Here’s how to maintain compliance when making cosmetics.
The Key: Ensure Your Product Does Not Become Adulterated
According to FDA regulations, cosmetics may be manufactured at home, at a salon, or small facility. This is allowed as long as the environment does not cause the product to become adulterated. This means that the environment in which you manufacture your cosmetics must not cause them to become contaminated or potentially harmful when used as directed.
Cosmetic Compliance Checklist
Look at each area of your cosmetic manufacturing to be certain that nothing is causing your product to become adulterated.
Contamination. The FDA does not require a sterile environment for cosmetics manufacturing. However, you still need to be aware of contamination. Contamination includes bacteria, microbes, or other substances. You must do all that you can to prevent it by maintaining a clean working environment.
Restricted Colors and Additives. Certain color additives and other compounds are banned by the FDA. These components cannot be used in any cosmetic product, regardless of its intended use. Any banned color additives or compounds can cause your product to become adulterated and is in violation of FDA regulations.
Unsafe When Used as Directed. Your cosmetics must not harm to a person when the product is used according to package directions in a safe and reasonable manner.
Examine each aspect of your cosmetic thoroughly. Be certain that the ingredients and packaging do not cause the product to become adulterated. If you are inspected by the FDA, you could receive a cease and desist if your cosmetics become adulterated.
When to Get Legal Help
Navigating FDA regulations, even the simpler ones having to do with cosmetics, can be challenging. If you’re manufacturing cosmetics in a small facility, a salon, or at home, maintain compliance with FDA laws and guidelines.
An experienced FDA lawyer can help you learn more about the regulations you need to meet. Contact us today for a consultation to discuss your cosmetics venture and how to best maintain compliance with Food and Drug Administration guidelines. Call now for a consultation.
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“Cosmeceutical” is a marketing term, not an FDA category. Your claims decide whether your product is a cosmetic or an unapproved drug. Capote Law Firm reviews skincare claims before they become warning letters.
“Cosmeceutical” is a marketing term, not an FDA category. Your claims decide whether your product is a cosmetic or an unapproved drug. Capote Law Firm reviews skincare claims before they become warning letters.
“Cosmeceutical” isn’t a legal category — and using it can turn your cosmetic into an unapproved drug. FDA recognizes only two categories: cosmetics and drugs. Your claims decide which one you’re in.