FDA finally publishes transcript from cosmetic microbiological safety public meeting

By Michelle Yeomans

- Last updated on GMT

Related tags Risk assessment Cosmetics

FDA finally publishes transcript from cosmetic microbiological safety public meeting
The FDA has published the minutes of a public meeting it held over five months ago where the CFSAN's Office of Cosmetic and Colors and industry stakeholders gathered to discuss the issue of microbiological safety in cosmetics.

The meeting held on the 30th of November last year, included presentations on the subject, a brief overview as to where the FDA stands on the matter, as well as giving the industry the opportunity to suggest areas for improvement in the testing of cosmetics, and product and packaging characteristics that ultimately affect microbial growth.

FDA’s perspective

Dr. Linda Katz, director of the Office of Cosmetics and Colors kicked things off by stating that the goal of the gathering was to hear from stakeholders, particularly in science and technology areas while mentioning that the FDA was currently updating and restructuring its cosmetics information sources.

We really want to hear from you, we need insight into current manufacturing and testing practices, suggestions about future areas of research and stakeholder needs and concerns​."

In terms of what role the government plays in cosmetics, Katz said the FDA's authority is “only post-market, the law does not provide for FDA to have pre-market approval of cosmetics​. Our responsibility is really to monitor safety and ensure the proper labeling of cosmetics​.”  

What the FDA is doing now

According to the transcript, the FDA is currently working on its cosmetic compliance program to ‘remove obsolete or extraneous information, clarifying ambiguous areas and in general, really pulling it up to date​.’

We are also presently engaged in revising the Cosmetic GMP Guidelines and Inspection Checklist while considering incorporating elements from the corresponding ISO guideline​,” states Katz.


Key speakers on the day included Etan Yeshua of the Environmental Working Group, Jay Ansell of the Personal Care Products Council, Phil Geis from Geis Microbiological Quality and David Steinberg of the Cosmetic Preservative Council delivering presentations on the safety issue, its history and preventive perspectives for the industry, for a more in-depth account on those presentations, see here​.

Raised issues

Scott Sutton, the principal consultant with the Microbiology Network raised the issue of where bacillus cereus and risk assessment is going and if the industry is more concerned with hazard avoidance or in risk assessment with Dr. Geis.

To which, Dr. Geis responded that from his perspective,  risk assessment is the most important element, rather than risk elimination for the industry.

The microorganisms in our cosmetic products are such a low concentration that whatever is in there is dwarfed by whatever you see on the skin when you apply it, by your face, by whatever intimate body surface you put it on. So that's why the risk assessment, I think, has to be the paradigm we use​.”

For more information on the issues raised by stakeholders please see here​.




Related topics Regulation & Safety

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