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Wednesday, August 15, 2012

Dietary Supplement Educational Opportunities


Many of our dietary supplement clients have come to us for proactive assistance with proper labeling and other FDA regulatory issues.  Unfortunately, some companies only found us after they had problems and were subject to enforcement action by FDA.  It is expensive and time consuming to have to respond to FDA warning letters or have products held at the border.  Further, some violations raise the possibility of product recalls or even complete removal of the product from the US market.  My team and I do our best to alert our clients and help them understand the FDA’s Good Manufacturing Practices (GMP) regulations and I want to be sure you have heard about two opportunities to learn more about them.

August 22nd from 1:00 pm to 3:00 pm Eastern Time (Webinar)
The Natural Products Association is Sponsoring a webinar on the GMPs the effect companies that distribute but do not manufacture their own products. FDA calls such companies ‘Own Label Distributors’. I believe this information is crucial for dietary supplements that want to grow and stay out of trouble with FDA. Here is a link to registration for this webinar and a brief description follows:
FDA says that if your name is on the product, you are responsible for it. The agency has issued numerous warning letters to own-label distributors for GMP violations—Ensure your product is in compliance with GMPs by registering for this webinar. Hear directly from FDA about their expectations are for specific for own-label distributors, re-packagers, and re-labelers, and hear from our industry speaker about how to achieve compliance.

September 13th and 14th In person conference in Boulder, CO
Sponsored by The Rocky Mountain Dietary Supplement Forum: What Does FDA Really Expect from Us?
At this day and a half seminar you will learn directly from industry experts.
    Learn how to dramatically change the outcome of your inspection with the Agency
    Hear from FDA Denver District representatives on what they expect during an inspection plus the top 483 items trended by FDA 
    Receive step-by-step instructions and a template on how to respond to 483s and Warning Letters
    Interact with other industry professionals who are facing the same challenges you are

We at and Bioscience Translation & Application hope that you find this information helpful.  If however, you wish to receive these occasional posts as newsletters, please post a reply to this entry.

Meanwhile, we would be pleased to help you with your questions about FDA regulations. 

All the best to you and yours!

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