"Our range of shampoos, including the product in question, was launched 10 years ago and has since been used by millions of customers worldwide. Not a single case of adverse effect has been reported to date.
"To address the issue of 1, 4 dioxane raised in the news report forwarded by you, we would like to briefly explain the presence of dioxane in shampoos.
"Most shampoos contain sodium laureth sulfate, a USFDA (United States Food and Drug Administration) recommended foaming agent that generates lather.
"1, 4 dioxane is a by-product of sodium laureth sulfate and present in small amounts in cosmetics, shampoos and many products on the market today. The USFDA has set a limit on 1,4-dioxane at 10ppm (parts per million) in approving glycerides and polyglycerides for use as excipients in products such as dietary supplements (which are ingested).
"Hence, it would be safe to use this limit as a benchmark for products like shampoos and cosmetics that are applied externally.
"The 1,4 dioxane content in Himalaya shampoos is well within the limits set by regulatory bodies. Our quality department ensures that 1,4 dioxane is present in very minute ppm concentration. Since dioxane is a volatile substance, it evaporates during application.
"Research by the FDA determined that 1,4-dioxane evaporates readily, further diminishing the already small amount available for skin absorption, even in products that remain on the skin for hours.
"A shampoo being a wash-off product, contact is limited to a few seconds. Hence, chances of this chemical being absorbed are highly unlikely. As mentioned, we ensure that 1,4 dioxane is present within permissible limits making our product safe for long-term administration.
"In addition, all our personal care products undergo rigorous quality tests and analysis before launch.
The raw material and ingredients used in our products are procured from certified and authentic suppliers who adhere to internationally approved cultivation guidelines and good agricultural practices.
"Himalaya follows a 'seed to shelf' policy, which ensures that we stay engaged in the entire process of product development - from raw material to finished product.
"Our herbs and finished products undergo several quality checks from chemical tests to High Performance Thin Layer Chromatographic (HPTLC) fingerprinting technique. This allows us to maintain batch to batch consistency and guarantee superior quality products.
"Please be assured that we adhere to very strict quality and safety norms for all our products, employing good manufacturing practices (GMPs) and earning ISO 9001:2000 certification for excellence in manufacturing.
"Our modern research and development centre ensures that each and every product undergoes extensive clinical studies. Often, the studies can take up to 10 years.
"These studies are conducted and the results published in leading Indian and international journals including European Journal of Clinical Pharmacology, Alternative Medicine, Asian Medical Journal, Phytotherapy Research, Phytomedicine, The Antiseptic and The Indian Practitioner. We have also conducted multiple toxicity and stability studies on all our products.
"Our anti-dandruff shampoo has been clinically tested by leading dermatologists for safety and efficacy. Results of this test have been published in The Antiseptic (2004; 201 (1), 5-8).
"The fact that we are present in more than 60 countries including the US, Singapore, Russia and Malaysia, should give you an idea of the kind of quality checks we perform on our products and our conformance with international protocols set by various regulatory bodies."
Dr S K Mitra
Executive Director, Research and Development, Himalaya Global Holdings
Copyright 2008 Gulf Daily News
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