Warning letters sent to five US skin care brands over drug classification in 2017

By Lucy Tandon Copp 20-Jul-2017

The FDA raises concerns over whether certain products by Soapwalla, Perfectly Posh, Irie Star, Aegeia Skin Care and Star Health & Beauty should be classified as a drug instead of cosmetic

FDA warning letters have been sent to five US skin care brands since the start of the year, as the regulator continues to clamp down on incorrect classification.

Under the Federal Food, Drug, and Cosmetic Act, products for use on the skin must either be classified as a cosmetic or a drug – incorrect classification carries regulatory consequences including injunctions and seizure of products.

Since January 2017, Soapwalla, Perfectly Posh, Irie Star, Aegeia Skin Care and Star Health & Beauty have been informed that certain products appear to violate the Act.

After analysing the ingredients and claims of specific products, the FDA came to the conclusion that certain skus fall under ‘new drug’ classification because they are “intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease and/or articles intended to affect the structure or any function of the human body”.

‘New drugs’ require prior safety and efficacy approval from the FDA before introduction or distribution into interstate commerce.

The most recent warning letter was sent to Julie Longer, owner of Irie Star on 6 July.

Products in question include: Flawless - Equalizing Anti-Blemish Oil Serum; Lavish - Loving Recovery Beta-glucan Mask and Restore - Deep Healing Oil Serum.

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In total, since January 2016, 37 companies have been sent warning letters from the FDA regarding incorrect drug/cosmetic classification.