In what appears to be yet another hole in the Food and Drug Administration’s safety network, ConsumerAffairs.Com has found illegal tubes of toothpaste, intended for sale in foreign countries, in U.S. discount stores.

Like over-the-counter medication, the great majority of toothpastes are subject to labeling requirements because they contain fluoride, a cavity-fighting ingredient that can be dangerous in high doses.

Because of this, only tubes that meet the FDA’s guidelines are allowed to be sold in the U.S. But a quick glance at seven Washington, D.C.-area discount and dollar stores found 17 tubes of toothpaste not intended for sale in the United States.

The finding coincides with reports that potentially deadly toothpaste manufactured in China was exported to Panama. The toothpaste contained a deadly chemical that is being blamed for 51 deaths in the Central American country.

Although ConsumerAffairs.Com did not find the same toothpastes that were shipped to Panama, we did discover Chinese-manufactured toothpastes that are not intended to be sold in the U.S.

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

No Comment

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.

No Drug Facts

None of the foreign-manufactured tubes of toothpaste met the FDA’s labeling requirements. Two tubes didn’t list any ingredients at all.

Although many of the tubes ConsumerAffairs.Com discovered appear to be safe and most met the FDA’s fluoride requirement, it can be difficult to tell since much of the packaging is not written in English.

American Brands

Familiar American brands such as Colgate and Crest manufacture many of the foreign tubes discovered.

“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.

Crest ignored our inquiry and did not return two phone calls and two e-mails.

Although many of the illegal toothpastes were limited to small local discount stores, one chain, National Wholesale Liquidators, had a dozen different kinds of illegal tubes for sale. National Wholesale Liquidators did not return two e-mails. Repeated phone calls to the phone number on the company’s website were not answered.

Castro said consumers should ensure that the toothpaste has the “drug facts” labeling before they buy it.

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