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Wednesday, September 28, 2016Congresses

USA: how to distinguish a cosmetic product from an OTC?

© CosmeticOBS-L'Observatoire des Cosmétiques

It is common knowledge that American regulations classify certain cosmetic products as OTC products, which involves increased requirements in terms of formulation, approval before marketing, and labelling. As a result, companies should avoid any classification mistake before exporting to the USA… which is not always that simple. At the Cosmetic World Tour organized by the FEBEA (French Federation of Beauty Companies) on September 19-20, 2016, Anne-Marie Breton provided practical keys to distinguish cosmetics from OTCs.

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~ 8 minutes

As FEBEA’s International Regulatory Affairs Manager, Anne-Marie Breton receives a lot of questions from the Federation’s members about how to determine the status of a cosmetic product intended for the American market, and many of them can be summed up as follows: ‘Is my product a cosmetic product or an OTC?’, but mostly ‘How can I prevent my product from being considered an OTC?’
This recurring problem made her decide to set up a presentation for the Cosmetic World Tour, which consists of two days of conferences on international regulations. It was held for the first time by the FEBEA on September 19-20.

Understanding FDA’s approach

To make the question more explicit, she started by reminding everyone of FDA’s (Food and Drug Administration) scope of action and way of thinking, as it is the competent authority in the USA for these matters.

FDA regulates a whole series of products:
• Food, drinks, food supplements
• Biotechnologies
• Medical devices
• Veterinary products
• Products that emit waves
• Tobacco
and of course,
• Pharmaceuticals and
• Cosmetics.

As a matter of fact, certain products considered as ‘mere’ cosmetics in Europe can be classified as cosmetics or drugs… or both, in the …

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