Cosmetic Compliance
Intelligence & Solutions

Understanding Cosmetic Regulations in the United States

Mike Sohn, Shannon L. Gainey, Ph.D.
Thursday , 10th Mar 2022

In the US, the Food and Drug Administration (FDA) does not require pre-approval of cosmetic products and ingredients (with the exception of color additives) prior to being placed on the market. This is often misunderstood to mean that cosmetics aren’t regulated in the US. Although the FDA doesn’t require pre-approval of cosmetics, there are very specific requirements prohibiting the adulteration or misbranding of cosmetics, which ensures the products being offered for sale do not pose risk of harm to users under normal conditions of use.

In this webinar, Dr. Shannon Gainey, the Technical and Regulatory Director from REACH24H USA, will provide an overview of the US regulatory framework for cosmetics according to the Food and Drug Administration, specific requirements for ingredients and the label, how products that are both a cosmetic and drug are regulated as well as some of the regulatory requirements that are specific to several states within the US.


  1. The English session will be presented by Dr. Shannon Gainey on March 10th. Same content in Korean will be held by Mr. Mike Sohn (리이치24시코리아㈜ 손성민 대표) on March 15th to facilitate the attendance of audiences from different language backgrounds.

  2. To have a better chance of your questions being addressed, you’re welcome to email us the questions before the webinar.

  1. Overview of the US FDA Cosmetics Regulations

  2. Ingredient/Label/Package Requirements

  3. Voluntary cosmetic registration

  4. Cosmetics that are also a drug

  5. State cosmetic regulations

*The final outline may be subjected to subtle revision.

Contact Information

If you have any questions about this webinar, please contact us at:


TEL: +86 (0) 571 8609 4444

  • General Manager at REACH24H KOREA
    Mike is a South Korea market access expert with comprehensive knowledge of South Korea trade policy, laws and regulations in Cosmetic/ Chemical/ Food sectors. He had been a researcher in Korea Cosmetic Industry Institute (KCII), an overseas marketer in Won Tech, an RA at Daewoong Pharmaceuticals and worked at Histogenetics. He has been invited as the key speaker for more than 50 times all over the globe. He is acknowledged as a PR Agent of K-Beauty.
  • Technical and Regulatory Director
    Dr. Shannon Gainey is Technical and Regulatory Director for REACH24H USA. She has nearly 18 years of experience working for multi-national organizations, where she has supported the global compliance of products in various countries and markets. As Technical and Regulatory Director, Dr. Gainey provides North American regulatory support to clients. She has a wealth of knowledge and experience with Global Chemical Control Laws including the Toxic Substances Control Act (TSCA), the Canadian Environmental Protection Act (CEPA), the regulation of cosmetics and food/food contact materials under the Food & Drug Administration (FDA) and OSHA’s Hazard Communication Standard. Dr. Gainey’s global regulatory expertise and strong business acumen afford her a strategic vision to navigate the regulatory and compliance challenges that too often accompany new technologies and growth into new markets.