POSTED: July 30, 2009

FSBS+ and the FDA

We've heard from several customers recently who were concerned the FDA had banned FSBS+. So, we wanted to let you know what's going on:

FSBS+ has NOT been banned. You can continue to order FSBS+ and we will continue to make it and stock it and none of us will be going to jail.

Here's what happened: The FDA set up a task force to specifically deal with all of the products released or advertised in relation to the pandemic or H1N1. This FDA task force posted a list of companies on their web site with pandemic-related products that were not FDA approved and of course, that includes us.

Several months ago, the FDA Task Force listed FSBS+ and contacted us about it because of the way we had worded the product description on our web site. We worked directly with the FDA to address their concerns right away and we adjusted the wording on our web site accordingly, so as not to give the FDA heartburn. The FDA now considers Perelandra and the FSBS+ product description to be in compliance.

The reason for the confusion (and I might add, we were confused as well as the FDA rep on this): Once you are put on the above-mentioned FDA list, you stay on it. They don't take products or companies off the list after they have complied, they just change one word in one column on the chart — from a "yes" to a "no." And this is where confusion runs rampant.

With each product that the FDA lists, they have a column to denote:
"Unapproved/ Uncleared/ Unauthorized Claims Currently on Website (Yes/No)"

For Perelandra and FSBS+, that column now has a "No" (to indicate we currently do not have unapproved claims on our web site).

If FDA approval is important to you, we want to be clear about this: The FDA has not tested, evaluated or approved any Perelandra products, including FSBS+. However, the FDA has looked at our web site, FSBS+ and Flu Season Balancing Solution product descriptions and has determined that we are in compliance with their regulations concerning the labeling of these products.

If you have any concerns about this, please feel free to contact us. Note: Our new friend at the FDA was perfectly pleasant and helpful, so please don't call them and complain about them giving us a hard time. They didn't, and we appreciate their working with us in this matter. But, know that we also appreciate your loyalty in pointing out your concerns and bringing your questions directly to us.

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