Reducing Regulatory Risk in the Cosmetic Industry with Product Specification Management

Posted on 
December 21, 2020
Tom Preston
VP Business Development, Specright

The cosmetics industry often comes under fire from consumers since products do not need FDA approval before entering the market. However, that doesn’t mean cosmetics aren’t strictly regulated. There are a number of cosmetics regulations companies are required to follow. What’s more, companies still have an ethical and legal responsibility to properly label their products and ensure consumer safety. Because cosmetics are defined by the FDA as any item intended to be “rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance,” it’s important to understand whether your products are classified as cosmetics. And if they are, regulations in formulating, packaging, and labeling your products will apply. Here’s how cosmetics are regulated in the United States and how companies can use specification management to mitigate regulatory risks:

The FDA’s Role in Regulating Cosmetics

Though the FDA doesn’t micromanage cosmetic product releases, the organization does outline specific guidelines that cosmetic companies must follow. These guidelines include:

  • Avoiding the use of banned or restricted ingredients due to safety reasons
  • Using only color additives that have been approved by the FDA
  • Including warning labels on products
  • Recalling products that are deemed to be unsafe
  • Adhering to labeling requirements
  • Requiring ingredient labeling (there are a number of additional regulations as to how and where ingredients must be listed on the product packaging)

The FDA does not test and approve individual cosmetic products. However, the organization does collect samples for examination when conducting import or plant inspections. The FDA also conducts research on ingredients to identify safety issues and address consumer concerns.

How Product Specification Management Can Help Manage Risk

One of the key challenges for cosmetics manufacturers is tracking ingredients that have been deemed unsafe or risky by the FDA. As research is conducted and new ingredient information becomes available, it’s important to review your own ingredients to ensure they’re removed from your formula. And when they are, you’ll need to find a viable replacement ingredient, as well as removing any existing products with the unsafe ingredient from the market.Swapping ingredients isn’t always a simple process. In addition to finding an alternative, you’ll also need to consider how to source the new ingredient, how much it costs, and how the swap will impact the price of your product.

You’ll also need to figure out which of your products contain newly-deemed unsafe ingredients so those products can be removed in a timely manner.Doing all of the above at scale is made easier with specification management software. By monitoring cosmetic products at the spec level (e.g. ingredients, suppliers, lead times, price points, etc.), companies can become more agile in finding safer alternatives while remaining in compliance with the FDA.

Addressing Cosmetic Regulation Challenges with Specright

As a product specification management solution, Specright brings clarity to your cosmetic data to help you streamline decision making, improve your time to market, and ensure compliance-related details don’t fall through the cracks.

Download our ebook to learn more about Specright’s solutions for managing ingredients, suppliers, lead times, and price points across the cosmetics industry.


Tom Preston

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