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 FDALabels.com 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 5^th.  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. http://www.naturalproductsinsider.com/articles/2013/01/keeping-aer-requirements-in-focus.aspx
2. More free information for Dietary Supplement companies can be found at http://www.sidiworkgroup.com/. 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 31^st unless your original registration was after October 2012.  Visit this site to register: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/default.htm.  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: www.BioTransApp.com and www.FDALabels.com to learn more about our services.  You may also reply to this post to be added to our newsletter distribution list.

Regards,

Evelyn

Reportable Food Registry

Hello!

I received the following email from FDA today and wanted to pass it along to you.  Please let me know if you have any questions.

The U.S. Food and Drug Administration has a new way to head off potential cases of foodborne illness – the Reportable Food Registry (RFR), where food industry officials must use to alert the FDA quickly, through an electronic portal when they find their products might sicken or kill people or animals. The requirement, a result of legislation, took effect with the launch of the portal.

Facilities that manufacture, process or hold food for consumption in the United States now must tell the FDA within 24 hours if they find a reasonable probability that an article of food will cause severe health problems or death to a person or an animal.

The reporting requirement applies to all foods and animal feed regulated by the FDA, except infant formula and dietary supplements, which are covered by other regulatory requirements. Some examples of reasons a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

The requirements apply to any person who has to submit registration information to the FDA for a food facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States. These people are termed responsible parties.

A responsible party:

1. Must investigate the cause of the adulteration if the adulteration of food may have originated with the responsible party
2. Must submit initial information; followed by supplemental reports
3. Must work with the FDA authorities to follow up as needed

A responsible party is not required to report if it found the problem before the food was shipped, and corrected the problem or destroyed the food.

The agency issued draft guidance on the RFR in June and sought comment. The FDA also held three public workshops across the country in which FDA representatives explained the RFR requirements and how the portal will work. A Federal Register notice was issued on September 8, 2009, announcing the opening of the RFR electronic portal and the availability of final guidance to assist the food industry in complying with the requirements of the RFR.

For more information, please read the RFR Guidance at www.fda.gov/ReportableFoodRegistry.