“FDA sources tell RegWatch; the spammed entry of over a quarter-million fake comments is ‘extraordinary’ and ‘unprecedented’,” writes RegulatorWatch.com. “It nearly brought down federal servers and so bogged-down the internal network it’s become next-to-impossible to process any submissions at all. It’s a massive assault on the credibility of the public consultation process.”
Each ANPRM could dramatically change or alter the tobacco industry. The ANPRM on flavors could lead to new regulations that either restrict if not completely ban flavors in covered tobacco products from menthol in cigarettes to flavors in cigars and e-liquids. Carried out by a bot implemented by an unknown source, the commenting function was disrupted, causing the FDA to have to sort through comments and decide on their legitimacy. The bot attack began on June 8, 2018 and ended on June 11, 2018. If this attack was indeed legit, the credibility of entire commenting process.
The FDA is required to review each submission before it officially publishes those comments at the end of the commenting period.
