Jonathan Berman presented May 10 regarding FDA's May 4 announcement that U.S. FDA and Canadian Food Inspection Agency mutually recognized each other as having comparable food safety systems. The process of recognizing foreign regulatory agencies has its roots in FSMA, and in the recognition that much of our food supply is imported, and that FDA's oversight over imported food can be strengthened and made more streamline through cooperation with foreign agencies that administer substantially similar food safety regulations. The impact of this mutual recognition remains unclear. However, it may be relevant in how FDA determines the priority it places on inspecting facilities (especially facilities that import into the United States). In addition, FDA and CFIA have pledged to continue and increase their efforts to cooperate, communicate, and share information.
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July 21, 2015 presentation (by Nazish Shabbir and Kelly Dawson on behalf of Laurie Henry and Madeleine McDonough):
International Cooperation on Cosmetics Regulation (ICCR)
ICCR is a volunteer international group of cosmetic regulatory authorities from Brazil, Canada, the U.S., and the E.U. The organization meetings annually to discuss common issues on safety and regulation. FDA will be holding a public meeting on 9/10/15 to receive input from the public on the various topics pertaining to regulation of cosmetics to help the agency prepare for the upcoming ICCR meeting in Brussels, Belgium on November 4-6. ICCR’s purpose is to provide a multilateral framework to maintain and enable the highest level of global consumer protection by working towards promoting regulatory convergence, while minimizing barriers to international trade. The organization sets out to “harmonize” regulations, facilitate common goals like promotion of international trade by removing regulatory obstacles, exchange scientific and regulatory knowledge, and develop equivalent compliance and enforcement standards to protect the public health. FDA’s goals in participating in ICCR include: accepting equivalent standards, compliance activities, and enforcement programs of other countries, if they meet FDA’s level of public health protection; avoiding lowering public health protection afforded by US law; promoting mutual understanding; and facilitating scientific and regulatory knowledge with foreign countries to the extent allowed by law.
ICCR has both members and observes. Current members include the following regulatory authorities: Anvisa (Brazil), Health Canada, European Commission, Japan Ministry of Health Labor and Welfare and FDA. Industry participants include: The Canadian Cosmetic, Toiletry and Fragrance Association; China Association of Fragrance, Flavor, and Cosmetic Industry; Cosmetics Europe, Personal Care Products Council (PCPC); Independent Cosmetic Manufacturers and Distributors (ICMAD); and the Japan Cosmetic Industry Association.
Topics for this year’s conference include: allergens, microbial limits, international standards processes, and the white paper on the importance of product preservation.
FDA Warning Letters
FDA warning letters continue to be a “hot” issue for cosmetics manufacturers. Between 2012 and the present, FDA issued a number of warning letters to cosmetics companies relating to product claims. These letters target performance claims in product packaging and marketing literature that the FDA considers “drug-like” or suggestive of an intent to “diagnose, mitigate, treat, or prevent disease, or to affect the structure or function of the body” – things only a regulated drug is permitted to do. These warning letters sparked an uptick in unfair and deceptive trade practices class action lawsuits, with plaintiffs claiming that many of the targeted product claims were false or overstated. Recently, the FDA has set its sights on a new cosmetics target – products such as dermabrasion pens and injectable fillers – which the FDA determined are intended to “affect the structure or function of the body,” and are therefore medical devices, subject to pre-marketing regulation.
During the call, one of the committee members referenced a medical devices resolution that was submitted and withdrawn. I believe the member stated that it proposed precluding punitive damages in lawsuits involving a regulated medical device. He suggested there may some overlap with our “hot topic,” but I was not familiar with the proposed resolution as I do not regularly attend the ABA committee meetings. I agree, however, that there is likely overlap, and would be interested to learn more about (1) the proposed resolution; and (2) the reasons for withdrawal. Would you mind forwarding this information, or having the Committee member contact me personally to discuss?