The company has spent the past 2 1/2 years, investing time, capital and resources into creating a compliance portfolio that reduces risk for retailers. It includes …
Full toxicology review leading to Self-GRAS Affirmation (according the FDA Red Book requirements)
Full Topical toxicology review asserting safe use for its topically applied products
DNA verification of its EU Commission registered Industrial Hemp cultivars
With regards to topicals, the company focused on OTC (over-the-counter) Drug Listed products that allow for specific claims but that require significant validation to be sold as a Drug addressing explicit needs legally such as "Pain Relief" which is legally only allowed if a product is in fact listed officially as a drug with an NDC # (National Drug Code)
And finally its involvement in the largest Human Observational Liver and Reproductive toxicology study in the World that was based on the requests made by the FDA for human data.
HempFusion’s FDA drug listed OTC topicals are a game-changer, providing the company with a significant industry differentiator that very few competitors have achieved.
To date HempFusion has launched 8 FDA Drug Listed OTC topicals.
While the FDA has not committed to a legal framework and there are regulatory uncertainties, this is the beginning of a very big market and HempFusion has positioned itself for when that headwind turns into a tailwind.
It should also be noted that the company’s CEO has formulated over 300 dietary supplements and is an expert in the FDA process the many brands at market will face when the FDA gives guidance.
This is a long-term investment, and really a play on the developing hemp and CBD market, which will include more FDA oversight in the coming year.
