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

Food Facility Registration and Biennial Registration Renewal

Hello!

If you are crunched for time during this end of year holiday season, this may be good news from FDA:

In 2003 food and dietary supplement facilities were required to register with FDA. Re-registration or renewal was only required when information about the facility changed. As part of the Food Safety and Modernization Act enacted on January 4, 2011, a new biennial renewal requirement was established and all facilities were to renew their registration by December 31, 2012.  FDA was slow to establish a system to handle the renewals and this week FDA extended the deadline to January 31, 2013 for all food and dietary supplement facilities to renew their registration. 

All foreign and domestic facilities that manufacture or hold food or dietary supplements for sale in the US market must submit the following information:

• Facility name, address, phone number, and emergency contact phone number;
• Parent company name, address, and phone number (if applicable);
• Name, address, and phone number of the owner, operator, or agent in charge;
• Email address for the contact person of the facility or, in case of a foreign facility, the U.S. Agent for the facility;
• All trade names the facility uses;
• Applicable food product categories, as listed on the registration form;
• Name, address, and phone number of a foreign facility’s U.S. agent, and phone number of the facility’s emergency contact if it is someone other than the U.S. agent;
• Certification that the information submitted is true and accurate and that the person submitting the registration is authorized to do so; and
• Assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.

There is no fee for registration and it can be done online (at Food Facility Registration or using paper or CD-ROM (see Paper or CD Registration).

A helpful set of questions and answers regarding food facility registration is available at Facility Registration Q&A

All of us at FDALabels.com and Bioscience Translation & Application wish you a joyous holiday season and a great year in 2013.
If you would like to subscribe to our FDA update newsletters, please reply to this post.

Regards,
Evelyn

Dietary Supplement Educational Opportunities

Hello!

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 22^nd 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:

http://www.npainfo.org/NPA/EducationCertification/NPAGMPWebinar.aspx

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 13^th and 14^th 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

http://www.regonline.com/builder/site/Default.aspx?EventID=1055067http://www.regonline.com/builder/site/Default.aspx?EventID=1055067

We at FDALabels.com 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!

Evelyn

An Introduction to Importing FDA-Regulated Products into the US

As posted here previously, FDA has committed to greater inspection of imported products; particularly imported food and dietary supplements (supplements are regulated as a special class of foods).  

We frequently work with companies that wish to import products into the US and have developed the following list of steps necessary to do so.  Note that each step involves many sub-steps not listed here.  Many of the same steps apply to cosmetic products.  Drugs and Medical devices must first be approved or cleared by FDA for use in the US and then steps 4-7 apply to them as well.

Steps to import foods & dietary supplements into the US

       1.  Register the facility where the products are produced and held. FDA Food Facility Registration and What You Need to Know About Registration of Food Facilities

       2.  Review FDA Food Safety requirements and GMP regulations to ensure that the facilities can comply with them since registration puts you on FDA’s inspection list. See FDA webpage on Food Safety

3     3.  If your product is a liquid or gel and preserved by either a) having a low pH or b) being thermally processed, then you must register your facility (a separate registration than 1 above) and submit your processing steps for FDA review and approval prior to shipping product to the US. (Note: FDA uses the term ‘canned’ food to refer to any shelf stable product that has liquid or gel content.) Information for Aseptic Processors and Acidified or Low-Acid Canned Food Registration

4    4.   You must have a US Agent that is physically located in the US to serve as a domestic point of contact and communication with the FDA. US Agent

      5.  You must ensure that your product ingredients are permitted in the US. Unfortunately, there is not a comprehensive list of what is or is not permitted and not everything that is permitted in the EU is permitted in the US. Even FDA's Everything Added to Food in the United States is only a partial list.

i      6.  You must ensure that the product label is in compliance with FDA regulations FDA Food Labeling Guide; Dietary Supplement Labeling Guide; Cosmetic Labeling Guide

      7.  You must notify the FDA of your shipments so then can be inspected upon import. Prior Notice of Imported Foods

NOTE: This list only covers FDA’s side of importing. US Customs and Border Protection has other regulations which are outside of our expertise.  We recommend that you work with a reputable Custom Broker to ensure compliance with those other import regulations.

We at Bioscience Translation & Application and FDA Labels.com hope that you find this information helpful. Contact us with question or post a comment.