I’ll believe it when I see it enforced!clip_image050face

There are a lot of revolutions in the world but an US government agency is preparing to launch a battle against the Goliath-type multibillion dollar cosmetics industry.

The US Food and Drug Administration (FDA) has published a guidance requiring cosmetics researchers to obtain an Investigational New Drug (IND) application before embarking on clinical trials with humans.

As far as the US government has been concerned, a cosmetic improves appearance, whereas a drug diagnoses, relieves , or cures disease.

Drugs have been subjected to an intensive review and approval process by the FDA while cosmetics have been almost completely unregulated.

The FDA’s attempt to regulate cosmetics today is admirable but will the agency be successful? The guideline states:

With the exception of color additives and a few prohibited ingredients, a cosmetic manufacturer may use almost any raw material as a cosmetic ingredient and market the product without an approval from FDA.”

Under the new guidelines,an IND will require pre-clinical trial approval.

The FDA checks an IND application for safety to ensure participants in a clinical trial will not be subjected to “unreasonable risk’”

“For example, a study of the effect of a cosmetic product containing human or animal biological material (such as placenta) on skin repair mechanisms would require an IND, even if the study is intended only to support a claim of younger looking skin.”

What a major blow the Cosmetic industry will take if they have to forgo promoting  products as “anti-aging”?

The new guidelines for cosmetics were originally published in The Federal Register, September 2013. The FDA has since delayed the deadline for comment submission until April 7, to allow more time for the beauty product producers to ask further questions and, of course, to state objections..

The cosmetic industry has already warned the impact of the new IND regulations, if enforced, will increase development time and expense of many cosmetics.

2 Comments Add yours

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