FDA Adjusts Civil Monetary Penalty Amounts for Inflation
The Food and Drug Administration is increasing civil monetary penalty amounts for violations of the Food, Drug and Cosmetic Act to adjust for inflation. Instead of going through the normal notice-and-comment process, FDA is implementing the across-the-board increase through a…
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direct final rule here). The rule also allows FDA staff other than the Office of Chief Counsel to authorize civil monetary penalty complaints against tobacco retailers. The new provisions are set to take effect June 18, unless FDA gets adverse comment in response to a concurrent proposed rule by April 17 (here), in which case it will withdraw the direct final rule and follow normal notice-and-comment procedures.