FDA GMP Listening Session: CDU Takeaways & Available Resources

01-Jun-2023 - Last updated on 01-Jun-2023 at 22:58 GMT

The session, which featured public comments from approximately 100 scheduled speakers, urged the FDA to consider the interests of small businesses as well as international guidelines for implementation of GMP regulations by the end of 2025. © limeart Getty Images

Related tags Fda MoCRA GMP Cosmetics

The FDA opened a Listening Session for public commentary of the Good Manufacturing Practices section of MoCRA today with an open docket for commentary through July 3, 2023.

Today, CosmeticsDesign attended the FDA’s “Good Manufacturing Practices (GMP) for Cosmetics Products Listening Session,” a virtual public event with the purpose of “consulting cosmetics manufacturers, including smaller businesses, consumer organizations, and other experts, to inform Agency efforts to develop regulations to establish good manufacturing practices for facilities that manufacture, or process cosmetic products distributed in the United States,” as detailed on the FDA docket.

About the Listening Session

The session, which spanned approximately five hours, and was moderated by Dayle Lewis Cristinzio, Director, Stakeholder Engagement, Office of External Affairs of the FDA, hosted approximately 100 scheduled speakers from across the US as well as international participants from Mexico, the UK, Germany, Canada, Pakistan, China, Belgium, France, Taiwan, Nigeria, South Africa, Brazil, Columbia, Morocco, Peru, Turkey, and India.

Participants ranged from representatives of small businesses and non-profit organizations like the Personal Care Product Council and the Environmental Working Group to speakers from large corporations like L’Oreal, Procter & Gamble, Estee Lauder, and Mary Kay.

The Listening Session was broken into several sections, beginning with opening remarks from Dr. Namandjé N. Bumpus, Chief Scientist of the FDA’s Office of the Chief Scientist, and Linda M. Katz, M.D., M.P.H., Director, Office of Cosmetics and Colors, CFSAN, FDA, before leading into two sessions of public comments from scheduled commentators.

The third session featured public comments supported by slide presentations before the session closed with a fourth and final public commentary session and shared resources for next steps.

Regarding MoCRA & GMP regulations

MoCRA’s GMP Sec. 606 details that the FDA shall “by regulation establish good manufacturing practices for facilities that are consistent, to the extent practicable, and appropriate, with national and international standards,” as detailed in a speaker presentation from EAS Consulting Group.

The EAS Consulting Group speaker further detailed that these regulations “shall be intended to protect the public health and ensure that cosmetic products are not adulterated, may allow the FDA to inspect records necessary to demonstrate compliance with GMPs during an inspection conducted under section 704, and shall include simplified GMPs for smaller businesses.”

Of important note, while MoCRA’s provisions will begin to be enforced at the end of this year, the FDA will publish a notice of proposed rulemaking regarding GMPs no later than two years after MoCRA’s enactment, or December 29, 2024, and shall publish a final such rule no later than three years of such date of enactment, or December 29, 2025.

Key Listening Session takeaways

ISO 22716:2007

Many speakers urged the FDA to consider ISO 22716:2007, which establishes the international standard for GMP compliance and is already observed by many international cosmetics companies. This standard “gives guidelines for the production, control, storage and shipment of cosmetic products” and is internationally recognized as an existing GMP standard.

The application of ISO 22716 would aid companies looking to export product internationally and would also support cosmetics companies in other countries looking to export products to the US.

Concerns regarding undue burdens on small businesses

Many commentators like the Handcrafted Soap & Cosmetics Guild and the Indie Business Network represented the interests of small businesses, which the FDA defines as having no more than 500 employees including affiliates, and raised concerns about the GMP regulations as imposing undue burdens regarding compliance. While MoCRA stipulates that small businesses with less than $1 million average annual turnover for the previous three years can qualify for some exemptions, many small businesses operate on thin margins that just breach that cap.

For those small companies, many of which are owned and operated by women or people of color, adhering to regulations could potentially create additional financial stress.

Potential international impact

Many international commentators spoke in support of MoCRA’s GMP regulatory implementations. For example, a regulatory spokesperson from China detailed that current Chinese GMP standards are stricter than the current standards in the US, which can slow a US company’s attempted entries into the Chinese market. Reciprocally, clarifications to the US GMP regulations and definitions will also make it easier for Chinese companies to enter the US market. Cosmetics are currently defined differently in the US and China.

The FDA defines a cosmetic product as “articles 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."

The China State Council, which released the Cosmetics Supervision and Administration Regulation (CSAR) in 2020, defines a cosmetic product as “daily chemical products intended to be applied on human skin, hair, nails, lips, mouth, etc., by spreading, spraying or other similar ways for cleansing, protecting, beautifying, or grooming purposes.”

Most international commentators urged the consideration of ISO 22716, which would clarify these issues by establishing an internationally recognized guideline for GMPs and provide a universal set of standards for all companies to follow regardless of origin. This would also solve issues regarding mislabeling of ingredients upon import and export.

Moving forward

All speakers and attendees were encouraged to submit additional comments to FDA Docket No. FDA-2023-N-1466 by the July 3, 2023 deadline. Comments can be submitted electronically, and there is an option to submit written/paper comments via mail/hand delivery/courier to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

A transcript of today’s Listening Session will be posted at https://www.regulations.gov/ as soon as it becomes available, and additional resources can be found at the Federal Register Notice of Public Meeting or on the FDA’s website section covering MoCRA.

Additional questions can be directed to the FDA by calling (240) 402-1130, or by email at ZbPENTZCZrrgvat@sqn.uuf.tbi.