Contamination Crisis: Verifying the Safety of Imported Herbs
By Jim English
We have recently heard from several readers concerned about the growing problem with tainted products imported from China. While these problems are serious, (i.e., melamine in pet foods, diethylene glycol in toothpaste, antibiotics in fish, etc) there have been no recent reports of similar problems with herbal products. Still, we take product purity very seriously and view the current situation as an opportunity to address the issue as it relates to our formulas.
All Tango Advanced Nutrition formulas are manufactured to the highest standards and are guaranteed to be safe, effective and free of adulterants. Our formulas are processed in certified Good Manufacturing Practice (GMP) facilities and are thoroughly screened before receiving an export license.
Fig. 1. High Performance Liquid Chromatograph
Used to separate components using a variety of
chemical interactions between substances being analyzed.
Upon arrival in the US each formula must be cleared by US customs and released by the FDA before being forwarded to an American certified GMP facility for packaging. Finally, prior to assembly and packaging (i.e. encapsulation or tableting, bottling, safety seals, etc.), each formula again undergoes an additional panel of extensive testing in one of two certified ISO 17025 analytical laboratories to confirm that they match our specifications and Health and Safety Guidelines for potency and purity (Figures 1 and 2).
Fig. 2. Gas Chromatograph/Mass Spectrometer
Combines features of gas-liquid chromatography and mass
spectrometry to identify different substances.
Selecting Safe Products
To understand why we go to such lengths–and why our company is especially dedicated to quality control issues– requires some additional explanation.
Tango was founded on the basis of a unique relationship with leading herbal researchers affiliated with the Chinese Academy of Sciences in Beijing, China. Even as we drafted plans to form Tango in order to introduce several new breakthrough formulas developed by these gifted researchers, we were acutely aware of the need to address the serious issue of heavy metals, pesticides and pharmaceutical contaminants that often turn up in low-quality herbal formulas. Consequently, from the very beginning we were committed to ensuring that all of our formulas would be contaminant-free. To achieve this goal we implemented an extensive, multilayered product evaluation process a full two years before we introduced our first formula.
When considering a formula for evaluation we begin with a thorough check on the institutional source of the formula (i.e. National Academy of Sciences, Beijing, or the Academy of Traditional Medicine, Shanghai, etc), the source of the raw materials that serve as the foundation for the formulas, and most importantly, the developer of the formula (i.e. Dr. Dexin Yan, Vital Cell®, Herbal Boost® and ImmunoPhase®, Dr. Chuang, MetaPhase®, etc.).
This selection process is greatly aided by the fact that every formula we review is already approved for in use in Chinese hospitals, medical schools and teaching clinics. Strict adherence to this product screening process has resulted in access to a selection of complex herbal formulas designed by leading anti-aging scientists and researchers in China. In fact, all but one of our formula designers works with, or is affiliated with, the National Academy of Sciences in Beijing. The sole exception is Dr. Jake Fratkin, one of the most respected herbal researchers in the United States, and the formulator of our BronchoPhase® formula.
Analytical Testing
Once we select a formula for evaluation, the next step is to submit samples to an extensive battery of tests capable of detecting 600 potential contaminants and drugs, some of which have previously been found in imported and domestically produced supplements. Once the samples are cleared, they undergo further testing to assure that the formulas exceed FDA and United States Pharmacopeia (USP) limits for lead, cadmium, mercury and arsenic. All of these tests employ state-of-the-art atomic absorption and high-speed gas chromatography and mass spectrometry analysis to detect even the most minute levels of heavy metals, pharmaceuticals, chemicals and pesticides.
The final step in our selection process is to construct a sophisticated analytical “fingerprint” of each formula to verify that all future batches match for consistent ingredient composition and purity.
Clinical Validation
Once we are satisfied with the safety and composition of a formula we enter into the final, and in our opinion, most important stage of product evaluation – efficacy; i.e. does the formula really do what it’s supposed to do? This process, which takes anywhere from six months to more than a year, involves medical practitioners and clinics around the country who assist us in conducting in-clinic evaluations of each formula.
While comments and feedback from doctors and patients weigh heavily in this stage of the evaluation process, the most compelling factor in our final decision is demand: when the results are so clear that clinics and doctors begin to request larger quantities for their patients, we know we have a good formula. In the final analysis, our product selection process is driven by the pull of demand, rather than the push of marketing.
Ongoing Evaluation
This last phase of product evaluation marks the tipping point where we often decide to reject a candidate formula without further consideration. Regardless of the time and money invested to prepare a formula for clinical evaluation, if it isn’t demonstrably more effective than other formulas currently available from other sources, we close the books and move on to more promising candidates. For this reason, over the last four years we have evaluated, and rejected, dozens of formulas purported to support an array of health concerns ranging from prostate issues to Alzheimer’s disease and sleep disorders. Adherence to this standard is the reason why Tango offers such a limited number of formulas – only 9 at present.
At any given time we are actively evaluating anywhere from 6 to 10 promising formulas from the dozens submitted to us each year. Current candidates include formulas for people concerned with urinary incontinence, blood pressure, Alzheimer’s disease, rosacea, chronic constipation and gum disease. And while we have high hopes for each of these formulas, if even one survives our testing and verification process to eventually be included in our product line, we can take pride in knowing that we’ve done all we can for ourselves and our clients.
Jim English
President/CEO