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European Union looks at dietary reference values for sodium

Tue, 10/03/2017 - 00:00

Its own draft scientific opinion on dietary reference values for sodium is the European Food Safety Authority’s next subject for public comment.

The Parma, Italy-based authority (EFSA) is especially seeking feedback on the way it plants to select and use evidence in its salty assessment. The EFSA is the agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.

As part of the assessment, EFSA will systematically review literature on the relationship between sodium intake and health problems such as cardiovascular disease and bone health.

EFSA’s Panel on Dietetic Products, Nutrition, and Allergies (NDA) has developed a protocol describing the steps to be followed for the collection, selection, appraisal and integration of the evidence.

The draft protocol applies to the missing sections of the EFSA’s scientific opinion — the assessment of possible relationships between sodium intake and health outcomes, including dose-response relationships, and the integration of different lines of evidence for setting dietary reference values (DRVs).

The documents are published together in order to receive input from stakeholders on the parts of the opinion that have been used to inform the draft protocol, and on the methodology foreseen to inform the remaining parts covered by the protocol.

The protocol was developed in accordance with EFSA’s Prometheus approach to dealing with data and evidence in scientific assessments.

Interested parties are invited to submit comments on the proposed protocol and other parts of the assessment by Nov. 12.

The EFSA will revise the draft opinion and protocol in light of the comments received. The completed assessment, including recommendations on DRVs, will be made available for a second public consultation.

In line with EFSA’s policy on openness and transparency, the scientific community and other stakeholders are invited to submit written comments. The documents and comment instructions are available at: Public consultation on draft scientific opinion on dietary reference values for sodium.

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Aldi, Publix, Weis ground turkey recalled after metal bits found

Mon, 10/02/2017 - 20:11

St. Pauls, NC-based Prestage Foods Inc. Monday recalled 38,475 pounds of ground turkey after a retailer found extraneous metal in the product, according to the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS).

The problem was discovered on Sept. 27 when FSIS was contacted by plant employees who were sanitizing processing equipment. On the same day, one of the retail locations that received some of the products noticed “metal shaving” in a package of ground turkey from the recalling firm and notified the company, according to the recall notice on the FSIS website.

Prestage Foods shipped the ground turkey to retail distribution centers in Alabama, Connecticut, Florida, Georgia, New York, North Carolina, South Carolina, Pennsylvania and Tennessee. The recall notice did not indicate whether those distribution centers sent the recalled product to other states.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

“Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase,” according to the recall notice.

Publix and Weis Markets branded ground turkey, as well as Aldi’s house brand of Fit & Active ground turkey, are included in the recall. The fresh ground turkey was produced on Sept. 25 and 26.

Consumers can identify the recalled ground turkey by looking for the following label information:

  • 1.3-lb. White Styrofoam trays with clear plastic film covering packages containing ground turkey labeled “Publix ground turkey breast WITH NATURAL FLAVORINGS” with inkjet printing on the side of trays displaying the first 4 digits of 7268 and 7269.
  • 1.3-lb. White Styrofoam trays with clear plastic film covering packages containing ground turkey labeled “Publix ground turkey WITH NATURAL FLAVORINGS” with inkjet labeling on the side of trays displaying the first 4 digits of 7268 and 7269.
  • 1.2-lb. White Styrofoam trays with clear plastic film covering packages containing ground turkey labeled “Fit & Active Fresh Ground Turkey With Natural Flavoring” with inkjet labeling on the side of trays displaying the first 4 digits of 7268 and 7269.
  • 1.0-lb. White Styrofoam trays with clear plastic film covering packages containing ground turkey labeled “Weis Markets Fresh Ground Turkey Breast” with inkjet labeling on the side of trays displaying the first 4 digits of 7268 and 7269.

All of the products subject to recall also have the establishment number “P-22000” printed inside the USDA mark of inspection.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website.

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Antibiotic disclosure — another first for San Francisco?

Mon, 10/02/2017 - 02:01

Once again, San Francisco is poised to become the first city in the nation to take a legislative stand on a controversial topic. Its Board of Supervisors is set to vote tomorrow on an ordinance to require disclosure about the use of antibiotics by meat and poultry producers.

The proposed ordinance does not, however, require the meat and poultry producers to take action. Rather, it seeks to require large grocery chains to gather information annually from their meat and poultry suppliers and provide it to the city.

San Francisco’s Department of Environment would post the information about the meat and poultry operations’ use of antibiotics in their animals. The ordinance requires grocers to maintain documentation of their suppliers’ antibiotic use policies.

Consumer watchdog groups and environmentalists such as the Environmental Working Group and the Natural Resources Defense Council are supporting the proposed local law while industry groups, including the California Grocers Association, are opposed to it.

Jeff Sheehy, appointed in January to represent the Board’s 8th District, introduced the ordinance June 20. A Board committee of three — including Sheehy — unanimously approved it Sept. 27, forwarding it to the full 11-member body for a vote at tomorrow’s meeting.

“The proposal would also require city departments procuring raw meat to conduct an audit of their meat purchases of the year prior to this proposal’s enactment,” according to the digest version of the legislation in board members’ packets for tomorrow’s meeting.

“These city departments would be required report to the (Environment) Department information regarding the use of antibiotics in the purchased meat, and an estimate of when and whether they may be able to transition to procurement of meat raised without the routine use of antibiotics.”

The goal
Sheehy and other San Francisco board members and city officials contend the ordinance will not only provide consumers with information about their food is produced, but will also put pressure on meat and poultry producers to reduce the use of antibiotics in their animals.

The use of antibiotics in animals used for human food is contributing to the proliferation of antibiotic resistant bacteria, according to public health officials around the world.

Every year in the United States antibiotic-resistant bacteria sicken 2 million people, killing 23,000 of them according to the Centers for Disease Control and Prevention. The CDC lists the spread of antibiotic-resistant bacteria as one of the top five health threats facing the United States.

“Overuse of antibiotics in meat production is an issue we have been concerned about,” Debbie Raphael, director of the San Francisco Department of the Environment, said in a statement when Sheehy introduced the ordinance.

“Knowledge is power when it comes to our health and the environment.

“The public has a right to know whether the raw meat and poultry they purchase is produced using antibiotics in ways that can encourage the proliferation of antibiotic resistant bacteria.”

San Francisco elected officials cannot compel specific antibiotic labeling information on meat and poultry packages because the subject is one of federal jurisdiction.

The mechanism
By requiring large grocers — defined as those with at least one store in San Francisco and a worldwide total of 25 or more locations — to gather antibiotic use policies from meat and poultry suppliers for public dissemination, Sheehy and others say they will force companies to review their supply chain partners.

The 25-or-more grocers, including Walmart, Costco, Trader Joe’s, Whole Foods and Safeway, would be required to collect information from producers on several points:

  • Average number of days of antibiotic use per animal;
  • Percentage of animals treated with antibiotics;
  • Number of animals raised; and
  • Total volume of antibiotics administered.

Grocers would also be required to back-up the reporting via evidence such as a third-party certification. About 110 stores in San Francisco would be required to comply if the ordinance is approved. Violators could be fined up to $1,000 per day, per violation. The annual reporting requirement would kick in six months from approval.

“Under the proposal, grocers for whom compliance would be infeasible may apply to the Department for a waiver from some or all reporting requirements,” according to the digest version of the ordinance.

Though the proposed ordinance would apply only to grocers selling meat or poultry within San Francisco, its impact could reach protein producers across the country and around the globe. Regardless where their suppliers are located, the San Francisco grocers will be required to collect information from them to provide to the city for publication.

Environment Department Director Raphael told the San Francisco Chronicle newspaper this past week that she hopes consumers will shift to buying meat with lower antibiotic content once they have access to that information.

One of the three Board committee members who voted in favor of the ordinance, Sandra Lee Frewer, told the Chronicle she would like to see the city do more to force industry to reduce antibiotic use.

“I’m assuming that this is a first step,” Frewer told the Chronicle.

Frewer’s comments alluded to a 2015 California bill signed into law by Gov. Jerry Brown that restricts the use of antibiotics in livestock and poultry unless  it is prescribed by a veterinarian. That law goes into effect in January 2018.

The opponents
Finding themselves in the crosshairs of the proposed ordinance, grocers are saying the San Francisco Board of Supervisors is off target.

“… this proposal is focused on the production of meat products and treatment of animals while under the control of producers and is not about the safety of products while in grocers control,” according to a letter sent to the Board by Timothy M. James, senior manager of local government relations for the California Grocers Association.

“We believe the city should continue its leadership in regards to EPR (Extended Producer Responsibility) with this issue and work directly with producers who control antibiotic use, instead of taking the more difficult route of simply regulating grocers.

“Unfortunately, this ordinance is determined to hold grocers responsible for information for which they have no control over and is more easily retrieved by the city directly from producers.”

The grocers’ association contends several “adjustments” should be made to the proposed ordinance:

  • Use of the information provided by grocers by the Department of Environment;
  • Depth of information required to be provided by retailers; and
  • Retention of documentation received by grocers from producers.

“… and, most importantly, providing retailers liability protection while providing information for which they have no control or ability to compel,” James wrote in his letter.

The proponents
An array of environmental, consumer and medical groups are on record supporting the San Francisco ordinance. Statements from the Natural Resources Defense Council and the Environmental Working Group are at the head of the line of supporters, but a number of other organizations have aligned with them on this issue, all signing a letter of support sent to the city:

  • Alliance of Nurses for a Healthy Environment;
  • Antibiotic Resistance Action Center;
  • Milken Institute School of Public Health;
  • George Washington University;
  • Center for Food Safety;
  • Center for Foodborne Illness Research & Prevention;
  • Center for Science in the Public Interest;
  • Clean Water Action;
  • Food & Water Watch;
  • Food Chain Workers Alliance;
  • Health Care Without Harm;
  • Healthy Food in Health Care;
  • Keep Antibiotics Working;
  • Physicians for Social Responsibility;
  • San Francisco Bay Area Chapter Prevention Institute;
  • Roots of Change; and
  • San Francisco Marin Medical Society.

“With the rise of antibiotic resistance, it’s critical that we use antibiotics less frequently so that they’ll be effective when our lives depend on it,” NRDC senior attorney Avinash Kar said in a written statement. “That is why more and more consumers are making the choice to buy meat from animals raised without the routine use of antibiotics.”

The Environmental Working Group (EWG) cited statistics and science to support its position in a statement on its website.

“… 70 percent of medically important antibiotics sold in the U.S. are used to treat farm animals raised for food, and that much of that use is on animals that are not sick,” according to the EWG.

“In a study published this year, researchers from Case Western Reserve University School of Medicine reported a sevenfold increase in drug-resistant bacterial infections among children, specifically for the family of bacteria that includes E. coli and salmonella.

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Cracker manufacturer warned for insanitary conditions

Mon, 10/02/2017 - 00:00

A cracker manufacturer in New York is on notice from the FDA because of insanitary facility conditions, which renders the firm’s food products adulterated in that they have been prepared, packed, or held under conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath.

Staff from the Food and Drug Administration inspected the Hempstead, NY, location of Cracker King Corp. on June 7, 8, 15, and 20, and discovered the “serious violations” of the Current Good Manfacturing Practice (CGMP) regulation for foods, according to a Sept. 15 warning letter made public by the FDA in recent days.

“Your firm failed to take effective measures to exclude pests from the processing areas, as required by 21 CFR 110.35(c). This is a repeat observation from previous inspections,” according to the letter sent to Leonardo C. Morales, president of Cracker King Corp.

Specifically, FDA’s Division 1, Eastern Operations officer Ronald Pace, noted the following observations logged during the inspection:

  •   About 30 apparent rodent excreta pellets (REPs) were observed on the floor underneath and along the side of the employee hand wash sink in the production area.
  • Too numerous to count apparent REPs were observed on a stack of unused pallets along the west facing wall of the loading dock area.
  •  Too numerous to count apparent REPs were observed on a pallet located along the west facing wall of the loading dock area. This pallet was being used to store cardboard boxes used for finished product packing. Four apparent REPs were also found lying on top of the first box in the stack.
  • Approximately 10 apparent REPs were observed on a pallet containing old equipment and located beside the hopper used to store anise seeds.
  • Too numerous to count apparent REPs were observed underneath a pallet located on the left-hand side of the production facility beside the cracker cutting line. This pallet held cardboard boxes used for finished product packing.
  • The backdoor located next to the ovens consists of a traditional solid door plus a separate screened door. To allow for air flow during production, the solid door was observed to be opened while the screened door was left closed. However, the screen door has a gap of ~1 inch on the lower left-hand corner.
  • The loading dock door has gaps of ~1/2 inches between the floor and the bottom of the door.
  • Crackers and pieces of cracker were spilled on the floor underneath the conveyor line used to move the crackers from the oven area after baking and into the packing area. Approximately 6 apparent REPS were observed on the floor in this same area. Crackers were also left uncovered on the conveyor line.

Foods prepared, packed, or held under conditions that are in violation of the CGMPs are considered adulterated and not fit for sale.

“During the inspection, you informed our investigator that you had hired a third party to provide pest control services,” However, “…your response to date does not include further information such as a pest control service contract or monthly inspection records to demonstrate you have fully corrected all of the issues observed” according to the warning letter.

Other significant violations observed during the time of inspection include:

  • The firm manufactures products which contain egg and soy products. However, they have no allergen control program in place, such as scheduling production based on allergens, having dedicated equipment, or effectively cleaning between their products;
  • The firm failed to clean food-contact surfaces and utensils as frequently as necessary to protect against contamination of food;
  • Employees were observed using brushes to dry clean and remove food debris from the dough sheeter. The brushes bristles were soiled and frayed from repeated use and inadequate cleaning to remove the food debris;
  • The conveyor belts made out of a fabric material on the cracker cutting line, which is not an easily cleanable food contact surface, were found to be frayed and damaged;
  • The rotary cutter on the cracker cutting line was observed to have a sponge-type material inserted into each mold on the die. This sponge-type material does not appear to be cleanable and you stated that these sponges are replaced as needed only when they begin to exhibit signs of deterioration;
  • Flaking and peeling paint was observed in multiple areas of the ceiling in the production facility including above in-process dough and baked crackers that were uncovered;
  • A significant amount of unused and old equipment, pallets, and other miscellaneous items were observed to be stored throughout the production facility. These locations are potential harborage areas for rodents;
  • The firm failed to provide employees with suitable outer garments that protect against contamination of food, as employees were observed using their bare forearms to transfer in-process dough from the dough sheeter to a wooden table for slicing and then onto the cracker cutting line;
  • The hand wash sinks located in the men’s and women’s restrooms were lacking soap. Also, an apparent bar of soap, not appropriate for cleaning hands, was observed at the hand wash sink located in the production area;
  • The hand wash sinks located in the men’s and women’s restrooms, as well as the hand wash sink located in the production area, were all observed lacking a sanitary drying device, such as paper towels or automatic hand dryer. These are the only hand wash sinks available for the employees to use during production;

The majority of the above violations are “repeat observations[s] from previous FDA inspections.” The warning letter referred to the firm’s efforts through, “email correspondence on June 22, 23, July 14 and 19, in which you provided a response to Form FDA 483, Inspectional Observations.” However, the FDA continuously noted that the firm’s, “responses are not adequate since you did not fully demonstrate you have corrected or plan to correct all of the issues observed.”

Food companies are given 15 working days to respond to FDA warning letters. “You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by FDA without further notice, including, without limitation, seizure and injunction,” according to the warning letter.

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Food industry welcomes new deadline to revise nutrition labels

Mon, 10/02/2017 - 00:00

Food manufacturers are getting an extra 18 to 30 months to begin putting revised Nutrition Facts, Supplement Facts and Serving Size labels on their products.

The U.S. Food and Drug Administration announced the delay on Sept. 29. The food industry hailed the delay, while consumer organizations said it is detrimental to public health.

Current labels, left, provide information based on smaller portions than most consumers eat, according to federal research, and use small print to disclose calories. The new labels, right, define portion sizes more in line with how people eat and prominently display the calories in bold type. The new labels also show how much sugar has been added.

In the announcement, FDA said it was releasing a proposed rule to extend the compliance dates for the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule from July 26, 2018, to Jan. 1, 2020, for manufacturers with $10 million or more in annual food sales.

Manufacturers with less than $10 million in annual food sales would receive an extra year to comply — Jan. 1, 2021. FDA finalized the Nutrition Facts and Supplement Facts Label and Serving Size final rules in May 2016.

FDA determined that additional time would provide manufacturers covered by the rule, and with necessary guidance from the agency, would help them to design and print updated nutrition facts panels for their products before they are expected to comply.

The McLean, VA-based American Frozen Food Institute (AFFI) was among industry representatives that reacted positively to the deadline extension.

“AFFI commends the U.S. Food and Drug Administration’s decision to provide frozen food and beverage makers additional time to implement changes to the NFP until Jan. 1, 2020,” Alison Bodor, president and CEO of industry group.

“AFFI members are committed to updating the NFP and providing consumers with the information they need to make informed choices. This additional time will help AFFI’s members, especially our small and medium-sized companies, make these changes and also lessen the financial burden of doing so.”

Dr. Peter G. Lurie, president of the Center for Science in the Public Interest (CSPI), was also swift in getting a statement out. He charged FDA with caving into the food industry’s demands while obesity rates continued to climb.

The new nutrition facts label, according to FDA, will help consumers make “better-informed food choices.” The added information is supposed to link diet and chronic diseases like obesity and heart disease to better inform consumers.

FDA pointed to these advantages of the new labeling:

Refreshed design
The “iconic” look of the label remains, but with significant updates to ensure consumers have access to the information they need to make informed decisions about the foods they eat. These changes include increasing the type size for “Calories,” “servings per container,” and the “Serving size” declaration, and bolding the number of calories and the “Serving size” declaration to highlight this information.

Manufacturers must declare the actual amount, in addition to percent Daily Value of vitamin D, calcium, iron, and potassium. The gram amount for other vitamins and minerals may also be listed.

The footnote is changing to explain better what percent Daily Value means. It will read: “*The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day amount used for general nutrition advice.”

Updates information about nutrition science
“Added sugars,” in grams and as percent Daily Value, will be included on the label. Scientific data shows that it is not easy to meet nutrient needs while staying within calorie limits if you consume more than 10 percent of your total daily calories from added sugar, and this is consistent with the 2015-2020 Dietary Guidelines for Americans.

The list of nutrients that are required or permitted to be declared is updated. Vitamin D and potassium are required on the new label. Calcium and iron will continue to be required.

Vitamins A and C will no longer be required but can be included on a voluntary basis.

While continuing to require “Total Fat,” “Saturated Fat,” and “Trans Fat” on the label, “Calories from Fat” is being removed because research shows the type of fat is more important than the amount.

Daily values for nutrients like sodium, dietary fiber, and vitamin D are being updated based on newer scientific evidence from the Institute of Medicine and other reports such as the 2015 Dietary Guidelines Advisory Committee Report, which was used in developing the 2015-2020 Dietary Guidelines for Americans.

The daily values are reference amounts of nutrients to consume, or not to exceed, and are used to calculate the percent Daily Value (% DV) that manufacturers include on the label. The %DV helps consumers understand the nutrition information in the context of a total daily diet.

Updates serving sizes, labeling requirements
By law, new serving sizes must take account of the amounts of foods and beverages that people are consuming, not what they should be eating. How much people eat and drink has changed since the previous serving size requirements since 1993, the time of the last changes. For example, the reference amount used to set a serving of ice cream was previously 1/2 cup but is changing to 2/3 cup. The set amount for a serving of soda is changing from 8 ounces to 12 ounces.

Package size affects what people eat, according to federal research. So, for packages that are between one and two servings, such as a 20-ounce soda or a 15-ounce can of soup, the calories and other nutrients will be required to be labeled as one serving because people typically consume it in one sitting.

For certain products that are larger than a single serving but that could be consumed in one sitting or multiple sittings, manufacturers will have to provide “dual column” labels to indicate some calories and nutrients in both a “per serving” and “per package”/“per unit” basis. Examples would be a 24-ounce bottle of soda or a pint of ice cream. With dual-column labels available, people will be able to easily understand how many calories and nutrients they are getting if they eat or drink the entire package/unit at one time.

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CDC still stumped on source of Cyclospora; victims top 1,000

Sun, 10/01/2017 - 00:01

With more than 1,000 victims confirmed since May 1, the so-called seasonal outbreak of cyclospora in the United States has slowed down, but officials say more people are expected to get sick — and they have not identified the source of the parasite.

Investigators at the Centers for Disease Control and Prevention have identified victims in 40 states, but they are not sure if there is one big outbreak or multiple outbreaks, according to the agency’s most recent update.

Photo illustration

As of mid-day Sept. 27, the CDC had laboratory confirmation of 1,054 people with infections from the Cyclospora parasite. The most recent illness onset reported was Sept. 13. However, people who became ill after Aug. 16 might not have been reported yet because of the time it takes between when a person becomes ill and when lab tests are completed and reported.

“At this time, no specific vehicle of interest has been identified, and investigations to identify a potential source, or sources, of infection are ongoing. It is too early to say whether cases of Cyclospora infection in different states are related to each other or to the same food item(s),” according to the CDC update.

Previous U.S. outbreaks of cyclosporiasis have been linked to various types of imported fresh produce — e.g., basil, cilantro, mesclun lettuce, raspberries, snow peas. Consumers should continue to enjoy the health benefits of eating fresh fruits and vegetables as part of a well-balanced diet. Consumers and retailers should always follow safe produce handling recommendations.”

It usually takes about a week after ingesting Cyclospora parasites for symptoms of cyclosporiasis infection to develop. The parasite infects the small intestine and usually causes watery diarrhea, with frequent, sometimes explosive, bowel movements.

Other common symptoms include loss of appetite, weight loss, stomach cramps/pain, bloating, increased gas, nausea, and fatigue. Vomiting, body aches, headache, fever, and other flu-like symptoms may be noted. Some people who are infected with Cyclospora do not have any symptoms.

If not treated, the illness may last from a few days to a month or longer. Symptoms often may seem to go away and then return one or more times. It’s common for infected people to feel very tired.

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Sandwiches recalled for Listeria from Target, Walgreens, others

Sun, 10/01/2017 - 00:00

Fresh, ready-to-eat egg salad and ham salad sandwiches, as well as a seafood stuffing mix, are under recall from several retailers and a vending machine company because federal inspectors found Listeria monocytogenes in the Greencore USA LLC facility where the products were made.

To view labels of all of the products subject to this recall, please click on the image.

Greencore is recalling sandwiches distributed between Sept. 24 and 27 to American Food and Vending, Hannaford Brothers, Target and Turkey Hill locations in Massachusetts, Rhode Island, Connecticut, Maine, Vermont, New Hampshire and New York.

To see more labels for the products subject to this recall, please click on the image.

There is concern that consumers may have unused portions of the recalled products in their homes because some of the sandwiches have use-by dates of Oct. 2. Of even greater concern is the seafood stuffing, which was only distributed to Hannaford locations, but has use-by-dates reaching to Oct. 19.

“The products are being recalled because Listeria monocytogenes was found in environmental sampling conducted by the FDA (Food and Drug Administration),” according to the Greencore recall notice.

“Greencore has not received any reports of confirmed illnesses associated with these recalled sandwiches. As of Sept. 29, all (corporate) customers have been instructed to remove and destroy impacted product.”

Consumers are urged to not eat any of the recalled products. For labeling details that can be used to identify the recalled products, please see chart at bottom.

Although no finished products had been found to be contaminated with Listeria as of the posting of the recall notice, the FDA did find Listeria monocytogenes in the production facility.

Consequently, anyone who has eaten any of the recalled products is urged to monitor themselves for symptoms of Listeria infection for the coming weeks. It can take up to 70 days for symptoms to develop. Anyone who develops symptoms should immediately seek medical attention and tell their doctors about the possible exposure to the bacteria.

Symptoms include high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea. Young children, the elderly, pregnant women and people with compromised immune systems can develop serious and sometimes deadly infections from exposure to Listeria monocytogenes bacteria.

Not the first time
In January 2011 and June 2012, FDA inspectors found Listeria monocytogenes in the Greencore production facility in Byfield, MA. The inspectors found the pathogen on food contact surfaces, as well as on equipment and other surfaces.

After working with the company officials to resolve the cleaning and sanitizing problems that allowed the bacteria to thrive in the facility, the FDA issued a warning letter to Greencore in October 2012.

The FDA ordered Greencore to clean up its operations and institute ongoing programs to prevent pathogen contamination of its food production facility. In April 2013 the FDA finally issued a close-out letter regarding the 2011 and 2012 inspections.

In November 2016, Greencore recalled Fresh to Go brand chicken hummus sandwiches sold to 7-Eleven stores because of possible Listeria contamination, but it was a secondary recall. Sabra Dipping Co. had recalled its red pepper hummus — an ingredient in the Greencore product — for potential contamination.

Customer Product Size UPC Use-by date Hannaford Egg Salad Club Roll 5.1 oz 4126816587 9/28 – 10/2 Ham Salad Club Roll 5.1 oz 4126816589 9/28 -10/2 Seafood Stuffing 10 oz 4126820509 10/2 – 10/19 Walgreens Egg salad
on White Bread 6.1 oz 4902272043 9/29 – 10/1 Turkey Hill
Fresh Selects Egg salad
on Homestyle Bread 4.7 oz 7350875001 9/29 – 10/1 Ham salad
on Homestyle Bread 4.9 oz 7350875003 9/29 – 10/1 Target Egg salad
on White Bread 5.9 7350875792 9/29 – 10/1 American Food
and Vending Enza Choice Egg Salad
on White Bread 4.7 7350875735 10/1 American Food
and Vending Enza Choice Ham Salad
on White Bread 4.7 7350875815 10/1

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Unknown amount of turkey drumsticks recalled across the U.S

Sat, 09/30/2017 - 01:06

Belmont Sausage Co. of Elk Grove Village, IL, is recalling an undetermined amount of smoked turkey products because of misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced Friday night. The products contain milk, a known allergen, which is not declared on the product label.

To view other labels of products subject to this recall, please click on the image.

The smoked turkey drumstick items were produced from Sept. 27, 2015, through Sept. 27 this year. The following products are subject to recall:

•25- to 29-oz. plastic-lined, boxed packages containing 18 pieces of “Wolverine Packing Co. complete protein solutions Smoked Turkey Drumsticks” with lot code 20144.

•20- to 24-oz. plastic-lined, boxed packages containing 20 pieces of “Wolverine Packing Co. complete protein solutions Smoked Turkey Drumsticks” with lot code 20148.

The products subject to this recall have establishment number “P-21309” printed inside the USDA mark of inspection. These items were shipped to an institutional location in Michigan that further distributed nationwide.

The problem was discovered by FSIS Inspection Program Personnel while performing routine label verification checks.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

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Publisher’s Platform: It’s past time for FDA to out retailers

Sat, 09/30/2017 - 00:13

This peanut butter substitute was still on the shelf at a Luckys Market earlier this week, despite having been recalled in March for E. coli contamination.

On March 7, 2017, The SoyNut Butter Company recalled all varieties of I.M. Healthy SoyNut Butters and all varieties of I.M. Healthy Granola products. On March 10, 2017, The SoyNut Butter Company expanded its recall to include Dixie Diner’s Club brand Carb Not Beanit Butter.  This after poisoning over 30 people – mostly kids – several that suffered from acute kidney failure.

The recall notice, drafted by I.M. Healthy, on the FDA website did not mention where the tainted product was sold. Nearly six months later Food Safety News reported on September 5: “Earlier today, was still selling I.M. Healthy soy nut butter that was recalled in March when federal officials traced an E. coli outbreak to the product.”  Then on September 26 a friend of a client whose son nearly died from consuming the soy nut butter found the product on “Close Out” at Lucky’s Market on 200 Woodside Rd, Redwood City, CA 94061.

So, why does the FDA not release the names of retailers to retailers and consumers during a recall and/or an outbreak?

Caitlin Dewey of The Washington Post asked the same question in March of this year – “Why the FDA hides the names of grocery stores that sell contaminated food.”  I reread it today and it still makes my head hurt.

According to Caitlin:

The FDA does not specify, however, which stores, centers or schools — because that would violate its interpretation of an obscure trade secret rule. 

This interpretation differs from that of other agencies in the federal food safety system, an overlapping and often illogical network of regulatory fiefdoms. The system, which is responsible for keeping food free of bacteria and other pathogens, frequently has to weigh the very real interests of private food companies against potential risks to the public. In the case of releasing retailer lists during major outbreaks, the FDA has historically sided with business, ruling that such lists constitute “confidential commercial information” and thus should not be available for public consumption. 

Critics say that the agency’s unwillingness to share this information poses a clear danger to public health, particularly in cases like the current E. coli outbreak, where parents may not know if their child consumed the recalled product.

 “Our mantra is that a more transparent food system is a safer food system,” said Thomas Gremillion, the director of food policy at the Consumer Federation of America. “And there are lots of instances where having that distribution list would help victims of food-borne illness.”

The FDA’s current recall process has been in effect for years, though the agency did gain more recall authority under the FDA Food Safety Modernization Act of 2011. It is, for the most part, a voluntary system — which means there’s some variance in how quickly recalls happen. While most companies are highly motivated to clean up any contamination, it takes time to evaluate and respond to possible threats. And that time can be multiplied several times over if a product has moved through the hands of several distributors, manufacturers or other middlemen, an issue that the FDA was faulted for in a June 2016 alert by the Inspector General’s Office.

When a company does issue a recall, it has wide latitude over the amount of information it shares; in some cases, a recall will never be made public. Recalls that are made public typically contain a description of the product and an explanation of the problem. But companies are not required to reveal where the product was sold — whether to a store, a school, a restaurant or another manufacturer that put it in other products.

The recall for SoyNut Butter, for instance, says that “products were distributed in multiple states and may have been purchased in stores or through mail order. They were also distributed to childcare centers and schools in multiple states.” Those states include Virginia and Maryland, where two people have fallen ill. I.M. Healthy did not respond to a phone call or email requesting comment, though a statement on its website called the contamination “deeply concerning” and said that the company had immediately issued a recall. A list compiled by the site eFoodAlert claims that the product was sold at a number of major grocery chains, including Kroger, Giant and Whole Foods.

“Industry argues that they don’t want to turn over who they sell to, because competition will know and try to undercut them,” said Bill Marler, a prominent food safety lawyer who is representing the parents of one of the children sickened in the SoyNut outbreak. “That’s all well and good under normal circumstances. But those rules should not and do not apply to a product that could cause people to become ill.”

In a statement to The Washington Post, the FDA affirmed that it believes its disclosure measures are sufficient and blamed the lack of downstream recall information on federal disclosure rules. Federal regulations do limit the sort of information that can be released to the public. Under the Freedom of Information Act and Title 21 of the Code of Regulations, government agencies — and specifically, the FDA — are told to exempt trade secrets and commercial information from any of their releases.

“Examples of [confidential consumer information] include raw material supplier lists, finished product customer lists, trace back information, etc.,” said Peter Cassell, a spokesman for the FDA. “CCI is exempt from Freedom of Information Act requests, but can be shared through certain information sharing agreements (including with other Federal agencies).”

“The FDA publicizes recall notices, including pictures of affected products, and uses social media accounts to reach consumers as swiftly as possible,” he later added. “In some cases, the FDA can release certain information that is otherwise exempt from disclosure if it is necessary to effectuate a recall. In many cases, it is most efficient for the company to directly notify its distributors so they can take appropriate action.”

Cassell declined to make an agency lawyer available for comment or explain how the FDA had arrived at its definitions. But it’s probably worth noting that when another agency considered similar precedents, it came to different conclusions.

In the early 2000s, the Food Safety and Inspection Service — the branch of the U.S. Department of Agriculture that regulates meat, poultry and egg products — decided to revisit its own interpretation of the trade secrets rule. During a lengthy comments period, industry groups concerned with protecting their distribution lists from competitors faced off against consumer advocates. In 2008, after several years of debate, FSIS’s final rule concluded that it would “not cause substantial harm to the competitive position of any business” to disclose retailer names.

“FSIS now routinely posts these lists,” said Deirdre Schlunegger, the chief executive of STOP Foodborne Illness, an advocacy group for patients that lobbied FSIS 10 years ago. “We obviously believe consumers should have as much information as possible to make safe food decisions.”

Today, when FSIS issues a Class I recall — those that seem “reasonably” likely to cause health problems — it also issues a list of all the retail locations that have, or have had, the product. During last month’s massive cheese recall, for instance, FSIS published a list of every Safeway, Albertsons and Pak ’n’ Save that sold Taylor Farms salads containing Sargento pepperjack. But because FDA regulates the cheese itself, there was no such list of stores that sold the cheese outside salads.

“It does makes me wonder why the FDA can’t do the same,” said Sandra Eskin, the director of the Safe Food Project at Pew Charitable Trusts. “The fundamental issue is — is this information important to consumers during a recall? I would argue yes.”

But the man who led the effort to reform FSIS’s traded secrets rule has his own suspicions as to why the FDA hasn’t followed his lead. Richard Raymond, who was the undersecretary of agriculture for food safety under President George W. Bush, says that the fiercest opposition to the change came from the food industry. Raymond, who had been the chief medical officer in his home state of Nebraska, came to Washington, D.C., determined to change the rules on confidential information. He found himself surprised by the level of resistance.

“They were scared to death it would hurt their business,” Raymond said. “The retail stores want to protect their brand. … When you ask why FDA hasn’t done it, I suspect they don’t want that fight themselves.”

The FDA did not respond to Raymond’s comment by press time. But Gremillion, of the Consumer Federation, would like to see the agency take action.

“Why do confidential business interests trump public health in some cases and not others?” he asked. “We need more transparency around this.

I think it is past time for the FDA and the industries it oversees to be transparent – willingly or not.

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FDA’s delay of Nutrition Facts label a blow to public health

Sat, 09/30/2017 - 00:00

Editor’s note: This contributed opinion column by Dr. Peter G. Lurie, president of the Center for Science in the Public Interest is republished here with permission. To read this column on the CSPI website, click here.

The Food and Drug Administration’s decision to cave in to food industry demands and delay the deadline for companies to update their Nutrition Facts labels harms the public’s health, denies consumers vital information, and creates an unfair and confusing marketplace as many companies have gone ahead with the labels anyway.

The FDA, which published the final rule for Nutrition Facts updates in May 2016, has now delayed the deadline to use the new labels from July 2018 to January 2020 for large companies. It has further delayed compliance for small companies from July 2019 to January 2021, and they account for a whopping 90 percent of the industry.

The FDA’s delay, announced as a proposed rule that provides for public comment, is all the more shocking coming on the heels of the latest data from the Centers for Disease Control and Prevention, which reported that all 50 states had prevalences of self-reported obesity higher than 20 percent in 2016, reflecting an upward trend since 2010.

Twenty-five states, Puerto Rico and the Virgin Islands had rates of 30 percent or higher. The estimated annual medical costs of obesity are $147 billion in 2008 dollars, according to one study cited by CDC. Two out of three adults and one out of three children are overweight or have obesity, conditions that raise the risk of type 2 diabetes, heart disease, stroke and certain cancers.

Current labels, left, provide information based on smaller portions than most consumers eat and use small print to disclose calories. The new labels, right, reflect more realistic portion sizes, display the calories in bold type, and reveal the amount of added sugar.

The updated labels will disclose “added sugars” in grams and as a percent of a day’s recommended maximum intake. Added sugars, especially sugar-sweetened beverages, are linked to a higher risk of weight gain, heart disease, type 2 diabetes, tooth decay, and nutrient-poor diets, according to the scientific report of the federal 2015 Dietary Guidelines Advisory Committee. The new labels will also display calories more prominently and use more realistic serving sizes.

Despite the critical public health need for the updated labels, the Trump Administration has yielded to the industry’s arguments that it will cost too much to meet the original deadlines. The FDA also blamed its favorite scapegoat, the Obama Administration, for rushing the agency to implement the new requirements and giving it too little time to provide guidance to the industry.

In fact, the hollowness of the FDA’s decision is underscored by the many updated labels that are already in grocery stores, with more added each week. Label Insight, a firm that tracks food labeling, estimates that at least 8,000 products, from dozens of companies, already carry the new label.

Products of familiar brands with the updated labels include Triscuits’ entire line of crackers, Wheat Thins Cracked Pepper and Olive Oil Snacks, Fritos Honey BBQ Flavor Twists, Green Giant Beet Noodles and Marie Callender’s Dutch Apple Loaf. Major companies, such as Campbell’s, Hershey, Panera and Mars have publicly stated their commitment to meet the original July 2018 compliance date.

We can hope the FDA reverses course once it hears from the public, but so far, all too often, the Trump Administration has displayed a tin ear for public health.

Peter Lurie

About the author: Peter Lurie, M.D., M.P.H., is president of the Center for Science in the Public Interest, a nonprofit health advocacy group based in Washington D.C. that focuses on nutrition and food safety policies.

Previously, Lurie was the associate commissioner for Public Health Strategy and Analysis at the Food and Drug Administration. While at FDA he worked on antimicrobial resistance, transparency, caffeinated beverages, arsenic in rice, fish consumption by pregnant and nursing women, expanded access to investigational drugs, and prescription drug abuse. Prior to that, he was deputy director of Public Citizen’s Health Research Group.  Earlier, he was a faculty member at the University of California-San Francisco and the University of Michigan.

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