Fluoride Action Network

FDA Bans Toothpaste from China after 51 Deaths in Panama

Source: ConsumerAffairs.Com | May 24th, 2007 | By Joseph S. Enoch

The Food and Drug Administration said it is blocking all shipments of toothpaste from China after 51 Panamanians apparently died after brushing with poisonous toothpaste from China.

However, a ConsumerAffairs.Com investigation reveals the FDA’s action may be too little too late and that importers still may be able to sneak tubes past FDA inspectors.

ConsumerAffairs.Com recently discovered illegal tubes of toothpaste being sold in discount stores in the Washington, D.C. area.

The tubes were manufactured in other countries and not intended for sale in the U.S. We found 17 different tubes of all makes being illegally imported from countries such as India, Peru, South Africa, Thailand and China.

Although most of the tubes appear safe for use, none of them followed the FDA’s fluoride toothpaste labeling requirements. Two tubes didn’t even list all the ingredients.

The FDA is focusing on the issue after Panama discovered diethylene glycol, a potentially dangerous chemical used in antifreeze, in tubes branded “Mr. Cool” and “Excel.”

These efforts will not affect major brands such as Crest and Colgate as their U.S. products are made in the U.S. However, many of the illegal tubes we discovered were Crest and Colgate, manufactured overseas and illegally imported. Although the Crest and Colgate tubes failed the FDA’s labeling requirements, they all contained the FDA’s fluoride dosage requirement, making them safe for use.

“Regardless of the country where we manufacture it, Colgate toothpaste is made in strict adherence to our global safety and quality standards,” Colgate spokesman Tom Paolella wrote in an e-mail.

The FDA’s increased scrutiny will likely be aimed at knock-off brands.

The one illegal tube of toothpaste we discovered from China is called “Classic” and is packaged in colors and a font similar to that found on Crest products. It does not contain diethylene glycol, but appears to be many years old and does not have the correct labeling.

When shopping at discount stores, consumers should ensure the product has the drug facts labeling that includes: a list of active ingredients, a description of the product’s use, warnings, directions, a list of inactive ingredients and a toll-free phone number.

FDA’s Problems

The toothpaste alert follows Congressional and Government Accountability Office charges that the FDA is not doing enough to protect American citizens from dangerous foods and drugs.

While FDA spokeswoman Veronica Castro did confirm that it was in fact illegal for those tubes of toothpaste to be sold in the U.S., the agency’s spokespeople, including Castro, refused to say whether the manufacturer, distributor, importer or store would be held legally liable.

Agency spokespeople also refused to say what penalties might be applied and how the tubes made it past the FDA’s import inspectors. Agency spokespeople then refused to say why they refused to comment.

Fluoride a Concern

The primary concern with foreign toothpastes is the level of fluoride.

Much of the water consumed in the U.S. is fluoridated, according to the Centers for Disease Control. But in many other countries, particularly poorer countries, there is limited or no fluoridation. Because of that, individual countries may require more fluoride in their toothpaste – a recipe that could be detrimental for Americans.

Fluoride can be found naturally and artificially in many of the products consumers eat and drink everyday and generally, those levels of fluoride are considered safe for the body and healthy for teeth, Lydia Hall, American Dental Association spokeswoman, said.

But too much fluoride can lead to fluorosis, Castro wrote in an e-mail. Fluorosis usually afflicts infants and children. It destroys enamel and gums. In severe cases, which are very rare in the U.S., it can lead to a crippling skeletal breakdown in both children and adults.

The FDA requires that fluoride toothpaste manufacturers include a list of active ingredients, a description of the product’s use, warnings, directions, a list of inactive ingredients and a toll-free phone number. These “drug facts” requirements are identical to those found on the back of any over-the-counter medication, Castro wrote.