05.04.23
The US Food and Drug Administration (FDA) will hold a virtual meeting entitled Good Manufacturing Practices for Cosmetic Products Listening Session on June 1, 2023.
The purpose of the listening session is to consult cosmetics manufacturers, including smaller businesses, contract manufacturers, consumer organizations, and other experts to 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 June 1 virtual listening session will be held from 10:00 AM to 1:00 PM Eastern Daylight Time (EDT) via Zoom Webinar. Registration for this free virtual listening session is required.
The meeting will include brief remarks on cosmetic product GMPs and public comments on GMPs for cosmetic products. FDA has developed a series of topics covering the types of information that it is interested in obtaining, which are centered around GMP and economic impact.
Topics Related to Good Manufacturing Practices
1. Identify any national or international standard (e.g., International Organization for Standardization (ISO) standard 22716:2007) and the extent to which it would be practicable for good manufacturing practice regulations for cosmetic products to be consistent with such standard. Please include whether there are specific items in the standard which are perceived to be burdensome or for which a less burdensome alternative exists that would protect the public health and ensure that cosmetic products are not adulterated.
2. Describe what constitutes sufficient flexibility within good manufacturing practices for cosmetic products to ensure regulations are practicable for all sizes and types of facilities to which such practices may apply. Please take into account the size and scope of the businesses engaged in the manufacture of cosmetic products and the risks to public health posed by cosmetic products.
3. Describe what constitutes simplified good manufacturing practices requirements for cosmetic products for smaller businesses to ensure regulations do not impose undue economic hardship.
4. Describe appropriate compliance times for good manufacturing practices regulations.
Topics Related to Economic Impact
1. To what extent are manufacturers of cosmetic products already following a national or international standard for good manufacturing practices? For manufacturers of cosmetic products that are not currently following such a national or international standard, what would it cost to implement good manufacturing practices consistent with such a standard?
2. Please provide reports or examples of adverse events or recalls associated with a cosmetic product that were linked to manufacturing practices. How would implementing good manufacturing practices impact the likelihood of a recall of cosmetics products? How would implementing good manufacturing practices impact the likelihood of consumers experiencing adverse events from the use of cosmetics products? How would these impacts differ by type of cosmetic product?
• May 22, 2023: Deadline to submit all presentation materials, in PDF format, to MoCRAGMPMeeting@fda.hhs.gov, for persons selected to speak at the meeting. FDA ask that all presentation materials also be submitted to Docket No. FDA-2023-N-1466 by June 1, 2023.
• June 1, 2023: Deadline to register to attend the listening session; registration may be performed at any time before or during the listening session.
• July 3, 2023: Deadline to submit comments to Docket No. FDA-2023-N-1466.
More info is available here on the FDA website.
The purpose of the listening session is to consult cosmetics manufacturers, including smaller businesses, contract manufacturers, consumer organizations, and other experts to 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 June 1 virtual listening session will be held from 10:00 AM to 1:00 PM Eastern Daylight Time (EDT) via Zoom Webinar. Registration for this free virtual listening session is required.
The meeting will include brief remarks on cosmetic product GMPs and public comments on GMPs for cosmetic products. FDA has developed a series of topics covering the types of information that it is interested in obtaining, which are centered around GMP and economic impact.
Information Wanted By FDA
Topics Related to Good Manufacturing Practices
1. Identify any national or international standard (e.g., International Organization for Standardization (ISO) standard 22716:2007) and the extent to which it would be practicable for good manufacturing practice regulations for cosmetic products to be consistent with such standard. Please include whether there are specific items in the standard which are perceived to be burdensome or for which a less burdensome alternative exists that would protect the public health and ensure that cosmetic products are not adulterated.
2. Describe what constitutes sufficient flexibility within good manufacturing practices for cosmetic products to ensure regulations are practicable for all sizes and types of facilities to which such practices may apply. Please take into account the size and scope of the businesses engaged in the manufacture of cosmetic products and the risks to public health posed by cosmetic products.
3. Describe what constitutes simplified good manufacturing practices requirements for cosmetic products for smaller businesses to ensure regulations do not impose undue economic hardship.
4. Describe appropriate compliance times for good manufacturing practices regulations.
Topics Related to Economic Impact
1. To what extent are manufacturers of cosmetic products already following a national or international standard for good manufacturing practices? For manufacturers of cosmetic products that are not currently following such a national or international standard, what would it cost to implement good manufacturing practices consistent with such a standard?
2. Please provide reports or examples of adverse events or recalls associated with a cosmetic product that were linked to manufacturing practices. How would implementing good manufacturing practices impact the likelihood of a recall of cosmetics products? How would implementing good manufacturing practices impact the likelihood of consumers experiencing adverse events from the use of cosmetics products? How would these impacts differ by type of cosmetic product?
Deadline Dates
• May 18, 2023 (6:00 pm EDT): Deadline to register if you wish to speak at the meeting. Each speaker will be limited to approximately 3 minutes; length of time may vary depending on the number of registered speakers.• May 22, 2023: Deadline to submit all presentation materials, in PDF format, to MoCRAGMPMeeting@fda.hhs.gov, for persons selected to speak at the meeting. FDA ask that all presentation materials also be submitted to Docket No. FDA-2023-N-1466 by June 1, 2023.
• June 1, 2023: Deadline to register to attend the listening session; registration may be performed at any time before or during the listening session.
• July 3, 2023: Deadline to submit comments to Docket No. FDA-2023-N-1466.
More info is available here on the FDA website.
