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Center for Food Safety and Applied Nutrition

Constituent Update

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CFSAN to Issue PDF Export Certificates for Food Products

February 15, 2017

Starting February 20, 2017, certificates of free sale (COFS) for food products regulated by the U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition (CFSAN) will be issued online as downloadable PDFs. The change from paper to PDF certificates will make the process of issuing COFS more efficient for both exporters and the agency.

Review of a certificate may be required by foreign countries as part of the process to import a product into those countries. FDA issues COFS for certain CFSAN-regulated food products upon request by an exporter. FDA does not require export certificates to export foods to foreign countries.

The FDA Certificate Application Process (CAP) is CFSAN's web-based application for accepting requests, reviewing, processing, managing, tracking, and administering CFSAN export certificates. To access CAP, log in to FDA Industry Systems athttps://www.access.fda.gov/oaa and select the "Certificate Application Process" option from the list of systems available. If you do not have an account with FDA Industry Systems, you will need to create one.

The advantages of CAP include:

• Online submission of applications;
• Reduction in application processing time;
• Online receipt of certificates via PDF;
• Real-time status updates via email and online tracking; and
• Ability to copy, edit, and resubmit applications.

If exporters are unable to use the new PDF system, they may contact FDA and we will provide assistance.

CFSAN COFS will have a new look, including an updated letterhead and image of the HHS seal. PDF certificates issued directly to the applicant are considered original certificates and the Department of State is able to authenticate the certificates. For each certificate, FDA will provide a unique Certificate Identifier (ID). Foreign government officials authorized by the FDA can use this Certificate ID to verify the authenticity of the certificate. Exporters will need to ensure that the printed certificates are clear and legible. An example of the new look of the certificate is below.

If you have any questions or concerns, please emailCFSANExportCertification@fda.hhs.gov or call 240-402-2307.

          

See an enlarged version of the sample certificate (PDF: 77KB).

For Additional Information:

• FDA Export Certificates
• Export Certificates
• Food Export Certificate Application Step-by-Step Instructions

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Additional Updates from the FDA Center for Food Safety and Applied Nutrition

Center for Food Safety and Applied Nutrition

Constituent Update

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FDA Announcing Public Meeting to Discuss Use of the Term “Healthy” in Food Labeling

February 15, 2017

The U.S. Food and Drug Administration announced today a public meeting to discuss the use of the term “healthy” in the labeling of food products. The public meeting will be held on March 9, 2017 from 8:30 a.m. until 5:30 p.m. at the Hilton Washington DC/Rockville Hotel, 1750 Rockville Pike, Rockville, MD 20852.

The public meeting will give interested parties an opportunity to discuss the use of the term “healthy” in the labeling of human food products. The meeting format will include introductory presentations, stakeholder perspective panel sessions, and multiple opportunities for individuals to express their opinions through oral presentations and breakout sessions. Parties who are unable to participate in person will be able to join the meeting via live webcast.

Public meeting attendees are encouraged to register online to attend the meeting in person. For questions about registering for the meeting or to register by phone, contact Jim Nakayama, The Nakamoto Group, Inc., 11820 Parklawn Drive, Suite 240, Rockville, MD 20852, phone: 301-468-6535 ext. 212, fax: 301-468-6536, email:events@nakamotogroup.com. Early registration is strongly recommended because seating is limited.

For general questions about the meeting or to request special accommodations due to a disability, contact Juanita Yates, Center for Food Safety and Applied Nutrition (HFS-009), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, phone: 240-402-1731, email: Juanita.Yates@fda.hhs.gov.

For more information about the meeting, as well as instructions on registration and requesting to make an oral presentation, see the Federal Register notice about the meeting.

Important Dates to Remember:

• Request special accommodations due to disability 
  February 21, 2017
• Request to make an oral presentation 
  February 21, 2017
• Advance Registration 
  March 2, 2017
• Public Meeting 
  March 9, 2017, 8:30 a.m. to 5:30 p.m.
• Deadline to submit written/electronic comments 
  April 26, 2017

For Additional Information:

• Federal Register notice
• Meeting registration
• Background and Information about Submitting Comments
• Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products
• Federal Register Notice for the Guidance for Industry
• Federal Register Notice for the Request for Information

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Additional Updates from the FDA Center for Food Safety and Applied Nutrition

The FDA is issuing this recall notice from the Canadian Food Inspection Agency to alert U.S. consumers who may have purchased these products in Canada not to eat or serve them. The products under recall were manufactured specifically for the Canadian marketplace. - Updated Food Recall Warning - PC Organics brand baby food pouches recalled due to potential presence of dangerous bacteria

02/15/2017 04:49 PM EST

The food recall warning issued on February 3, 2017 has been updated to include additional products. This additional information was identified during the Canadian Food Inspection Agency's (CFIA) food safety investigation. Loblaw Companies Limited is recalling PC Organics brand baby food pouches from the marketplace because they may permit the growth of Clostridium botulinum.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

Guggisberg Cheese, Inc. Recalls Various Colby Type Cheeses due to Possible Listeria Monocytogenes Contamination

02/15/2017 09:26 AM EST

Out of an abundance of caution and with an emphasis on its customers’ wellness and safety, Guggisberg Cheese Inc. is recalling various types of Colby type cheeses and sizes due to a potential contamination of Listeria monocytogenes.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

Learn Strategies to Engage Students about WWI

This summer, the Library of Congress is hosting special, free programs for teachers—including a special WWI program for the centennial year! These 4 and 5 day courses include materials highlighting primary sources and model strategies to build student engagement. Applications are due by March 17, 2017 for all programs. Choose from: General Focus K-12 (June 19-23, June 26-30, July 10-14) Science, Technology, and Engineering Focus (July 17-21) World War I Focus (July 31-August 4). Participants have the option to complete additional coursework to pursue graduate credit at George Mason University. Programs are offered in Washington, D.C., but teachers across the country are encouraged to apply. Learn more about the Summer Teacher Institute and apply now Allergen Alert Expansion: Legendary Baking Issues Allergy Alert - Almonds And Egg In Salted Caramel Chocolate Almond Pie - Allergens Not Declared In Ingredient List 02/15/2017 02:00 PM EST Legendary Baking of Denver, CO, has expanded its recall of 34 ounce packages of Private Selection Salted Caramel Chocolate Almond Pie because the almonds and eggs were not listed in the ingredient statement. People who have allergies to almonds and eggs run the risk of serious or life-threatening allergic reaction if they consume these products. For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin. Φεβ 15 τις 10:17 μ.μ. FTC Testifies Before Senate Judiciary Committee on Its Efforts to Combat Fraud Affecting Older Americans In testimony before Congress today, the Federal Trade Commission described the current trends relating to fraud affecting older Americans, and how the FTC uses law enforcement and other tools at its disposal to combat these frauds. Testifying on behalf of the Commission before the Senate Special Committee on Aging, Lois Greisman, Associate Director of the FTC’s Division of Marketing Practices, said certain types of scams are more likely to affect older Americans, such as fraudulent prize promotion schemes. The Commission’s efforts to identify and stop illegal marketing affecting seniors has become increasingly vital as the population of older Americans is growing rapidly, the testimony states. “To protect seniors, the Commission has implemented a multi-faceted approach that encompasses robust law enforcement, strategic policy initiatives, and vigorous consumer education and outreach,” the testimony states. The Commission has identified several varieties of fraudulent and deceptive schemes that affect seniors, including: (1) sweepstakes, prize promotions and lotteries, (2) timeshare sales and re-sales, (3) health care products and services, (4) investments, business opportunities and work-from-home programs, (5) technical support services, and (6) charitable donations. The Commission has filed 45 cases against 163 companies and 121 individuals responsible for billions of illegal robocalls, as well as numerous Do-Not-Call violations, many targeting older Americans, and it has brought 25 cases involving conduct that specifically targeted or disproportionately harmed older adults. For example, the FTC has aggressively pursued the money transfer services commonly used in scams targeting older Americans. Just two weeks ago, Western Union agreed to historic settlements with the FTC and the Department of Justice. The FTC’s action alleged that despite knowing its service was used by scammers, including some who were using the so-called “grandparent” scam, Western Union failed to take reasonable steps to stop the frauds. As part of the FTC’s case, as well as a deferred prosecution agreement Western Union entered into with the Department of Justice, the company has agreed to pay $586 million to redress victims. The FTC also has collaborated extensively with criminal and foreign law enforcement agencies to combat fraud, including scams affecting the elderly. Hundreds of fraudsters have faced criminal charges and prison time as a result of FTC prosecution referrals, the testimony states. The Commission, with the Department of Justice, also organizes and participates in a multilateral network of agencies that enforce laws prohibiting mass marketing fraud, which was pivotal in recent enforcement actions to dismantle a global network of mass mailing fraud schemes that allegedly defrauded millions of elderly and vulnerable consumers out of hundreds of millions of dollars. In addition, the Commission partners with multiple foreign agencies to combat cross-border fraud that affects the elderly. Outside of enforcement, in order to address changes in the marketplace that relate to fraud against older Americans, including rapid developments in both demographics and technology, the FTC uses a variety of policy tools including holding workshops, coordinating with industry, and holding public contests seeking technological innovation. For example, in 2014, the FTC created Pass It On, an innovative education effort aimed at active, older adults that covers topics such as imposter and health care scams, charity fraud, and identity theft, the testimony states. The Commission seeks to reach older adults where they gather and live: libraries, social and civic clubs, senior centers, adult living communities, and veterans’ facilities. It recently has released a number of new videos to encourage people to talk about the frauds they experience. Since 2014, the FTC has distributed 5.9 million pieces of Pass It On print material in English and Spanish. Committee members or their constituents can post them, link to them, or order printed copies from www.ftc.gov/bulkorder. The Commission vote approving the testimony and its inclusion in the formal record was 3-0. The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about consumer topics and file a consumer complaint online or by calling 1-877-FTC-HELP (382-4357). Like the FTC on Facebook, follow us on Twitter, read our blogs and subscribe to press releases for the latest FTC news and resources. FTC Undercover Inspections of Funeral Homes in Nine States Prompt Compliance with Funeral Rule Disclosure Requirements FTC’s Funeral Rule requires funeral homes to provide itemized price lists to consumers Federal Trade Commission investigators working undercover in nine states found failures to disclose pricing information to consumers, as required by the FTC’s Funeral Rule, in 31 of the 133 funeral homes they visited during 2015 and 2016. The FTC conducts undercover inspections to ensure that funeral homes comply with the Funeral Rule. Issued in 1984, the Rule gives consumers important rights when making funeral arrangements. Key provisions require funeral homes to provide consumers with an itemized general price list at the start of an in-person discussion of funeral arrangements, a casket price list before consumers view any caskets, and an outer burial container price list before they view grave liners or vaults. The Rule also prohibits funeral homes from requiring consumers to buy any item, such as a casket, as a condition of obtaining any other funeral good or service. By requiring the provision of itemized prices, the Funeral Rule enables consumers to compare prices and buy only the goods and services they want. Funeral homes that violate the price list disclosure requirements for the first time can enter the Funeral Rule Offender’s Program (FROP), a training program run by the National Funeral Directors Association (NFDA) designed to increase compliance with the Funeral Rule.  All the homes found in violation during the past two years have chosen to enter the FROP rather than subject themselves to the possibility of an enforcement lawsuit seeking civil penalties of up to $40,654 per violation. The FROP provides participants with a legal review of the price disclosures required by the Rule, and on-going training, testing and monitoring for compliance. Funeral homes that participate in the program make a voluntary payment to the U.S. Treasury in place of a civil penalty, and pay annual administrative fees to the NFDA. The results of the FTC 2015-2016 undercover inspections for price list disclosures by region are as follows: In Bakersfield, California, none of the 10 funeral homes inspected in 2016 failed to make a price list disclosure; In Atlanta, Smyrna and Marietta, Georgia, one of the 10 funeral homes inspected in 2015 failed to make a price list disclosure; In Detroit, Warren and Ann Arbor, Michigan, 10 of the 15 funeral homes inspected in 2015 failed to make a price list disclosure; In St. Louis, Missouri, three of the 16 funeral homes inspected in 2015 failed to make a price list disclosure; In Alamogordo and Roswell, New Mexico, nine of the 14 funeral homes inspected in 2016 failed to make a price list disclosure; In Bismarck, North Dakota, none of the six funeral homes inspected in 2016 failed to make a price list disclosure; In Oklahoma City, Oklahoma, four of the 34 funeral homes inspected in 2015 failed to make a price list disclosure; In Fairfax, Loudoun and Prince William Counties in Virginia, two of the 17 funeral homes inspected in 2016 failed to make a price list disclosure; and In Tacoma, Washington, two of the 11 funeral homes inspected in 2015 failed to make a price list disclosure. Since the FROP began in 1996, the FTC has inspected more than 3,000 funeral homes and found 530 homes with violations. In addition, the FTC identified a number of homes, within the nine states, with only minor compliance deficiencies. In such cases, the FTC requires the funeral home to provide evidence that it has corrected the problems. The FTC educates consumers in English and Spanish about their rights under the Funeral Rule, and provides guidance to businesses in how to comply. For more information, read Shopping for Funeral Services, Paying Final Respects, Your Rights When Buying Funeral Goods and Services, and Complying with the Funeral Rule. The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about consumer topics and file a consumer complaint online or by calling 1-877-FTC-HELP (382-4357).  Like the FTC on Facebook, follow us on Twitter, read our blogs and subscribe to press releases for the latest FTC news and resources. Celebrate President's Day What does it mean to be the president of the United States of America? In preparation for President's Day, study the presidency and give students a new way to explore American history (PDF).  Learn How the Heart Works We always hear and talk about the heart, but do we really understand how it works? Check out  this video about your heart and circulation, the system that sends blood throughout your body.  Civil Rights Lesson Plans Teachers: check out these lesson plans, created by teachers for teachers, to explore civil rights. Topics range from post-reconstruction to more modern times.  Inside the Smithsonian's Fossil Prep Lab Have you ever wondered how scientists decipher the information encrypted in fossils? Meet Michelle Pinsdorf, fossil preparator at the National Museum of Natural History. Join the live Q&A on March 9 at 11am and 2pm. Find more resources on Kids.gov Brought to you by USAGov, Kids.gov is the official