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FDA action on anti-bacterial handwashes

You may have read reports in the media about a recent decision by the Food & Drug Administration (FDA) in the US that Over-the-Counter (OTC) consumer anti-bacterial wash products containing certain active ingredients should no longer be marketed in the US.

CTPA would like to explain the strict laws that cover such products in the UK that ensure they are safe and effective.

In the UK and across Europe anti-bacterial soaps may be classed as cosmetic products. Cosmetic products are covered by strict safety legislation which requires that only safe cosmetic products can be made available for sale. In order to ensure this, each cosmetic product must undergo a safety assessment by a qualified and experienced safety assessor before it is placed on the market. The safety assessment takes account of all the ingredients used in the product, how the product will be used, by whom, where and how often. If an ingredient is not safe as used in a cosmetic product it would be banned.

The regulations in the US are very different from the EU for anti-bacterial soaps, as they are classed as OTC (Over the Counter) medicines in the US. The standard of proof in support of efficacy is also different. For an OTC medicinal soap containing anti-bacterial agents the company must demonstrate that the product with the relevant anti-bacterial agent is significantly more effective than soap and water alone. This, according to the FDA, the manufacturers have not done to their satisfaction and so the proposal to ban their sale in the US.

The EU cosmetic laws require that any claim made by a product must be honest and substantiated with robust science. For example, a product containing an anti-bacterial agent must be proven to be effective against bacteria to make an anti-bacterial claim. In order to do this manufacturers of these types of product substantiate their claims by using European Standard test methods that look at microbial contamination and the kill rate by the anti-bacterial hand wash being tested. So robust, standardised methods to support their claims.

Dr Emma Meredith, a qualified pharmacist and Director of Science at CTPA says :
"Cosmetic products are covered by strict EU laws that require all cosmetic products to be safe. It is also a legal requirement that all claims of efficacy must be substantiated. Expert scientists carefully develop each cosmetic product and must build up a bank of data which provide evidence of any claims being made before the product is put on the shelf."

Some media articles suggest that the FDA claims some of the ingredients are endocrine disruptors. This is not the case. In fact, the FDA acknowledges that the available data on endocrine effects of Triclosan cannot be used to determine endocrine effects in humans.

It must be stressed that cosmetic products do not contain endocrine disruptors. 'Endocrine disruptor' is the term given to certain chemicals which allegedly act as, or interfere with, human hormones in the body and lead to harmful effects. The World Health Organisation (WHO) defines an endocrine disruptor as follows:

"An endocrine disruptor is an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations".

The crucial point is that an endocrine disruptor produces adverse health effects in a whole body.

Dr Chris Flower, Director-General of CTPA, a toxicologist and Chartered Biologist, says:

"There is currently no evidence that at low levels endocrine mimics harm human health. Scientific studies have consistently failed to establish a causal relationship. We can state categorically that cosmetic products are required by strict European laws to be safe. The industry and the regulators are aware of concerns regarding possible endocrine effects and if such a risk was present from cosmetic products, action would have been taken to deal with it."

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