Its not the safety studies. I'm sure the safety studies were done in other countries so they can submit it in the US. But if the company claims some beneficial

Its not the safety studies. I'm sure the safety studies were done in other countries so they can submit it in the US. But if the company claims some beneficial properties to your body then its considered a drug and they need to show efficacy. But if they didn't advertise Novamin as an active ingredient they could sell it in the US but then they can't claim the benefits of that ingredient. I'm not sure how in the EU they can claim benefits without trials.