It seems the only thing that’s permanent is change and our labels often reflect this simple reality. There are several reasons why we occasionally have to change our formulas, but we do our best to minimize the need for change as we understand people come to rely on consistency. Needless to say, we always seek to use the best raw materials available in our formulas and that efficacy is our priority.
Sometimes our ingredients change because we have found a new raw material that will enhance the efficacy of that formula. For example, previously, in our Joint formula we were using Curcumin with 95% curcuminoids. That form was one of the best raw materials available at the time. As soon as Meriva® became available from Indena Labs, with phytosome technology that significantly increased the bioavailability of the curcumin, we went ahead and changed to that raw material.
Another reason for change is when a fellow practitioner suggests the inclusion of another raw material that would add to the effectiveness of that formula. That has happened more times than one would expect. I certainly don’t profess to know everything and, being aware of that fact, I take full advantage of the suggestions I receive from my brilliant colleagues.
Regulation by the Food and Drug Administration is also sometimes a source for change in our formulas. We recently reformulated our Cholesterol formula to meet the FDA’s enforcement on their ban of therapeutic forms of red yeast rice powder (RYRP) as an ingredient in nutritional supplements. Certain red yeast rice strains are specifically cultured to increase the concentration of ten naturally occurring mevinc acids (also known as monacolins) that contain lovastatin.
Lovastatin is the active ingredient in the prescription drug Mevacor®. Although RYRP with mevinic acids has long been a nutritional aid to help lower cholesterol, Merck® is the pharmaceutical manufacturer of Mevacor® and they argued that they own the rights to the ingredient lovastatin, regardless of the fact RYRP is a food. The FDA is known for making laws that protect the financial interests of the pharmaceutical companies they were legislated to regulate and as a result, the FDA is now fully enforcing the ban of RYRP for use in nutritional supplements as the natural form of lovastatin are now classified as drugs. Many companies may choose to continue to use RYRP, but it’s important to understand that their raw material will not claim any content of mevinic acids or else they will face an FDA retaliation.
Regardless of these challenges, our Cholesterol formula has benefited from the reformulation. By doubling the quantity of the Guggul extract and our phytosterol complex we increased the efficacy of the formula. As a personal testimony, my cholesterol came down from 209 to 178 after the changes to the formula!
Finally, we sometimes must change our formulas because the raw material is no longer available. Recently we had to change our Acid Reflux formula because we could no longer purchase D-limonene powder. Actually, the loss was more than made up for by additional amounts of other strong demulcent herbs: Aloe Vera, Marshmallow, and Slippery elm bark.
Please rest assured that when we do change our formulas the result is better patient outcomes. Our goal is to inform you as soon as possible whenever there is a change.