FDA Lawyers Fight National Resources Defense Council
FDA Lawyers Fight National Resources Defense Council
Thirty years ago, FDA considered regulating two chemicals that can damage reproductive organs, sperm quality, and hormone production. After its initial consideration, FDA did nothing. In the beginning of August, the National Resources Defense Council sued FDA, requesting that FDA laws be changed regarding chemicals triclosan and triclocarban.
"Plaintiffs contend that the FDA violated federal law in its delay over establishing safe conditions of use. More than 30 years ago, the agency first proposed to regulate such products for over-the-counter use, but they remain on the market and are unregulated," said a spokesperson for the National Resources Defense Council.
FDA laws are charged with the regulation of all drugs including proposing over-the-counter drugs which are found to be safe and effective. FDA lawyers in their Office of Regulatory Affairs will now be required to defend FDA's lack of regulatory action.
In 1978, FDA proposed a ban from interstate commerce of triclosan and triclocarban, however no further action was taken until 1994, when some ingredients were reclassified.
FDA lawyers have been attempting to review various over-the-counter monographs which were never completed, including the FDA law which still permits triclosan and triclocarban. In April FDA announced to Congress its intent to look into the two chemicals, however no action seemed to be forecoming. As a result, the National Resources Defense Council is requesting a court order requiring FDA action by a specific date. FDA states it is "working diligently" to finish the regulations.
Ms. Capote represents businesses with regulatory compliance issues and litigation. She focuses her practice on representing clients before regulatory agencies, such as the Consumer Product Safety Commission, Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Customs and Border Protection (CBP) and United States Department of Agriculture (USDA).
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