US trade bodies the Personal Care Products Council (PCPC) and the Independent Cosmetics Manufacturers and Distributors (Icmad) are backing the FDA’s decision to publish adverse event report data for cosmetics.
The PCPC says publishing the reports is a necessary and important aspect of cosmetic safety. And in a written statement to Chemical Watch, Icmad says it supports transparency and information sharing when it comes to adverse events, and that access to information helps “level the playing field for all involved”.
Reports are submitted to the FDA’s centre for food safety and applied nutrition' adverse event reporting system (CAERS). This, said PCPC spokesperson Lisa Powers, gives the FDA the information to “appropriately regulate our products”. It has led to investigations to specific products, targeted inspections and product testing, import alerts, warning letters and enforcement action.
However, Ms Powers says that there are some “crucial caveats” about the use of CAERS data, which have also been highlighted by the FDA. “CAERS captures any adverse events or complaints related to foods or cosmetics. These can include minor to major medical events, but also complaints about off-taste or colour of a product, defective packaging, and other non-medical issues.”
She says that it is important to understand that the information in the database is exactly as reported to the FDA, and the agency has not necessarily determined if the products in question were the actual cause of the events reported.
Chemical Watch also contacted three global cosmetics companies for comment. L’Oreal and Avon declined and Estee Lauder did not respond.
US NGO, the Environmental Working Group (EWG), also welcomed the FDA’s decision. Publishing these reports, said Tina Sigurdson, assistant general counsel, will allow consumers to more easily identify potential risks associated with personal care products. This, she says, is particularly important because the FDA has insufficient resources and authority to adequately regulate these products.
The law governing cosmetics regulation is “woefully inadequate”, said Ms Sigurdson, with many of its provisions unchanged since 1938.
“Increased action by the FDA is crucial for keeping risky products off the market, but the agency lacks the statutory authority it needs to protect the public. Congressional action could empower it to take essential regulatory steps like requiring premarket safety substantiation of products and issuing mandatory recalls when the need arises.”
This, she says, would help prevent adverse reactions before they occur. “Legislation proposed in the House and Senate would increase the FDA’s authority over personal care products and better fund the agency’s oversight.”
In 2015, two bills aiming to update the current law were introduced in the US Senate. These are the Personal Care Products Safety Act and the Cosmetic Modernization Amendments of 2015. And earlier this year, US Congressmen Frank Pallone Jr (D-New Jersey) and Leonard Lance (R-New Jersey) released a discussion draft of legislation intended to strengthen the FDA's oversight of cosmetics.
The bills have remained stalled in committee, but those introduced in the 2015-16 Congress may still be considered during the “lame duck” session which runs until 3 January 2017.