FDA recently published guidelines for recommending the filing of criminal misdemeanor charges against owners and executives of supplement companies.  These are included in the agency’s regulatory procedure manual to give procedures as to when they should recommend to Federal prosecutors the filing of indictments of individuals when there is a violation of the Food, Drug & Cosmetic Act.

The agency will look at the person’s position and authority, whether the violation was obvious, the severity of the violation, whether there is a likelihood of harm to the public, as well as if there was a pattern of illegal behavior and whether or not warnings were ignored. One does not have to meet all of these criteria, but these are the factors FDA will look at to determine whether or not charges should be filed.

FDA bases its authority on a decades old Supreme Court case called U.S. v. Park.  That case has now been dusted off and is being used to prosecute individuals whose company is found to have violated the FD&C Act. 

And, as with any other crime, pleading ignorance will not get you off.  Someone can be found guilty simply by having the authority to stop the illegal behavior. The penalties for such negligence can be anything, including disgorgement of one’s income.

By publishing these guidelines, FDA is sending out an important notice to the industry; if you own or run a company, don’t stick your head in the sand – make sure you know what is going on and if you find inappropriate behavior move swiftly to correct it.  Otherwise it could be your own pocket that’s affected.