Are you looking to introduce a new cosmetics product? If so, you may need to have it cleared by the Food and Drug Administration (FDA) and there is also the possibility that it may be regulated as a drug. This will depend on whether the cosmetic is aimed at diagnosing, curing, mitigating, treating, or preventing disease. It may also be regulated as a drug if it affects the structure of any body function.
There may be some confusion as to what type of cosmetic may be regulated as a drug. Let’s take sunscreen, for example. It more than likely contains a Sun Protection Factor (SPF) indicating it is meant to prevent sunburn. Antiperspirants affect the sweat glands and also prevent seating. Toothpaste will prevent tooth decay. A face wash meant to address acne may also treat the acne and affect the pores.
Each of these examples has certain “keywords” you can use in helping you determine whether the cosmetic will be regulated as a drug (i.e.: “prevent”, treat”). Should you need any additional assistance with this, we will be happy to help you guide you.
UReg FDA Registrations is committed to assisting domestic and foreign clients in navigating and simplifying the often convoluted process of registering with the FDA. We have worked with an extensive array of clients across a broad spectrum of industries such as cosmetics, food and beverage, medical devices, and more through providing experienced, researched, and professional advice on FDA compliance and its multitude of legal regulations. For more information on FDA registration, please visit our website or call 786-504-6363.