On March 5, 2019, FDA Commissioner Scott Gottlieb, M.D. and FDA/CFSAN Director, Susan Mayne, Ph.D., released new independent test results confirming asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers.  The agency also issued a safety alert warning consumers not to use the cosmetic products sold by Claire’s that had tested positive

A recent warning letter suggests that FDA, in regulating user generated content (“UGC”) on social media pages, will likely treat all companies the same. Earlier this year, FDA released two guidance documents for drug and medical device companies on social media. Those documents provided the following stance on UGC: “[A] firm generally is not responsible

The FDA today published a Federal Register notice reopening the comment period on the Final Guidance entitled “Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can be Conducted Without an IND.” FDA published the IND guidance document in draft form in October 2010. FDA then released a significantly expanded version of the

According to the 2013 unified agenda for the Department of Health and Human Services, FDA plans to recommend several changes to U.S. OTC drug labeling, safety monitoring, and manufacturing standards in 2013 which may impact future marketing and product development strategies for consumer products. Forthcoming FDA proposals include the following:

 Proposed Monograph Modifications

  •  Amending

A recent decision in the U.S. District Court of the Northern District of California, Brown v. Hain Celestial Group, Inc., provides important insights into cosmetic and food product organic claims. In 2011, a complaint filed against a cosmetic company alleged that the company’s organic claims violated the California Organic Products Act of 2003 (“COPA”).

On March 27, 2012, the House Energy and Commerce Committee held a hearing entitled “Examining the Current State of Cosmetics,” which considered existing FDA authority over cosmetics and calls to modernize that authority to address technological advances and globalization of the cosmetics industry. The hearing provided regulators and stakeholders an opportunity to voice their perspective on the future of the regulatory landscape governing cosmetics, with most expressing approval for adapting existing FDA authority to meet new industry needs while emphasizing extensive safeguards already put in place by industry. Witnesses further noted that maintaining FDA regulatory authority would help prevent individual state regulations which could deter innovation and disrupt interstate commerce.
Continue Reading

The Food and Drug Administration (“FDA”) has submitted its Report to Congress on the FDA Foreign Offices. Under the Food Safety Modernization Act (FSMA), FDA is required to update Congress on the agency’s progress in establishing foreign posts and working with foreign government counterparts to further FDA’s mission. Companies that import food, drugs, devices or cosmetics into the United States or are part of the import supply chain for food, drugs devices or cosmetics may wish to review the report to learn how FDA currently plans to rely on foreign posts to accomplish its mission, and what the foreign posts have accomplished so far.

FDA currently has thirteen foreign posts: three in China, two in India, four in Latin America, three in Europe, one in South Africa to serve the Sub-Saharan Africa region, and one in Jordan to serve the Middle East and North Africa. FDA has requested permission to establish an additional post in Brazil but has no current plans for additional posts. Decisions to establish foreign posts are based on the volume of imported products, the magnitude of problems associate with imported products, the value derived from leveraging activities and resources of foreign counterpart regulatory authorities, the ability of FDA to contribute to promoting U.S. public health priorities, the stability of political and security environments in the foreign country, and the political relationships and receptiveness of the foreign country to the presence of FDA staff. FDA staff are deployed to U.S. embassies or consulates. In Europe, FDA also has senior technical experts embedded in the European Medicines Agency and in the European Food Safety Authority.
Continue Reading

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