Background
In late May 2007, several countries such as Panama, Dominican Republic, U.S. and Singapore have found contaminated Chinese dental products. In June, the U.S. Food and Drug Administration (FDA) warned consumers to avoid using tubes of toothpaste labeled “Made in China,” and issued an import alert to prevent toothpaste containing diethylene glycol (DEG) from entering the U.S.

FDA Increases Scrutiny and Issues Information for Industry
The FDA increased its scrutiny and began sampling toothpaste and other dental products manufactured in China. The highest level found was between 3-4% DEG by weight.

In May, the FDA issued a guidance to industry recommending methods of testing glycerin and other controls to identify any contamination with DEG before use in the manufacture or preparation of pharmaceutical products. In June, the FDA published information on test methods specifically for toothpaste, entitled, Gas Chromatography - Mass Spectrometry (GC-MS) Screening Procedure for the Presence of Diethylene Glycol and Ethylene Glycol in Toothpaste.

About DEG
DEG is used in antifreeze and as a solvent. It is also illegally used as counterfeit glycerin in some nations and sold internationally as a component of cough syrup and toothpaste. DEG is toxic to humans and animals. Because of its toxicity, it is not allowed for food and drugs. The U.S. CFR allows no more than 0.2% of diethylene glycol in polyethylene glycol when the latter is used as a food additive.

The FDA is concerned about potential risks from chronic exposure to DEG and exposure to DEG in certain populations, such as children and individuals with kidney or liver disease. DEG in toothpaste has a low but meaningful risk of toxicity and injury to these populations. Toothpaste is not intended to be swallowed, but the agency is concerned about unintentional swallowing or ingestion of toothpaste containing DEG.

Bureau Veritas an Industry Leader in Health, Beauty, Household & Food Testing

With experienced technical professionals in the area of health, beauty, household, and food testing and quality, we are committed to assisting industry in testing for the presence and percentage of DEG in toothpaste and other dental products. We can test using FDA recommendations and methods to determine if DEG is present in your product.

Our testing services are just one method in which we can help you deliver compliant and reliable products to market. By examining the various points in your supply chain, we can further help you assess and maintain product quality throughout the lifecycle of your product.     

Taking Proactive and Preventive Steps

Implementing the right services at the right point along the supply
chain can dramatically increase the effectiveness of a quality assurance program. As the marketplace continues to evolve and shift, it is important to re-evaluate your current program against the regulatory and industry changes taking place today.

With years of experience, a strong reputation and a full  understanding of the retail marketplace, we are ready to help you get through existing and future challenges to protect your company’s most important asset –  your brand. We offer a variety of solutions and services throughout the supply chain. Please call your program manager or contact our nearest location to discuss how we can help you.

Contact Information
Please contact your local customer service representative or the Bureau Veritas office in:

Americas: info@us.bureauveritas.com
Europe: info@us.bureauveritas.com
Asia: marketingmail@hk.bureauveritas.com

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Bureau Veritas Consumer Products Services, Inc. (“BVCPS”) provides the information in this client bulletin as a resource of general information.  It does not replace any applicable legal or regulatory requirements and is provided “as is.”  BVCPS will not be liable for any indirect, special, punitive, consequential or other damages (including without limitation lost profits) of any kind in connection with this client bulletin.  BVCPS DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, IN CONNECTION WITH THIS CLIENT BULLETIN.

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