Learning to Dance with the FDA

wet&wildOver the past 20 years I’ve had the opportunity to meet with several FDA Investigators. In recent years the rules have changed allowing them more involvement in our association.  Learning how to deal with nonsense they thrust upon us has been like learning to dance to a strange and unusual tune.  Common sense need not be applied.

The latest dance steps were spun through this past Monday & Tuesday.

The FDA is here. We were just getting started with our day when they arrived for another inspection. It is so unnerving to have them show up. I just hang onto the truth that the Lord is in charge and it will all be for the very best. He will give strength for the day.

Today is also my husbands birthday. I’ve been so blessed to have him in my life. Aside from being my best friend he has stood by me through it all and today appears to be another of those stand together days.

UPDATE TO FDA VISIT POST FROM JUNE 12

The FDA investigators arrived for their second day of their inspection and they left last night just before 6 pm. The team consisted of two women, very nice people overall. I think I could like them under different circumstances.

OK, so the bottom line is this is a dance we will have to learn and do if we are going to continue doing what we do. It is do-able.

Over the last two days Michael and I put them through their paces, we made sure we understood exactly what they want and how we are to achieve it.

I finally get it, I believe. That does not mean I agree with the complete stupidity of these regulations. Little of what we are having to do has anything to do with the quality of the herbal combinations we put out and everything to do with paper trials.

For those of you who may one day need to know here is what they want to see. I have to put in writing directions, that of course, agree with their regulations, for every thing we do. How we make our labels and apply such label. How we combine our herbs, the steps we go through when setting extracts. Every step of what we do has to be written out and comply with what they think it should be.

There is a rule book to follow so it is not arbitrary for the inspector or should I say the inspector does not get to make it up as they go. They were a bit surprised when I quoted their rules and made a stand on several points. I’ve read the complete FDA rules that apply to us. I put them into a kindle book so I can search easily.

Since their last visit I have been working on all these written documents they want but still did not understand exactly how it all fit together. IT makes more sense now. My husband and I do not feel discouraged but empowered, the women who were here gave us the gift of their knowledge and we were able to put our aversion to what they are and who they are aside so we could hear.

This is a long post I wanted to share the understanding that this is the world we are living in, to do the good we want to do we must learn to abide here while trusting in the one who has promised to see us through whatever may come.

Please feel free to ask questions, I will be happy to help.

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