A Comprehensive Guide for Beauty Brands to Navigating FDA Regulations for Cosmetics

Whether you’re a brand-new startup, or a well-known manufacturer of the most popular cosmetics, everyone has to follow the FDA regulations if they want to sell their products to consumers in the USA.


These regulations are put in place not just to keep customers safe and to follow legal requirements, but also to maintain credibility in an industry that is integral to so many people’s daily lives.


In this article, we’ll be delving into the world of FDA regulations for beauty brands and sharing some of the most important guidance that you should follow if you want to avoid getting into potentially catastrophic legal issues.

 Are you selling a cosmetics product or a drug?

The first, and probably the most obvious thing, to pin down is what you’re selling. Under the FDA guidance, there are two main categories that beauty products could fall under: a cosmetic or a drug. 

Cosmetic products are those that are designed to be applied to the human body with the purpose of cleansing, altering appearance, beautifying, or promoting attractiveness.

A drug is intended to treat, cure, or prevent disease.

Depending on what product you are selling, you will have to follow a very different regulatory pathway so it’s important to make this distinction as early on as possible.

Be aware of restricted ingredients

The FDA has a fairly long list of ingredients that are not allowed to be used in cosmetics products, under any circumstances. These restrictions are put in place because the ingredients pose a threat to safety and are not fit for human use.

Some of these ingredients include Bithionol, Chlorofluorocarbon propellants, Chloroform, or Halogenated salicylanilides.

Be aware of what ingredients are on the prohibited list so that you can ensure that none of them are used the next time you’re formulating a new beauty product. Working with a contract manufacturing expert like Adonis can make navigating the FDA requirements that much easier.

Be careful about the claims you make

You may want to do whatever you can to convince someone to buy your product, but you could be in trouble with the FDA if you make too many claims that could potentially be misleading some of your customers.

According to the FDA, claims must be truthful and substantiated by scientific evidence. Plus, if you are selling cosmetics, you must avoid making any drug-like claims that could affect the regulatory requirements for your product.

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