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TIMOTHY MAILER: With studies of choline, we have used both men and women.

MARITZA RUBIO-STIPEC: Do you have the distribution by gender?

TIMOTHY MAHER: No. But, most of the studies of the individual amine acids have been in men, especially the ones that have dealt with athletics and performance.

ROBERT NESHEIM: A question?

MACKENZIE WALSER: I wanted to comment. I was on that same committee that Dr. Maher was on, and I think one point that you did not bring out was that we were concerned about quality control. You can put sugar on the shelf in a grocery store, and it is going to have to meet certain standards. I have no idea what they are, but it does have to meet certain standards, or the FDA will impound it.

On the other hand, you can put lysine on the shelf, and it can actually be sodium cyanide. I am not kidding. There is absolutely no control of quality.

I will never forget that while working in this committee, we got some table—not sodium cyanides—but we did get some tablets of lysine and put them in a beaker of water to see what the dissolution time was. Three days later, they were still there, intact.

So there are no criteria, either, for dissolution, which is a minimum requirement for any capsule that is sold as a drug.

So I don't understand why the FDA, cannot design standards for quality control, at least for amine acids, before we have these tremendous studies of efficacy.



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