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April 24, 2024
April 24, 2024

Frequently Asked Questions on FDA’s Cosmetic Regulations [UPDATED]

Shirly Christy

Frequently Asked Questions on FDA’s Cosmetic Regulations [UPDATED]

April 12, 2024
April 24, 2024
Shirly Christy


Navigating the world of FDA regulations can be confusing. With a million cosmetic brands popping up every day in the market, we’re often left wondering what goes in to our go-to matte lipsticks and sunscreens. 

Cosmetics are not just about the glam — the companies behind them have a crucial role to play. It is essential for cosmetic brands to understand the regulations set by Food and Drug Administration (FDA) and Food, Drug, and Cosmetic Act and comply to them

First, making the FDA and Food Drug & Cosmetic (FD&C) Act their holy bible. But don’t worry — this blog post can help you solve the problem. In this article, I will help you deep dive into the most common — and sometimes confusing — FDA cosmetic compliance laws. Let’s dive right in. 

1. Under what law are all the cosmetic products regulated in the US? 

Like the standard regulations, the Federal Food, Drug, and Cosmetic Act (FD&C) governs the regulation of cosmetic products produced, manufactured, and distributed across the United States. 

2. What happens when your cosmetics products are not FDA-approved? 

In the last decade alone, the FD&C Authority recalled over 1037 cosmetic products. It is important to understand that the FDA has no legal power to approve any cosmetic products before they reach the end customer, except for color additives. 

There are provisions in the law where cosmetics, if found to be misbranded or adulterated, can attract legal regulations. It is also important to note that the FDA will check whether all your labels have the right usage directions, ingredients and allergens mentioned, and the right branding. If your labels are found to be non-compliant, the FDA will recall your cosmetic product. 

Also read: We analyzed 800+ product recalls - Here’s what they had to say 

3. Do all personal care products count under the category of cosmetics and fall under the FDA? 

Personal care products and cosmetics are often used synonymously because of the similar spectrum of products found in the beauty and personal care industry. However, according to FDA regulations and laws, they are two different categories. 

Products that are made with the intent to cleanse and beautify are generally regulated under the label of "cosmetics." Products like moisturizers, perfumes, lipsticks, nail polishes, makeup, shampoos, toothpaste, and deodorants are not subject to FDA approval, except for color additives. All cosmetic companies have to mention their ingredients on the labels, considering the safety of their products for consumers. 

4. What drugs fall under the label of "cosmetics"?

In simple words, products intended to treat, prevent disease, or change or affect the structure and functioning of a body are called drugs. It holds true even if a product affects the way you look. The main difference between a cosmetic product and a drug is that all drugs require premarket approval from the FDA, but cosmetic products do not require such approval. 

There's a thin line of difference between cosmetics and drugs, which we've summarized below. 

5. Can some cosmetics be called drugs? 

Absolutely! Some products fall into the bucket of cosmetics as well as drugs. This can get confusing, but let us break it down for you. For example, if a sunscreen mentions SPF with a specific number, they are automatically classified as both drugs and cosmetics. 

Note: The FDA law doesn't recognize products as "cosmeceuticals." If a product possesses drug properties, it must meet the requirements for drugs. 

6. What are the ingredients that are prohibited for cosmetic products? 

Apart from  color additives, a few prohibited ingredients that every cosmetic manufacturer must be aware of are: 

  • Bithionol
  • Mercury compounds
  • Vinyl chloride
  • Halogenated salicylanilides
  • Zirconium complexes in aerosol cosmetics
  • Chloroform
  • Methylene chloride 
  • Chlorofluorocarbon propellants and hexachlorophene

These ingredients are prohibited in cosmetic products. The FD&C Act has made it mandatory for all products with color additives to be tested for safety and checked for their intended use by the FDA. The FD&C Act has strict regulations against harmful cosmetic products marketed to customers. 

7. What are the GMPs cosmetic manufacturers follow? 

All manufacturers, especially cosmetic ones, must follow Good Manufacturing Practices (GMPs) in their production process. GMP are structured systems that lead the production of products in specific industries and their conditions.  

In addition to the standard FDA and Cosmetic Act, GMP guidelines include every element that helps producers, such as: 

  • Building 
  • Equipment 
  • Personnel
  • Production 
  • Lab controls and samples 
  • Records 
  • Complaints

Following these GMP guidelines can help minimize health risks and avoid misbranding and adulteration cosmetic products. While the FDA continues to evaluate and inspect cosmetic products, it is also suggested that you periodically review your GMP guidelines and ensure you stay compliant with the rules. 

8. What are some tools that can help you comply with FDA regulations? 

Ensuring that your labels remain compliant with FDA regulations are essential. Cosmetic products that don’t comply with FDA regulations will be recalled and can damage your brand image and losses in millions. 

Artwork Flow’s ComplyAI can help you comply with FDA regulations effortlessly. ComplyAI is an AI-based compliance tool that helps you create your own custom rules based on custom parameters like typography, branding, and other regulatory requirements and then review all your labels according to the set rules to ensure compliance. 

This will allow you to quickly rectify any label errors before they go into print. 

Let’s take an example and see how ComplyAI works. In 2023, Gliss Hair Care Shampoo by Testanera was recalled due to the presence of Butylphenyl Methylpropional, an allergen. Let’s see how ComplyAI can help flag such an error for you in minutes. 

Every cosmetic brand has multiple product lines and each of these product lines have several products under them. Each product would have different regulatory requirements. Let us assume that one product had a different kind of typography, a few safety icons, disclaimers, and allergens. Walking through them all manually might lead you to missing some errors. With ComplyAI, you can create a rulebook for each of these parameters and catch these errors automatically.

Let’s take an example and see how ComplyAI works. In 2023, Gliss Hair Care Shampoo by Testanera was recalled due to the presence of Butylphenyl Methylpropional, an allergen. Let’s see how ComplyAI can help flag such an error for you in minutes. 

All you have to do is create a rulebook, mentioning the allergen as a positive keyword, run spell checks, check your font style, identify missing safety icons and once you run the test on the label, ComplyAI will catch errors and now you can go back in and rectify your mistake. 

9. What are MoCRA regulations? 

In the year 2022, the Modernization of the Cosmetic Regulations Act (MoCRA) came into existence. This means that FDA’s regulations now get overhauled over new MoCRA regulations. These regulations offered new rules to the FDA for a series of requirements that include: 

  • Event keeping and recording the occurrence of any adverse events. 
  • Ensuring proper registration of facilities and products. 
  • Complying with the good manufacturing practices (GMP). 
  • Issuing guidance for safety substantiation, fragrance allergen labeling and  facility suspension in case of non-compliance. 

Also Read: A makeover for your cosmetic brand: Everything you need to know about MoCRA

10. Can ComplyAI help me with MoCRA regulations? 

MoCRA regulations now involve a huge shift for every brand in the cosmetic industry in the US. While the costs to be borne by the company is high, MoCRA aims at improving overall consumer safety and providing them with ample information, keeping the production to purchase cycle transparent. 

It is said that an average American consumes over 6-12 cosmetic products everyday. While every product comes with its own set of regulatory conditions it can be difficult for cosmetic brands with different products to go through each of them and check against MoCRA regulations . Additionally with MoCRA regulations coming into the picture, we can only imagine the levels of compliance checks that every cosmetic product has to undergo. It is here where ComplyAI comes to the rescue. 

MoCRA compliance can become confusing due to the multiple laws and regulations around it. Artwork Flow’s new AI-led compliance tool ComplyAI can primarily help you solve this in just a jiffy. Here’s what ComplyAI can help you with: 

  • Flag all your MoCRA listed allergens and make sure your product labels remain compliant. 
  • Identify any ingredient in your formulations and see if they stand compliant with MoCRAs law. 
  • Review your labels at ease without worrying about missing any crucial information on your cosmetic label. 
An example of how ComplyAI can skim and scan your labels to make them MoCRA compliant. 

See how ComplyAI can help you with MoCRA regulations in a live demo

Lastly, ComplyAI is just a tool to help you catch label errors through label rulebooks you create. ComplyAI cannot offer any product suggestions or consultations based on FDA regulations. Before making any regulatory decision, we recommend you visit the FDA website. 

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