• Today, FDA announced that it will be holding a virtual listening session on June 1, 2023 for interested parties to consult cosmetics manufacturers, including smaller businesses, contract manufacturers, consumer organizations, and other experts to help inform FDA’s efforts in developing regulations to establish good manufacturing practices (GMPs) for facilities that manufacture, or process cosmetic products distributed in the United States.

• The event will include preliminary introductions and brief remarks on cosmetic product GMPs, followed by public comments on cosmetic GMPs.

• To facilitate the discussion, FDA has developed topics covering the types of information the Agency seeks to obtain from industry, including:

  • Cosmetic GMPs

    • Identify any national or international standard and the extent to which it would be practicable for GMP regulations for cosmetic products;

    • Describe what constitutes sufficient flexibility within GMPs for cosmetic products to ensure regulations are practicable for all sizes and types of facilities;

    • Describe what constitutes simplified GMPs requirements for cosmetic products for smaller businesses to ensure regulations do not impose undue economic hardship; [and]

    • Describe appropriate compliance times for GMP regulations.

  • GMP Economic Impact

    • To what extent are manufacturers of cosmetic products already following a national or international standard for GMPs?  If an entity is not currently following a standard, what would the cost to implement GMPs consistent with such standard be?

    • Provide reports or examples of adverse events or recalls associated with a cosmetic product that were linked to manufacturing practices. How would implementing GMPs impact the likelihood of a recall of cosmetics products?  How would implementing GMPs impact the likelihood of consumers experiencing adverse events from the use of cosmetics products?  How would these impacts differ by type of cosmetic product?

• Interested parties may register for the event at this link. The session will take place on June 1, 2023 from 10AM- 1PM EST.

Lauren Haas, Frederick Stearns, and Emily Thomas also contributed to this article.