Supplement Brands Not All Equal

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Some brands of vitamins, herbs and food supplements do not contain exactly what they advertise. It has been this way for at least 30 years that I know of, and it has probably been this way much longer than that. Unfortunately, it appears we will continue to have supplements on the market that do not contain exactly what they advertise.

Pointing this out was one of my main objectives when I wrote this Glucosamine article. However, some readers felt that article was biased in favor of one particular brand. The reason I named a specific brand that works well is because I tried many brands that do not work at all. The brand of supplement you purchase can make all the difference. Below is another example.

About two weeks ago ConsumerLab.com updated its review of garlic supplements. They found that almost half of all the garlic supplements they tested failed their test (subscription). Here is a summary of what they found.

Garlic supplements are one of the most popular herbal products in the U.S. Garlic may help lower cholesterol and high blood pressure, slow the development of atherosclerosis, and aid other conditions.

But testing by ConsumerLab.com found one product without any of a key garlic compound and another had less than 1% of the expected amount of this compound. Other products claiming "high potency" were actually low potency. Two products were contaminated with lead. In all, 8 [of 17] products failed testing.

This situation is not restricted to glucosamine or garlic. I was recently reading about melatonin and saw palmetto. Again, ConsumerLab.com found products that did not meet potency and safety standards. Again, there was a brand that contained lead! How upset would you be if you found that you had spent all that money on a supplement that was supposed to be good for you but in actuality was doing you harm!? Please educate yourself so you can avoid this fate. I will continue to point out differences among brands that I am aware of.

Lack of advertised potency and contamination are problems that affect almost every type of nutritional supplement available. Do you know the full story behind L-Tryptophan? That is an example where choosing the correct brand was a life and death choice and where the problem was one of contamination. (L-Tryptophan is not on the market now, but the problem was not L-Tryptophan, it was contaminated product produced by a single manufacturer, Showa Denko.)

As if potential contamination were not enough, many supplements lack the correct ingredients or advertised potency — despite claims on the packages guaranteeing potency and quality.

This year the National Institute of Standards and Technology (NIST) issued the first suite of Standard Reference Materials (SRMs) in a planned series of reference materials for botanical dietary supplements. This is one good step, but the fact of the matter is that these NIST reference materials were designed to test only one botanical product out of over 29,000 total products available in the dietary supplement industry. Furthermore, the product targeted (ephedra) is not even on the market any longer. That shows how far we still have to go.

You can find more information here: National Institutes of Health Statement on Dietary Supplement Standards

Finally, I am going to reproduce the full statement from one supplement manufacturer (ViTal NUTRIENTS) discussing problems with certified potency. I am not endorsing this manufacturer. I am only listing them by name because I have to give credit for the material I am reproducing below. I believe this is an accurate description of the current problems, but I also believe there are other more widely available supplement brands that measure up to acceptable quality standards and even exceed those listed by ViTal. In fact, if you read my article on Ranking the Safety of Nutritional Supplements, you know I am not a big fan of the standardized potency "fad" in herbal products that ViTal builds its quality strategy around. Simply using a TLC fingerprint and HPLC assay, as described below, is still a long way from being "bullet proof" as ViTal claims. In fact, I'll go ahead and make this a really long article. After the material from ViTal NUTRIENTS, I will share come statements on quality from another manufacturer that I think goes one step further in the right direction.

LABORATORY TESTING PROCEDURES AND STANDARDS

By Enrico Liva, N.D., RPh
President of ViTal NUTRIENTS

As the public and the professional community make greater use of natural products for general wellness, prevention, and the treatment of disease, the quality assurance of natural products has received greater scrutiny. It is important to know that the brunt of that scrutiny ultimately falls upon the commercial natural products testing laboratory.

Manufacturers make product and distributors sell those products. The company that encapsulates or tablets the product is the last one to verify quality assurance before the product gets to the consumer. The only resource the encapsulating or tableting company has to prove the veracity of the product is to use an in-house lab or a commercial contract lab that tests natural products.

The bad news is that the commercial natural products contract lab industry is completely unregulated. The good news is having a good working knowledge of laboratory testing and knowing what questions to ask and when, greatly increases your chances of getting accurate results using ethical and scientifically valid methods of testing.

Current State of the Natural Products Contract Lab Industry

You cab start a lab in your basement or garage, with poorly trained personnel and testing equipment that is poorly maintained. A nice brochure, a good marketing campaign and reasonable prices may be all it takes to get a foothold in the market place. No license is necessary to open a lab. No inspection is required by any government agency. There is no requirement to follow any set of rules, guidelines or quality standards. In short, each lab can do as they please.

Dry Labbing

The unfortunate news in this laboratory industry is a phenomenon called dry labbing. This is where a lab claims to actually perform the requested test but it really does not. They make up the desired result and give it to the customer. The customer has no clue the test was never performed.

It is important to know about dry labbing and how to read a laboratory test (particularly if you are an encapsulating or tableting manufacturer), because some results are scientifically impossible to obtain.

Dry labbing is probably not wide spread, but it does occur. If you are the buyer of lab services testing natural products or you scrutinize lab test data, it is important to know how to discern what is scientifically valid verses accepting a lab result at face value.

FDA Certified and FDA Inspected

Some manufacturers claim that their products are tested by FDA certified labs. THE FDA does not certify labs or manufacturing operations. They do inspect labs that are testing pharmaceuticals and over the counter drugs (OTC's), but they do not inspect contract labs testing natural products.

If a lab is set up to test pharmaceuticals, OTC's, and natural products, one could make the assumption that the same level of quality and rigor applied to the drug side of the lab carries over to the natural products division. However, when FDA inspects such a lab, they focus their attention on the pharmaceutical and OTC drug side and ignore the natural products side.

GLP's and GLP Audits

GLP stands for good laboratory practices. This is a set of guidelines that if followed will go a long way to assure overall quality practices in a lab. Labs are not required to follow them. Some do, some don't, and all of them should. If a lab does, they can be independently audited for compliance with GLP's. Successful completion of an independent GLP audit is one way to gain confidence in a lab.

Testing Methods

Let's make the assumption that a lab has adequately trained personnel, well-maintained instruments and chemicals, follows GLP's, and successfully passes a GLP audit. The most important and major factor determining accurate lab results is the method used to test the product. The method is like a recipe. It governs sample preparation, chemicals used, instrumentation, timing, etc.

One of the major problems in the natural products testing industry is the fact that there are very few universally accepted proven methods for all labs to use. Labs make up their own methods or use methods provided by the maker of the product or industry groups. While this is not necessarily always bad, it makes for the possibility of a huge discrepancy in results coming from various labs.

The FDA and private groups are working toward method standardization, but this is not going to happen soon. In the meantime, it is up to the person requesting the test to scrutinize the scientific validity of the method the lab will use.

Reference Standards

Assuming we have a scientifically valid method, obtaining an accurate lab result is equally dependant upon the reference standard that is used to test the sample against. A lab can have a great method and use a poor standard, which produces an inaccurate result, either high or low.

Ideally a lab would only buy guarantee potency reference standards. The information accompanying the standard should state the percentage of purity and identify the impurities. Upon receipt of the standard, the lab would have a valid method in place to test and verify the potency of the standard. This is necessary because many commercially available reference standards vary in potency despite claiming a specific potency.

Once the potency is verified, the standard should be stored adequately, an expiration date assigned and a schedule of testing instituted to verify continued potency. It is critical to inquire about the standard used to test natural product. Failure to do so may lead to an unacceptable, inaccurate result.


Validation of Analytical Methods for Analyses of Nutraceuticals

Once a testing method is developed, it has to be validated. Validation is the proof that a method is suitable for its purposes, is reproducible and shows that it is able to accurately determine the level(s) of analyses of interest in the product.

According to the FDA, all products sold to consumers (pharmaceutical and nutritional) must meet label claim. The FDA position on validation is that any method used to determine if a product meets label claims must be validated. The FDA, USP and other scientific groups have published guidelines for validating a method.

If a contract lab uses an in house method (a method they developed) or a method from another source, it should validated following either FDA guidelines or another reputable guideline. If the method used has not been validated, it greatly increases the likelihood of obtaining inaccurate results.

A Quality Lab

In choosing a laboratory, it is important that they meet some of the following criteria:

1) The lab should follow GLP's.

2) The lab should have successfully passed an independent audit for GLP's, following good methods that have been validated using the FDA validation guidelines or another acceptable guideline.

3) They should buy guaranteed potency standards, and test them to verify potency.

Quality Assurance Testing of Hypericum perforatum (St. John's Wort)

The majority of Hypericum extract on the market is standardized to 0.3% Hypericin. The most widely used method to test the Hypericin level is an Ultra Violet Spectrophotometric or UV method.

UV Method: This method has been more or less accepted as the industry standard for quality assurance testing of Hypericum extract 0.3%. Essentially this method checks for a certain color (Hypericins fluoresce red) at a specific wavelength and does not distinguish total Hypericin content. The method is woefully inadequate for 3 reasons. First, it does not guarantee you have the right plant. Only microscopic examination of the plant or TLC (thin layer chromatography) will assure correct genus and species. Second, you could easily manipulate this test with very poor quality Hypericin extract and spiking it with the correct amount of red dye. Third, in addition to Hypericin(s) being counted by the UV method there are other substitutes in the plant material that get counted along with it, thus inflating the value of the total Hypericin count. The method cannot distinguish between Hypericin and these other similar substances.(1)

HPLC Method: This method also does not completely authenticate genus and species but comes very close, because it does check specifically for Hypericin, Pseudohypericin and other Hypericins found in Hypericum perforatum. The total Hypericin yield via HPLC is 0.2%-0.25% vs. the inflated 0.3% Hypericin claim for the UV method. It is scientifically possible to fool the HPLC method, but it's difficult and not really worth the time, energy, and trouble to do so.

To authenticate this plant and its potency, a TLC fingerprint and HPLC assay would be performed. This would leave little or no room for poor quality raw material to slip by. In view of the fact that many contract manufacturers might not foot the bill for both tests, the HPLC assay should be performed at the very least. The UV method should pass into oblivion.

Quality Assurance Testing of Boswellia serrata

This fairly popular plant medicine has a similar quality assurance dilemma as Hypericum perforatum. Boswellia extract on the market is standardized to 60-80% Boswellic acids. The most widely used method to test the Boswellic acids is titration for organic acids.

Titration method: This method does not test for specific Boswellic acids at all, only organic acids. The raw material can easily be manipulated and spiked (with some organic acid) to pass, just like the Hypericum situation. It gives no real assurance of potency or correct plant genus and species.

HPLC Method: An HPLC method does exist that quantitates four specific Boswellic acids; beta Boswellic Acid, Acetyl-Beta Boswellic Acid, 11-Keto-Beta Boswellic Acid, and Acetyl-11-Keto-Beta Boswellic Acid. The total Boswellic acid content of raw material is usually around 25%. This is much less than the stated claim of 60-80% for the titration method.

To authenticate this plant and its potency, a TLC fingerprint and the HPLC assay for the four stated Boswellic acids would pretty much make it bulletproof. However, the HPLC assay may suffice as the four Boswellic acids are specific enough to the genus and species that it makes the TLC identification much less warranted.

As can be seen, regulation and validation of laboratory test methods is an arduous and difficult task. Finding a nutritional supplier that is dedicated and committed to finding honest laboratories, and producing high quality supplements is of utmost importance when choosing a nutritional supplier.

Reference

• Kurth PhD, Herman, Spreemann PhD, Ralf. Phytochemical Characterization of Various St. John's Wort Extracts. Advances In Therapy. Vol.15 #2, march/April 1998, pg. 117-128.

In the next section, I am not endorsing this company so much as suggesting that these particular quality claims represent the quality level we should seek in any and all supplements we take, regardless of who manufactures them. Please note the section on herbal intelligence.

Statement on Quality from Maharishi Ayurveda Products International (MAPI)

All Natural, Vegetarian & Tested For Heavy Metals
All our formulations are tested for heavy metals both at our facilities in India and again in USA. Our formulations are all-natural—they contain no artificial colors of flavors or excipients of any kind. Natural binders collected from the wild, such as gum arabic, are the only binders used in some formulas. All capsules are vegetarian, and the coatings on tablets are vegetable glycerin. No animal products are used in the formulas or during processing.

Stringent testing
Every batch of finished product undergoes a battery of tests at our state-of-the-art processing facility in India. These tests include examination for overall purity, heavy metals (lead, arsenic, cadmium and mercury), residual pesticides and biological contamination.

When the product arrives in the United States, it is once again subjected to a series of tests by a premier independent analytical laboratory before it is bottled for sale.

Quality certifications
The Maharishi Ayurveda manufacturing facility in India has earned a number of international quality certifications:

ISO 9001 - ISO certification is the international standard for assessing management, testing and manufacturing for production companies. The ISO review targets twenty quality categories including design control, production, storage, inspection and testing procedures. The stringent criteria used to evaluate Maharishi Ayurveda are the same as those used to assess nuclear power plants.

GMP - The Good Manufacturing Practices certification is awarded for manufacturing and delivering consistently effective, safe and reliable products batch after batch. An independent panel of experts conducts extensive investigations to verify that the company has established manufacturing systems and practices that ensure error-free, safe and consistently high quality products before this certification is issued.

HACCP - Hazard Analysis Critical Control Points requires a close focus on achieving step-by-step process quality at all stages of production identified as critical control points. The objective is to produce and deliver health-hazard free (i.e., clinically safe) products.

  • Ten Reasons to Choose Maharishi Ayurveda
  • Why You Can Trust The Safety Of MAPI - Comments on 15 Dec 05 JAMA Report [Safety problems are not limited to ayurvedic herbs, as I pointed out above. JAMA simply singled out ayurveda, but the problems can occur in any dietary supplement product - Ed.]
  • Herb Combining
  • Herb Processing
  • Independent Certification: ISO 9001, HACCP and GMP

    Herbal Intelligence

    Herbs contain the most concentrated form of nature's intelligence. Our goal is to preserve this natural intelligence through the harvesting and manufacturing processes so that the finished herbal preparations can work effectively at the deepest levels of the physiology.

    We harvest our own herbs. Herbs naturally vary in potency with seasons, cycles of the moon and even by the time of day. Following traditional harvesting and processing techniques ensures natural standardization of potency. Where possible without threatening the natural ecological balance, our herbs are gathered in the wild, because wild-crafted herbs can be as much as 100 times more potent than their cultivated counterparts.

    Experts in dravyaguna—plant identification—examine each batch of harvested herbs. It takes great attention and expertise to correctly identify herbs.

    Each batch of herbs is then sorted for quality. It's not unusual for over half the crop to be rejected, because ayurvedic standards for maturity, purity and potency are stringent. When the herbs enter the processing plant, they are also examined using HPLC (High Performance Liquid Chromatography) to chemically identify them and ensure potency.

    We use traditional methods of extraction and processing. Extracts are processed using steam distillation, never with alcohol or benzene. We do not expose herbs to high temperatures that can destroy the healing intelligence they possess.

    Our formulations are all-natural—they contain no artificial colors of flavors or excipients of any kind. Natural binders collected from the wild, such as gum arabic, are the only binders used in some formulas. All capsules are vegetarian, and the coatings on tablets are vegetable glycerin. No animal products are used in the formulas or during processing.