Dietary supplements: Scary substances manufactured under scary conditions

If there's a law that I view as a horrible, horrible, law, it's the Dietary Supplement Health Education Act of 1994 (DSHEA of 1994). It is a law that blog bud and former ScienceBlogs blogger Dr. Peter Lipson has rightly called a travesty of a mockery of a sham, and, quite frankly, I think he has been too easy on it. Clearly, if there is a single instance of a massive triumph of the forces of quackery in the U.S. that I could point to, the DSHEA of 1994 would be it. This particular misbegotten law in essence opened the floodgates for the sale of dubious supplements and turned a relatively small industry into a huge industry.

The way that the DSHEA accomplished that was to make a distinction between food and medicine. While on its surface this would appear to be a reasonable distinction, given that it doesn't make sense from a policy or scientific standpoint to hold food to the standards as rigorous as the standards to which drugs are held, as implemented by the DSHEA this distinction has the pernicious effect of allowing manufacturers to label all sorts of botanicals, many of which possess pharmacological activity, as “supplements,” and supplements, being defined as food and not medicine, do not require prior approval by the FDA before marketing. In other words, supplement manufacturers basically work on the honors system when it comes to deciding what they will market as a supplement, and the FDA can't do anything about a harmful supplement until after it has been on the market and caused harm. The only real practical restriction on them is that they can't make specific health claims for their supplements in terms of their being able to treat or diagnose any disease or medical problem. Allowed are vague "structure-function" claims. These include suitably vague claims that I've seen or heard in ads such as "boosts the immune system," "protects prostate health" (whatever that means), "strengthens your liver," or "aids in digestion."

If the dietary supplements on the market were, in fact, food or real nutritional supplements, this might not be such a problem. I like to quote Quackwatch when explaining the problem because it's about as concise an explanation of what is wrong as I have ever found:

DSHEA worsened this situation by increasing the amount of misinformation that can be directly transmitted to prospective customers. It also expanded the types of products that could be marketed as “supplements.” The most logical definition of “dietary supplement” would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.

The ban on advertising supplements as having the ability to treat or diagnose specific diseases is widely flouted, as well. For example, manufacturers themselves often try to inoculate themselves with what Peter Lipson has so brilliantly referred to as the "Quack Miranda Warning," while implying all sorts of health benefits that are not supported by science. As I mentioned only a couple of weeks ago, there are also companies who make sure that their literature strictly complies with the DSHEA ban on making specific health claims but then wink at proxies who sell their products as a cure-all, making claims up to and including that the product can cure cancer or AIDS, claiming plausible deniability regarding their actions. Meanwhile, any time any attempt is made to tighten up regulations on dietary supplements, legislators who have been bought and paid for by the supplement industry, like Utah Senator Orrin Hatch or Indiana Representative Dan Burton, pounce, doing their best to kill or water down any legislation that strengthens the FDA's hand in removing potentially dangerous supplements. Indeed, some legislators go beyond defense and go on offense, trying to widen the scope of the health claims that can be made for supplements, as long as a single study can be found to support the claim.

Yet, despite these problems, the supplement industry assures the government and its customers that its products are safe and effective, that they are manufactured according to the most rigorous standards. We've discussed the issues of efficacy before, discussing how there is little or no evidence that supplements prevent cancer, for example, and that there is no evidence that they prolong life. Over the weekend, Chicago Tribune reporter Trine Tsouderos published a damning report that indicates that many supplements are not safe either, because of criminally shoddy manufacturing standards.

Tsouderos' article, Dietary supplements: Manufacturing troubles widespread, FDA inspections show, is an indictment of the entire supplement industry. It also shows that, due to lack of resources, the FDA is clearly not up to the task of exercising even the minimal level of oversight required by the DSHEA. In the last four years, according to Tsouderos, the FDA has found major violations of manufacturing rules in nearly half of the 450 companies it has inspected:

The inspection reports portray an industry struggling to meet basic manufacturing standards, from verifying the identity of the ingredients that go into its products to inspecting finished batches of supplements.

Some firms don't even have recipes, known as master manufacturing records, for their products.

Others make their supplements in unsanitary factories. New Jersey-based Quality Formulation Laboratories produced protein powder mixes and other supplements in a facility infested with rodents, rodent feces and urine, according to government records. FDA inspectors found a rodent apparently cut in half next to a scoop, according to a 2008 inspection report.

"It's downright scary," said Daniel Fabricant, head of the FDA's Division of Dietary Supplement Programs. "At least half of industry is failing on its face."

As a result of these inspections, one in four supplement manufacturers has received a warning letter, which is considered significant, and:

So far this year, FDA inspectors have found violations of good manufacturing practices during two-thirds of the 204 inspections they have conducted in nearly 200 supplement firms' facilities, agency officials said. Seventy of these inspections resulted in the agency's most serious rating.

Personally, I find it rather ironic that one of the key arguments that the supplement manufacturing industry always makes whenever attempts are made to tighten regulations governing supplements is that supplements are "food, not medicine." Yet, the most important aspects of food preparation and manufacturing are aspects where the supplement industry fails almost completely: Sanitary conditions and knowing that the ingredients for their "food" product are pure. In fact, in many cases, supplement companies don't even have real recipes for their products, which makes me wonder exactly how it is they make their products. A pinch of this and a pinch of that? Remember, for example, how CanCell was made on a hot plate in Jim Sheridan's kitchen, and how Sheridan was described as having "no tolerance for complying with rigid manufacturing procedures that the FDA demanded."

The excuses of the supplement industry, as reported by Tsouderos, are pathetic, as well. Hilariously, a flak for the Natural Products Association, in a classic bit of massive understatement, referred to the inspection numbers as "unfortunate," while other representatives of various trade organizations for the supplement industry whine that the industry hasn't had enough time, even though the more recent rules, which should have been in effect all along, were only finalized in 2007. Yes, that's right. Five years apparently isn't enough for the industry to get more than half of its members into compliance with basic food manufacturing standards.

Lest you think that this issue doesn't have potentially horrific consequences, consider the story of John Adams and 200 people who were poisoned by a supplement:

In 2008 more than 200 people — including a 4-year-old — were poisoned by selenium after taking liquid multivitamin dietary supplements that were sold in health stores and by chiropractors, according to a medical paper published on the mass poisoning. The products, called Total Body Formula and Total Body Mega Formula, contained an average of 40,800 micrograms of selenium per serving instead of 200, according to the paper.

John Adams, of Chipley, Fla., was one of the victims. His silver hair — which had earned him the nickname "Silvertop" at work — began falling out in clumps. His fingernails and toenails became discolored, peeled off, regrew and peeled off again. He had a hard time remembering how to do his job as a telephone repairman. He became so weak it was hard to get in and out of his work truck, and eventually he was forced to retire.

Adams and his wife, who also experienced problems, sued along with dozens of others. This year, the couple received a settlement. Adams, now 65, said he is still weak on his left side, has ruined fingernails and toenails that do not grow and struggles with memory problems.

So what was the excuse given by Total Body Essential Nutrition, the distributor of the supplements that caused the mass poisoning? A lawyer for the company blamed a contractor for incorrectly interpreting the formula, incorrectly formulating it, or both. I kid you not. Amusingly (from a schadenfreude standpoint, not from the standpoint of any injury to any person), it's not just Total Body Essential Nutrition who's produced a dangerous batch of supplements and tried to blame it on a contractor's screw-up. In fact, two years ago Gary Null, conspiracy theorist and quack supreme, suffered a similar fate to that of John Adams, but he was poisoned by one of his own products. Specifically, what happened was that Null overdosed on vitamin D consuming Gary Null’s Ultimate Power Meals. As a result, he suffered from “excruciating fatigue along with bodily pain,” and “began to suffer from extreme cracks and bleeding from within his feet." The reason? There was 1,000 times as much vitamin D in his power meal than what the label listed. That meant that instead of ingesting 2,000 IU of Vitamin D daily, Null was ingesting 2 million IU. The usual recommended daily intake is 600 IU per day.

One thing that came to mind as I read this article is a simple question: Why did it take the FDA until 2008 to begin to enforce in a serious way manufacturing standards in the supplement industry? After all, even with the DSHEA, the FDA always had the power to do this, just as it's always had the power to enforce rules and regulations governing the manufacture and production of food and food products. Take a look at the Dietary Supplement Current Good Manufacturing Practices (CGMPs), as finalized in 2007. There's nothing radical there. There's nothing even controversial there when examined from a food manufacturing point of view. The requirements include that manufacturers:

  • Employ qualified employees and supervisors;
  • Design and construct their physical plant in a manner to protect dietary ingredients and dietary supplements from becoming adulterated during manufacturing, packaging, labeling and holding;
  • Use equipment and utensils that are of appropriate design, construction, and workmanship for the intended use;
  • Establish and use master manufacturing and batch production records;
  • Establish procedures for quality control operations;
  • Hold and distribute dietary supplements and materials used to manufacture dietary supplements under appropriate conditions of temperature, humidity, light, and sanitation so that the quality of the dietary supplement is not affected;
  • Keep a written record of each product complaint related to CGMPs; and
  • Retain records for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records.

These are some very basic standards that one would expect to be in force for any food manufacturing facility. Certainly they're far less stringent than what is required for pharmaceutical manufacturing. Yet, the supplement industry is still, four years after the standards have gone into effect and five years after it knew the final form they would likely take, apparently unable or unwilling to comply with some very basic good manufacturing processes that a typical cannery would be expected to follow. Note that, until recently, the actual ingredients weren't really that big an issue; the FDA only wanted to make sure that what the manufacturer lists as being in the supplement and what is actually in the supplement match. Regarding what is actually in the supplement, the FDA appeared to be more or less agnostic. Indeed, it took some fairly egregious examples to get the FDA to act, such as the attempt to label an industrial chelator as a dietary supplement by chemist-turned-antivaccinationist.

Yet, still the supplement industry resists, as described by Tsouderos:

Bradford Williams, manager of the FDA Division of Dietary Supplement Programs, expressed exasperation while addressing an audience at SupplySide West, a large dietary supplement conference in Las Vegas in October.

"It doesn't seem that the firms are getting it," Williams said. "How do I reach this industry? Do I have to use nuclear bombers to do it?"

And:

Fabricant said the FDA's rules are basic and often cover practices — like ensuring the finished product matches specifications — that should have been in place long ago. Warning letters typically are sent after firms fail to fix problems identified in earlier inspections, he said.

Exactly.

Ironically, before becoming director of the FDA's Division of Dietary Supplement Programs, Daniel Fabricant, PhD was vice president of the Natural Products Association, the largest trade group in the U.S. representing supplement manufacturers and distributors. One wonders if it is the knowledge he acquired serving in that capacity that now informs his actions as the main honcho spearheading the FDA's renewed drive to bring supplement manufacturing processes into line with at least the same sorts of basic rules that factories making bread, cookies, crackers, cake, soups, pasta, potato chips, and soda, in fact, of pretty much every sort of food, have had to follow for decades.

Although it is heartening to see an actual effort seeking, if not to require scientific evidence of efficacy for supplements, at least to hold supplement manufacturers to good manufacturing guidelines that make sure that whatever manufacturers list as being in their products is actually in their products, it is sad that it took so long for the FDA to undertake. It is also a perilous time for the FDA, because the supplement industry is powerful, with lots of influential friends in Congress. It has already succeeded in getting the FDA to issue a "clarification" of new rules regarding New Dietary Ingredients (NDI) proposed for supplements, and its friends in Congress have successfully beat back pretty much every attempt to strengthen the DSHEA. So while I cheer the new effort since 2008 to make sure that supplements are at least manufactured according to food industry standard practices, I fear that any victory will be short-lived.

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Well, it solution is obvious: reclassify supplements as something for which there aren't any sanitary or purity requirements. Art, perhaps - if the ingredient lists are recognized as fiction, nobody can complain if they're mendacious.

By Andreas Johansson (not verified) on 01 Jul 2012 #permalink

"the solution", that was supposed to say. Oh for an edit function!

By Andreas Johansson (not verified) on 01 Jul 2012 #permalink

Jeez - and what excuse does the industry give for not maintaining any decent level of quality standards?

They're playing coy - "Oh, we're not medicine, we're FOOD!" to exploit the shit regulations.

My other half works for Novo Nordisk - they get surprise visits from every regulatory agency from each country they sell their product to - most recently the FDA went through the plant with a white glove.

The supplement shysters don't want to endure the same scrutiny, because doing so would reduce their profits to nearly nil, given the amount of training protocols, equipment and whatnot they'd have to implement. Stuff that should have been there from the beginning.

The inspection reports portray an industry struggling to meet basic manufacturing standards, from verifying the identity of the ingredients that go into its products to inspecting finished batches of supplements.

Some firms don’t even have recipes, known as master manufacturing records, for their products.

Others make their supplements in unsanitary factories. New Jersey-based Quality Formulation Laboratories produced protein powder mixes and other supplements in a facility infested with rodents, rodent feces and urine, according to government records. FDA inspectors found a rodent apparently cut in half next to a scoop, according to a 2008 inspection report.

I know this is nothing new,but the autism biomed movement has been one of the biggest godsends and cash cows of all for the supplement industry.These parents can scream all day long about "toxins",but don't care a rat's ass,literally,about what goes into this stuff they shovel into their kids by the ton.They have Trine Tsouderos' article behind a paywall.

By Roger Kulp (not verified) on 02 Jul 2012 #permalink

Lawrence -- basically, "it's too hard and those FDA people are weenies anyway." I think they genuinely have no idea why it matters -- and don't care anyway. There is no industry standard, there is no collaboration, there is no concern for the future; it is all move as many units as possible and worry about the future later. In short, a similar business model to that seen at many Chinese manufacturers, which are not actually evil but just so focused on moving product that safety is a secondary concern (if it's a concern at all).

By Calli Arcale (not verified) on 02 Jul 2012 #permalink

I have recently become aware ( via quackwatch/ see article on the quack) that there have been some developments in Null's supplement fiasco:
two cases( a couple and a woman) have settled out of court for un-disclosed amounts. However, a gentleman suing on behalf of mother's estate has NOT settled. This suit seems to have been filed late in 2011.

By Denice Walter (not verified) on 02 Jul 2012 #permalink

I read the article by Trine Tsouderos that you mentioned and it really came across as a hatchet job. Her top two examples were: an incident that happened in 2008; and amazingly, a Panamanian pharmaceutical company. Really? The salient question here is why did FDA take 17 years to issue GMP guidance? FDA General Counsel at the time, Peter Barton Hutt, writes that the FDA knowingly refused to issue GMPs with the hope that an unseemly element would move in, ruin the industry, and then FDA could shut it down. It almost worked. Supplements aren't held to the same standard as drugs for one simple reason -- supplements are far and away safer than drugs. How many thousands were killed before Vioxx was taken off the market?

By Michael Richard (not verified) on 02 Jul 2012 #permalink

Where's Upton Sinclair when you need him?

By Bronze Dog (not verified) on 02 Jul 2012 #permalink

Fascinating. Can you imagine the hue and cry the alt med community would raise if this story was about drug manufacturers?

And I'd have worried that Fabricant would prove to be the fox guarding the henhouse. Nice to be wrong.

@ Bronze Dog:

Hilariously, the aforementioned quack- a vegetarian...pardon me , a vegan- likes to provide an encapsulated synopsis of The Jungle in order to scare and disgust his audience about eating meat.

That's like Mike Adams writing exposes about websites providing mis-information - which he does.

By Denice Walter (not verified) on 02 Jul 2012 #permalink

Perhaps a counter-rumour for the anti-vac crowd: The rise of suppliments in the diet is the main cause for the autism epidemic?

I wonder if it would sell?

By jrkrideau (not verified) on 02 Jul 2012 #permalink

It's not only the quality standards, it's the whole CONCEPT of "dietary supplements" that puzzles me. What kind of diet includes things like shark cartilage and human placenta? Yet, these things are sold under the guise of being "dietary supplements."

By Marry Me, Mindy (not verified) on 02 Jul 2012 #permalink

jkrideau

I wonder if it would sell?

I think you just answered your own question in the negative.

Retain records for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records

Libertarians view keeping records "for the convenience of the government" to be a horrendous violation of their rights.

By Militant Agnostic (not verified) on 02 Jul 2012 #permalink

"the industry hasn’t had enough time"

The Pure Food and Drug act was enacted on June 30, 1906.
106 years is a reasonable amount of time to get one's isht together.

I suggest that 106 years is also enough prison time for the owners and officers of Total Body Essential Nutrition.

By Spectator (not verified) on 02 Jul 2012 #permalink

@Marry Me, Mindy - Shark cartilage is certainly eaten in Chinese and Japanese cuisine, It would not surprise me if people who live off the sea wouldn't eat it as well (you just caught a shark, you're going to eat as much of it as you can...).

By Mephistopheles… (not verified) on 02 Jul 2012 #permalink

" (you just caught a shark, you’re going to eat as much of it as you can…)."

No. You are going to hack off its fins while it is still alive, and throw everything but the fins back into the sea.

Amazing. If I wanted to start a business baking cakes, I'd have to meet health department regulations more strict than this. I'd get inspected regularly and shut down if I messed up.

I wonder--if you claimed those cakes "boosted the digestive system, would you get a pass on all those regulations?

"Those aren't cakes, inspector--those are supplements"

evilDoug - I guess I was thinking of poorer people living off the sea, not people fishing for high priced delicacies.

By Mephistopheles… (not verified) on 02 Jul 2012 #permalink

Hello friends -

I don't think that unsanitary conditions and/or quality control are necessarily the biggest problem; does anyone believe that any factory farm that is producing our poultry, beef, and pork never get "significant" FDA letters? I'm not particularly impressed by the fact that in 2008 a company had a dead rat on the floor or whatever; you produce food/medicine/"supplements" for a gazillion people at lowest cost and you are going to have some of that.

The bigger problem to my mind is that the supplements are probably working, but in ways other than we might anticipate. The calcium supplement / heart attack study that came out a few weeks ago is a great example of this; we are a lot smarter than we used to be about tinkering with our bodies, but that doesn't mean we are all that clever.

I do think that the pharma companies have a point in that they are at least mandated to try to discern non-desired effects; they might not do a good job, and they may engage in creative literature schemes to make their designer supplements look more effective than they are, but there is a non trivial cost attached to being a pharma developer and a supplement maker.

- pD

By passionlessDrone (not verified) on 02 Jul 2012 #permalink

pD:

; does anyone believe that any factory farm that is producing our poultry, beef, and pork never get “significant” FDA letters?

Well, actually yes. That is because those plants are inspected by the US Dept. of Agriculture. And sometimes they actually get aasaulted and even killed.

@PD - because we don't regulate them like drugs, we'll never know, now will we?

Currently digging around to see if USP certification is of any relevance (have an old bottle of USP-certified Vitamin E lying around - don't ask):

http://www.usp.org/usp-verification-services/usp-verified-dietary-suppl…

Best I can tell, USP certification doesn't mean anything other than you're producing what you say you are without those pesky rat bits and lead. Somehow doubt

In my own field (semiconductor manufacturing) I was involved in the torture - er, process - of ISO certification. That standard requires uber-documentation of everything you do, statistical process control, regular upstream supplier audits, downstream customer audits, and independent sideways audits (to prove you're complying with the original certification). Not fun, but definitely keeps you on your toes.

By Infuriatingly … (not verified) on 02 Jul 2012 #permalink

Aargh.

.....Somehow doubt that Joe's Miracle Supplement and Tackle Shop is even aware of the independent non-governmental quality standards required to make his computer work, never mind what the FDA requires.

By Infuriatingly … (not verified) on 02 Jul 2012 #permalink

I’m not particularly impressed by the fact that in 2008 a company had a dead rat on the floor or whatever; you produce food/medicine/”supplements” for a gazillion people at lowest cost and you are going to have some of that.

Only if you don't care about the quality of your products or the health and safety of your customers. Somehow Anheuser Busch manages to produce beer for a more than that gazillion people without dead rats on their brewery floors, so scale can be no excuse.

I've been peripherally involved with both FDA and EMEA manufacturing audits--they're easily as rigorous (if not more) as ISO certification.

Re jrkrideau's suggestion, to develop the rumor that the increased use of diet supplements is the basis of increased autism rates:

This is very tempting! It's unfortunately true that the general public has difficulty with distinguishing correlation & causation so the could be a lot of room for persuasive-sounding argument. Business plan - write a book. What are the ethics of this? One wonders, given the potential toxicity of some of these nostrums...certainly there are some people who poison themselves & their family, though most folks just are wasting money, I hope.

Yesterday I discovered the Respectful Insolence blog. I was particularly appalled at the MMS revelations. Lost some sleep over it. (OMG -bleach enemas; tried to explain this to my wife.) Friday dose of woo - wonderful phrase. We get a lot of that out in these parts. It ranges from harmless, even quaintly charming -- to pernicious.

How many other people were poisoned by Null's delicious Power Meal! I cannot find any references but there had to be others.

By Kelly M Bray (not verified) on 02 Jul 2012 #permalink

Suggest Orac write science fiction as an outlet because it
seems like only regulars read this blog. He could donate the proceeds to cancer research since it appears he is coming up with nothing important.

@Lurker

I'm sure Orac really gives the proverbial "two shits" about your opinion of him or his line of work.

....and if you don't read the blog anymore, you wouldn't have posted.

In other words, supplement manufacturers basically work on the honors system when it comes to deciding what they will market as a supplement, and the FDA can’t do anything about a harmful supplement until after it has been on the market and caused harm.

For some reason Orac always states this incorrectly. For supplements the FDA has mandatory recall authority; if a product is merely suspected of potential harm, the agency can take it off the market. The FDA does not have mandatory recall authority for drugs:

http://www.pharmalot.com/2010/05/should-the-fda-have-mandatory-recall-p…

Even after Vioxx caused up to 139,000 deaths, the FDA politely waited for a "voluntary recall" by Merck.

Dude, this post's been up for less than a day, and a lot of people work 9-5 or, this being the internet, aren't even up yet cause it's still o-dark-thirty where they are.
Also, due to the recent reformat, some people may not have found their way back here yet. Check back tomorrow, and there'll be a lot more posts.

By Politicalguineapig (not verified) on 02 Jul 2012 #permalink

Don’t read this blog anymore but I doubt Orac would comment on the following
http://www.reuters.com/article/2012/07/02/glaxo-settlement-idUSL2E8I24J…

Oh look, big pharma isn't all powerful and gets smacked for violating laws. News at eleven.

Suggest Orac write science fiction as an outlet because it
seems like only regulars read this blog. He could donate the proceeds to cancer research since it appears he is coming up with nothing important.

If that's what you think then why request his commentary on your linked news article? As for 'coming up with nothing important', when was the last or only time you ever stepped foot in a laboratory for research? Kvetching isn't exactly a contribution to society. Go back to AoA; their scientific incompetence and dishonesty are more your speed lurker.

By Science Mom (not verified) on 02 Jul 2012 #permalink

Orac is guilty of hyperbole when it comes to Alt med.
I bow down to Emergency room physicians and staff and their dedication and SBM in genearal but Orac is really guilty of hyperbole when it comes to his posts. He is bordering on the kind of hysteria seen in Health Ranger. Patients are helped and harmed by Parma that's the reality. My bias leans to Alt Med and I know it. I also was prescribed Paxil at one time to which I had an awful reaction.

@ Lurker...What was the awful reaction to Paxil? Sanity?

By Kelly M Bray (not verified) on 02 Jul 2012 #permalink

@Science Mom- You are unbelievable in your comment.
Tell that to the moms who children committed suicide while taking Paxil.

Tell it to the families of people who committed suicide due to depression. I bet that is a far larger crowd

By Kelly M Bray (not verified) on 02 Jul 2012 #permalink

One more horror story to add: the woman who tracked the source of her lead poisoning to the dolomite "supplement" she was taking. Leaving aside the question of just whose diet normally contains rocks, it seems that there is no source of dolomite that doesn't contain some lead.

By Old Rockin' Dave (not verified) on 02 Jul 2012 #permalink

pD: I work on an agriculutre setting and been invoked with my whole life, though admittingly that's not very long compared to some peoples careers here. I can tell that inspections and meat packing and slaughter houses are very extensive. Some plants are inspecting weekly and reserve a spot for the USDA in large parking lots. They must keep safety protocols up to date. If there is one thing the USDA is good at it is keeping the the food supply relatively safe.

By Matt ford (not verified) on 02 Jul 2012 #permalink

I think the image of herbal medicine many people have is the wise old Chinese man with the white beard to his knees in his dark shop full of little drawers and bottles full of strange things dispensing nuggets of Charlie Chan-style wisdom.
If he ever existed, that old man is DEAD for years. His grandson runs the business, a large sweatshop full of low paid workers, dangerous machines, and toxic fumes. He is not a font of great wisdom. He is an overdressed businessman too busy talking to his broker on the cellphone while he drives around in his Italian sports car with girls half his age.

By Old Rockin' Dave (not verified) on 02 Jul 2012 #permalink

@ Lurky...I am not ignorant. It has been scientifically proven that sanity is a good thing. Try it some time.

By Kelly M Bray (not verified) on 02 Jul 2012 #permalink

Ah, lurker. Again he/she has come back to post a link to something that doesn't say what he/she claims it says. It's a habit he/she can't seem to break.

The letter also says that "it is difficult to conclude a causal relationship between paroxetine and suicidality due to the small incidence and absolute number of events, the retrospective nature of this meta-analysis, and potential for confounding by the fact that the events of interest are a symptom of the psychiatric illnesses themselves."

Ah, Kelly...to lurker, a warning of a possible risk = children committing suicide because they took Paxil. Even though no one is claiming that.

Except lurker of course, who still needs to work on that whole reading comprehension thing.

Intelligent people should research all drugs they take.That includes supplements .
I am appalled that there are not more controls. I also learned on alt med sites that some manufacturers are using a toxic source of selenium to save costs.
Dolomite was known to contain lead for years.
I will research everything I ingest including fruits and vegetables and their known pesticide residue and hope for the best in this polluted world.
My advice do your research and have a nice life.
This blog offers nothing that I don't already know.

Paxil doesn't work very well-
"The frequency of suicidal behavior was higher among those taking Paxil than placebo, with 11 cases of suicidal behavior among 3,455 patients taking Paxil and one out of 1,978 taking placebo."

You are all really highly verbal idiots.

I retract my insult. Not nice. Hope you weigh risks.
Thank you Orac for the following link
http://nccam.nih.gov

Now, lurker, if only we could get that kind of regulatory action on the supplement manufacturers. Perhaps if the place that gave folks overdoses of Vitamin D and selenium were given huge fines they would be more careful. Perhaps their factories should actually be inspected, and pass the same kind of sanitary standards required of food processors.

Don't you think that would be a good thing?

@Kelly
Paxil and Suicide Risk
psychcentral.com/blog/archives/2008/06/16/cover-up-paxil-and-suicide-risk/

So, lurker, do you agree that supplements should be regulated the same as drugs and processed food?

@Chris Of course. However the GSK debacle shows how
ineffectual this can be. Just google paxil and suicide.

Just to clarify about "Lurker's" identity. She claims to be a 68 year old grandmother whose last shtick was serious side effects and autism caused by vaccines.

When asked for "citations" our Lurky usually cuts and pastes from the vaccine manufacturer's prescribing information...citing every side effect/every untoward reaction that has ever been reported for that particular vaccine.

When I explained to her that these *events* must be listed, in order to be FDA compliant, Lurky then cherry-picked some sentences/paragraphs from websites. She was found out for her trollish behavior and flounced off, clutching her pearls and indignant that we all were *mean to her*.

Best to just ignore Lurky...just another ignorant troll.

@lilady- Your lack of comprehension is amazing.
Try some paxil and tell me how you feel.

Lurker, if the regulation is so ineffectual, why is GSK being fined three billion dollars, and yet supplement manufacturers can have rat parts in their nostrums and only get a warning letter?

evilDoug @1:06 pm

No. You are going to hack off its fins while it is still alive, and throw everything but the fins back into the sea.

Then there's rhinoceros horn.
~~
Old Rockin' Dave @5:11 pm

I think the image of herbal medicine many people have is the wise old Chinese man with the white beard to his knees in his dark shop full of little drawers and bottles full of strange things dispensing nuggets of Charlie Chan-style wisdom.

Exactly. The reality is that in the case of some of the most popular herbal supplements, e.g. Echinacea, Black cohosh, Ginseng, there's not enough supply in the wild to meet demand. Enter field farming (complete with fungicides, pesticides) and species substitution.

By Sauceress (not verified) on 02 Jul 2012 #permalink

Try some paxil and tell me how you feel.

I've taken it for twelve years now. Really cuts the edge off that crippling anxiety I used to have.

By dedicated lurker (not verified) on 02 Jul 2012 #permalink

Perhaps, lurker, the supplement manufacturers should be fined for making claims that their nostrums work for things like (quoting Orac) ' “boosts the immune system,” “protects prostate health” (whatever that means), “strengthens your liver,” or “aids in digestion.”' When in fact there is absolutely no proof they do any of those things.

So, while you are getting your panties in a twist over GSK and paxel, this article is about applying not same, but some actual regulations on the supplement industry. Perhaps if the FDA received some actual funding (perhaps part of that three billion dollar payment), they will be more effective.

Intelligent people should research all drugs they take.That includes supplements .
I am appalled that there are not more controls. I also learned on alt med sites that some manufacturers are using a toxic source of selenium to save costs.
Dolomite was known to contain lead for years.
I will research everything I ingest including fruits and vegetables and their known pesticide residue and hope for the best in this polluted world.
My advice do your research and have a nice life.
This blog offers nothing that I don’t already know.

Let me get this straight; Orac posts about egregious manufacturing violations in the supplement industry, you agree but accuse him of hyperbole and go on a rant about regulations working to punish pharmaceutical violations and studies being conducted to elucidate if a drug may have serious adverse effects. Do you just have verbal diarrhoea or is no one in real life paying any attention to you? Because generally people don't go frothing at the mouth when they are in agreement about a topic.

By Science Mom (not verified) on 02 Jul 2012 #permalink

@Chris The risks of Paxil were known for over ten years and no one acted. Name supplements with that kind of risk or the egregious marketing tactics.
@lilady-
I don't follow anyone slavishly, I will make up my mind after reading enough research.

Name supplements with that kind of risk or the egregious marketing tactics.

Name supplements on the market that have properly studied in order to identify risks and substantiate claims made in their own 'egregious advertising'

lurker @ 5:27 pm

This blog offers nothing that I don’t already know.

Sooo..can't find your way out?

By Sauceress (not verified) on 02 Jul 2012 #permalink

Try some paxil and tell me how you feel.

I've taken it for 6 years now. Anxiety and depression under control. Still not dead.
Paroxetine was only ever recommended for severe clinical depression here in Australia. It is accepted that mild depressive symptoms will not benefit from the drug. And I'd much rather be able to function and interact rather than be withdrawn and isolated.

The inspection reports portray an industry struggling to meet basic manufacturing standards, from verifying the identity of the ingredients that go into its products to inspecting finished batches of supplements.

It doesn't sound to me like they're "struggling" at all. "Not bothering" might be a more appropriate description.

"This blog offers nothing that I don’t already know."

and....

"I don’t follow anyone slavishly, I will make up my mind after reading enough research."

Can I help you *out* Lurky? Which way did you come in?

The Altie Delusion:
Now you too can live your life Naturally (TM), simply by popping a handful of supplement pills.

By Sauceress (not verified) on 02 Jul 2012 #permalink

lurker:

It doesn’t sound to me like they’re “struggling” at all. “Not bothering” might be a more appropriate description.

So you support the repeal of DSHEA? That way the FDA will have the power to bother with dealing with shady supplement manufacturing.

Or do you support rat bits in your supplements?

When we are accused of being part of Big Pharma, we should accuse the of being Big Suppla.

By Kelly M Bray (not verified) on 02 Jul 2012 #permalink

@Chris The risks of Paxil were known for over ten years and no one acted

Oh BS. You can thank your politicians for hamstringing the FDA in favour of protecting their campaign contributers. http://newsmine.org/content.php?ol=cabal-elite/corporate/pharmaceutical…

"This isn't Harvey Pitt and the S.E.C.," he said, referring to the former chief of the Securities and Exchange Commission, whom Mr. Spitzer criticized as less than vigorous in enforcing federal securities laws. Instead, Mr. Spitzer said that the F.D.A. had been hamstrung by court rulings that have used free-speech arguments to limit the agency's power to regulate what drug companies can say to doctors. Such rulings do not limit his powers, Mr. Spitzer said.

"You cannot invoke free-speech arguments as a defense to fraud," he added.

Similar suits against other drug companies are likely, Mr. Spitzer said. "This is an area that we're interested in," he said, "and I think there are other cases out there that are analogous."

A spokeswoman for the F.D.A. would not comment on the lawsuit but noted that the agency required companies to submit all data related to the safety of their drugs. Because so much drug company data submitted is considered proprietary, it is up to the F.D.A. to decide when to disclose possible public safety concerns.

That is what it did last year, when it warned doctors on the use of Paxil for adolescents and children. Earlier this year, it required antidepressant makers to strengthen suicide warnings on labels."

Name supplements with that kind of risk or the egregious marketing tactics.

http://www.fda.gov/Food/DietarySupplements/Alerts/default.htm

And that is just a small sample.

@lilady-
I don’t follow anyone slavishly, I will make up my mind after reading enough research.

Sure, some research skillz you have there lurker; you can't even discern the FDA's role in Paxil and you couldn't even find a single risk or marketing violation with supplements.

By Science Mom (not verified) on 02 Jul 2012 #permalink

Sorry for the double post, HTML fail and I hate no preview.

@Chris The risks of Paxil were known for over ten years and no one acted

Oh BS. You can thank your politicians for hamstringing the FDA in favour of protecting their campaign contributers. http://newsmine.org/content.php?ol=cabal-elite/corporate/pharmaceutical…

"This isn't Harvey Pitt and the S.E.C.," he said, referring to the former chief of the Securities and Exchange Commission, whom Mr. Spitzer criticized as less than vigorous in enforcing federal securities laws. Instead, Mr. Spitzer said that the F.D.A. had been hamstrung by court rulings that have used free-speech arguments to limit the agency's power to regulate what drug companies can say to doctors. Such rulings do not limit his powers, Mr. Spitzer said.

"You cannot invoke free-speech arguments as a defense to fraud," he added.

Similar suits against other drug companies are likely, Mr. Spitzer said. "This is an area that we're interested in," he said, "and I think there are other cases out there that are analogous."

A spokeswoman for the F.D.A. would not comment on the lawsuit but noted that the agency required companies to submit all data related to the safety of their drugs. Because so much drug company data submitted is considered proprietary, it is up to the F.D.A. to decide when to disclose possible public safety concerns.

That is what it did last year, when it warned doctors on the use of Paxil for adolescents and children. Earlier this year, it required antidepressant makers to strengthen suicide warnings on labels."

Name supplements with that kind of risk or the egregious marketing tactics.

http://www.fda.gov/Food/DietarySupplements/Alerts/default.htm

And that is just a small sample.

@lilady-
I don’t follow anyone slavishly, I will make up my mind after reading enough research.

Sure, some research skillz you have there lurker; you can't even discern the FDA's role in Paxil and you couldn't even find a single risk or marketing violation with supplements.

By Science Mom (not verified) on 02 Jul 2012 #permalink

lurker:

Name supplements with that kind of risk or the egregious marketing tactics.

So you did not even bother reading the above article.

Or you are a big fan of extra rodent in your supplements (more protein?), and overdoses of selenium don't bother you.

@lurker

Keep up posting your utter ignorance.

I need a good laugh, and you seem like the perfect fool to provide some good chuckles.

more protein?

Adds a bit of crunch too.

By Sauceress (not verified) on 02 Jul 2012 #permalink

Perhaps the extra crunch is needed after losing her fingernails and hair after an overdose of selenium.

Lurker, I've been aware of the problem with psych meds (paxil among other) and suicide risk and I do condenm them but if you want to visit an audience favorable to that issue, go visit the drugmonkey blog; in any case, drugmonkey has been condemning the tactic of the various pharma company who has been polluting the literature of drug research with the help of Charlie "bling bling" Nemeroff. also, see www.1boringoldman.com for more on that same angle.

no need to put us all in the same bag just because we are pro-vaccine and SBM because we'd likely hate it if we had a Nemeroff lookalike corrupting our literature. SBM isn't synonymous with pro-pharma.

A.L.

By Autistic Lurker (not verified) on 02 Jul 2012 #permalink

Also, if you read this blog with an open mind, you will find that Orac has several articles that criticize pharmaceutical companies. Especially when some were paying folks to write favorable papers and get them indexed on PubMed.

Now, of course, that is not the subject of today's article, which apparently lurker has not even read. It is ironic that she posts an article about a pharmaceutical company having to pay a multi-billion dollar settlement to an article about the FDA not even being allowed to have any power over Big (or Little) Supplement.

@Chris- Bravo Spitzer-but I was prescribed Paxil in Jan 2007 in NY. Still prescribed. Had a bad reaction stopped taking it.
Hardly anyone takes the supplements listed in the link you provided compared to the millions who have taken pharma drugs later removed from the market.
@novalox- Are you a parrot? You keep on saying the same thing over and over-who trained you?

Last week there was a big ol' slug resting comfortably in the otherwise perfect head of lettuce we got from our CSA farmer. I flicked away the slug, did the standard "double rinse", and made a fine salad for dinner. Shrug. If the slug warn't dead, the lettuce prolly won't kill me either Which is kinda the whole idea behind natural organic food, dontcha know.....

IIRC, the FDA/USDA does have rules on critter bits acceptable in processed food - the main rule is that they not be dangerous.

That said, if I found a dead slug corpse in a can of tomatoes, I'd be pretty peeved. I wouldn't be peeved at gubmint so much as the processor being slackadaisical.

By Infuriatingly … (not verified) on 02 Jul 2012 #permalink

@Chris- Bravo Spitzer-but I was prescribed Paxil in Jan 2007 in NY. Still prescribed. Had a bad reaction stopped taking it.

I linked to that article. Did you even bother to read it? Yes it's still being prescribed but with the warnings and information that should have been available when they came to light and from the clinical trials. You are not an adolescent so the information didn't apply to you.

Hardly anyone takes the supplements listed in the link you provided compared to the millions who have taken pharma drugs later removed from the market.

Oh I see, first you said name one violation. Done. Then you shift the goal-posts to downplay the number of people taking those. What, do you people have a playbook or something? Unless you want to add up those taking supplements and have been harmed compared to those taking pharmaceuticals and have been harmed, I'd STFU if I were you.

By Science Mom (not verified) on 02 Jul 2012 #permalink

What, do you people have a playbook or something?

"It looks like one of our thermal pods... but it's a very bad design."

lurker:

Hardly anyone takes the supplements listed in the link you provided compared to the millions who have taken pharma drugs later removed from the market.

What link? I was referring to the words written on the top part of this page! Try reading the article you are commenting on.

Oh, and Infuriatingly Moderate, I had a small snail on some of my lettuce. Though that was from my own yard.

And speaking of the weather, I got drenched last week when I went on the Edible Garden walking tour in Ballard last week. I'm growing some peppers indoors, but some aphids got into the house. I don't really want to introduce ladybugs because the bright open window is in my bedroom (and they bite!). So sometimes my hubby finds plants in the shower.

@Science Mom-there can be no comparison because
pharmaceuticals are prescribed by medical doctors who in some cases should be more informed. I may have had a bad
reaction to Paxil but I trusted the doctor who prescribed it. This was not a personal choice. Also a bad reaction to naproxen for sciatica. I will now research any drugs prescribed. I'm in good health and yes I'm 69 now lilady. I have had no bad reactions to any of the supplements I have been taking for 40 years. Stress B complex, Vit C etc. I am taking no prescription drugs.

Oh, yeah, like the time the dental surgeon prescribed percodan after I had my wisdom teeth removed. I ended up throwing up all weekend.

Then there was a time I was prescribed a similar narcotic when I broke my ankle. It is really annoying to get to the toilet to vomit on crutches.

Apparently, I am one out ten who get sick to their stomach on narcotics. That still leaves 90% who benefit from the pain relief (and some who steal the stuff, which I don't understand).

Okay, Paxil (I think I am learning to spell it) does not work for you. Okay, we get that.

But that does have anything to do with the absolute lack of regulations pertaining to safety and sanitation of supplements!

@lurker

Oh lurker, do try to keep your half-witted attempts at insult coming. I do enjoy your pathetic attempts, but you really should try harder.

There should be more regulations pertaining to the safety and sanitation of supplements.
Also in a perfect world people would not eat junk food, smoke, not exercise and expect doctors to cure them when they get sick.

@novalox Take your Ritalin and STFU

In a perfect world no one would exercise? That's odd.

Also, Abilify made me throw up every time I took it, Haladol made me unable to concentrate on anything for more than five minutes, and Wellbutrin gave me abdominal pain so bad I wondered if I was having a heart attack.

Why do you consider taking psychiatric medication an insult anyway? Do you also tell people to take their thyroid medication and STFU?

By dedicated lurker (not verified) on 02 Jul 2012 #permalink

@lurker

Yawn., do try harder with the insults.

But it is amusing to see you actually show a potty mouth, such foul language for a old woman. Perhaps in time, you can come up with an actual insult that, dare we say, actually works.

Keep dancing, my little puppet lurker, your stupidity is amusing and worth a few good chuckles.

@novalox- Have a nice life
@dedicated lurker- novalox thinks she's hot s___.
That was not an insult. She may need it.

Lurker: Nothing wrong with ADD. And some people do juust fine on ritalin.
I'll admit your right about paxil, but the broken clock rule applies. Just because SSRIs are rubbish for some people, doesn't mean that doctors are wrong about everything. And I'd still rather have paxil then selenium or dolomite.

By Politicalguineapig (not verified) on 02 Jul 2012 #permalink

@lurker

Hmm, still try harder with the insults. At least you're trying the scatological angle, that's new, but still you're flat.

At least the posters here can see your mindset, and I get to have some entertainment value with my new puppet.

@Pol GP I'll take neither Thank you.
Sorry about the above random posting but sometimes even profs can be loony. I am not.
I will not post for another month or so ,maybe never- enjoy

Michael Richard

What proof do you have that supplements etc are safer than medicines if no one is monitoring their safety etc?

@lurker

Seriously, a link to the daily mail? If there's one news source you could link to that just screams "sensationalist rag that deliberately misinterprets everything in order to get its audience worked up", it's the Daily Fail.

Wow.

By nastylittlehorse (not verified) on 02 Jul 2012 #permalink

Most of the quacks I survey ( including Null, Adams, ANH- both sides of the pond) are putting out warnings to their devotees that governments are attempting to make ALL supplements into prescriptions and that small companies will be squeezed out by the giant pharma corporations(because of testing dictates). Yes, it is all just around the corner... you won't be able to buy your cherished vitamins/ herbals/ compounds unless a doctor says so! Or you will only be able to surchase tiny amounts ( not 100s of mgs). It will be just like Germany!
The first signs and warnings** will involves tales of tainted products and the need for oversight... And here they are!

** sounds like the Apocaclypse

By Denice Walter (not verified) on 02 Jul 2012 #permalink

In a perfect world no one would exercise? That’s odd

The syntax of that post isn't very clear, but I think lurker meant "not not exericse".

By Andreas Johansson (not verified) on 02 Jul 2012 #permalink

Okay, Paxil (I think I am learning to spell it) does not work for you. Okay, we get that.

But that does have anything to do with the absolute lack of regulations pertaining to safety and sanitation of supplements!

Yeah, I think I've shared my and my brother's experience with Ritalin before. We were both prescribed it for the same condition; for him it gave him temper control and for me it made me feel constantly on the edge of erupting. People's brain chemistry being so unique means that results will vary, widely.

But at the best, this is just a tu quoque argument, and at the worst, an irrelevant tu quoque because the variability in Paxil comes from the variability of the recipient, not in the factory having no quality control and the levels of ingredients varying by three orders of magnitude.

By Antaeus Feldspar (not verified) on 03 Jul 2012 #permalink

Narad:
“It looks like one of our thermal pods… but it’s a very bad design.”

You just made my day. A Buckaroo Banzai quote. ;-)

Just remember, no matter where you go . . . there you are.

By Calli Arcale (not verified) on 03 Jul 2012 #permalink

Lurkey honey, you're a bit all over the place. Righteously angry. Contrite. Mocking. Reasonable. Potty mouthed. Pearl clutchy. Self-reliant. Sarcastic. Victimized. Now, I realize we all have our various moods and emotions, but usually not all in one thread. Consider picking one persona and sticking with it, it's less confusing to us shills and minions.

By Pariedolius (not verified) on 03 Jul 2012 #permalink

One tactic alt med advocates use to combat news of discoveries of contamination or mis-labelling of supplement products is by saying that this occurs only when you buy cut-rate, low-end products**; of course it would never happen if you select *la creme de la creme*, i.e. their own marvellous creations.
see this type of argument at Natural News today - Craig Stellpflug.

** or cast aspersion elsewhere - "The manufacturer didn't follow my instructions!"

By Denice Walter (not verified) on 03 Jul 2012 #permalink

Denice,

One alt med defender actually said the Gary Null poisoning was a set-up by the FDA, to tarnish all supplements as dangerous. Someone i Big Pharma sabotaged a batch of his magic powder to discredit the entire natural health movement.

By Marc Stephens … (not verified) on 03 Jul 2012 #permalink

@ Marc Stephens Is Insane:

Oh yes, I've heard his rap! Null has several set-pieces that explore how the powers-that-be have opposed his brave maverick-ness over the years: they were responsible for his loss of a television show, appearances on PBS, threats to his safety et al.

The best one involved a tale of heavy man in a small foreign car, who followed him while he was walking in NY: the guy confessed that he was paid to ' find dir't' but couldn't, thus he felt obliged to issue a dire warning. The sweaty fellow told him that he would always have problems because his investigative journalism and brave opposition to Big Pharma, Big Money, Big Lies etc have upset the status quo established by the powers that be.

The idiot now has a documentary along these lines available at his websites : The War on Health: The FDA's Tyranny or something

By Denice Walter (not verified) on 03 Jul 2012 #permalink

@nastylittlehorse:
To the Daily Mail, there are only two kinds of substances in the world - the ones that cause cancer and the ones that cure cancer. Depending on when you pick up a copy, they are often the same ones. And they never have any relationship to anything in the real world.

By Old Rockin' Dave (not verified) on 03 Jul 2012 #permalink

PDrone : your argument is a combination of the Tu quoque fallacy and Anecdata. Stories do not make for valid evidence.
Foodstuffs are regulated by the Federal government under authority of the pure food and drugs act. A law which Bronze Dog might know was brought about by the popular work "The Jungle" by Upton Sinclair. (who was oddly trying to bring about a socialist movement in the United States by his work -- he later wrote : "I tried to start a revolution and all I did was give people the bellyache." )

Orac : a decent use of the ole Tarial Cells, as always.

To the Daily Mail, there are only two kinds of substances in the world – the ones that cause cancer and the ones that cure cancer. Depending on when you pick up a copy, they are often the same ones.

Ah, you are familiar with the Daily Mail Oncological Ontology Project?

By Roadstergal (not verified) on 04 Jul 2012 #permalink

This website goes into detail about the Daily Mail's valiant war on cancer. Someone has a little too much time on their hands methinks.

By Krebiozen (not verified) on 04 Jul 2012 #permalink

@Roadstergal:
"Ah, you are familiar with the Daily Mail Oncological Ontology Project?"
Is that the one being run by the Merde-Docs?

By Old Rockin' Dave (not verified) on 04 Jul 2012 #permalink

@DLC:

Stories do not make for valid evidence.

But they aren't just 'stories'; the FDA is sending out warning letters to food producers all the time.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm3099…

United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of flunixin at 1.03 parts per million (ppm) in the liver. A tolerance of 0.125 ppm in the liver has been established for residues of flunixin in the edible tissues of cattle

I wonder how you might know if you've eaten other cattle from this producer? At least with supplements you have a pretty good idea whose supplements you purchased.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm3056…

Laboratory analysis of these environmental samples found Salmonella in twenty-one separate subsamples collected from processing locations. Sixteen of these positive samples were taken from locations where food is likely to be exposed.

Specifically, dead beetle-like insects too numerous to count were observed on totes containing product and the floor surrounding these totes.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm2966…

Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 0.25 parts per million (ppm) of sulfadimethoxine in the liver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the edible tissues of cattle

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm3094…

Three dead rodents were observed on glue traps along the wall, as well as, beside and behind pallets of chocolate products being stored in what you refer to as the "chocolate room." Rodent excreta pellets were observed along all walls in the chocolate room, as well as on pallets used to store food products in this room. Approximately eight of twenty-one pallets holding chocolate and pasta products stored in the chocolate room contained what appeared to be rodent gnawed holes penetrating through to food products.

Have you ever eaten chocolate produced by Gordon? They appear to have the same, or worse, sanitary problems that the supplement makers had.

The FDA warning letter site is a scary place; the fact that a supplement producer had sanitary problems is technically true, but a drop in the ocean for everyone participating in our food chain. It's great fun to beat up on the supplement guys, I happen to think they deserve it for the reasons I tried to state above; but to simultaneously think that they stand alone in having unsanitary conditions is a special kind of doublethink. If they don't stand alone, if violations are incredibly widespread, then jumping up and down about a specific incident is more about stroking a bias than anything else.

- pD

By passionlessDrone (not verified) on 05 Jul 2012 #permalink

@ pD:

Sure, there are lots of food producers with violations. Because there are lots of food producers, period.

But a THIRD of all inspections of supplement manufacturers found the most serious grade of violation, and another third found less serious violations.

So supplement manufacture is clearly unsafe throughout the industry. Picking out particular spectacular food producer violations doesn't change that fact, nor does it even hint that the broader food industry is anywhere near as unsafe as supplements.

@pD: Beamup makes the best point you can about food producers. There is alot is in the US so there will be alot of warning letters. While on the other hand 2/3 of supplement producers have received letters. Secondly do you have any idea what flunixin is? It a NSAID, while sulfadimethoxine is an antibiotic. So, many slaughter house have no control over those two things. They are usually given earlier up road. Many times following the withdrawal date, but repeated use and fatter cattle can extend the time the drug is found on the cattle's system. So of you blame anybody there blame the feed lot or ranch that originally sold the cattle.

By Matt ford (not verified) on 05 Jul 2012 #permalink

A couple of interesting facts I just came across.
Vioxx increased the risk of a heart attack by 24% in one study (PMID:15809459).
Calcium supplementation increased the risk of a heart attack by 86% in another very large study (PMID: 22626900).
Just saying...

By Krebiozen (not verified) on 05 Jul 2012 #permalink

Hey Guy's, regarding food, there are 4 mega-producer of meat in the US and they hold 80% of the US market. In the 1970, the FDA did on average 50 000 inspections per year while currently, it's a bit over 9000 per year and they're having problems policing the producers and the processing manufactures. Finally, cow are being fed corn nationwide which increase the presence of E-Coli in cow stool which can be found in crop so you might want to take a look at all the recall of vegies and fruit contaminated with it.

You might want to see the movie Food, inc., there's lot of useful data in that movie (I listened to it as a class project today). It's a real eyes opener.

A.L.

By Autistic Lurker (not verified) on 05 Jul 2012 #permalink

cow are being fed corn nationwide which increase the presence of E-Coli in cow stool

Do you have a citation for the claim that being fed corn increases the presence of E. Coli in stool?

By Mephistopheles… (not verified) on 05 Jul 2012 #permalink

no but I'll find one.

A.L.

By Autistic Lurker (not verified) on 05 Jul 2012 #permalink

@ Autistic Lurker: While the Science article that you linked to may have showed some preliminary studies about grass feed versus corn fed cattle not being linked to E. coli human disease outbreaks...a later Slate Magazine article, seems to dispute that:

http://www.slate.com/articles/health_and_science/green_room/2010/01/bew…

I'm sure you could find MMWR articles that linked unpasteurized apple cider as the culprit for large E. coli human outbreaks. (the same cows who fed on the grass in adjacent fields...and whose manure was used as fertilizer in those apple orchards, were implicated in these outbreaks.

For some reason I still don't know, supplement manufacturers here in the Philippines are allowed to make more specific therapeutic claims (e.g. Uric acid excretor, anti-hypertensive). I forgot the names so I can't link to them yet. Another major advantage of supplement manufacturers here in the Philippines is that the quack Miranda warning is "No Approved Therapeutic Claims", which is not easy to understand, especially among the lower socioeconomic class.

The now former Secretary of Health proposed a law stating that this Quack Miranda warning be converted into "This is not medicine" in native language. Predictably, the supplement manufacturers howled in protest. As is obvious, they are relying on people not knowing any better.

http://www.philstar.com/Article.aspx?articleId=578823&publicationSubCat…

By FilipinoMDstudent (not verified) on 06 Jul 2012 #permalink

Ok, I stand corrected. I guess that manure should be used after a long drying session (the more it's dried, the less pathogen are found) but in the case of mega-farms, it might not be possible and this is something they have to dispose off.

A.L.

By Autistic Lurker (not verified) on 06 Jul 2012 #permalink

supplement manufacturers here in the Philippines are allowed to make more specific therapeutic claims (e.g. Uric acid excretor, anti-hypertensive)

Thing I don't get is that if consumers (or marks) believe these products have such profound healing properties then they also believe these pills and potions are producing physiological activity. So why aren't the all the alternative medicine/supplement consumers demanding studies be done on the effects of possible interactions between their "Natural" miracle cures and supplements.

Expecting too much common sense from the Woosters?

Oh and what was the definition of a "drug" again?

Still it must be nice for the con artists to know that all they have to do to get free shill advertising all over the net for one's majik cure invention is to claim a secret conspiracy between drug companies and the FDA.

I hear Dire Staits..
Money for nothing and your shills for free

By Sauceress (not verified) on 06 Jul 2012 #permalink

Dire Straits even...

By Sauceress (not verified) on 06 Jul 2012 #permalink

@Sauceress

Based on what I observe here in the Philippines, my hypothesis is that most consumers do not know how to differentiate medicines from supplements. Although, it's possible that this hypothesis also applies to consumers elsewhere. Our version of the quack miranda warning is almost completely worthless since, although it is big and on the front of the package/bottle, lay people don't know what it means. In contrast, the US version is clear and straightforward but hidden from view, or in tiny print.

Since some consumers simply don't know the difference between meds and supplements, I think many of them aren't necessarily anti-conventional medicine. The problem is that they probably also do not understand the concepts of physiology and pharmacology, so they won't question safety and efficacy of either conventional medicines or supplements.

By FilipinoMDstudent (not verified) on 07 Jul 2012 #permalink

Whole Foods Market bought a company called Amrion back in the late 90s to be its captive supplement producer. WFM failed to do due diligence on the manufacturing/warehouse part of the business. All they saw was the cash. I worked in the warehouse/plant, which was filthy. Machines and surfaces were never cleaned, nothing was stored in temperature controlled conditio ns, raw ingredients were obtained from the most dubious sources possible. FDA warned them for multipleviolations, including no MSDS in the lab. There were safety issues also. WFM quietly shuttered the plant 2 years after they bought AMRN and got huge tax incentives from the city if Thornton Co to move it to the former Gerry Baby Products distribution center. True story. I was there.

@ Sauceress:

The woo-meisters I survey first disperse a smoke screen that simultaneously lauds the inherent healing qualities of vegetables / fruits/ natural minerals and casts aspersion on any pharmaceutical product/ products of modern farming/ husbandry as being threatening to health...

Then, they sing the praises of the divers natural substances within plants/ the earth- that maintain the life force itself- and are now encapsulated intact in the supplements they sell. They also educate their audiences about juicing- selling the juicers et al- and using various powders ( dried vegetables and fruits)- which they sell- to add to the real juice.
Some who allow animal products ( Adams, Mercola) have highly speciific ways of selecting appropriate products ( raw, organic, grass-fed, free range etc)- not contaminated by modern processing/farming techniques, pesticides or hormones.

Now, they claim to have research " from peer-reviewed journals" ( that you never heard of before) that illustrate the miraculous healing properties of mundane vegetable *essences* ( phytonutrients) and minerals, often doing the studies on their clients or themselves ( N=1 is no problem here).

Lastly, the *coup de grace* is to claim that real studies that do NOT show great value in supplements or in specific phytochemicals are biased, compromised research paid for by Big Pharma, Big Food, the Medical Industrial Complex, you know the drill...

Recently, I believe that they have spread the derision to include the Government ( your choice of country) and the Media that work hand-in-glove with the others- giving examples of how the goverment and media are dens of iniquity.

My simple question to all onlookers: they say you shouldn't believe your government, the medical establishment, universities or the media BUT
you should believe some guy with a website who is selling your over-priced supplements and juicers.
I hereby rest my case.

By Denice Walter (not verified) on 07 Jul 2012 #permalink

Above, you should realise that they masquerade as scientists and practictioners- they brag unabashedly of their own success stories with patients and healings of serious conditions without resort to Pharma products.

This Cargo Cult adorns itself in the trappings of science/ research/ medicine without its substance or meaning: thus, it mis-appropriates language, speaking of "clinical trials, counselling, statistical analysis, peer review, scholars-in-residence..." They produce tomes of protocols for curing various conditions and documentaries on similar topics, as well as "investigative journalism" about just how corrupt the government, pharma, doctors, universities, media and journalists ACTUALLY are! A diversionary tactic: so that their clients don't look at THEIR own slimey business.

By Denice Walter (not verified) on 07 Jul 2012 #permalink

I think we have the solution to the problem of getting the quackosphere to accept vaccines: Just call them nutritional supplements. They might be a little dubious about injected vaccines, but nutrition is sometimes supplied via IV.

By Joseph Hertzlinger (not verified) on 07 Jul 2012 #permalink

Finally, cow are being fed corn nationwide

While this is literally true, I think it deserves some qualification. Feeder cattle are mostly not raised on grain but finished on it (partially), typically for three or four months.

I guess that manure should be used after a long drying session (the more it’s dried, the less pathogen are found) but in the case of mega-farms, it might not be possible and this is something they have to dispose off.

CAFO manure management is probably as tightly tuned as the rest of the operation. It's smaller operations that seem to be the source of most such problems. The Purdue Extension has a number of articles on the general topic; see Manure and Pathogens. (Like the bulk of ag extension publications, it's not an in-depth piece, but it is referenced, including the MMWR cider reference.)

I also found this vegan-visits-a-feedlot piece interesting the last time I was thinking about the subject. (The timings suggest that this is a calf-fed operation.)

Thanks Narad for the link, I'll collect them and present them in class.

A.L.

By Autistic Lurker (not verified) on 07 Jul 2012 #permalink

@narad that is probably the best article written by a vegan about feedlots and raising cattle ever. No bias really shows through unlike a majority of these types of articles and a former roomate of mine.

By Matt ford (not verified) on 07 Jul 2012 #permalink

@Matt ford: Yah. I do in fact restrict myself to non-CAFO beef, but in terms of humane raising, it's the meat that's probably of least concern. (As opposed to the separate issue of abattoirs; I abandoned all kosher meat after the Rubashkin/Agriprocessors debacle.) I can get reasonably priced pork that I'm comfortable with, but poultry is fiendishly difficult and expensive.

@Narad - if you were near me and willing to butcher your own I could probably get you four or five cockerels a year relatively cheaply. With a 50/50 hatch rate you just end up with too many roosters.

@Mrs Woo, how about roasting some capon?

@Narad: There is no problem with that. When I still living with my family our meat always came from market projects at our local county fair. In my experience it always seemed to taste better. It just pisses me off when someone writes about the ah industry who doesn't know the first thing about it. honestly there are things to criticize they just always focus on something out of the park, or animal rights, though welfare has greatly improved in the last 30yrs.

By Matt ford (not verified) on 08 Jul 2012 #permalink

if you were near me and willing to butcher your own I could probably get you four or five cockerels a year relatively cheaply.

I've got Jacques Pépin's The Art of Cooking, which has detailed photo instructions under the entry "How to Eviscerate a Poultry" (illustrated on a woodcock; remember, if the plate isn't garnished with the split head, you can't be sure it's really woodcock that you're getting). I think I'd have to be made of sterner stuff.

Bad poet: capon makes me queasy; I'm okay with castrating animals to make them biddable and increase their size before slaughter, but only ones with external gonads. The process for castrating a chicken is not only labor-intensive, it's kinda freaky. (Basically, abdominal surgery performed in a farmyard.) I'd rather take the cockerels as-is and make coq-au-vin. ;-)

By Calli Arcale (not verified) on 08 Jul 2012 #permalink

...And this is why I buy my supplements (pretty much limited to vitamins) from the grocery store and even then stick to well-known brands or the store-brand equivalents thereof. When you buy froma fly-by-night MLM get-up, you don't know what you're gonna get, and you've wasted your money to boot. Buyer definitely beware!

@Bad poet - what Calli said. That and I don't like to inflict pain on any animal unless it is necessary. Someone on one of the chicken information boards I regularly read actually advocated caponizing all cockerels that were not going to be used for breeding purposes. I would rather have them in "bachelor quarters" (when they have no hens to compete for, roosters very rarely fight once the original pecking order is established).

I said "butcher your own" for that matter because I can't bring myself to kill any of them!

@Calli - a chicken keeping book I have tells you how to clear an impacted crop if the less invasive methods fail and it pretty much tells you to perform surgery on the poor things without anesthetic - cut open the side of the neck where the crop is, cut into the crop, expel the impaction, then sew them back together!

None of my chickens have had to have that done yet, and if they do I think I'm going to be incredibly grateful that the closest vet deals with birds, too. I don't mind healing up an injury and taking care of that kind of thing, but deliberately cutting open my bird would be an option of last resort!