Injuv comes in 6.3 but the site recommends 70mg?

When things have an RDA, or we are under a trademark licensing agreement, sometimes we are forced to list things in the Supplement Facts box in a certain way. For things with an RDA that means listing the amount of the raw dietary ingredient in the box with a "from Xmg of X." So what that means is that for something like magnesium glycinate is that we have to list the amount of elemental magnesium per dose, not the total amount of magnesium glycinate. So magnesium glycinate says 200mg per serving "from 1,500mg magnesium glycinate."

Things under a TMLA are under a similar situation. So for Injuv we list the total hyaluronic acid in the box, then put "from 70mg Injuv®" next to it. The FDA requires us to list the common name for things in there, rather than the trademarked ones. This is to prevent confusion and provide consistency.

To further complicate things, the FDA regulations and USP regulations don't exactly match. So the FDA stipulates that we have to be at or above label claims (within reason). USP capsule regulations say you have to be 10% (up or down) from target on capsule fills. I am simplifying things greatly, but you get the idea. Then you have raw material specs. So magnesium glycinate can be in spec from 12.9% to 15% elemental. So we need to leave room for raw material variance and capsule variance on our label claims. So the vast majority of the time you are getting more than what the label claims. We just have to ensure we are never under, so we lower the claim in the Supplement Facts box to ensure that.

Hopefully that explains it a bit. It can be really complicated complying with the regulations. We just went through an FDA/NSF audit in preparation for NSF certification. So we literally went through every little detail in the regulations and 21 CFR 111 and had an inspector here looking at everything we do. I find it funny when people say "the FDA doesn't regulate supplements." If they only knew how insanely detailed the regulations actually are... Did you know that we have to have written SOPs for the color of pens we use to sign documents! Unregulated? Hah!