17 replies to this topic

[doug123]

News Source: Kentucky.com



Posted on Sun, Jun. 10, 2007
Tainted supplements raise regulation issue
FDA APPROVAL NOT NEEDED FOR PILLS MADE WITH LOW-COST INGREDIENTS
By Tony Pugh
MCCLATCHY NEWSPAPERS

The $22 billion dietary supplement industry operates with minimal oversight from the U.S. Food and Drug Administration, despite a history of suspect quality and safety. About one in four dietary supplements tested don't meet quality or safety standards, according to former FDA research scientist William Obermeyer, a co-founder of the independent testing firm ConsumerLab.com, which tests thousands of supplement products.

Some are tainted with pesticides, salmonella, glass, bacteria or heavy metals such as lead and cadmium. Others fail for a variety of reasons including a lack of ingredients, improper ingredients, failure to disintegrate properly and mislabeling.

Because manufacturers seek low-cost ingredients, Obermeyer said, it's a safe bet that some of the tainted products contain ingredients from China, which typically are cheaper.

Under a 1994 federal law, most dietary supplements -- vitamins, minerals, herbs, amino acids and other substances such as enzymes and metabolites, which are taken orally and intended to augment the diet -- don't need to be registered or approved by the FDA.

FDA inspections have found supplement manufacturing plants with pest infestations, defective equipment and pipes that leak liquid onto products.

But after more than 10 years of development, the FDA still hasn't set minimum standards for the safe manufacture of dietary supplements. Instead, manufacturers set their own standards. Because supplements are classified as food, they aren't regulated by the same strict guidelines that govern drugs. Supplement manufacturers are responsible for ensuring that their products are safe and include all the ingredients listed on the package label.

And like food manufacturers, supplement makers don't have to record, review or provide the FDA with reported injuries or illnesses that result from their products. Reporting is voluntary, although information typically is provided willingly. If safety, health or mislabeling problems develop, the FDA can restrict or remove a supplement from the market. Drugs, however, must be deemed safe and effective before they can be prescribed or sold.

China's emergence as a leading ingredient supplier for the supplement industry has raised new fears since a recent pet food scare was traced to adulterated Chinese wheat gluten. Earlier this year, a shipment of bacteria-contaminated vitamin A from China also was flagged before it could be added to infant formula in Europe. And the FDA will start testing toothpaste imported from China after a poisonous ingredient used in antifreeze was found in Chinese-made toothpaste in Panama.

Record requirements allow officials to track ingredients to the country and plant where they were manufactured. Supplement companies are urged to buy quality ingredients from reputable firms, whatever the country, said Judy Blatman, a spokeswoman for the Council for Responsible Nutrition, which represents supplement manufacturers and suppliers.

Consumer confidence was shaken in 2004 when the FDA banned the sale of dietary supplements containing ephedra, which caused tremors and heart palpitations and was cited as a factor in numerous deaths.

In February 1997, the FDA proposed mandatory rules outlining "good manufacturing practices" for the safe production of dietary supplements. But those rules still haven't been finalized.

Supplement makers argued that the proposals would cost the industry some $245 million a year, more than 10 times the FDA estimate. FDA spokeswoman Kimberly Rawlings would say only that the guidelines would be issued soon.

© 2007 Kentucky.com and wire service sources. All Rights Reserved. http://www.kentucky.com

[Athanasios]

Once I tainted one of my brothers supplements. He didn't know it and took it. Now I know that no matter what happens I will have the upper-hand. I know that he took a supplement that I tainted.

seriously though:
I have a question Adam. Have you personally had problems with this? I am just wondering because you follow the news on this issue closely.

[Shepard]

Once I tainted one of my brothers supplements. He didn't know it and took it. Now I know that no matter what happens I will have the upper-hand. I know that he took a supplement that I tainted.

I don't know if we're thinking of the same usage of the word "tainted", but damn, that would be horrible.

[health_nutty]

lol, You're killing me Chris.

[doug123]

I have a question Adam. Have you personally had problems with this? I am just wondering because you follow the news on this issue closely.

I am not sure. I must confess that I do generally try my very best to find the strongest sources of evidence to support any hypothesis I can, however. On most matters of human health, I start by gathering the opinions of licensed health care practitioners.

And after considering potential conflicts of interest, it seems the strongest evidence suggests that the law of supply and demand works in the dietary supplement market, just like any other!

Potentially related stories on this matter:

1. The Seattle Times: China corners vitamin market

2. The New York Times: From China to Panama, a Trail of Poisoned Medicine

3. US Pharmacist: The USP Dietary Supplement Verification Program: Helping Pharmacists and Consumers Select Dietary Supplements

Let me know if you -- or anyone else -- has any opinions, questions, thoughts, or comments on this matter.

Take care.

[Anthony_Loera]

It appears this all stems from the toothpaste deaths, so I'll add some stuff as well:

This is taken from a news source: ( http://www.insidebay...tar/ci_5995179)
"(Products with the issues use) Diethylene glycol. It is important as an industrial solvent as well as a major ingredient in antifreeze. But the poison has been mixed into a variety of medicines — cough syrup, fever medication, injectable drugs — because of counterfeiters who profit from substituting the sweet-tasting solvent for a safe, more expensive syrup, commonly used in drugs, food, toothpaste and other products."

From another source: (http://www.sge-ssn.c...tract_diezi.pdf )
"Diethylene glycol is mostly used as an industrial solvent and additive, and is not a normal constituent of alcoholic beverages. Its sweetness however was used to improve the taste of some cheap Austrian wines, and this illicit use was finally discovered in 1986. Apparently, no human health harm could be attributed to this adulteration. At higher doses, diethylene glycol may entail acute renal failure and other organ toxicity. Minimal human lethal amounts have been estimated at ca.1 ml/kg BW."


Not many supplement capsules are sweet tasting, but testing is a concern nonetheless.

RevGenetics is a member of the NPA, and I strongly ask more small businesses to become members of the NPA, and their 'TruLabel' (http://www.naturalpr...=ic_bg_trulabel) program. It allows them to test your products, and increase consumer confidence in your products.

Self-regulation works only if you buy products from a business that belongs to a group or association that tests your products. It doesn't work if you keep buying from folks that follow no rules. At this time we don't regulate foods, but if we did, instead of giving the consumer a choice to buy 'Farmer Joes Backyard Cow Milk' or 'MacArthur's Milk', we would simply destroy 'Farmer Joes' business, as he is likely small and would not be able to afford legally selling you his cow's milk anymore. his production would be so small that lab tests that would be required (if regulated) may simply eat up his profit and give him nothing to live on anymore.

He would have to sell his cow to MacArthur's at a discount, and get a job at a fast food joint.

Now if he was a part of an association who tests his milk, things would then be flipped around. He would have some profit to live on, and the public could have confidence in his cow's milk, and still be able to compete with MacArthur. (dont get me wrong, I love MacArthur's milk we buy, but it is rather expensive.)

This is one of those debates that can go on for a long time, but I think it is worth the effort to come to a good solution that will benefit consumers and small businesses.


Anthony Loera

[Brainbox]

Look at it this way. Manufacturing a product of outstanding quality is expensive. Proving that the quality is indeed outstanding using a statistically proven method makes it even more expensive. Regarding the possible benefit of supplements from China, do you think manufacturing supplements is labour intensive? So why are Chinese supplement products cheap?

Or am I just to narrow-minded?

Or do I use to many question marks? [lol]

[david ellis]

Brainbox, the Chinese are capitalists and understand the power of a monopoly. They are following the John D Rockefeller example. John D gave the Chinese oil lamps for free, then he sold them oil for the lamps. The Chinese monopoly of vitamin C has already allowed them to double the price of Vitamin C. I imagine they intend to repeat this success with many other supplements.

Anthony_Loera. small supplement companies should not pay for quality certification tests. So many tests would be expensive. You should require certifications from your suppliers. That would be much more efficient than many small supplement companies paying for testing the same product from the same company. If you could certify that your packaged supplements were made from manufacture tested and certified supplies you would be able to charge more.

I had a small experience of the tryptophan incident in the late 1980's. Something happened to the manufacturing process and 37 people died, 1500 were permanently disabled. No satisfactory explanations were ever made. My small experience is that I bought tryptophan then, used it one time and got an excruciating headache. So I never used it again, but I feel like it was a close call. There was a problem with the manufacturing process and about 1% of the delivered product was poisonous. I would pay more for certified supplements.


Link to more info on tryptophan incident

[Karomesis]

Look at it this way. Manufacturing a product of outstanding quality is expensive

it sure is. 350$ for 30g of NtBHA isn't cheap nor is 60$ for a months supply of Gerenovas mito gold but both are the best of the best.

cut corners on your car, housing, clothing, flat screen tv, but NEVER on supps when you an avoid it.


what do people think? that the stem cell treatments around the corner are going to be dirt cheap? like 99% of things in life, you get what you pay for. idiots go to Mexico to save a few thousandbucks and have horror stories to show for it....not smart. If you can't afford a qualified practitioner, stay ugly till you can afford it.

[Brainbox]

The Chinese monopoly of vitamin C has already allowed them to double the price of Vitamin C.  I imagine they intend to repeat this success with many other supplements.

Yes, I guess you're right on this being the long-term motivation. But for the short-term, I also guess that the Chinese are not investing (yet) in expensive quality assurance systems that would reduce short-term profit. They may have long-term goals but probably are not investing with only a long-term return in mind. Adam had a very informative post on this that I'm unable to find at the moment.

Furthermore, reputable western supplement companies are probably using these Chinese products, but being reputable, they will enhance the insufficient Chinese QC protocols with their own. Something a single customer or small company cannot afford. Testing a sample for heavy metals alone costs about 500$ or more.

I would like to hear the position of e.g. Anthony on this since I would like to be proven wrong.

Edit: I read he more or less already did this, but the question remains if in the current situation small companies can act in a sufficient proactive way by doing sufficient testing. Instead of reacting on customer feed-back?

[Anthony_Loera]

Anthony_Loera. small supplement companies should not pay for quality certification tests. So many tests would be expensive. You should require certifications from your suppliers. That would be much more efficient than many small supplement companies paying for testing the same product from the same company. If you could certify that your packaged supplements were made from manufacture tested and certified supplies you would be able to charge more.

Although we do have HPLC testing from our powder suppliers, most people would like to see 3rd party independent tests. Ask most folks on this board, I believe they would agree.

I believe trying to get together a group of buyers, that will split testing is the way to go.

Having said that, it is difficult to do sometimes as the small competitors are afraid to show others their "cards" even though they may paying a larger price when going at it alone. Ihe fact is that all of us small companies know where to get decent prices, those that think they are getting a better deal than myself are probably are wrong. I believe that, if we gather together we can get much better pricing, better response, pressure companies to our specs, and share the costs of the tests.

Customer feedback is important, I am always pleased to hear it myself even if it's a less than stellar perception about RevGenetics.

Coming back to China... in the past 8 months I have seen an increase in quality that I never had expected. The quality of the powder products has really had a remarkable change for the better.

Anthony Loera

[david ellis]

Anthony_Loera,

Although we do have HPLC testing from our powder suppliers, most people would like to see 3rd party independent tests. Ask most folks on this board, I believe they would agree.

I have a question, would HPLC testing have caught the bad tryptophan? I re-read the article and discovered that the problem was only .1% of the total. And the problem molecules were chemically related to tryptophan. My point is that quality is probably not as simple as one HPLC report.

Rather than expensive "after the fact" testing, I would prefer that everybody had defined processes with quality assurance tests built in to verify the processes. These procedures would be certified by an independent agency. That seems a long way off. But I am very disappointed so far in 3rd party testing. ConsumerLab does about one supplement a month, apparently not many of us are willing to put up the money required. One supplement a month doesn't begin to cover the need.

I am very pessimistic -I don't see how we can get to certified processes. And I don't see how we can get to high coverage 3rd party testing. Perhaps we are doomed to muddle along.

Karomesis/Brainbox

Look at it this way. Manufacturing a product of outstanding quality is expensive.

Equating expensive with quality is not always correct. The 37 people who died and the 1500 people who were disabled did not get hurt because they were buying cheap tryptophan. E-coli grows on both filet mignon and chuck steak. Throwing money around doesn't guarantee effectiveness or safety.

Toyota has proved outstanding quality can mean lower costs. Because a Toyota factory stops when a defect is found, two things happen. One, nobody wants to be responsible for stopping the factory so everybody takes their job seriously-and errors are very infrequent. Two, little money is spent on correcting errors, so production costs are very low.

[Anthony_Loera]

From the article:

"Showa Denko was allowed to sell the tryptophan produced in genetically engineered bacteria without safety testing because they and other companies had been selling tryptophan produced in non-genetically engineered bacteria for years without ill effects."

I see your point here, I don't think HPLC testing would have not caught the tryptophan produced in genetically engineered bacteria. But I am not sure if a 3rd party would not 'certify' this process in the short term if it appeared that the new process 'tryptophan' was found to be tryptophan through testing ...
(kind of like saying, you can test meat to be clean, and it will pass USDA inspections and be certified... but to test it specifically for "mad cow", that goes above and beyond what USDA normally tests for and it is only tested if the cow appears to be sick... )

This is a difficult one, and it is my understanding that it is not related to the recent toothpaste poisoning.

Anthony Loera

Edited by Anthony_Loera, 15 June 2007 - 01:24 PM.

[Brainbox]

Throwing money around doesn't guarantee effectiveness or safety.

Agreed. It's just an enabling factor that cannot take anything else for granted.

[david ellis]

Thanks Anthony for your quick and honest reply. I agree tryptophan is a different kind of error than the toothpaste problem. The toothpaste problem is the result of greed and incredible stupidity, and the blame does not lie entirely with the Chinese. Hopefully, we will see fewer and fewer "toothpaste" problems as communications improve. (The stuff was labeled "imitation glycerin" in Chinese and if the buyers had been able to read Chinese they might have noticed). And hopefully, if everybody, supplement manufacturers and compounders, start emphasizing control of process, a repeat of the tryptophan type of problem will also become less likely. The tryptophan error was very expensive to Showa Denko. And the rest of the supplement world noticed. Enterprise failure can be the reward for the unlucky who do not control their processes and quality. Supplements also carry a 3rd type of risk not yet mentioned. This is the risk that the supplement will have unintended consequence when used. Unfortunately in the current scheme of things, correction takes place after errors are made. Laissez faire economics is expensive to some.

Keep all of this in perspective. Supplements have been very safe, possibly not effective, but very safe. Especially compared to the pharmaceutical industry, which has thousands of deaths and injuries since the late 1980's. But even with recent safe history, we all have to be aware of the risks. And as the science has gotten better, and supplements are targeted at specific metabolic processes the risks are climbing to match the increased benefits promised.

[krillin]

I have a question, would HPLC testing have caught the bad tryptophan?  I re-read the article and discovered that the problem was only .1% of the total.  And the problem molecules were chemically related to tryptophan.  My point is that quality is probably not as simple as one HPLC report.

Since the contaminant(s) was dubbed "peak X" and since "peak X" shows up on HPLC, I think that HPLC testing would have caught it.

Adv Exp Med Biol. 1999;467:461-8.
Eosinophilia-myalgia syndrome case-associated contaminants in commercially available 5-hydroxytryptophan.
Klarskov K, Johnson KL, Benson LM, Gleich GJ, Naylor S.

Department of Biochemistry and Molecular Biology, Mayo Clinic, Rochester, MN 55905, USA.

Recently, 5-hydroxy-L-tryptophan (5-OHTrp) has been promoted as an alternative to banned L-tryptophan as a dietary supplement. It has been claimed to help alleviate obesity, insomnia, depression, and headaches. However, eosinophilia-myalgia syndrome (EMS)-like symptoms have also been associated with ingestion or exposure to 5-OHTrp. HPLC-UV analysis of EMS-implicated 5-OHTrp revealed the presence of peak X, described as case-implicated. We show that peak X is actually a family of contaminants with the same molecular weight (234 Da) and similar HPLC retention times. We also demonstrate that all eight samples of commercially available 5-OHTrp analyzed by HPLC-MS contained three or more contaminants of the peak X family. The significance of these findings is discussed.

PMID: 10721089

[david ellis]

Krillin-

Adv Exp Med Biol. 1999;467:461-8.  .....

Recently, 5-hydroxy-L-tryptophan (5-OHTrp) has been promoted as an alternative to banned L-tryptophan as a dietary supplement. It has been claimed to help alleviate obesity, insomnia, depression, and headaches. However, eosinophilia-myalgia syndrome (EMS)-like symptoms have also been associated with ingestion or exposure to 5-OHTrp.

Your link gave me a shock because it was dated 1999. 10 years after the deaths and injuries. I would have thought that safe tryptophan was a given after an event like that. So, I checked around some, and found a contrary opinion that didn't think much of the peak values found in the HPLC tests. Tryptophan because of its effect on serotonin is a direct competitor to many prescription drugs. I am guessing that has something to do with the dueling studies.

Toxicol Lett. 2004 Apr 15;150(1):111-22. Related Articles, Links
    Click here to read
    Safety of 5-hydroxy-L-tryptophan.

    Das YT, Bagchi M, Bagchi D, Preuss HG.

    ISSI Laboratories Inc., 515 Blue Ridge Avenue, Piscataway, NJ 08854, USA.

    5-Hydroxy-L-tryptophan (5-HTP) is the immediate precursor in the biosynthesis of 5-hydroxy-tryptamine (5-HT; serotonin) from the essential amino acid L-tryptophan (L-Trp). The use of L-Trp as a dietary supplement was discontinued in 1989 due to an outbreak of eosinophilia-myalgia syndrome (EMS) that was traced to a contaminated synthetic L-Trp from a single manufacturer. 5-HTP has since become a popular dietary supplement in lieu of the removal of L-Trp from the market. Because of its chemical and biochemical relationship to L-Trp, 5-HTP has been under vigilance by consumers, industry, academia and government for its safety. However, no definitive cases of toxicity have emerged despite the worldwide usage of 5-HTP for last 20 years, with the possible exception of one unresolved case of a Canadian woman. Extensive analyses of several sources of 5-HTP have shown no toxic contaminants similar to those associated with L-Trp, nor the presence of any other significant impurities. A minor chromatographic peak (peak X) reported in some 5-HTP samples lacks credibility due to chromatographic artifacts and infinitesimal concentrations, and has raised undue speculations concerning its chemistry and toxicity.

link

[mirian]

The Chinese monopoly of vitamin C has already allowed them to double the price of Vitamin C.

That's why I buy the best priced GMP vitamin C I could find. Only $4.29 for 250 capsules of 500mg:

http://www.swansonvi...null&Ntk=Level1