Thursday, September 26, 2013

FDA Finally Issues Definition of "GLUTEN FREE"!

FDA issued the update below DEFINING the term "Gluten Free".   As a Celiac, this is extremely exciting news! The reason this is a HUGE deal?  Us Celiac's need to know we can trust food products that are labeled "gluten free".  If they are not, the repercussions are severe, ranging from serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers...

My sincere hope is FDA will now test imported products that make "GLUTEN FREE" claims, and assure these companies are legitimately using the gluten free claim.  Meaning, I hope FDA will enforce and penalize those that are importing misbranded product and not correctly utilizing the gluten free claim!  The enforcement tools I will look for include FDA detaining imported product making gluten free claims, and sending them to FDA's own laboratories to check the parts per million of gluten in the product.  If the product contains more than 20 parts per million of gluten, FDA should refuse admission of the product - meaning it would need to be exported or destroyed within 90 days of the refusal, otherwise, companies would face a liquidated damages claim. I also hope FDA will take the added step of adding non-compliant companies to the FDA's Import Alert (black list) so that the products are AUTOMATICALLY stopped before entering the U.S. and the importer is forced to prove compliance prior to getting FDA to release the goods.

The "Compliance Date" for this final rule is August 5, 2014. If consumers see products labeled "gluten free" we should be able to TRUST that those products legitimately do not contain gluten. Now, we have a standard. Products labeled gluten free must contain LESS than 20 parts per million of gluten to be legitimately labeled so.

This is a fantastic start!!! Here's what the FDA had to say, and the actual FINAL RULE is included as a hyperlink at the end.
FDA defines “gluten-free” for food labeling
New rule provides standard definition to protect the health of Americans with celiac disease
The U.S. Food and Drug Administration today published a new regulation defining the term "gluten-free" for voluntary food labeling. This will provide a uniform standard definition to help the up to 3 million Americans who have celiac disease, an autoimmune digestive condition that can be effectively managed only by eating a gluten free diet.
“Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s new ‘gluten-free’ definition will help people with this condition make food choices with confidence and allow them to better manage their health.”
This new federal definition standardizes the meaning of “gluten-free” claims across the food industry. It requires that, in order to use the term "gluten-free" on its label, a food must meet all of the requirements of the definition, including that the food must contain less than 20 parts per million of gluten. The rule also requires foods with the claims “no gluten,” “free of gluten,” and “without gluten” to meet the definition for “gluten-free.”
The FDA recognizes that many foods currently labeled as “gluten-free” may be able to meet the new federal definition already. Food manufacturers will have a year after the rule is published to bring their labels into compliance with the new requirements.
“We encourage the food industry to come into compliance with the new definition as soon as possible and help us make it as easy as possible for people with celiac disease to identify foods that meet the federal definition of ‘gluten-free’” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.
The term "gluten" refers to proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains. In people with celiac disease, foods that contain gluten trigger production of antibodies that attack and damage the lining of the small intestine. Such damage limits the ability of celiac disease patients to absorb nutrients and puts them at risk of other very serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers.
The FDA was directed to issue the new regulation by the Food Allergen Labeling and Consumer Protection Act (FALCPA), which directed FDA to set guidelines for the use of the term “gluten-free” to help people with celiac disease maintain a gluten-free diet.
The regulation was published in the Federal Register.

Wednesday, September 25, 2013

Join FDA in Miami to Discuss Major FSMA Proposed Rules

The U.S. Food and Drug Administration (FDA) announced it will hold two additional public meetings to discuss the Food Safety Modernization Act (FSMA) Proposed Rules on Foreign Supplier Verification Programs (FSVP) and the Accreditation of Third-Party Auditors/Certification Bodies
The two proposed rules are designed to strengthen assurances that imported food meets the same safety standards as food produced domestically.  The FSVP proposal provides requirements for importers to verify that their foreign suppliers are implementing the modern, prevention-oriented food safety practices called for by the FSMA, and achieving the same level of food safety as domestic growers and processors. This will create a new burden for importers to know and trust their manufacturers.  I believe we can expect to see enforcement and penalties from FDA - if you have not met your manufacturer yet, now is the time!
The second proposed rule on the Accreditation of Third-Party Auditors/Certification Bodies provides for the strengthening of quality, objectivity, and transparency of foreign food safety audits on which many U.S. food companies and importers currently rely to help manage the safety of their global food supply chains.
The purpose of the FDA’s public meetings is to solicit public comments on the proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the proposed rules.
If you are interested in commenting on these proposed rules, contact me to discuss the process. Please note the timeline below to submit comments to the FDA. 
These two added meetings will take place in Miami, FL and Long Beach, CA.

  • Miami meeting - October 10-11, 2013, at the Hyatt Regency Miami, 400 SE Second Avenue, Miami, FL 33131.
October 10, 2013
8:30 a.m. – 5:00 p.m.
October 11, 2013
8:30 a.m. – 12:30 p.m.  

  • Long Beach meeting - October 22-23, 2013, at the Hilton Long Beach & Executive Meeting Center, 701 West Ocean Boulevard, Long Beach, CA  90831
October 22, 2013
8:30 a.m. – 5:00 p.m.
October 23, 2013
8:30 a.m. – 12:30 p.m.
Please note the following important dates for the meetings in Miami, FL and Long Beach, CA:

  • Meeting in Miami, FL

    • September 24, 2013: Closing date for request to make oral comment

    • September 24, 2013: Closing date to request special accommodation due to a disability

    • October 1, 2013: Closing date for advance registration

  • Meeting in Long Beach, CA

    • October 1, 2013: Closing date for request to make oral comment

    • October 1, 2013: Closing date to request special accommodation due to a disability

    • October 8, 2013: Closing date for advance registration

  • November 26, 2013: Closing date to submit either electronic or written comments to FDA’s Division of Dockets Management; for the proposed rule on Foreign Supplier Verification Programs, see Docket No. FDA-2011-N -0143. For the proposed rule on Accreditation of Third-Party Auditors/Certification Bodies, see Docket No. FDA-2011-N-0146.
If you manufacture or import food products you MUST stay on top of FSMA and the new rules FDA will implement.  For assistance in commenting on these important new changes, contact me.  See you at the Miami meeting.

Monday, September 23, 2013

REGISTRATION OPENS for CBP's 2013 East Coast Trade Symposium in D.C.

Mark your calendars for the CBP 2013 East Coast Trade Symposium, scheduled for October 24 – 25, 2013, at the Washington Hilton Hotel in Washington, D.C. This year’s theme is “Increasing Economic Competitiveness Through Global Partnerships and Innovation”.

Based on the overwhelming interest received by CBP for participation at the Symposium, CBP is limiting attendance to three (3) participants per company to afford equal representation from all members of the international trade community. If a company exceeds the limitation, subsequent registrations will automatically be placed on the waiting list.

Registration for onsite participation is $108, and is open as of September 18, 2013 at 12:00 p.m. EST. Act fast, this event sells out quickly!

Attendance at the Symposium is an excellent opportunity to meet with all levels at CBP, so take advantage of this opportunity! For a sneak peak at what to expect in DC, see the agenda here. See you at the CBP Symposium!

An added bonus:
  • As a special opportunity for U.S. citizens participating in this year’s CBP 2013 East Coast Trade Symposium, U.S. Customs and Border Protection (CBP) will be on-site to conduct interviews for those interested in enrolling in the Global Entry program. Act within the next week, in order to be eligible for on-site enrollment. This offer is only available to those who have completed the online application, paid the $100 application fee, and are pre-approved through the Global Online Enrollment System.
  • Interested attendees must apply for Global Entry by Friday, October 10.
  • When applying, be sure to only select the Global Entry option. Global Entry is extremely popular with frequent international travelers because approved travelers use a kiosk to enter the U.S. rather than waiting in line to see an officer. For U.S. travelers, Global Entry approval also allows you to enroll in the Transportation Security Administration’s (TSA) PreCheck trusted traveler program, which expedites screening through TSA checkpoints at participating airports.
This is a terrific benefit I hope you will take advantage of.  I am a HUGE advocate of the TSA PreCheck program, check out my blog post regarding this wonderful program here.