It is often said that “beauty lies in the eye of the beholder.” A review of Food & Drug Administration (FDA) enforcement activity in 2011 reinforces how personal care products are beheld by FDA. A new article published by HAPPI — the Household and Personal Products Industry magazine — highlights important regulatory considerations for personal

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.


Continue Reading FDA Holds Public Meeting on Cosmetic Microbiological Safety Issues to Consider Need for New Guidelines

The Food and Drug Administration (“FDA”) recently completed an evaluation of the legal basis for federal preemption policy statements the agency has issued under the Federal Food, Drug & Cosmetic Act (“FDCA”) during the past 10 years. FDA initiated the review in response to a memorandum issued by President Obama in May 2009 which directed

Last week, the Center for Environmental Health, a non-profit organization, filed a complaint in California Superior Court alleging that 34 cosmetics companies violated the California Organic Products Act of 2003 (“COPA”) by selling, labeling, or marketing cosmetic products containing less than 70% organic ingredients as “organic.” The Center seeks an order enjoining the defendants from

This Monograph, published by the Food and Drug Law Institute, is designed to assist lawyers, regulatory advisors and marketing professionals answer the question “Can we say that?” as they design and execute programs to promote consumer health products such as foods, dietary supplements, non-prescription drugs and medical devices, cosmetics and pet care products. It serves