What’s the big deal with the FDA disclaimer? I’d really like to make some marketing claims about my product – and everyone else seems to be doing it!
If you make claims about your product, you might as well start the ball rolling with a new drug application (NDA) – because that’s how the FDA looks at it. You have to be able to prove those claims, prove them scientifically – and that takes more than performing a couple of tests. We offer testing to give you better information about your products – and because we’re proud of what we manufacture.
If you make claims about your product, it becomes subject to all the FDA regulations in regards to drugs. If you utilize a substance known to be therapeutically useful, it might well be “implied” as a drug. This needs to be thoroughly researched prior to manufacturing.
American Custom Technologies has its products manufactured in an FDA-registered facility. We consult with FDA representatives when we’re in doubt about the legality or advisability of a particular action*. We aren’t about to advise our customers to do something that will cost them money, time, reputation… maybe even bankruptcy! No one wants to get on the wrong side of the legal system – and the way to prevent that is to play by the rules.
American Custom Technologies values our customers, and we don’t want to see anyone end up with a recall or a fine.
*This is not to say that we’re FDA legal experts. If you want to start that NDA, please get a lawyer that specializes in pharmaceutical law. We recommend that all of our customers consult with a legal expert in labeling and marketing claims prior to submitting their artwork for use.