FDA Regulation of Health Products
For foreign companies seeking to introduce medicines and health products into the US, whether or not that product would need FDA approval is a very important consideration. How the FDA would regulate a product depends in great measure on the intended use of the product as evidenced by the labeling and promotion of the product. There are two broad categories:

Products designed to treat a specific disease would meet the definition of a "drug". The FDA would require the pre-market submission of clinical data from clinical trials in a new drug application to evaluate safety and efficacy.

On the other hand, it is possible that a "naturally occurring substance" promoted for the maintenance of health (as opposed to the cure or treatment of a disease or condition) might meet the definition of a "dietary supplement." If it does, it is possible to market it in the US without FDA pre-approval, so long as certain regulatory administrative requirements were met, including FDA notification.

Kemarra Inc. would investigate the applicable regulations specific to your product, and evaluate options and provide the optimal strategy. This would be undertaken by Kemarra personnel with extensive experience in working in the private sector with companies putting drugs through, or avoiding, the FDA process, and also specialized independent lawyers with prior experience of working for the FDA.