EdNet - December 2011
EdNet, the National Food Safety Educator’s Network, is a monthly, multi-agency electronic news journal from the U.S. Food and Drug Administration (FDA), Food Safety and Inspection Service (FSIS), and the Centers for Disease Control and Prevention (CDC). EdNet provides up-to-date information about food safety and nutrition programs and activities for educators, consumer advocates, government officials, and industry representatives.
If you have questions or comments about this issue of EdNet, send e-mail to the Center for Food Safety and Applied Nutrition (FDA).
In this issue:
Advisories, Alerts, and Warnings
- USDA Food Safety Tips for Areas Affected by California Windstorm
- FDA Warns Consumers Not to Eat One Batch of Loyd Grossman Korma Sauce
Resources for Educators
- Food Safety Tips for Healthy Holidays
- USDA Awards Grants to Universities in 13 States to Improve Food Safety through Research, Education and Extension
- USDA Announces Proposed Rule to Streamline Generic Labeling Approval Processes
- FDA Widens Look at Arsenic in Apple Juice
- FDA’s Questions & Answers: Apple Juice and Arsenic
- FDA: HCG Diet Products Are Illegal
- FDA: Import Alerts Guard Against Unsafe Products
- FDA: New Food and Feed Safety Videos
- USDA's Blog
- New FSIS Podcasts
- “Amber Waves Magazine," December 2011
- FDA’s CFSAN Education Resource Library
Meetings, Conferences, and Workshops
- Regulatory Webinar Available on Recalls of Products With Undeclared Allergens
- People in the News
- Webinar and Comments on USDA’s Proposed Rule to Streamline Generic Labeling Approval Processes
- FDA: Foreign Exporters Study Food Safety Law
- FDA: U.S. Marshals Seize Products Containing Banned Ephedrine for Dietary Supplements
- FDA, FTC Act to Remove “Homeopathic” HCG Weight Loss Products from the Market
- The Food Safety Law and the Rulemaking Process: Putting “FSMA” to Work
- FDA: U.S. Marshals Seize Dietary Supplements, Drugs Manufactured by Syntec Inc.
- FDA Takes Enforcement Action Against Pennsylvania Dietary Supplement Maker
- FSIS Posts New Report on Residue Sampling Programs
- FSIS Method Extension
- FSIS Policy Updates
Advisories, Alerts, and Warnings
USDA Food Safety Tips for Areas Affected by California Windstorm
On December 1, 2011, the USDA's Food Safety and Inspection Service (FSIS) issued a news release with recommendations for affected residents in California to minimize the potential for foodborne illnesses due to the aftermath of a fierce windstorm, which disrupted power for more than 340,000 residents.
Read this news release:
FDA Warns Consumers Not to Eat One Batch of Loyd Grossman Korma Sauce
FDA is warning consumers not to eat Loyd Grossman Korma Sauce in 350 ml jars with the batch code 1218R and sell by date of February 2013. The distributor of this product, Premier Foods in England, is recalling this batch of Loyd Grossman Korma Sauce. This product has been linked to two cases of botulism in Scotland. There are no reported cases of illness related to this product in the United States. The product is not believed to be distributed in the United States, but consumers may have obtained it through internet sales. Consumers are warned not to use the product even if it does not look or smell spoiled.
To learn more about how this product may put consumers at risk for botulism, go to:
Resources for Educators
Food Safety Tips for Healthy Holidays
Parties, family dinners, and other gatherings where food is served are all part of the holiday cheer. But the merriment can change to misery if food makes you or others ill. Typical symptoms of foodborne illness are vomiting, diarrhea, and flu-like symptoms, which can start anywhere from hours to days after contaminated food or drinks are consumed. Combating bacteria, viruses, parasites, and other contaminants in our food supply is a high priority for the Food and Drug Administration. But consumers have a role to play, too, especially when it comes to safe food-handling practices in the home.
Food Safety Tips for Healthy Holidays can be found at:
USDA Awards Grants to Universities in 13 States to Improve Food Safety through Research, Education and Extension
On December 7, 2011, Agriculture Deputy Secretary Kathleen Merrigan visited Michigan State University today to announce that USDA has awarded 17 grants to improve the safety of the food supply in the United States through research, education and extension. USDA's National Institute of Food and Agriculture (NIFA) awarded the grants, totaling $10.4 million, to universities in 13 states to help address a broad of food safety issues.
Read this news release:
USDA Announces Proposed Rule to Streamline Generic Labeling Approval Processes
On December 5, 2011, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) issued a news release announcing it is proposing a new rule that will allow establishments to label a broader range of products without first submitting the label to FSIS for approval, should it become final. Under the proposal, FSIS will continue to verify that labels are accurate, not misleading, and in compliance with all labeling features.
Read this news release:
FDA Widens Look at Arsenic in Apple Juice
Some consumers are understandably surprised to learn that arsenic is present in water, air, and soil, and as a result, it can be found in certain foods and beverages, including apple juice and juice concentrates. Arsenic is present in the environment as a naturally occurring substance and as a result of contamination from human activity, such as past use of arsenic-based fertilizers, which may still be in the soil, explains Donald Zink, Ph.D, senior science advisor at FDA’s Center for Food Safety and Applied Nutrition.
To read about how the FDA and EPA are taking action to protect the public health, visit: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm283235.htm
FDA’s Questions & Answers: Apple Juice and Arsenic
Arsenic is present in the environment as a naturally occurring substance or as a result of contamination from human activity. It is found in water, air, food and soil in organic and inorganic forms. There are two types of arsenic: organic and inorganic. The inorganic forms of arsenic are the harmful forms, while the organic forms of arsenic are essentially harmless. Because both forms of arsenic have been found in soil and ground water, small amounts may be found in certain food and beverage products, including fruit juices and juice concentrates. The FDA has posted questions and answers regarding apple juice and arsenic on its Web site.
To view these questions and answers about apple juice and arsenic, go to:
FDA: HCG Diet Products Are Illegal
Anyone who has ever been on a diet—and there are many of us—knows that there are sensible ways to lose weight. These include balanced diets, exercising and realistic goals. And then there are reckless ways to shed pounds—fads and diet aids that promise rapid weight loss, but often recommend potentially dangerous practices. These include HCG weight-loss products marketed over-the-counter (OTC) that are identified as "homeopathic" and direct users to follow a severely restrictive diet. The Food and Drug Administration (FDA) is advising consumers to steer clear of these "homeopathic" human chorionic gonadotropin (HCG) weight-loss products. They are sold in the form of oral drops, pellets and sprays and can be found online and in some retail stores.
To read this Consumer Update in its entirety, visit:
For the list of manufacturers, distributors and products—and more information about FDA’s concerns about HCG visit: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm282465.htm
FDA: Import Alerts Guard Against Unsafe Products
Keeping unsafe foods, drugs, devices and other products from reaching consumers is the Food and Drug Administration’s mission. Among the prevention measures used by FDA is the issuance of import alerts to keep potentially dangerous products from other countries out of the U.S. marketplace.
Consumer Updates regarding import alerts can be found at:
FDA: New Food and Feed Safety Videos
Seven new Food and Feed Safety Videos are available on the “FDA You Tube” page and are available in seven foreign languages. FDA offers these videos as a service to a broad international audience. While the Agency attempted to stay true to the English Language version, FDA recognizes that the translated versions of materials presented in these videos may not be as precise, clear, or complete as the English version. The official version of these videos is the English version.
Control/Click on the following links to access the videos, and then click the “CC” button beneath the video to apply language captioning:
1) Regulatory Approaches to Dietary Supplements and their Claims: http://www.youtube.com/watch?v=bsurxAb-vwE
2) Reportable Food Registry:
3) FDA's Pesticide Program:
4) FDA's Food Contact Substance (FCS) Notification Program: http://www.youtube.com/watch?v=i6vswVzDuxM
5) LACF and Acidified Foods Regulations and Requirements: http://www.youtube.com/watch?v=1EkG5oueF4w
6) Animal Feed Safety:
7) Current Issues in the Safety and Labeling of Cosmetics:
Every day, the USDA Blog shares something new about its expansive mission. The blog provides a rich and diverse look at the work within the department, spanning the nation-and even the world-and highlights the breadth of USDA programs and the role they play in the lives of every American.
See what's happening within the agency and across the department, visit USDA’s blog:
New FSIS Podcast
Tune in to podcasts on selecting, handling and preparing meat and poultry products to reduce the risk of foodborne illness. FSIS has released the following new podcast in English, Spanish and in ASL videocast:
- Food Safety At Home:
- “Eggs Products and Food Safety” – December 14, 2011
Check out this podcastst: http://www.fsis.usda.gov/news_&_events/Food_Safety_at_Home_Podcasts/index.asp (English)
Videocasts in American Sign Language: http://www.fsis.usda.gov/news_&_events/SignFSIS/index.asp
For other food safety podcasts: http://www.fsis.usda.gov/news_&_events/Podcasts/index.asp
Visit FSIS’ Food Safety page on YouTube: http://www.youtube.com/user/USDAFoodSafety
“Amber Waves Magazine," December 2011
The December 2011 issue of the "Amber Waves Magazine" from USDA's Economic Research Service is now available.
View online: http://ers.usda.gov/AmberWaves/December11/
FDA’s CFSAN Education Resource Library
FDA’s Center for Food Safety and Applied Nutrition (CFSAN) Education Resource Library is a compilation of printable educational materials on topics related to food safety, nutrition (including labeling and dietary supplements) and cosmetics. These materials are intended for educators, teachers, dietitians and health professionals as well as for general consumer education. Materials are available in PDF format for immediate download and may also be ordered in larger quantities using the CFSAN's Consumer Related Resources Order Form.
To see the full spectrum of CFSAN’s information on various topics, please visit: http://www.fda.gov/food
Meetings, Conferences, and Workshops
Regulatory Webinar Available on Recalls of Products With Undeclared Allergens
The Food Safety and Inspection Service (FSIS) will host a webinar on January 10, 2012 and
February 7, 2012 to provide guidance on addressing a recent increase of products recalled because of undeclared allergens. The discussion will focus on the steps establishments can take to prevent production of items containing undeclared allergens. Both webinars will begin at
2:00 p.m. ET. For questions, contact Kristin Goodwin at (301) 504-0878 or e-mail firstname.lastname@example.org.
To access the webinar, follow the on-screen instructions when you go to:
Webinar and Comments on USDA’s Proposed Rule to Streamline Generic Labeling Approval Processes
The Food Safety and Inspection Service (FSIS) is proposing a new rule that will allow establishments to label a broader range of products without first submitting the label to FSIS for approval. Individuals are invited to submit comments electronically through the Federal eRulemaking Portal at www.regulations.gov until February 3, 2012. Comments may also be mailed to USDA, FSIS, OPPD, RIMD, Docket Clearance Unit, Patriots Plaza III, 355 E St., S.W., Rm. 8-164, Washington, D.C. 20024-3221. All items submitted must include the docket number FSIS-2005-0016. In addition, webinars on this subject will be held on January 12, 2012 and
February 14, 2012 at 2 p.m. ET. To access the webinar, follow the on-screen instructions at:
For questions, contact Kristin Goodwin at (301) 504-0878 or email@example.com.
The proposed rule will be published in the “Federal Register” and is posted on the FSIS website:
FDA: Foreign Exporters Study Food Safety Law
The Food and Drug Administration’s international program has logged nearly 75,000 hits to its Web pages on the new food safety law, as foreign companies that export food to the United States scramble to learn how the law affects them. “A lot of our foreign offices are being deluged with questions,” says Mary Lou Valdez, FDA’s associate commissioner for international programs. “The China office has done significant outreach with Chinese officials and exporters.” Valdez says FDA translated seven documents about the “FDA Food Safety Modernization Act” into 11 languages that use eight different alphabets.
For more information about FDA’s increased authority, inspections abroad, and more on global initiatives, visit:
To view FDA’s translation of seven documents about the “FDA Food Safety Modernization Act” into 11 languages, visit:
FDA: U.S. Marshals Seize Products Containing Banned Ephedrine for Dietary Supplements
On December 6, 2011, at the request of the U.S. Food and Drug Administration, U.S. Marshals seized raw materials imported by Infinity Marketing Group, Inc. containing ephedrine alkaloids, a large family of pharmacological compounds called sympathomimetics banned by FDA since 2004 for use in dietary supplements. The seizure took place in Rancho Dominguez, CA. Through this action, FDA removed more than $70,000 worth of these potentially dangerous dietary supplement ingredients from the market. Judge Gary A. Feess of the Central District of California issued a warrant for the seizure of more than 4,000 pounds of raw material – Cissus quadrangularis and Cassia angustifolia extracts – containing the ephedrine alkaloids.
To read this FDA News Release, go to:
FDA, FTC Act to Remove “Homeopathic” HCG Weight Loss Products from the Market
On December 6, 2011, the U.S. Food and Drug Administration and the Federal Trade Commission (FTC) issued seven Warning Letters to companies marketing over-the counter (OTC) HCG products that are labeled as “homeopathic” for weight loss. Human chorionic gonadotropin (HCG) is a hormone produced by the human placenta and found in the urine of pregnant women. HCG is FDA-approved as an injectable prescription drug for the treatment of some cases of female infertility and other medical conditions. The letters warn the companies that they are violating federal law by selling drugs that have not been approved, and by making unsupported claims for the substances. There are no FDA-approved HCG drug products for weight loss.
For more detailed information, visit:
The Food Safety Law and the Rulemaking Process: Putting “FSMA” to Work
The FDA “Food Safety Modernization Act” (“FSMA”), which became law when President Obama signed it January 4, 2011, will be fully implemented over time, and the public, including companies affected by the new law, will have many opportunities to participate in the implementation process. Under the new food safety law, FDA will be issuing a number of rules including a preventive controls rule in food facilities, a foreign supplier verification rule, and a produce safety rule. In some instances, FDA holds public meetings to give all interested parties an opportunity to participate and provide comments even before proposing a rule. During these public meetings, FDA officials involved in the development of the rule often make presentations. Every rule is developed under slightly different circumstances, but this is an overview of the process FDA follows when it issues rules under “notice and comment rulemaking.” This process is set out in another federal law, the “Administrative Procedure Act.” Final rules issued by FDA under this process have the force of law.
To view detailed information about the process FDA follows when it issues rules under “notice and comment rulemaking,” visit:
FDA: U.S. Marshals Seize Dietary Supplements, Drugs Manufactured by Syntec Inc.
On December 1, 2011, U.S. Marshals, at the request of the FDA, seized all dietary supplements by a Wisconsin maker for false claims made about their safety and effectiveness in treating a number of diseases. The products manufactured at the Hillsboro, WI, facility of Syntec Inc. are not FDA-approved and a complaint filed in the United States District Court for the Western District of Wisconsin alleges that several of Syntec Inc.’s products are unapproved new drugs that may not be introduced into interstate commerce and are misbranded in violation of the “Federal Food, Drug, and Cosmetic Act.” The government alleges that the company claimed in videos and promotional materials that some of its products could be used to prevent, treat, or cure diseases such as asthma, cardiovascular disease, cataracts, glaucoma and infections. The products are not FDA-approved as safe and effective for treating any diseases.
To read about how thisWisconsin facility was previously warned not to make disease claims for products and more, go to:
FDA Takes Enforcement Action Against Pennsylvania Dietary Supplement Maker
The FDA took legal action against a dietary supplement maker and owner for substituting ingredients and products without noting the changes on the final product labels. The permanent injunction, filed on behalf of the FDA by the U.S. Department of Justice, would stop the defendants from making and distributing more than 400 products for being in violation of the “Federal Food, Drug, and Cosmetic Act.” This is the first time FDA has taken legal action against a dietary supplement manufacturer of this size for failure to comply with the dietary supplement current Good Manufacturing Practice (cGMP) regulations. The cGMPs for dietary supplements went into effect in 2007, in a stepped process based on company size. This company's compliance date came into effect in 2010, and they did not meet the relevant cGMP requirements after that date.
For more information about this enforcement action, visit:
FSIS Posts Humane Handling Enforcement Reports
The Food Safety and Inspection Service (FSIS) has posted on its website a Humane Handling Quarterly Report. The report provides an overview of humane handling and slaughter procedures performed by FSIS inspection program personnel in federally inspected livestock slaughter facilities performed for the 12 month period ending March 31, 2011.
To view these results, go to
FSIS Posts New Report on Residue Sampling Programs
The Food Safety and Inspection Service (FSIS) is featuring on its website a new report on Microbiological and Residue Sampling Programs. This document serves as the first of a two-part effort by FSIS to increase transparency and share information on the agency's microbiological and residue sampling efforts
Read this report:
FSIS Method Extension
The FSIS CLG Method, “Screening and Confirmation of Aminoglycosides” by UHPLC-MS-MS has been updated to extend to porcine tissues (kidney, liver and muscle) to improve the handling of sample extraction and to include lower levels of applicability for several analyses. The method will be posted to the FSIS “Chemistry Laboratory Guidebook” once finalized, with an effective date no earlier than December 15, 2011.
FSIS’ “Chemistry Laboratory Guidebook” can be found at:
FSIS Policy Updates
FSIS issues Notices and Directives to protect public health. The following policy updates were recently issued:
- FSIS Notice 70-11: “Recording Inspection Tasks as Not Performed in the Public Health Information System (PHIS)”
All Notices and Directives are available at: