SupplySide

We have great half day workshops going on during SupplySide West.  Check them out:

Superfruits: Science, Innovation and Market Opportunities: from “new” ingredients from all regions of the world, to emerging science that helps us better understand “old” superfruits like berries, this category is moving fast.

Probiotics: From Physician to Consumer - Market Trends and Stakeholder Perspectives: attend this workshop to find out the latest market trends, health care professional's viewpoint, consumer understanding and regulatory climate.

Stevia: Trends, Product Development and Regulatory Update Workshop: attend this workshop to get the insider knowledge on flavor and formulation developments, consumer awareness and behavior, and a glimpse of the future.

All of the workshops are industry relevant, popular topics that would benefit anyone in the product formulation and marketing/sales aspect of products.

Don’t forget to register for the Official GMP training workshops for SupplySide West.  These are interactive training courses that provide real-world, hands on training and tools, with a focus on documentation management and inspection readiness.  If you’re involved in dietary supplement manufacturing, labeling, management, auditing, quality control, supplying, distributing, or laboratory operations, this is a must-attend workshop.

Official GMP training for SupplySide West workshops are presented by DBA Analytical, an NSF International Co.  Best rates expire August 27.

You can read about the course details and fees here.

Robert Moore of the FDA brought up how our industry constantly complains that dietary supplements receive a fraction of the adverse event reports (AER) that pharmaceuticals get, yet seem to be unfairly treated in comparison.  He stated that we aren’t comparing apples to apples when it comes to an AER from a dietary supplement.  During CRN’s webinar “Dietary Supplement Safety: Understanding the Role of Adverse Event Reports in Product Recalls, Moore stated that the FDA’s reasoning is that side effects of pharmaceuticals are known and expected, and there’s sufficient benefit of the drug that outweighs the danger of the side effect; whereas dietary supplements are taken by generally healthy people, and the risks don’t outweigh the benefits.

Do you think this is fair reasoning?  I’d like to hear what industry members have to say about that statement. 

The webinar itself was outstanding.  There are so many variables that come into play with adverse event reporting.  Questions such as: 

What do you do if a serious adverse reaction comes up in your premarket product, and you see another company already has the product on the market? 

What do you do if no AER has been reported on your product, but you see a consumer talk about a side effect on a social media forum? 

For a risk to benefit analysis, is there a clear definition of “sufficient benefit”? 

What do you do when you’ve followed every protocol, done your due diligence, and still can’t find the problem that could explain the AER on your product?  Run away? 

If you missed the live webinar, I highly suggest you register for the on-demand session.  As James Neal Kababick, one of the adept webinar speakers stated, “You can only run away if the AER is caused by the killer rabbit from Monty Python”.  If not, be prepared!