If it is sold as a cosmetic product it does not need FDA approval. IRB clinical approval is more than what is required for these products. Because there are no "drugs" in the product I'm not sure if it will ever require FDA approval as topical medicine. It may be sold OTC in drugstores everywhere, or at least in states that have MMJ guidelines. I'm no expert on this but because there are no pharmaceutical drugs in the product it may allow us to market it OTC. In time they may opt for FDA approval... I would think the path for that would be a lot easier now that they have IRB approval. Very similar guidelines. I think in Europe and Israel IRB approval is similar to FDA approval here. Imagine, a safe and effective psoriasis cream available OTC that is safer and MORE EFFECTIVE than the "leading" pharmaceutical product. It will FLY off the shelves.
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