Food and Drug Administration (FDA) leadership and staff are accustomed to external criticism and pressure.

After all, FDA-regulated products account for 20 cents of every dollar spent by American consumers, so criticism comes with the job. Over the past year, the volume of noise aimed at FDA over one particular duty—its review of applications for electronic nicotine delivery systems (ENDS) and other “deemed” new tobacco products—has been dialed to 11.

Pressure has come from a variety of voices and in different forms. Antitobacco activist groups, for example, have lobbied FDA to subject ENDS products to the new-drug approval process instead of the legislatively prescribed Premarket Tobacco Product Application (PMTA) process. FDA has thus far ignored that demand, as we discussed in our last commentary.

Read full article here.

Glenn G. Lammi – Forbes – 2021-09-10.

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