When I created my company Labrada Nutrition my main goal was (and continues to be) to produce the purest, result producing, supplements on the market. Doing so, requires a constant commitment to quality and lot of investment towards quality assurance. It baffles me how many other companies we test that simply do not have anywhere near the amount of ingredients that they claim to have. And some even have contaminants on their products! Thus, the fact that it is on the label for a lot of companies does not mean that it is in the product!
Recently, we introduced HICA MAX™ Muscle Growth Stimulator, and the results have been overwhelming– people are raving about how well it works! The success of HICA MAX™ is giving rise to the introduction of competing products that claim to have HICA in them. Buyer beware! Much of the HICA supplies that we have tested are NOT MEETING LABEL claim. Other suppliers are passing less costly leucine off as HICA!
Just to give you an example of how complex the process required to ensure top quality is. Here is an article that my good friend Damon Armani, who is a top expert in product testing and development, put together on the subject. Basically, you need to first ensure the quality of the raw material before you even begin to put your product together! Unfortunately, not everybody in the industry does this. However, you can rest assured that we are one of the companies that do!
Exploding the Myth that All Products Are Created Equal
Ensuring the quality of products that are produced and manufactured is anything but a straightforward task. It is extremely complex especially for naturally derived compounds whose “starting material” is subject to change due to exposure to moisture, air and light. A natural compound is similar to a moving target in that it requires competent analysis in order to make sure they hit their mark.
With the implementation of the new federal cGMP’s for manufacturing, a manufacturing facility must properly ID every batch of raw materials that enters its doors. This may be accomplished either with an “in-house” laboratory or a certified 3rd party analytical lab.
There are several steps that must be followed to properly identify the raw material before it can be released for use in the facility.
Below is an outline of the steps necessary to approve the material.
1. In-house or 3rd party lab will initially search for a monograph for the specified ingredient. If none is available then typically the lab will contact the supplier to see if they will provide the “method” they used to validate the material and which testing equipment was used. A “CofA” will accompany the raw material sample and provides necessary information, which identify’s the method used to identify the material. It is no longer acceptable to use the “CofA” alone unless the manufacturer has “verified” the raw material supplier. So the manufacturer is responsible for conducting a similar test to verify the identity (either in-house or through a 3rd party lab). In either event, the method must be established which includes “methods verification” in order to approve. 21CFR Part 111 requires the method to be “scientifically sound.” There are many ways to verify identity but not all of them are appropriate for all ingredients.
2. A “reference standard” must be correctly chosen and purchased from a chemical research laboratory. Once the sample has been received, it must be stored properly (and possibly have some preparation performed such as drying) and then will be used to test against the sample (or batch) that has been sent by the pre-approved vendor.
3. The “Identity Test” can then be performed following the method that has been established and using the equipment specified. A standard variance of either 2% (HPLC) or 5% (FTIR) for a material typically be specified which means that a correlation of 98% (HPLC) or 95% (FTIR) will need to be achieved in order to pass. A negative test is referred to as “OOS” (Out of Specification), which will typically trigger a retest to ensure the results. A positive test qualifies the material to be released for use in manufacturing.
It is important to note at this point that without proper ID testing, there is almost no way to determine what caused a “finished good” product test to not match the label claim of the product. That is also why the cGMP’s call for finished product testing that includes identity, strength, composition, quality, and purity BEFORE the product can be released for sale. Many of the manufacturers on the market are still not conducting any finished goods testing other than comparing a “fingerprint” of the last batch to the current batch. This does not address label accuracy, micro or heavy metal contamination, or shelf-life stability.
Finished goods testing becomes all the more important when one asks if the samples submitted for ID testing truly are representative of the entire shipment of raw material. Sampling is a complex process and one that is still in somewhat of a gray area. This is quite relevant given the fact that many suppliers of raw materials are, in fact, brokers. They obtain the material from a variety of sources and may mix all of this material into one lot. A sound sampling process will minimize the chances of missing an inferior or adulterated ingredient in the shipment.
Currently, there are many labs that are relying only on a C of A (from the supplier) to determine if the material they have received is correct. Additionally, many manufacturers are under the mistaken notion that matching a sample obtained from raw material suppliers to the sample or batch of raw materials received is a valid format for ID’ing materials. At a cGMP training seminar, the program administrator was asked his feeling on this sort of testing and he indicated that it was the same as not testing at all.
- Mollie Kober, an NSF consultant responded to an online QA regarding using C of A’s as noted below:
What is the best way to authenticate a suppliers Certificate of Analysis (COA)? What should I expect back from my supplier that will be acceptable?
Really, the only way to authenticate a supplier’s COA is to perform the tests listed on the COA and compare results. This is something that you would need to do—not the supplier, as the supplier has already provided you with the COA. If you do not have an in-house laboratory capable of performing this testing, then you can send a sample to an outside lab. The lab should provide you with a test report indicating the results and test method used.
Again, whether the test is performed in-house or by a 3rd party lab, you must ensure the proper method is being used with the proper equipment and with the proper standard.
Another issue with regard to having tests performed is called “dry-labbing” where a laboratory will request the results (typically by asking for a copy of a product label) and then provide the results that are being looked for without actually performing the test. So someone at the manufacturing facility must be skilled in identifying this type of scheme. Recently a raw material supplier from overseas had submitted a sample of their material to a 3rd party laboratory here in the US in order to provide support to the C ofA that they were supplying with the materials. A quick look at the test showed that the method they used was “analysis by Polarized Light Microscopy, which was compared to a standard purchased from Sigma.” The chemist reviewing this laboratory analysis quickly realized that a standard is not used as a reference for this sort of test. The test is designed only to measure optical rotation in order to determine which “isomer” it is. So a standard would not have been necessary. The manufacturer’s lab then conducted a test using FTIR with the exact standard specified and the material sample only tested out 48% vs. the 99% shown on the 3rd party lab assay!
So, we definitely have a case of “Buyer Beware,” as well as concern that you are not getting what you are paying for. Unfortunately it is apparent that most supplement companies just do not want to spend the money to provide adequate product quality assurance and would rather put the extra cash into the pockets of the owner(s) and stockholders. It is also equally apparent that when a product does not test out properly (as noted in Appendix A ), that manufacturers are now equally to blame in addition to violating federal laws designed to protect consumers.
Appendix A: ConsumerLab.com Quality Tests
2000: 25 Products (5 with chondroitin)
- 53% of chondroitin containing products failed
- Approx. 40% of failures had <10% label claim for chondroitin
2003: 49 Products (24 with chondroitin)
- 16% of chondroitin containing products failed
- 50% of failures no detectable levels of chondroitin
2007: 29 Products (18 with chondroitin)
- 39% of chondroitin containing products failed
- Approx. 60% of failures had <10% label claim for chondroitin
2009: 54 products (40 with chondroitin)
- 63% of failures no detectable levels of chondroitin
- Lead contamination in 3 glucosamine containing products
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