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Updated health warning issued under Section 98 of the Medicines Act - Diethylene Glycol in toothpastes

The Director-General of Health today issued an update to the earlier warnings not to use certain brands of toothpaste because they may contain the toxic substance diethylene glycol.

The Director-General warns consumers not to use the toothpastes listed below because testing has shown they contain diethylene glycol. Diethylene glycol may cause harm in some people, in particular, young children or those with liver or kidney disease.

These toothpastes have been sold through specialty stores and discount chain stores. The products should no longer be on sale as retailers and distributors were requested to stop selling them whilst the Medsafe investigation was carried out.

On behalf of Medsafe, the Institute of Environmental Science and Research (ESR) has tested a total of 52 toothpaste products believed to have been manufactured in China - 16 of these have been found to contain unacceptable levels of diethylene glycol.

Products identified as containing diethylene glycol in New Zealand include:

Toothpaste name, description and size	Content of diethylene glycol
Excel 120g	2.45%
Maxam 120g	10.60%
Evafresh 90g	10.80%
Tian Qi in Green/Yellow pack 105g	2.70%
Hei Mei Cpp 160g	3.85%
Hei Mei Cpp 105g	4.07%
Hei Mei with Green/Yellow pack 160g	4.31%
Hei Mei with Green/Yellow pack 105g (2 samples)	4.25%, 4.30%
Mr Cool 120g	6.38%
Mr Fresh 120g	6.35%
Dr Cool 120g	3.92%
Smile 2 120g	3.99%
Crescent 181g	3.49%
Hei Mei in yellow pack with monkey detail 42g	2.43%
Hei Mei in green pack 160g	4.56%
Tri Leaf Spearmint 145g	11.83%

Consumers should contact Medsafe if any of these products are found to be on sale.

Photos of the products identified above are available on the Medsafe website at www.medsafe.govt.nz/hot/alerts/ChineseToothpaste/DGStatement.asp#photos

The media release sent out on 14 June on this same issue is available at www.medsafe.govt.nz/hot/alerts/Excel/DGStatement.asp

The media release sent out on 20 June on this same issue is available at
www.medsafe.govt.nz/hot/alerts/DrCool/DGStatement.asp

ENDS
Michael Flyger
Media Advisor
Ministry of Health
Ph: 04 496 2265
Mobile: 0274 346 878

Questions and Answers

What symptoms may be associated with consuming Diethylene Glycol?

Consuming diethylene glycol in toothpastes could cause harm in some people, in particular, young children and those with liver or kidney disease. Its use at high doses in pharmaceuticals has been linked to a number of deaths. Symptoms associated with consuming diethylene glycol may include: nausea, vomiting, headache. Symptoms of moderate exposure include: lethargy, weakness, inebriation, severe gastrointestinal symptoms and low urine output. Severe exposure can lead to liver, blood and kidney disorders, seizure and coma.

Have these products been removed from sale?

The toothpastes on the list have been removed from sale by the distributors identified during the investigation, however, it is possible that other distributors may still be selling these products. Consumers should contact Medsafe if any of the listed products are found to be on sale.

Other, as yet unidentified products may be on sale. Consumers are advised not to use toothpastes labeled as containing diethylene glycol and to report any found to be on sale to Medsafe for further action.

If a consumer is using one of these products what should they do?

Consumers should immediately stop using these products and seek medical advice from their doctor if they are or have felt unwell when using the products. There is no reliable information about how many people have used these products. Consumers can also report any concerns to Medsafe, for contact details please see: www.medsafe.govt.nz/other/contact.asp.

Consumers should be aware that some toothpastes contain the substance polyethylene glycol which, despite its similar-sounding name, is not regarded as toxic and is an acceptable ingredient in toothpastes.

Important advice to importers, distributors and retailers

Products for sale must be of a quality suitable for the purpose and must not contain potentially harmful substances.

All importers, retailers and distributors should check whether their products contain fluoride. Toothpastes containing fluoride or for which a therapeutic purpose is claimed must go through an assessment by Medsafe before they can be legally marketed in New Zealand. Products that have not gone through this process should be withdrawn from the market immediately. Selling a fluoride-containing toothpaste prior to approval is an offence for which the penalty on conviction is a fine of up to $100,000 for a body corporate or a fine of up to $20,000 or imprisonment for up to 6 months for an individual.

All importers, distributors and retailers involved in the supply of toothpastes that do not contain fluoride or claim a therapeutic purpose should urgently check that their products comply with the Enivironmental Risk Management Authority's 'Group Standard for Cosmetic Products'.

It is important to note that diethylene glycol may not be listed on the label and its absence from the label may not mean that that it is not an ingredient in the product so information should be sought from the manufacturer. Testing in New Zealand is advisable to ensure the toothpastes comply with the requirements. Medsafe can provide information on where toothpastes can be tested.

Further information

Information on the toothpaste brands identified in the US as containing diethylene glycol can be obtained from http://www.fda.gov/oc/opacom/hottopics/toothpaste.html#products

Information on the toothpaste brands identified in Canada as containing diethylene glycol can be obtained from
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/2007/2007_80_e.html