Last week U.S. District Court Judge Samuel Conti denied General Mills’ appeal to throw out a class-action lawsuit brought against it, which alleged the company’s marketing campaign for Fruit Roll-Ups,  Fruit by the Foot, is deceptive and misleads consumers about fruit snacks’ healthfulness.

The complaint contends that the labeling of fruit-flavored snacks violates various state laws, including Minnesota’s Uniform Deceptive Trade Practices Act, where the company is head quartered, and several California laws governing misleading and deceptive advertising and fraudulent business practices.

According to the complaint filed last year by the Center for Science in the Public Interest (CSPI) and the Reese Richman law firm on behalf of Annie Lam, a California mother, the company’s marketing campaign for Fruit Roll-Ups,  Fruit by the Foot and other fruit snacks included “misleading statements that its products were nutritious, healthful to consume, and better than similar fruit snacks,” when in fact, the complaint continues, the “fruit snacks contained trans fat, added sugars, and artificial food dyes; lacked significant amounts of real, natural fruit; and had no dietary fiber. The complaint also alleges the packaging was likely to deceive consumers into believing the snacks are healthful and natural, rather than a combination of artificial, non-fruit ingredients.

Commenting on his decision, Conti said, reasonable consumers might be misled by packaging that claimed the snacks are “made with real fruit,” and would not read the fine print.

“The court agrees with Lam. The fruit snacks’ ingredients list cannot be used to correct the message that reasonable consumers may take from the rest of the packaging: that the fruit snacks are made with a particular type and quantity of fruit,” he said.

The precedent is growing in California where food manufacturers are held liable for claims on the packaging that are technically compliant with FDA regulations and guidelines, but otherwise deemed reasonably misleading. Absent from many of these cases is any discussion of whether plaintiffs assumed the risk by not reading the ingredients label. Notice these cases are only arising in California, other courts may be less sympathetic to claims that exclude any reference to the back of the box.

Moon India became aware of the problem after the FDA sampled tuna strips from a lot not yet in distribution. However as a cautionary measure Moon India agreed to recall tuna strips that were already distributed, none of which is from the suspect lot sampled by FDA. Distribution of these AA or AAA Grade Tuna Strips Product of India is limited to 4 wholesalers: one in Georgia, one in Massachusetts, one in New Jersey and one in New York.

The wholesalers may have broken the shipments into smaller lots for further distribution. The frozen raw yellow fin tuna product was originally packaged in white boxes with black writing naming the importer as Moon Marine USA Corporation, a separate and independent company, and identifying the contents as Tuna Strips AA or AAA, Product of India. The boxes contain several vacuum-wrapped packages with no further labeling.

Distribution of the product has been suspended while FDA and the company continue their investigation as to the scope of the problem.

Product sellers, including distributors and restaurants, should consult their suppliers to determine whether the Tuna Strips from India in their possession originated from Moon India. The product may not be accompanied by lot numbers or labeling information.

(Source — FDA website Firm press releases for recalls)

Contributed By: Michael “Mick” Guerini, Microbiologist and Technical Writer 

All alfalfa sprouts produced by Cleveland Beansprouts are being recalled. There are no lot codes or any other identifier on the product. The alfalfa sprouts were only distributed in Ohio.

The contamination was discovered by the Ohio Department of Agriculture while collecting and testing samples under the United States Department of Agriculture’s Microbiological Data Program. No illnesses have been reported to date.

A similar recall in New York occurred about 14 days ago.

(Source — FDA Recall website)

Contributed By: Michael “Mick” Guerini, Microbiologist and Technical Writer 

The grocery bag contained cookies, potato chips and fresh grapes, and was kept in the bathroom of a hotel room where one of the girls who got sick stayed with an adult chaperone.  ABC News reports the person who put the bag in the bathroom was not aware that someone in the room was ill.

“This is the first published report of norovirus infection without person-to-person transfer,” said Kimberly Repp, a case study co-author and now an epidemiologist with Oregon’s Washington County Health & Human Services.  “Two groups of people were infected by transportation of an inanimate object.”

Norovirus can be transmitted by tiny particles of vomit and feces floating in the air, meaning the virus can easily contaminate surfaces and objects. ABC News report the sick child, who was suffering from vomiting and diarrhea, did not need to touch the bag or its contents. Simply using the bathroom with the bag sitting there throughout the night was enough to transmit the virus.

The next day, the bag ended up in another hotel room and the contents were handled and eaten by other members of the group.  After that, the others eventually became ill.

“When people are sick in a bathroom, we all need to think beyond cleaning the toilet,” Repp said.  “We need to clean all the surfaces where the virus may have landed and everything else in the bathroom.”

One person who fell ill sought medical attention, but no one was hospitalized.  Five other people in team members’ homes contracted the virus after the girls got home and got sick.  The virus can be shed in stool for up to two weeks after a person becomes ill.

If anyone gets the virus, containing it as much as possible is essential to preventing its spread.“When possible, quarantine or isolate sick people to a single bathroom,” Repp said.

The risk of contracting an illness from any particular reusable bag is low, Dr. William Schaffner, chairman of the department of preventive medicine at Vanderbilt University Medical Center in Nashville., told MSNBC News. Schaffner did point-out, however, that the Oregon case follows a 2010 paper by researchers at the University of Arizona and Loma Linda University that found large numbers of bacteria in reusable grocery bags, including 12 percent that were contaminated with E. coli.

When scientists in that study stored the bags in the trunks of cars for two hours, the number of bacteria jumped 10-fold.

Some critics dismissed that study, which was funded in part by the American Chemistry Council, which supports the makers of some disposable plastic bags.

But few have debated the study’s conclusion, which found that washing the reusable shopping bags regularly decreased contamination by 99.9 percent

Approximately 500 packages of affected product were distributed from April 12 through April 17, 2012 from this lot and as of the date of this release, 263 of these packages have already been retrieved from retail stores. Product was distributed to health and natural food retail stores located in the following states: AK, AR, AZ, CA, CT, FL, GA, ID, IL, IN, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, OH, OK, OR, SC, SC, TN, TX, WA, WI, and WV.

The product comes in a 6 oz pouch with the World Berries™ logo identified as Organic Cacao Nibs with the following UPC code 632474929022, affected lot code 161104 and the use by date for products for the affected lot 04/14, which are laser etched on the vertical edge of the back panel.

The potential for contamination was identified through the company’s own audit testing of finished product which detected the presence of E. coli 0157:H7. Production and distribution of the product has been suspended while FDA and the company continue their investigation. No other lots of this product and no other FunFresh Foods products are affected by this recall.

(Source FDA website, Firm Press Release)

Contributed By: Michael “Mick” Guerini, Microbiologist and Technical Writer 

The USDA also announced new regulations that require meat and poultry companies to prepare recall procedures and notify USDA within 24 hours that a potentially contaminated meat or poultry product has been shipped. In addition, the agency will offer new guidance to meat and poultry plants on how to make sure their food safety systems are effective in preventing foodborne illness.

More from the USDA’s Food Safety and Inspection Service:

The policy measures include the following:
USDA’s Food Safety and Inspection Service (FSIS) intends to implement new traceback measures in order to control pathogens earlier and prevent them from triggering foodborne illnesses and outbreaks. FSIS is proposing to launch traceback investigations earlier and identify additional potentially contaminated product when the Agency finds E. coli O157:H7 through its routine sampling program. When FSIS receives an indication of contamination through presumptive positive test results for E. coli, the Agency will move quickly to identify the supplier of the product and any processors who received contaminated product from the supplier, once confirmation is received. This proposed change in policy gives FSIS the opportunity to better prevent contaminated product from reaching consumers. Learn more about the traceback proposed change in policy.

FSIS is implementing three provisions included in the Food, Conservation and Energy Act of 2008 (the 2008 Farm Bill). The new regulations, published as a Final Rule and directed by Congress, require establishments to prepare and maintain recall procedures, to notify FSIS within 24 hours that a meat or poultry product that could harm consumers has been shipped into commerce, and to document each reassessment of their hazard control and critical control point (HACCP) system food safety plans. Learn more about the Farm Bill provisions.

FSIS is announcing the availability of guidance to plants on the steps that are necessary to establish that their HACCP food safety systems will work as designed to control the food safety hazards that they confront. This process, called “validation,” enables companies to ensure that their food safety systems are effective for preventing foodborne illness. This notice announces that the draft guidance document is available for comment. Learn more about HACCP validation draft guidance.

In the past two years, FSIS has announced several measures to safeguard the food supply, prevent foodborne illness, and improve consumers’ knowledge about the food they eat. These initiatives support the three core principles developed by the President’s Food Safety Working Group: prioritizing prevention; strengthening surveillance and enforcement; and improving response and recovery. Some of these actions include:

• Performance standards for poultry establishments for continued reductions in the occurrence of pathogens. After two years of enforcing the new standards, FSIS estimates that approximately 5,000 illnesses will be prevented each year under the new Campylobacterstandards, and approximately 20,000 illnesses will be prevented under the revised Salmonella standards each year.
• Zero tolerance policy for six Shiga toxin-producing E. coli (STEC) serogroups. Raw ground beef, its components, and tenderized steaks found to contain E. coli O26, O103, O45, O111, O121 or O145 will be prohibited from sale to consumers. USDA will launch a testing program to detect these dangerous pathogens and prevent them from reaching consumers.
• Test and hold policy that will significantly reduce consumer exposure to unsafe meat products, should the policy become final, because products cannot be released into commerce until Agency test results for dangerous contaminants are known.
• Labeling requirements that provide better information to consumers about their food by requiring nutrition information for single-ingredient raw meat and poultry products and ground or chopped products.
• Public Health Information System, a modernized, comprehensive database about public health trends and food safety violations at the nearly 6,100 plants FSIS regulates.

More from the Associated Press:

WASHINGTON — The government plans to speed up the process for tracking E. coli in meat, a move that will help authorities more quickly find the source of bacteria outbreaks and hasten food recalls.

The new Agriculture Department program announced Wednesday would begin tracing the source of potentially contaminated ground beef as soon as there is an initial positive test.

Current procedures require USDA officials to wait until additional testing confirms E. coli before starting their investigation. Under the new process, government officials could trace the source of E. coli 24 to 48 hours sooner.

“The additional safeguards we are announcing today will improve our ability to prevent foodborne illness by strengthening our food safety infrastructure,” said Elisabeth Hagen, the department’s under secretary for food safety.

Once E. coli is identified, the USDA can immediately begin efforts to link products, companies and the pathogen to the source supplier and any other processors that received the contaminated meat.

Thousands of people are sickened each year by E. coli, a group of bacteria that can cause diarrhea, dehydration and, in the most severe cases, kidney failure. The very young, the elderly and those with weak immune systems are the most susceptible to illness which can in rare cases be fatal.

About 12,000 to 13,000 samples of ground beef and beef trimmings are tested for E. coli every year. The earlier tracking procedure will begin when the USDA finds the common O157:H7 strain of the E. coli pathogen, which causes the most severe illnesses.

Caroline Smith DeWaal, food safety director at the Center For Science in the Public Interest, a consumer advocacy group, called the announcement a “very positive step.”

“This will allow them to hopefully reduce the burden of illness that can be linked to these outbreaks,” she said.

DeWaal’s group has called on USDA to go even further and offer similar protections against salmonella strains that are resistant to antibiotics.

The USDA will take comments on the new E. coli plan for 60 days. It is expected to go into effect in July, in time for the peak of summer grilling season.

While testing is now limited to the single E. coli strain, the USDA will begin expanding testing in the future for six other strains of the bacteria that are causing increasing numbers of infections.

Safety experts advise consumers to safely prepare raw meat products, including fresh and frozen, and only consume ground beef that has been cooked to a temperature of 160 degrees.

The company is recalling tempeh manufactured this year between Jan. 11 and April 11. The containers are marked with a best-by date of 7/11/12 through 10/25/12. Tempeh is used as a meat substitute in vegetarian cuisine. It originated in what is today Indonesia, and is especially popular on the island of Java, where it is a staple source of protein. Like tofu, tempeh is made from soybeans, but tempeh is a whole soybean product with different nutritional characteristics and textural qualities.

The company is directing consumers to return the product to the place of purchase for a full refund. “Anyone with this product in their possession should not eat it,” said Agriculture Commissioner Steve Troxler. “Smiling Hara launched the recall after samples collected by the N.C. Department of Agriculture and Consumer Services during a routine inspection tested positive for salmonella.”

Additional tests will be conducted by the N.C. Division of Public Health to determine whether the salmonella detected in the tempeh matches the strain found in an outbreak that has sickened 37 people. Cases appear to have been associated with residence or travel to Buncombe County since Feb. 28.

“We strongly encourage individuals to follow the recall guidelines to protect their health and the health of their families,”State Epidemiologist Dr. Megan Davies said.“We do not know yet if this is the same strain of salmonella that is causing the current outbreak.Any salmonella can be transmitted person to person, so it is very important for individuals to practice good hand-washing and to see a physician if they have any symptoms of illness.”

Symptoms commonly associated with this infection may include — but are not limited to — diarrhea that may be bloody, fever, headache and abdominal pain usually one to 10 days after exposure. The illness caused by salmonella infection usually lasts four to seven days, but may last longer. In some cases, people may need to be hospitalized.

(Source:  FDA press release)

Contributed By: Michael “Mick” Guerini, Microbiologist and Technical Writer 

The FDA would receive $2.52 billion total in fiscal year 2013 under a budget sent to the Senate floor by the Committee on Appropriations. That figure does not include funding derived from user fee programs, which Congress is working to reauthorize.

Check back for more details as they emerge.

The European Parliament is actively looking to pass legislation that would make it easier for regulatory authorities to track both medical devices and patients implanted with medical devices, according to reports from Fierce Medical Devices.

A Committee within the European Parliament unanimously passed a resolution on April 25th advancing the above proposals, saying “it is essential to […] strengthen surveillance and safety controls and placing on the market requirements.”

The members emphasize the registers should be interconnected between states to facilitate the exchange of information, for example, when device defects are detected. Members also expressed the need for a single European database that readily provides information about medical devices on the market, clinical investigations, EC certificates issued, as well as other relevant information.

The proposal by the European Parliament is only a starting point in the legislative process – how far they go remains to be seen. It is interesting to note, however, the proposals come soon after the FDA touted the superiority of the device regulatory process in the U.S. versus Europe.

Both types of sprouts were distributed in New York State.

The contamination was discovered after sampling under the USDA Microbiological Data Program by New York State Department of Agriculture and Markets inspectors and subsequent analysis by the New York State Food Laboratory personnel revealed the presence of Listeria monocytogenes in the product. No illness has been reported to date.

In late 2011, another recall, from a Texas company, relating to sprouts occurred.  This previous recall was initiated because of a positive test for Salmonella were later pulled because of Listeria concerns.

(Source FDA Firm Press Release recall)

Contributed By: Michael “Mick” Guerini, Microbiologist and Technical Writer