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How Are Cosmeceuticals Regulated?

Because cosmeceuticals straddle the line between drugs and cosmetics, there are many regulatory challenges that still need to be addressed. For now, the FDA regulates products as either a cosmetic or a drug, depending on the claims the company makes. If a product claims to alter the function or structure of the body in any way, it’s considered a drug and requires clinical trials. If the product is marketed as a beauty product, it’s a cosmetic. 

How Regulations Work

The Federal Food, Drug, and Cosmetic Act (FD&C Act) was established in the 1930’s to help the FDA operate and develop regulations on cosmetics, drugs, and foods to protect consumers. This set of laws regulates the manufacture, sale, and use of cosmetics and drugs in the United States but regulations can become confusing when it comes to cosmeceuticals, or cosmetic products that have some drug-like effects.

This is because the FDA does not have a separate classification for cosmeceuticals: the FD&C Act defines drugs and cosmetics separately, each with their own regulations. Cosmetics are not FDA-approved prior to sale to the public while drugs must go through a review and approval process. Products that do not have a clear line between drugs and cosmetics — or cosmeceuticals — are categorized as one or the other based on their intended use and this is usually done on a case-by-case basis.

Analyzing Cosmeceutical Claims

As a consumer, it’s important to understand the claims that can be made on cosmeceuticals. Cosmeceuticals should not be labeled in such a way as to indicate the product has drug-like properties or benefits unless these claims have been substantiated by clinical scientific evidence. Do not assume that a product that has been labeled as “FDA-approved” means that all claims have been backed by evidence; cosmetics do not need to be approved by the FDA, although color additives in cosmetics must be approved. An FDA-approved cosmetic means that the additives have been found to be safe.

The way in which cosmeceuticals are currently regulated may seem overly complex but this is because cosmeceuticals are a fairly new industry. For example, prior to 2005, there were no over-the-counter products on the market with retinol. Today, retinol is registered in more than 200 products. As a consumer, it’s important to research the cosmeceutical company as well as the ingredients.

Choose cosmeceuticals with listed ingredients that are backed by research and a company with a solid track record in the skin care industry with an in-house research and development department that tests the ingredients it uses – in other words, choose Hale Cosmeceuticals!


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