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How Does the FDA Determine Cosmetics and Drugs?

The U.S. Food and Drug Administration (FDA) oversees some products generally known as medications as cosmetics. FDA prescription product standards are strict and more detailed than conventional cosmetics regulations, which can also create concern for manufacturers.

The difference between a medicine and a cosmetic product is based both on the ingredients and the intended application of the product. Attempting to market a cosmetic product that may be subject to FDA drug regulations could lead to the product being deemed an unapproved drug. This type of marketing violates the Food, Drug, and Cosmetic (FD&C) Act and may lead to criminal and civil fines, warning notices, and other compliance actions by the FDA.

The distinction between cosmetics and drugs in FDA regulations is substantial. Generally, cosmetic products can be sold without the permission of the FDA provided are free of banned ingredients and suitable statements are made. Cosmetic manufacturers are not forced to register their facilities with the FDA, nor are they required to list products, but they may choose to do so.

Drug services and products, then again, have tighter specifications. Drug facilities are expected to register with the FDA and list the drugs treated at the facility. It is necessary to remember that FDA registration does not constitute approval by the FDA. Drug products must either adhere to an over-the-counter (OTC) monograph or, via a new drug proposal (NDA) to be sold in the United States, undergo the FDA approval process.

When they contain active drug ingredients, the FDA controls beauty products as drugs. Antiperspirant deodorants, for example, contain Aluminum Zirconium Tetrachlorohydrex, which is an ingredient designed to resist sweating. Products that fight dandruff and acne (Salicylic Acid), sunscreen, and SPF skin creams (octyl salicylate) are a few examples.

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