On November 30, 2011, the Food and Drug Administration (FDA) held a public meeting to consider the need to amend pre-existing guidelines or adopt new ones addressing microbiological safety in cosmetics. The FDA presented the meeting as an opportunity for industry and other stakeholders to provide input on whether current guidelines sufficed to address cosmetic microbiological safety.
The FDA and industry members have long acknowledged the capacity for microorganisms to grow and reproduce in cosmetics if certain precautions are not taken. This growth can cause chemical changes to the products, which may adversely affect the consumer. In explaining the impetus behind the meeting, FDA representatives noted that current FDA guidelines on microbiological safety have not been revised in some time. These guidelines include the Cosmetic Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist (2008) and the Bacteriological Analytical Manual (BAM), Chapter 23 “Microbiological Methods for Cosmetics” (2001). FDA representatives stated that they were in the process of revising these guidelines and also considering issuing entirely new guidelines on microbiological safety.