US FDA to continue withholding full rationale for tobacco product denials

While the US Food and Drug Administration (FDA) is embracing transparency by releasing full rejection letters for pharmaceuticals, it does not plan do the same for tobacco product denials and cites commercial confidentiality for the disparity.

Earlier this month, the FDA announced that it would release complete response letters (CRLs) that outline findings about the safety and effectiveness of drugs seeking approval to be sold in the US market.

However, the FDA has only chosen to release full marketing granted orders for nicotine products to this point. Marketing denial orders, like the CRLs for pharmaceutical drugs previously, have been restricted, with only a small summary being issued of the reasoning behind the decision to reject a product.