"Are you a small business with questions about your FDA-regulated product? Or, do you wonder if your product needs to be approved by the FDA? Contact us!" http://www.fda.gov/ForIndustry/SmallBusinessAssistance/Small...

I sent this question to the mentioned e-mail address industry@fda.gov last August, but never got a response. Retrying.

Any luck this time around? If not I'd give them a telephone call.

I got a copypasta response from them, outlining the steps I already took on their website. Will read it carefully to see if contains any of the info I actually asked for.

One thing is that they expect me to use their web interface to file "prior notice" for every single package I send. I see writing a scraping script in my future..

Government loves bureaucracy.

This is like contacting the IRS for assistance with your tax bill.

Is that supposed to be a bad thing? The IRS provides amazing tax advice -- on the phone, for free -- ask any question and they'll give a detailed answer, point you to the exact parts of the tax code that answer your question, and send you a copy of the documentation if you want.

That's not completely true: http://taxrelief.lifetips.com/faq/129997/0/what-if-i-rely-on...

You have to pay the tax, yes, but no penalty, so you have nothing to loose by asking.