Soaps, lotions, all manner of potions go straight to the consumer because they're not marketed as drugs. It only counts as a drug if you want to claim on the package that it has a biological effect.
The FDA process as it's set up now isn't about safety necessarily. It's about whether you're allowed to claim your product has an effect. If you want to say it protects against UV light, that's going to cost you about $20 million. If it's for a product you don't even have a patent on, that's just not going to happen.
The FDA process as it's set up now isn't about safety necessarily. It's about whether you're allowed to claim your product has an effect. If you want to say it protects against UV light, that's going to cost you about $20 million. If it's for a product you don't even have a patent on, that's just not going to happen.