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Cosmeceuticals are becoming more and more popular in the United States, with demographics being the primary driving factor due to the aging of the population. The extension of the average lifespan contributes to the increased purchase of these products in the US, as does an intense focus on a healthy lifestyle and on the use of wholesome products. The phenomenon of demographic ageing has generated a major demand for anti-aging products to prevent wrinkles, skin spots, and other skin conditions, thus creating room for innovation in cosmetics and cosmeceuticals in America.
Cosmetics are products which are applied to the body and “alter its appearance”. Meanwhile, soap is defined in two ways: soaps that have particular properties or that modify the condition of the skin are considered cosmetics in the United States and are thus subject to regulation by the FDA [Food & Drug Administration], while soaps that have only the function of cleaning are not considered cosmetics and are therefore not subject to regulation by the FDA.
Pharmaceuticals, on the other hand, are an entirely separate category of products which modify the structure or specific functions of the body. Furthermore, it is important to distinguish between cosmetics and cosmeceuticals: cosmeceuticals are products that have similar benefits to pharmaceuticals and that can also be a combination of cosmetics and pharmaceuticals.
In the United States a product can be a pharmaceutical, a cosmetic, or a combination of the two, but the term “cosmeceutical” is not found in the FDA regulations. While the term is not legally recognized, the cosmetic industry uses it [abundantly] to refer to cosmetic products that have medicinal benefits or benefits that are similar to those of a pharmaceutical.
Every product category must adhere to different regulations, and while cosmetics do not require FDA approval before being put on the American market, hybrid products (for example, a cross between a cosmetic and medicinal product) and pharmaceuticals must follow more stringent rules.
To determine in which of the FDA regulated categories a “cosmeceutical” product will fall, we always recommend consulting ExportUSA for an evaluation before putting the product on the market in the United States.
Is it a cosmetic or a drug? If the cosmetic is classified as a medicinal product or medical device, you must follow the FDA rules for drugs and medical devices
https://www.exportusa.eu/cosmetic_drug.php
ExportUSA takes care of ensuring that your products adhere to FDA standards. We make sure that all food products, cosmetics, medical devices, and dietary supplements comply with FDA regulations.
https://www.exportusa.eu/fda-compliance-exportusa.php