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Wednesday, January 30, 2013

Adverse Event Webinar and Other Useful Information for the Dietary Supplement Industry

Here’s hoping that the first month of 2013 has been a good one for you!  Thanks to our many valued clients, the year is off to a good start for our team. Our goal is to help your company comply with applicable FDA regulations. Accordingly, the team at and Bioscience Translation & Application try to bring useful information to our clients.  Today we have several things for you:
  1. A Free Webinar from Natural Products Insider on Adverse Event Reporting for the Dietary Supplement Industry is set for February 5th.  This is a very important topic for every company that has its name on a dietary supplement product able. You can visit the following webpage for more information and a link to registration.
  2. More free information for Dietary Supplement companies can be found at The Standardized Information on Dietary Ingredients (SIDI) Working Group is an association of trade groups that has put together very helpful information on complying with FDA regulations.  The home page (link provided above) has a new publication on how to ‘qualify’ your ingredient or product supplier. Supplier qualification programs are necessary so that you can determine how reliable the supplier is likely to be and whether or not you will get the ingredients or final product you have specified. You can also find links to sample certificates of analysis and  product information data sheets.  It is important to have and know how to use this information for each ingredient used in your products.  The site also includes other useful information on their FAQ page.
  3. Thursday, January 31, 2013 is the deadline for registering any facilities that warehouse or manufacture dietary supplements and foods.  ALL facilities MUST re-register by the 31st unless your original registration was after October 2012.  Visit this site to register:  FDA has provided some additional information on this topic:
Now Available: New FAQs Concerning Food Facility Registration
Please note the addition of two new FAQs concerning the renewal process:

IC.3.26 I do not have the Food Facility Registration PIN number that is required to access my registration in the online registration system, and therefore I am unable to renew my registration. What steps should I take?
Due to certain confidentiality constraints and the amount of time it takes the Agency to process PIN requests, the Agency is no longer able to fulfill PIN requests for registration renewals for the 2012 renewal period. If a facility is unable to renew its existing registration by January 31, 2013 because it does not have its PIN number, the facility may create a new registration by January 31, 2013 in order to be registered in accordance with section 415 of the FD&C Act.

IC.3.27 If I create a new registration, will I retain my compliance history or shipping history associated with my facility?
Some facilities may create new registrations rather than renew existing registrations because they no longer have the PIN numbers that are needed to access their existing registrations in the online registration system. For such a facility, the Agency does not anticipate a loss of compliance history or shipping history, provided that the facility’s new registration includes the same information such as facility name and facility address.
Please see the FSMA Registration page for additional resources.

It is our sincere hope that you will find this information helpful. Please feel free to forward this email to others who may be interested and please always contact us with any questions you may have.Visit our websites: and to learn more about our services.  You may also reply to this post to be added to our newsletter distribution list.


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