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Re: Jayyy post# 7992

Tuesday, 11/29/2016 4:11:07 PM

Tuesday, November 29, 2016 4:11:07 PM

Post# of 13735
You state "The scammers made claims in their BS press release--the FDA caught them--challenged them to go to COMPLIANCE which they have NOT done --".

This is a most twisted and contorted interpretation of the FDA letter, so here is the truth:

1) The press releases have nothing to do with the FDA letter.
2) The FDA did not 'catch' anyone.
3) There was no 'challenge' by the FDA to go to Compliance.

Additionally,
4) The FDA denied the appication for over-the-counter sales BECAUSE it is a drug.
5) The FDA invited, suggest, recommended (or whatever similar word one wishes to use) for Roth to submit an application to FDA Compliance Department for approval AS A DRUG.
6) Submitting an application to Compliance is optional, not required. Roth opted not to submit an application for drug approval as this is very exensive so Roth decided to market in other countries where FDA approval is not required.
7) Roth is in 100% good standing with the FDA.

This is the complete truth. This may not fit with your worldview, but it is the truth.