Bringing Beauty Across Borders: Master Class on the International Commercialization of Cosmetics and Personal Care Products

Mar 27, 2019 1:00pm - 4:30pm



Lisa Capote
FDA Regulatory Compliance Attorney
Capote Law Firm (Miami, FL)

Heili Kim
Venable LLP (Washington, DC)

Felicia Leborgne Nowels
Akerman LLP (Tallahassee, FL)

What is it about?

Registration begins at 12:30 pm

The international sales of cosmetics and personal products fuel a billion-dollar global industry. In some instances, exported products surpass sales for domestic products. This demand has led companies to enter into the international market, both established and emerging with the hopes of taking a slice of this growing area. In this session, our workshop leaders will help you understand this highly complex international market and help you devise strategies for regulatory approval and export. They will advise you of all of the regulatory challenges and give you an update on all of the relevant international laws governing cosmetics and personal care products. They will also provide a comprehensive and detailed review of labeling requirements, tariff and taxation laws, and the finer points of registration in order to ensure you are ready to enter the foreign markets with a clear idea and a specific business plan in place to avoid any missteps. Points of discussion will include:



  • Defining cosmetics, personal care, and drugs in international markets
  • Understanding the risks when importing products with structure/function claims
  • Examining the need for a single label for international harmonization
  • Assessing GMP requirements for international markets
  • Exploring matters of trade, tariffs and taxation affecting the global cosmetics and personal care industries


Addressing challenges associated with tariffs, treaties and customs

  • Assessing opportunities to sell products outside of the US in view of the current Administration’s policies
  • Exploring the present trade atmosphere in Asia for the cosmetics/personal care
  • Understanding how the renegotiation of NAFTA might impact the cosmetics industry
  • Dissecting concerns with customs controls, and tariffs and their impact on the cosmetics industry growth worldwide



  • Overview of EU regulations on cosmetics and personal care products
    • Strengthening the safety of the product
    • Outlining the responsibilities of the “responsible person” to manage the product
    • Using the CPNP for centralized notification
    • Use of nanomaterials as ingredients in the product
  • Understanding standards for cGMP
  • Examining advertising and labeling requirements
  • Identifying testing requirements
  • Exploring new requirements relative to Brexit


  • Obtaining pre-market approval
  • Examining post-market compliance responsibilities
  • Exploring Labeling requirements
  • Understanding the repercussions of new import requirements
  • Examining the present status of our relationship with China and the status of One China policy


South Korea

  • Understanding The Cosmetics Act
  • Adhering to the MFDA’s requirements for cosmetics
  • Identifying and defining the different types of cosmetics: general and functional
  • Labeling requirements



  • Identifying and defining the different categories of cosmetics
  • Testing and inspecting products by the MHLW
  • Labeling guidelines ASEAN countries
  • Update on the Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme
  • Clarifying registration requirements
  • Labeling requirements
  • Good manufacturing practices