FDA faces lawsuit for 'withholding' Total Colgate approval records

By Michelle Yeomans

- Last updated on GMT

FDA faces lawsuit for 'withholding' Total Colgate approval records

Related tags Hand sanitizer Triclosan

The Natural Resources Defense Council has filed suit against the Food and Drug Administration for allegedly failing to provide the full records of it's approval of Colgate Total back in 1997.

The filing at the Manhattan Federal Court reveals the environmental group to have requested the FDA’s records of its' '97 approval of the toothpaste last December, but had yet to receive all the information requested.

The NRDC says it is looking for the records to establish the possible health hazards of triclosan, which was used in the toothpaste.

"Scientific studies have linked triclosan to multiple health hazards​, including disrupting hormones that regulate brain and reproductive functions,​" the complaint states.

According to the group, because the FDA has only given it an edited version of its' records to date, it has therefore violated the Freedom of Information Act.

When Cosmetics Design contacted the Administration's officials to get a better insight into the matter, media rep Andrea Fischer only responded to state that they "cannot comment on pending or on-going litigation".

FDA has moved to govern triclosan…

This publication only just reported yesterday that the FDA had agreed to issue a new rule governing the use of the antimicrobial agent by 2016, a decision that's been in the making since 1978.

After 35 years of looking into Triclosan, the Authority has signed a new court agreement with the Natural Resources Defence Council to govern its' use in the industry.

The substance has been at the centre of many industry debates over the decades in regards to its safety, with some calling for it to be completely banned from products.

However; refusing to be rushed in its efforts, the Administration continued to state that it was still "too early to make a final judgement​" right up until 2010.

Substance at the centre of the debate

Triclosan first appeared in the 1960s as an anti-bacterial agent designed to slow or stop the growth of bacteria, fungi and mildew.

The ingredient has since become popular for personal care products that incorporate anti-bacterial agents, particularly liquid soap hand sanitizers, as well as toothpaste, deodorants and cosmetics, and is also used extensively in medical environments.

Previous research that has focused on the effects of triclosan on the environment have shown that it enters waterways such as streams and rivers through domestic wastewater, leaks in sewer systems and sewer overflows, causing damage to the environment.

Related topics Regulation & Safety

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