The laboratory notebook: answering important questions about quality.
Q. I am with a contract manufacturer that recently produced a multi-component supplement. I always have my products tested by an independent lab, and that lab issued an analytical report indicating that the product met specifications. My customer then sent samples to another lab, which reported that the product had an insufficient quantity of one ingredient. With a fight brewing, the customer's lab sent us details of the method of analysis used and provided the chromatogram. My lab refused to provide that material, saying it is "confidential." What do I do now?
A. We have discussed this matter before, and frankly, we are surprised
it still comes up (although we experience it from time to time). To be blunt, this problem exists because some in the industry permit it. You are now suffering the consequences.
The fundamental principal in analytical chemistry is that any reasonably competent analytical lab should be able to reproduce the analysis conducted by another lab. This is only possible if the other lab discloses the basic details of the analysis. By this we mean the instrumentation used (HPLC, GC, MS) and the parameter settings of the instrument. This information is generally provided in the source of the method, whether it is an official method of an organization (USP, AOAC) or a peer-reviewed paper, so providing that citation is generally sufficient. Merely providing a lab's internal designation ("analysis by Method 1234") is insufficient.
In the pharmaceutical world, this disclosure is an absolute must, and any lab skirting this principal would be out of business in no time flat. When we started testing supplements over 10 years ago we were shocked to discover that this disclosure was the exception, not the norm. Fortunately, with the increasing professionalism in the industry, most active labs now adhere to this principal of full disclosure. There are, however, still some holdouts.
The reason usually given for a refusal to disclose is that the information is "confidential." That's nonsense. There are a finite number of ways to test a nutritional supplement and experienced labs are familiar with them all. An assertion of "confidential information" is merely an excuse. Moreover, analytical methods used in commerce should be validated by other labs before they can be given any credence. Should someone really invent a unique analytical method it should not be used in commerce until it is validated by others.
Labs that refuse to disclose the methods used are really telling you that they lack the confidence to have their work checked by another. They refuse to disclose the most basic information to avoid scrutiny. As we have said in the past, if a lab is charging for an analysis it has a duty to disclose how that analysis was conducted.
Now let's review what you are and are not entitled to. While you are entitled to the basic details of the analysis, you are not entitled to the step-by-step protocol (what we fondly refer to as the "recipe") used. The reasons for this are two-fold. First, those step-by-step details could indeed contain confidential information enabling the lab to achieve consistent quality and/or speed of analysis that may set it apart from the competition. But more fundamentally, a reasonably competent lab does not need these details to duplicate the analysis.
Back to your question, you do indeed have a problem. Analytical chemistry is a science, and conflicting results can usually be resolved by adhering to basic scientific principals. When a lab refuses to disclose how its results were derived, that scientific discussion cannot occur. In our book, when a lab refuses to participate in a scientific discussion, that side loses.
A refusal to disclose an analytical method is not only unprofessional in our opinion, it also shows that the lab will not support its clients in a time of need. When you pay for an analysis you are paying not just for results, but for customer service, which includes an explanation of those results and future support if you require it after relying on the analysis.
This analytical problem can be eliminated tomorrow. If clients stop sending samples to labs that refuse to disclose, the problem would disappear. To avoid being placed in the losing position of our contract manufacturer, each of you should ask your lab to disclose the methods it is using to test your samples and you should ask for some chromatograms or comparable data to be sure your lab will supply them if needed. Better to find out now where you stand with your lab, instead of learning once it is too late.
Q. In your last column you mentioned that effective January 1, 2006, the amount of trans fat had to be added to nutritional fact panels on food products. I make an energy bar and heard that a new regulation will also require disclosure of allergens contained in foods. Please elaborate on this.
A. Let's start at the beginning. According to the FDA, about 2% of adults and 5% of children live with food allergies. Each year thousands of people visit the emergency room as a result of allergic reactions, and over 100 people die. Food allergic consumers depend upon the ingredient list on foods to decide whether or not they can eat them safely. This is not always an effective tactic, as there is no requirement to list these ingredients, let alone do so in a clear and consistent manner. That's all about to change.
Effective January 1, 2006, the Food Allergen Labeling and Consumer Protection Act of 2004 will require that eight major food groups accounting for over 90% of all food allergies must be clearly listed on the label. The "big eight" consists of milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat and soybeans.
Presumably, most manufacturers will know if a product contains any of these food groups and therefore will know if and what disclosures must be made. However, there are instances where an allergen may unintentionally find its way into a product. An example is a peanut-free product made in a plant where peanut-containing products are made. Fortunately, for these instances there are tests available to determine if a specific allergen is present.
Each allergen has its own test. In addition, there are tests that provide a "yes" or "no" and quantitative tests that provide approximately "how much." Most of these tests are enzyme-linked immunosorbent assays (ELISA). In short, first the protein of interest (let's say the peanut protein) is extracted from the sample. After some processing, the protein is added to antibody coated wells where the protein binds to the antibody. A second antibody which is enzyme labeled is added. This second antibody binds to the peanut protein. A substrate is then added and a color develops in the presence of the bound enzyme labeled antibody. This color change is used to determine the results.
This new law will require great care in manufacturing products where allergens are potentially present. Fortunately, we have the technology to confirm that the care taken was effective.
Robert Green is the president of Integrated Biomolecule Corporation. The IBC Labs division is a leader in the analytical testing of nutritional supplement raw materials and finished products and provides research, development, production and technical marketing services. The IBC Organics division conducts pharmaceutical research and development. Every other month he answers questions on quality issues in an easy-to-understand manner. He can be reached at 520-219-2900; Fax: 520-219-6090; E-mail: email@example.com; Website: www.integratedbiomolecule.com.
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|Title Annotation:||QUALITY FOCUS|
|Date:||Sep 1, 2005|
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