Excellent post Gary. There is no question that conducting what amounts to Phase II efficacy trials in Germany is overkill for a cosmetic product. I refuse to believe that Germany will not accept our pre clinical efficacy and IRB safety trials for a cosmetic. Even if I'm wrong and Germany demands more, there are several other countries and states here in the US where those two trials would be more than enough to introduce the cream to market. I've never heard of any cosmetic item, herb, vitamin, mineral, or enzyme having to go thru such trials. Even in my profession Chinese herbal medicines don't go thru such trials. They must be manufactured according to GMP standards that is overseen by the FDA, and there are several steps to insure safety, efficacy and authenticity by the profession, but FDA approved trials are not necessary because they are not drugs.