRI, if it happened to be effective for the individual patient.
While tryptophan was off the market, 5-HTP became popular in its place. Its immediate side effects pose less risk than those of SSRIs and for many people it's been more effective as well. But as far as I can tell, there is no agreement over whether 5-HTP is safe to take as a supplement. If 5-HTP were marketed as a drug, maybe it would be properly tested. But why should any one pharmaceutical company put that vast amount of money into researching a natural product that anyone can produce and sell? Companies already do everything they can think of to stay a step ahead of generics when they come onto the market.
So I guess I agree that "natural" supplements need regulation precisely because I believe that *some* of them are potentially far safer and more effective than drugs prescribed for the same conditions.
And as things stand, I am really concerned about supplement quality and contamination -- and also just plain safety. I like to think that there are vitamin and supplement companies that are in it for the right reasons. So on the one hand, I feel faith in certain small companies tied to clinics because on SOME level I think they care whether their products are safe and effective, and perhaps there's some personal accountability as well. On the other hand, I tend to put some trust in national brands whose stores can be found everywhere and whom body-builders and athletes rely on, because a bad case of contamination would be so devastating to their brand image (this may be naive of me, given what we've seen in the pet food market). But I have to trust somebody, because there's no other way I know to get these naturally-sourced over-the-counter drugs (=supplements).
And if they were regulated, I'd really want to be reassured that they would remain available at all!
Sarah, "Natural" thyroid is a pharmaceutical and is regulated by the FDA. When you buy it you get what you are paying for.
We have no way of knowing if supplements are safe and effective because the only studies that you read are paid for by the sleazy supplement manufacturers and are usually of extremely poor quality.
It takes large, carefully monitored studies to find out if a substance really works. I've looked at many studies used to support supplement claims and they are too small to yield results and often designed in ways that are skewed to produce the desired effect.
Sorry -- I know that natural thyroid is regulated and that its quality is ensured -- it's just that its availability has been an issue. The only major US supplier experienced a shortage, and Synthroid decided to announce to doctors that they would need to switch their patients to Synthroid, so I had to inform my doctor that this wasn't actually necessary. Meanwhile, there's been an effort to shut down compounding pharmacies, which was the alternative source. This is all business as usual, but the point is that the synthetic manufacturers have the advantage against the natural manufacturers when they're in the same market, and they know it.
I am sure that you about are right about the studies. All claims about supplements are anecdotal at best. I'm just not sure that the risk/reward calculus always recommends the prescription drug. But this is something to talk about with a doctor -- not to research in a magazine. I did recently read that in Germany, many vitamins and supplements ARE regularly prescribed as drugs, so maybe they have figured all this out! I hope the laws in America can be changed.
Final parenthetical: I think a lot of supplement purchasers would be surprised and angry if they saw the mark-up on vitamins and supplements, even if the bottles actually contained what the label promised.
What's wrong with Truth-In-Labelling
being applied to the supplement biz?
Maybe the Trial lawyers can chip in
for independent lab review. The FDA
is'nt going to do the obvious - Test
the stuff & publish - Without fines
& baksheesh in the offing...
Jack
John,
The supplement sellers wrote laws that handcuff the FDA. And they also supported Republicans and lobbied them to cut the FDA budgets for all the years they controlled congress. As a result the FDA doesn't have staff it needs to do any of the tasks it's charged with.
And if the Tea Party succeeds in selling the public the pipedream that life is better without government we can look forward to a regulatory climate like that in China where it takes the deaths of hundreds of children for anyone to investigate the industrial practices of those who profit by selling cheap poisons.
Amen to that Jenny.
Consumer Lab is an independent lab testing service that tests popular vitamins and supplements for discrepancies in labeled ingredients and amounts, contaminants, and so on. Most of their supplement reports are not free, however. A paid subscription to Consumer Lab reports might be a worthwhile expense for people who take commonly available popular vitamins and supplements. CL doesn't usually test the more obscure supplements and brands, especially products only available through health practitioners. www dot consumerlab dot com
Thanks for posting this! I'm a supplement skeptic, but I do use some. I try to research them thoroughly. Our family doesn't take kelp as a supplement, but sometimes eats seaweed as a condiment, and unfortunately, I think kelp has been in the mix. I had never heard of this.
I Googled dulse, which we have a packet of right now, and found this, about hijiki seaweed being high in inorganic arsenic. http://www.inspection.gc.ca/english/fssa/concen/specif/arsenice.shtml
Dulse (and other types of seaweed, like nori), appear to be okay from what I can gather.
Consumer Lab haven't tested any of the Vitamin D3 5,000IU products that I've used.
Capsules from Vitamin Research Products gave me good blood test results but were relatively expensive.
Some customer reviews on iHerb.com state that gelcaps from Now Foods & Healthy Origins give good blood test results, so HO is what I use now.
I've been using the Spring Valley brand of 'D' gelcaps from Wal-Mart. My 25OHD is 72, lab was Quest, though, so who knows?
Post a Comment