Norm Howe's blog

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.

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?

Our story moves forward in time and across the Atlantic to the battlefields of the First World War.  On the Eastern Front a young German Army medic tried to keep wounded soldiers alive in the filth of trench warfare.  Try as he might, it was a losing battle.  Even if he could sew the broken bodies back together, they would die from infection. 

When you're the one who has to lead a quality compliance effort, sometimes it's best to start with a current headline and then ask, "How did this happen?  Aren't there supposed to be laws protecting us from poisons in the products we buy?" 

You can find any number of treatises on delegation in management textbooks.  Here’s a more nuts-and-bolts approach that allows you to get started right away.

When you delegate a task to others, you need to empower them. It’s required in any field.  It’s especially important in FDA regulated industries.

Mention the word empowerment in any plant and you’ll see everyone nodding in agreement.  It’s almost a paradigm that empowered employees mean a productive workplace.  But look deeper and you’ll see fear in their eyes.