When I started this process, I knew I needed an attorney but had no idea where to start. Through one contact I found exactly what I needed. An attorney specializing in regulatory affairs for consumer product companies; counsels on clinical development, regulatory interactions, marketing practices and compliance; and prior to that spent 11 years in the legal department at one of the top 10 pharmaceutical companies in the world.
They also have a trademark team and like to work with both large and small companies. They are fantastic and obviously are outsourced. It's amazing who you can find when you ask your friends.
Read more: Oh, the People You'll Meet
So far I see no need for vertical integration in most facets of the company - but that may change at some point. Any horror stories on why this isn't a good idea is appreciated.
What I learned from the attorneys is pretty interesting. By having sunscreen in the moisturizer it makes it a combination over the counter ("OTC") drug and cosmetic. As such, marketing claims are governed by the FDA, FTC and National Advertising Division of the Council of Better Business Bureaus ("NAD"). That may seem a bit overwhelming but the good news is since the regulation is at the Federal level; you can use an attorney anywhere in the US. Even better, unlike say an insurance company that is regulated at the state level where you need to deal with 50 commissioners, it is actually easier to comply with one regulatory body = The Fed. Clearly, this will expand once distribution goes outside of the US.
Marketing claims include not only what is on the label; but any and all advertising, as well as what I say on this blog. There is regulation on where information is placed on the packaging; what font it is in and whether it is in regular or bold type. Currently, there is a white paper being circulated by the FDA which proposes new regulation for formulation, testing and labeling. It's a welcomed and necessary regulation for the industry - the final regulation and effective date is still to be determined. Here is the link:
Next up = the Scientists.