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Am I Making a "Cosmetic Product" Under MoCRA?

cosmetic product mocra

The Modernization of Cosmetics Regulation Act (MoCRA) has sent ripples through the beauty industry, leaving many manufacturers wondering: Does this new regulation apply to my product? Navigating the legalese surrounding "cosmetic products" can be tricky, but fear not! This guide dives deep into the definition under MoCRA and helps you determine if your creation falls under its purview.


The MoCRA Twist: "Cosmetic Product" vs. Traditional "Cosmetic"

The traditional definition of a "cosmetic" comes from the Federal Food, Drug, and Cosmetic Act (FD&C Act). It encompasses articles intended for cleansing, beautifying, or altering appearance that are applied to the human body. MoCRA, however, introduces a new term: "cosmetic product." This term carries a slightly different meaning.

  • MoCRA's "Cosmetic Product": Defined as a preparation with a specific and consistent composition of cosmetic ingredients intended for use in a finished cosmetic product. This definition emphasizes the predetermined formula and the end use as a finished product.


What Does This Mean for You?

MoCRA's definition seems broader than the traditional "cosmetic" definition. This likely applies to most items found in the Health & Beauty section of a store, from the obvious makeup and skincare products to lotions, shampoos, nail polish, and even hair styling products.


Important Exceptions to Consider:

While MoCRA appears to cast a wider net, there are still some exemptions:


  • Soap: Not all cleansers are exempt. Only soap meeting the specific criteria defined by the FDA, which essentially limits it to traditional bar soap, escapes MoCRA's reach.

  • Drugs and Medical Devices: Products with a medicinal purpose, even if they have a cosmetic appearance, are not considered cosmetics under MoCRA. Think medicated shampoos, anti-fungal creams, or acne treatments. These likely fall under drug regulations.


Beyond the Basics: Gray Areas and Expert Advice

The line between cosmetics and drugs can sometimes be blurry. Products that claim to address specific skin concerns (e.g., anti-aging creams) or have a dual purpose (e.g., sunscreen that also hydrates) might raise questions.


Here's where seeking professional guidance becomes crucial. If you have any doubts about whether your product qualifies as a "cosmetic product" under MoCRA,  consulting with Provision Consulting Group, a team of professional FDA consultants, is highly recommended. Provision Consulting Group is ready to provide specific advice based on the unique characteristics of your product.


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