January 2014

Symptomatic Solutions: the Slow, Gurgling Death of a Factory

Posted on Jan 26th, 2014 by Norm Howe

root causeWant to lower costs?  Want to reduce the risk of problems with FDA?  Train as many people in your organization as possible to write good Root Cause Analyses.  You will eliminate repeat errors, save prodigious quantities of money, and improve critical thinking skills.

How Do You Tell if a Dietary Supplement Will Work?

Posted on Jan 19th, 2014 by Norm Howe

In my last post I discussed the safety of Dietary Ingredients and Dietary Supplements.  We saw that a company that wants to market a New Dietary Ingredient* must notify FDA 75 days in advance, and in that notification must present information on the safety of the NDI.  The burden is on FDA to prove the NDI is unsafe if it does not deem the information sufficient.

This time I want to tell you about the claims that a Dietary Supplement marketer can make about their product.  Dietary supplement marketers do not need to register their products with FDA or get FDA approval before producing or selling dietary supplements.  They must, however, register their manufacturing facilities with FDA.

The Drugs and Dietary Supplements Dilemma

Posted on Jan 12th, 2014 by Norm Howe

How would you like to have a pill that would reduce body fat, increase muscle mass, and improve glucose tolerance?  Well, you do, if you’re a mouse.  Making a similar product available for people and knowing that it will work?  That’s another story.

Wonder Drug? 

Ursolic Acid, a component of apple peels, increases muscle mass and decreases fat mass when 0.14% of ursolic acid was added to the diet of mice.  In addition, it seems to increase the activity of insulin!  Ursolic acid also increases brown fat, a tissue that shares developmental origins with skeletal muscle.

Want to be Compliant? Know Your Technology!

Posted on Jan 5th, 2014 by Norm Howe

Do you spend too much time writing CAPAs and nonconformance reports?  Do your operators take too many shortcuts?  Do batch sheet errors take up your whole day?

If so, count yourself in good company.  Many companies are in the same boat (the one on the left).  The next question is, what are you going to do about it?