One of the things that irritates me about dealing with regulatory agencies is that the regulated organizations are sometimes victims of some individual martinet in the bureaucracy who takes it upon himself to engage in mission creep and expand the rules by adding his own peculiar interpretation. I am sorry to confess that I have often counseled "discretion is the better part of valor" when encountering such a situation, reasoning that it is less expensive to knuckle under to this bully than to engage in a war which ends up being a pyrrhic victory when it is won in a court or an appeal.
I don't recall the details, but a couple of years ago, one company DID take on the FDA and won, but it was a long and costly battle for the company, while there was no penalty for the FDA people who made an erroneous call.
As much as I would like to believe in Superman's ". . . never ending battle for truth, justice, and the American way," the fact is I still counsel my clients caught in a battle with a government agency to remember wars are rarely one by a single battle and to explore all options before entering into pitched battle with an agency that has virtually unlimited resources and can close down the business, shutting off income to fight the battle.