DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Silver Spring, MD 20993
Available in PDF (1.1MB)
September 26, 2013
Personal Care Products Council
1101 17th Street, NW, Suite 300
Dear Mr. Beattie:
I write to express my disappointment that the Personal Care Products Council (PCPC) appears to be unable to proceed toward legislation on the basis of the framework agreement that the Food and Drug Administration (FDA) reached with PCPC and the Independent Cosmetics Manufacturers and Distributors Association (ICMAD) over the summer. When PCPC approached FDA last year to initiate discussions about a new regulatory regime for cosmetics, I provided my personal commitment to pursue this important opportunity to give American consumers a modern and effective system of safety oversight for cosmetics. While our principal goal was ensuring the safety of products used by so many of our citizens, I understood that it would also allow your industry to move toward national safety standards for cosmetic ingredients. At the same time, I believed that we all understood that a strengthened regulatory system would bring the United States up to the level of other modern cosmetics regimes around the world, giving confidence to consumers, retailers, and foreign governments that U.S. cosmetics meet high safety standards, and enhancing international harmonization efforts.
After nine months of discussions, in July 2013, FDA, PCPC, and ICMAD reached agreement on a detailed framework of principles for a credible, modern cosmetics system. The agreement was embodied in a single document circulated by FDA to PCPC and ICMAD, which summarized the principles reached during the discussions. FDA representatives provided a briefing directly to industry leaders to answer questions, provide detail, and clarify the terms of the agreement to those who had not been present for all of the discussions. On July 10, representatives of PCPC and ICMAD told FDA that the Executive Committee of PCPC and the ICMAD board had agreed to the framework. The following day, we received email confirmation of this agreement, with the statement that the subsequent negotiations on statutory language would include further clarification, but not renegotiation, of certain aspects of the agreement.
The agreement included: (1) a set of basic regulatory tools that would enable enhanced oversight of cosmetic safety; and (2) a process for setting national safety standards for individual cosmetic ingredients and non-functional constituents (NFCs). A summary of the agreed-upon principles follows:
- FDA would gain the right to know who was manufacturing and marketing cosmetics for the American market, and what products they were producing or marketing, through a mandatory registration and listing system;
- FDA would review the safety of specific cosmetic ingredients and NFCs about which concerns have been raised, thus ameliorating much uncertainty about ingredient safety;
- FDA’s safety review for cosmetic ingredients and NFCs would be based on a “reasonable certainty of no harm” standard [the same standard that FDA has used to determine the safety of food and color additives]; “no harm” would be defined to exclude minor, transient reactions;
- Cosmetics firms would be required to maintain information substantiating the safety of their products, which in many circumstances would be CIR findings and finished product testing; firms could be required to submit that information to FDA;
- Cosmetics firms would be required to notify FDA of serious and other relevant adverse events (AERs) from cosmetic use, so that problems could be rapidly and effectively addressed;
- FDA would issue Good Manufacturing Practices regulations (GMPs) for cosmetics based on FDA’s existing guidance on quality control in cosmetics manufacturing; a side letter agreement would specify that cosmetics GMPs would be appropriate for cosmetics and not based on those for drugs or dietary supplements;
- FDA could require a mandatory recall of a dangerous cosmetic product if the company failed to recall it voluntarily;
- FDA would have access to GMP and AER records during inspections, and to other records if there was a safety concern based on enumerated factors;
- Once FDA found that an ingredient or NFC met the safety standard, with or without restrictions, States would be preempted from banning that cosmetic ingredient or NFC or imposing different safety restrictions from those imposed by FDA, but preemption would be limited in specific ways that were outlined in the framework agreement; and
- FDA would be permitted to assess modest user fees to fund this modern regulatory regime in the amount of $20.2 million/year; [the agreed-upon total fee amount is a small fraction of the amount assessed for other products regulated by FDA].
Many FDA staff spent numerous hours on this effort over the last nine months, and, having reached agreement with PCPC and ICMAD on each of these principles, believed that we were on a constructive path forward on legislation. In addition to meeting with PCPC and ICMAD, FDA staff also made a concerted effort to engage a range of consumer and small and micro-business interests so that eventual legislation would have broad support and could be presented to Congress as reflecting a consensus agreement on a path forward for cosmetics safety. Thus, PCPC’s change of heart is truly unfortunate. Not only will the public not reap the benefits of an effective regulatory scheme, but your industry will not achieve the credible, national regulation that industry representatives contended was needed, both domestically and in your export markets. That is a loss for us all, and a missed opportunity to better serve the public and strengthen your industry.
Margaret M. Hamburg, M.D.
Commissioner of Food and Drugs
Lezlee Westine, Personal Care Products Council
Pam Busiek, Independent Cosmetics Manufacturers and Distributors