FDA Closes Negotiations with ICMAD and PCPC, Prompting Industry Response

On Mar. 6, 2014, Michael Taylor, on behalf of th The U.S. Food and Drug Administration (FDA), responded to the Proposed Draft Legislation by the Personal Care Product's Council (PCPC) and the Independent Cosmetics Manufacturers and Distributors (ICMAD), effectively finding no common ground between the three and closing the negotiation.

In the response letter to Lezlee Westine, president and CEO of PCPC, and Pamela Jo Busiek, president and CEO of ICMAD, Taylor found that the proposed regulatory provisions would reduce the FDA’s current ability to take action against dangerous cosmetics. The letter notes, "Taken together with the sweeping preemption provisions, which almost completely eliminate States’ authority to protect their citizens from unsafe chemicals in cosmetics, the provisions of the draft industry bill could put Americans at greater risk from cosmetic-related illness and injury than they are today."

The letter notes that the Proposed Draft Regulation is not in line with what the decisions the three organizations made in July 2013. Among the differences the FDA finds between the prior agreement and the proposed legislation, it notes that the draft: would allow Congress to declare a wide range of potentially harmful chemicals “safe” for use in cosmetics without a credible scientific basis; require FDA to affirmatively find other cosmetic ingredients “safe” even if  knew that they posed real and substantial risks to consumers; require FDA to undergo a lengthy, unnecessarily burdensome process before declaring an ingredient unsafe; eliminate FDA’s ability to verify that cosmetic companies have substantiated the safety of their products; undercut FDA’s ability to enforce quality control rules for the safe manufacturing of cosmetics; prevent FDA from receiving reports of most illnesses and injuries from improperly manufactured or otherwise dangerous cosmetics; fail to give FDA the authority to require cosmetic companies to register annually with FDA; and eliminate States’ ability to oversee any aspect of the safety of cosmetics.

The FDA noted that it did not see common ground with ICMAD and PCPC and did not see a need to continue the negotiation.

In a response letter from the PCPC, Westine noted, “We are extremely disappointed that FDA has indicated they will not participate in further discussions with the cosmetics industry regarding cosmetic legislation and have taken such a hard line approach to our efforts to operate in good faith."

It believes the FDA misrepresented its intent and encourages the FDA to return to the negotiation table. "We all share in the common goal of protecting consumers – in fact; product safety is the cornerstone of all that this industry represents," notes Westine. She adds that there were 381 adverse reactions to cosmetics reported to the FDA in 2012 of more than 11 billion products sold in the United States, most of these reports being mild allergic reactions.

She continues that both the FDA and the PCPC has invested significant time to develop effective cosmetics regulation in the United States, concluding, “Regardless of whether the FDA chooses to return to the table, the personal care products industry will continue to work diligently to ensure that the families who trust and use our products continue to have the choices they want, the products they trust, and the confidence in their safety. We will work with Congress to pursue meaningful solutions.”

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