Food Safety News
The decision was prompted by the release of a new caffeinated gum called Alert, manufactured by Wrigley, which hit markets Monday.
The last time FDA looked at caffeine as a food additive was in the 1950s when the agency set a limit on the amount of the substance that could be added to colas. Caffeine is on the agency’s list of ingredients that are ”generally recognized as safe” (GRAS) when it comprises .02 percent of a cola beverage, but has not been regulated in other contexts.
“Today, the market has changed,” said FDA Deputy Commissioner for Foods and Veterinary Medicine in a statement posted on the agency’s website Monday. ”Children and adolescents may be exposed to caffeine beyond those foods in which caffeine is naturally found and beyond anything FDA envisioned when it made the determination regarding caffeine in cola.”
And while caffeinated gum has just landed on store shelves, artificially caffeinated beverages have been stirring controversy for years, as they have been tied to adverse health effects and even death.
Energy drinks are often exempt from the .02 percent limit because they are considered dietary supplements rather than food or drink.
Between 2004 and 2012, five people died after consuming Monster drinks, according to data from FDA. During this time period, 21 people experienced “adverse effects” after drinking Red Bull, although no deaths were reported.
In Canada, three deaths were reported after the consumption of Red Bull between 2003 and 2012.
A death or adverse health effect after consuming a product does not definitively prove that it was caused by the product, but these events have raised questions about the safety of caffeinated beverages.
Because so many artificially caffeinated food and drinks have hit the market since the time FDA considered caffeine in cola, ”FDA is taking a fresh look at the potential impact that the totality of new and easy sources of caffeine may have on the health of children and adolescents, and if necessary, will take appropriate action,” said Taylor.
According to Wrigley, Alert is not targeted towards young people, but is ”a new energy product available for adults 25-49 that lets people control the amount of caffeine they want on-the-go.”
However, there is no age minimum for purchasing the gum.
Each stick of Alert contains 40 milligrams of caffeine – half of the amount found in an 8.4 ounce can of Red Bull energy drink.
The federal watchdog organization Center for Science in the Public Interest questioned the safety of Alert, and said the new product stressed the need for regulation of added caffeine.
“Could caffeinated macaroni and cheese or breakfast cereal be next?” asked CSPI’s executive director Michael Jacobson in a statement Monday. “One serving of any of these foods isn’t likely to harm anyone. The concern is that it will be increasingly easy to consume caffeine throughout the day, sometimes unwittingly, as companies add caffeine to candies, nuts, snacks and other foods. And that’s on top of the soda, coffee, tea, and energy drinks that are already widely consumed.”
Get your personal signed copy of Poisoned, the true account of the 1993 Jack in the Box E. coli outbreak by award-winning investigative journalist Jeff Benedict at Food Safety Summit.
While attending the Food Safety Summit, be sure to visit Booth #221.
Poisoned, just released in paperback, is available for purchase for the retail price of $16.95 Wednesday only between 10:30 am and 2:30 pm at the Food Safety News booth #221. Author Jeff Benedict will be on site to sign books.
In Poisoned, award-winning investigative journalist Jeff Benedict delivers a jarringly candid narrative of the 1993 E. coli outbreak traced to Jack in the Box hamburgers, drawing on access to confidential documents and exclusive interviews with the real-life characters at the center of the drama—the families whose children were infected, the Jack in the Box executives forced to answer for the tragedy, the physicians and scientists who identified E. coli as the culprit, and the legal teams on both sides of the historic lawsuits that ensued.
The book—described as Fast Food Nation meets A Civil Action—is a riveting account of how we learned the hard way to truly watch what we eat. It has received critical acclaim from book reviewers and food industry experts:
“Movie-like … Benedict does a dramatic public service by showing us what happened behind the scenes.” – Rebekah Denn, The Christian Science Monitor
“A new, thriller-style account of the horrors of that E. coli outbreak and the subsequent events, including the groundbreaking rulings making O157:H7 an ‘adulterant.’” – Mark Bittman, The New York Times
Food Safety News staff will be available throughout the week at the Food Safety Summit, being held this week at the Baltimore Convention Center. Come by Booth 221!
Sunday’s end to the Washington State Legislature’s 105-day regular session means Evergreen State voters are going to decide whether genetically modified food should be labeled. That’s because lawmakers in Olympia took no action on Initiative 522, Washington State’s version of the “Right to Know” law California voters narrowly rejected last November.
I-522 is an “Initiative to the Legislature” under the Washington State Constitution. State lawmakers could have adopted it or even proposed their own version of I-522, but because they took no action, the measure goes on the November ballot with the language written by its sponsors.
“The People’s Right to know Genetically Engineered Food Act” will be voted up or down by Washington State voters who are as much experienced in deciding ballot measures as are Californians. Some language from California’s Proposition 37, however, did not make it up north. I-522 overall is similar to Prop 37, but it is missing language included in the California campaign to prohibit words like “Natural” or “All Natural” from being used on food labels.
As I-522 moves to the ballot, state Public Disclosure Commission records shows at least five separate committees registered to raise money in the support of the measure. Together they spent close to $1 million so far, most probably on petition signature gathering. Total cash on hand reported by the committees is more than $400,000.
Mark Funk, a well-known Evergreen State political operative, leads I-522’s opposition. His “No on 522″ committee has opened a bank account with $1,144 deposited so far. Opponents in California outspent Prop 37 supporters, $45 million to about $10 million.
A tax initiative could end up sharing the ballot with I-522. Petitions are being circulated for a November ballot initiative that would require voter approvals of new taxes. It’s not known how that measure might impact turnout if it does reach the ballot with I-522.
Some of the most disgusting images of modern agriculture being presented to the American public are those of old cull cows being inhumanely treated and mishandled by workers in the slaughter house pens.
The Humane Society of the United States, PETA and other organizations that want us to stop slaughtering animals for human consumption keep the videos and headlines coming, and we are making their task just too easy.
Many of these cull cows are spent dairy cows as was the case at Westland/Hallmark and most recently at Central Valley Meat Co.
The cow may be well over 10 years of age, 10 years that were spent basically eating and being milked without much physical conditioning present and now she is becoming lame, or producing less milk, or showing signs of deterioration of her health in some other fashion.
When an older cow has reached this point in her life, her owner may have her transported to a sale barn to be auctioned off. Following that she is reloaded onto another truck and transported to a slaughter plant and placed in a holding pen until the FSIS public health veterinarian can observe her in motion and at rest.
And then she must be able to walk to the knock box on her own legs and of her own free will. But she just may not be able and willing after all of this commotion.
The transporting may take place during inclement weather and cover hundreds of miles, and all this time the cow goes without being milked if still lactating.
No wonder some of them just lie down and refuse to get back up—they are weakened from their journey, they are old and tired, and they may be just plain miserable.
One might think that it is only logical to not send a lactating cow to market, but the cost of grain to feed a cow while going dry and administering antibiotics in the udder to prevent mastitis present a quandary of how best to handle the situation from an economic standpoint.
It used to be, after the first case of Mad Cow was found in Washington State and the Interim Final Rule was written to protect us from consuming the BSE prions, that if a cow had been observed in motion and at rest and passed by the vet and then refused to get up, the vet could return to the pen to examine her.
If a valid cause, such as a fractured leg or ruptured tendon, was found for becoming what is known as a “downer cow”, she could be humanely euthanized on the spot, labeled U.S. Suspect, and then taken to the facility for further fabrication and examination.
That rule changed after Westland/Hallmark when Secretary Vilsack declared all downer cows banned from the food supply.
In some cases perfectly good meat now is going to waste, which adds to the conundrum of what to do with cull cows.
These are high risk cows for becoming downers, but they are still a commodity with a price tag.
And they present the anti-meat groups with plenty of ammunition to try and portray an industry as being cruel and inhumane.
I suggest to the readers that it just might be cruel and inhumane to send a cow that is still lactating to the auction block and all that that entails.
It might also be cruel and inhumane to send a very old but dry cow on her final journey to the slaughter house if she is too weak and feeble to make the trip.
And it certainly is a very bad public relations move to do any of the above, enabling damning undercover footage to be filmed.
I believe the dairy industry must do a better job of evaluating which cows to send to slaughter and which ones to euthanize and send to rendering.
The industry could help its image by consistently following the 10 best practices for culling and transporting dairy cows to packing facilities as written by the National Milk Producers Federation after the Westland/Hallmark incident.
It would not only be the humane thing to do, it would be the politically correct thing to do.
But this is not just about the dairy industry. Once the cow leaves the dairy farm, someone else is responsible for feeding and watering that animal. They need to be held accountable as well.
The bottom line is pretty simple. If a cull cow is too weak to walk, there is no way to make her get up and go.
Just like there is no way to make the public forget those awful videos we have watched of people trying to do just that—make the cows get up and go against all odds.
More than one drought may be over in the heartland of America. Yes, there’s been enough snow and rain to drastically reduce the drought’s footprint on the land of the Southeast and West. But there is also a sign another drought may have ended, that’s the one where food industry executives skate after they’ve poisoned people by knowingly shipping adulterated products.
Sure, from time to time, corporations have pleaded guilty to some misdemeanors and paid fines in criminal courts. That’s what Odwalla Inc. did before Coca-Cola acquired it, after its apple juice killed a child and Sara Lee did after its hotdogs killed 15. We could cite other examples.
But the days of misdemeanor plea, fine, and sometimes even a joint press release with the government and food company all expressing their deep regrets may be over. Food industry executives may want to listen up. If you knowingly are taking actions that may result in someone’s’ poisoning or death, your butt, not just the shareholders’ money, may be on the line.
We’ve thought for some time that the 76-count federal criminal indictment against four former executives of the defunct Peanut Corporation of America is a game-changer. That’s why Food Safety News is committed to covering the judicial proceedings against the four.
We do not know how this is going to come out. Stewart Parnell, his brother Michael, and the two other former peanut processing plant managers are, under the law, all presumed innocent until a jury says otherwise.
But from the stands, we are able to factually report that what the government is doing with the criminal case has profound implications for the food industry. Its 52-page indictment presents a strong case against the PCA four, and Daniel Kilgore– a fifth former executive who has already pleaded guilty to the charges. He stands ready to testify for the government in the jury trial expected to get under way in October.
He’s long had good defense attorneys working for him, but it is doubtful Parnell knew how heavy the load was going to be until it dropped on him. In opposing Parnell’s request for return of his U.S. Passport, government attorneys speculated that if the Virginian “expected to be charged it is highly likely he believed he would only be charged with misdemeanor violations…”
“Historically, criminal prosecutions for shipment of adulterated food were almost always charged as misdemeanors,” the U.S. attorneys wrote. “The defendant Stewart Parnell did not anticipate a 76 felony count indictment.” If these same attorneys persuade an Albany, GA jury, Parnell’s maximum sentence would be 754 years in prison and $17 million in fines.
Under the federal sentencing guidelines that will take Parnell’s age of 58 years and other factors into account, the man many victims and their survivors blame for nine deaths and 700 illnesses in the 2008-09 Salmonella Typhimurium outbreak could get off with a just a life sentence.
So let’s review. Old system was the corporation pleading guilty to a misdemeanor or two and paying a corporate fine. The new system involves felony charges and hard time in prison.
Call me old fashioned, but I still think the felony charges and hard time in prison will be a more effective disincentive for shipping poisons that can injure and kill people, who are usually children or senior citizens. There are many miles to go before we know if this new approach by federal prosecutors will work. They got a complex case going, one that in some respect is looking down on PCA from 30,000 feet saying: “what was really going on here?”
Food industry executives who do not sit up and take notice will be doing so at their own peril because you never know how quickly you can go from sitting on dry ground to being in dire need of rescue from the flood waters.
Five more victims in four states were added Friday by the federal Centers for Disease Control and Prevention in Atlanta to the list of confirmed cases in the rare Shiga toxin-producing Escherichia coli O121 outbreak associated with Farm Rich brand products.
The additional victims—one each in California, Colorado, and Ohio and two in Florida—bring the total number of individuals infected with the outbreak strain of E coli O121 (STEC O121) to 32.
CDC says 35 percent of the victims have required hospitalization and two developed the kidney-damaging hemolytic uremic syndrome (HUS). No deaths have been reported among the mostly young (81 percent are age 21 or under) victims.
Among persons for whom information is available, illness onset dates range from December 30, 2012 to April 2, 2013. Ill persons range in age from one year to 75 years, with a median age of 17 years. Fifty-six percent of ill persons are female.
Illnesses that occurred after March 30, 2013 might not be reported yet due to the time it takes between when a person becomes ill and when the illness is reported.
CDC and state public health officials are interviewing ill persons to obtain information regarding foods they might have eaten and other exposures in the week before illness.
Information available to date indicates that consumption of Farm Rich brand frozen food products is one likely source of infection for the ill persons in this outbreak.
The outbreak strain of STEC O121 has been identified in two different Farm Rich brand frozen products collected from the homes of two ill persons.
The Outbreaks Section of the U.S. Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) Eastern Laboratory identified the outbreak strain from individually wrapped Farm Rich brand frozen mini pizza slices from an opened package collected from an ill person’s home in Texas.
The New York State Department of Health, Wadsworth Center Laboratory, identified the outbreak strain from an opened package of Farm Rich brand frozen chicken quesadillas from an ill person’s home.
On April 4, 2013, Rich Products Corporation expanded its recall to include all Farm Rich, Market Day, and Schwan’s brand frozen food products produced at its Waycross, Georgia plant between July 1, 2011 and March 29, 2013 due to possible contamination with E. coli O121.
The recalled products had “Best By” dates ranging from January 1, 2013 to September 29, 2014.
USDA-FSIS and the U.S. Food and Drug Administration (FDA) are currently conducting investigations to determine the source of product contamination.
The Indiana General Assembly early this morning adjourned for the year without passing any version of a proposed “ag-gag” law, including a tougher version that was favored by the Senate.
When Senate Bill 373 passed in the Senate again Friday on a 29-to-21 vote, the measure went over to House. In the House debate that followed for about 45 minutes, Democrats claimed the more sweeping Senate adopted bill was now a “gag all” bill that went beyond just farm protection.
The time-killing debate turned out to be the final straw for the Indiana House Speaker Brian C. Bosma, who then pulled the bill from the last day’s calendar without allowing another vote on the House floor. He said he wanted to force the Senate to vote on the milder House version of the proposed law.
But shortly after 8 p.m. Friday, Senate President Pro Tempore David Long, R- Fort Wayne, announced the upper chamber would be taking no more votes on “ag-gag” in 2013. His announcement made it official, “ag-gag” was dead for the year.
Ultimately, it was the Senate over-reach that killed “ag-gag” in Indiana this year. When members of the House could seriously question whether the bill as passed by the Senate would make it illegal for someone to text damaging information about a restaurant or nursing home, the bill was dead.
The Assembly-adopted version stuck to making it a crime to lie on a job application and re-defining criminal trespass to include crossing a fence or barrier that clearly implies entry is prohibited.
The down-to-the-wire defeat of SB 373 was a big victory for national animal activist groups.
Typical of the reaction was a statement from the American Society for the Prevention of Cruelty to Animals (ASPCA) that said “the harmful anti-whistleblower/”ag-gag” bill that would have suppressed whistleblowers and protected animal abusers instead of working to prevent such mistreatment. The bill would have also delivered an attack on core American values including food safety, environmental protection and workers’ rights.”
UPDATE: U.S. Magistrate Judge Thomas Q. Langstaff late Friday denied Stewart Parnell’s request to have his U.S. Passport returned, Without a hearing, the Judge said the Court is sympathetic with Parnell’s desire to pursue employment opportunities involving foreign travel, but said conditions of his release are already the “least restrictive necessary” to ensure his future court appearances.
Before Langstaff’s ruling, government attorneys said the 58-year old Stewart Parnell is more of flight risk now than before he was indicted on multiple federal counts that carry a maximum possible sentence of 754 years in prison and $17 million in fines. The lawyers for the government strongly opposed the former chief executive of Peanut Corporation of America’s April 9 request for the return of his U.S. Passport “for business purposes.”
The government attorneys — Patrick H. Hearn and Mary M. Englehart from the Consumer Protection Branch of the Department of Justice, and Assistant U.S. Attorney K. Alan Dasher of the Middle District of Georgia — showed that Parnell is no novice at world travel.
The government provided the U.S. District Court for the Middle District of Georgia with copies of Parnell’s travel records from the Treasury Enforcement Communications System (TECS), a Customs and Border Protection system for recording who leaves and returns to the U.S.
Before he was charged, the government knew Parnell was traveling abroad extensively, including trips to Nicaragua, Senegal and France.
U.S. attorneys agreed not to arrest and detain Parnell because he agreed to give up his passport. That allowed him to surrender to the U.S. Marshal’s Office on the day of his initial court appearance.
Parnell is free until the scheduled October jury trial on an unsecured $100,000 bail, but has asked the Court to order his passport returned on grounds that he needs it for business travel.
Parnell’s Atlanta attorney, Kenneth B. Hodges III, said his client needs his passport “returned to him so that he may secure employment with a company that requires him to travel overseas for business — not so that he may flee from the United States.”
Hodges argues the fact that Parnell traveled extensively outside the U.S. before being indicted shows he is not a flight risk. Instead, the attorney says, his client “chose instead to return to Virginia where he, his wife, children and grandchildren live.”
The government sees it differently. Until the indictment was unsealed, they argue, Parnell probably thought he would be charged with misdemeanor violations of the Food, Drug and Cosmetic Act. “Historically, criminal prosecutions for shipment of adulterated food were almost always charged as misdemeanors,” the U.S. attorneys say. “The defendant Stewart Parnell did not anticipate a 76-count felony indictment.”
Further, Parnell did not know prior to giving up his passport that former PCA insider Daniel Kilgore had plead guilty and now stands ready to testify against the four executives charged in the indictment.
“These facts are what make the defendant Stewart Parnell’s request for his passport alarming,” the government says. “One can draw the logical conclusion that defendant Stewart Parnell intends to flee prosecution in this case by leaving the United States due to the strength of case and life sentence he is confronting.”
Since about the time of the nationwide Salmonella Typhimurium outbreak linked to PCA products in late 2008, those government travel records show Parnell traveled to Argentina, South Africa and Zimbabwe. More recently, he’s been to France, Senegal, and made multiple trips to Nicaragua.
The government says once someone skips the country prior to trial, it can take a decade or more to locate and return to the U.S. to face prosecution. They say Parnell has been in some foreign counties long enough to establish ties. Some countries, like Nicaragua, also have a history of almost never deporting someone to the U.S. for prosecution.
“In light of the defendant Stewart Parnell’s unrestricted ability to work in the United States there is no need for a passport other than to flee prosecution,” says the government motion opposing the request.
Indicted with Stewart on Feb. 22 were his brother Michael Parnell and two former executives at the Blakely, GA peanut processing plant, Samuel Lightley and Mary Wilkerson. Michael Parnell was PCA’s peanut broker.
Nine people were killed and at least 700 people sickened in the outbreak. In prior civil litigation, more than 100 victims and their families were awarded $12 million in damages.
Federal and state health officials are currently investigating three multistate outbreaks of Salmonella infections all linked to contact with chicks, ducklings and other live poultry, according to the U.S. Centers for Disease Control and Prevention.
In the past week, health departments in four states — Minnesota, Nebraska, New Mexico and South Dakota — have announced Salmonella illnesses linked to live poultry that are also part of wider, multistate outbreaks.
On Thursday the CDC confirmed not one, but three separate multistate outbreaks of Salmonella Infantis, Salmonella Mbandaka and Salmonella Typhimurium. Minnesota has been the only state to further identify its cases as Salmonella Infantis infections.
The known case count currently sits at 20, with illnesses by state as follows: Minnesota (3), Nebraska (6), New Mexico (7) and South Dakota (4). It is unclear how many more states, if any, are involved in the outbreaks.
“In interviews, ill people reported purchasing live baby poultry (chicks, ducklings) from multiple feed stores and mail-order hatcheries,” the CDC advisory read. “Investigations are ongoing to determine the source of the live poultry in these outbreaks.”
Health professionals recommend thoroughly washing hands after handling live poultry, and making sure young children do not snuggle or kiss birds.
Last month, Food Safety News produced a video on safe handling of chicks in anticipation of chick season. Watch that video below:
As the Hoosier General Assembly moves toward adjournment, as early as today and no later than Monday, recent action taken by the Indiana House Speaker is not looking too favorable for critics of the state’s farm protection legislation, also known as “ag-gag.”
National animal advocacy groups thought that the differing versions of Senate Bill 373 adopted by the Senate and House might kill the bill because it seemed the differences that needed to be resolved would not be overcome in time by a House-Senate conference committee.
As it passed the Senate, the original SB 373 is a classic “ag-gag” bill in that it makes it a crime to shoot video or take pictures of animal abuse on private property without the owner’s permission, or to fail to tell nothing but the truth on a job application. The House stripped these provisions mainly out of concern that such items are likely to be unconstitutional.
Now, according to the Humane Society of the United States’ state lobbyist Matt Dominquez, the provisions the House stripped out are being put back in through the conference committee report. He says Republican State Sen. Travis Holdman, SB 373’s prime sponsor, has insisted on having the bill entirely restored and, for whatever reason, the GOP House Speaker is going along with him.
To accommodate Sen. Holdman, the Speaker removed at least one House Democrat from the conference committee and replaced him with a Republican likely to be more friendly to a hard “ag-gag” bill.
If a conference report gets votes in the House and Senate, it’s also likely to contain a 120-hour deadline for anyone with evidence of animal abuse to provide it to local law enforcement. “At this point,” Dominquez told Food Safety News, “whatever Senator Holdman wants, he is going to get.”
Legislative leaders Thursday were still trying to work out the timing of the end of the session with Republican Gov. Mike Pence.
A bipartisan group of U.S. senators this week asked the U.S. Food and Drug Administration to be more transparent when they publish data regarding the use of antimicrobial drugs in food animal production.
The lawmakers, including Sens. Tom Harkin (D-IA), Lamar Alexander (R-TN), Dianne Feinstein (D-CA), Kirsten Gillibrand (D-NY) and Mark Kirk (R-IL), most of whom serve on the Senate Health, Education, Labor, and Pensions Committee, said in a letter to FDA Commissioner Margaret Hamburg that they support FDA’s recent efforts to encourage veterinary pharmaceutical drug companies to drop growth-promotion claims form their antimicrobial labels and to rein in injudicious uses. But the senators are asking FDA go a step further and set “a clear timeline” to develop an antimicrobial data collection strategy based on the comments the agency has received from stakeholders.
The senators want FDA, along with the U.S. Department of Agriculture and the Centers for Disease Control and Prevention, to conduct a needs assessment to figure out what data the agency needs regarding antimicrobial uses. They also asked that FDA publish the assessment and present it to Congress. On top of that, they want the agency to report more detail, such as dosage and container size, in the next antimicrobial sales report.
Health advocates have long sought more data on the use of antibiotics in food animal production in an attempt to more definitively link the use of a particular antibiotic product to the level of resistance among pathogens. Recent attempts to mandate that FDA collect and report more data, as part of the Animal Drug User Fee Act, have failed.
The letter said that reporting more data will give scientists what they need to “further evaluate the effectiveness of current public health programs.”
The senators requested that FDA finalize the Draft Guidance for Industry 213 “as soon as possible” to help eliminate the “injudicious uses” of the drugs in agriculture and they also want to see a plan to evaluate the policy going forward.
The Centers for Disease Control and Prevention (CDC) announced Thursday that a multi-state Salmonella outbreak was likely caused by the consumption of cucumbers imported from Mexico. The announcement came one day after USA Today reporter Liz Szabo reported that the FDA would be conducting 18 percent fewer food inspections this year due to a loss of funding and that “even before the sequester, the FDA was able to inspect less than 2 percent of all food imports.”
According to the CDC, at least 73 people fell ill with Salmonella serotype Saintpaul infections between January and April of this year after eating cucumbers. On April 24, the U.S. Food and Drug Administration placed two Mexican import firms on an “import alert,” stating that cucumbers from the farms would be denied admission into the U.S. unless the suppliers were able to prove the produce was free of Salmonella.
People started falling ill with Salmonella infections before the Sequester, so there’s no question that these cucumbers made it into our food supply even before cuts to food inspection. When the funding cuts are in full effect, will we see even more outbreaks from both imported and home-grown food?
I shudder at the thought of what these cuts will truly mean in terms of the safety of our food supply.
The USDA’s Microbiological Data Program (MDP), which used to conduct 80 percent of all federal produce testing for pathogenic bacteria, officially shut down on December 31, 2012.
Would MDP have discovered contamination on cucumbers before they got to market?
We may never know—and we may think of cucumbers as fairly benign since they’re not linked to food safety problems as often as leafy greens or melons, but this outbreak demonstrates that all fresh produce poses a food safety threat and cuts to federal programs may already be having an impact.
After administering ginkgo regularly to rodents over a two-year period, researchers at the National Toxicology Program (NTP) found that the animals were more likely to develop thyroid and liver tumors than those who did not receive the plant extract, or who received low doses.
In a shorter three-month trial, rats and mice who were administered ginkgo displayed characteristics that predict tumor growth.
“The tumors found in mice were pretty impressive,” said Dr. Cynthia Rider, NTP’s study scientist for ginkgo. “They were among the highest in NTP studies for one of the tumors that doesn’t occur simultaneously all the time in mice,” Rider explained in an interview with Food Safety News.
The mice in the three-month study were put into six dosage groups – no ginkgo, 125 mg per kg of body weight, 250 mg/kg, 500 mg/kg, 1,000 mg/kg and 2,000 mg/kg. Doses were administered five times a week. After three months, all mice who had received 250 mg/kg or more had heavier livers than those who had received no extract.
Over the course of the two-year study, cancerous tumors developed in all dosed male mice and in female mice who had been given 600 mg/kg or higher.
Only some rats in the two-year study developed liver tumors, but higher levels of thyroid tumors were noted among these rodents.
How do these results translate into advice for consumers? What dose of ginkgo extract could put a person at risk for cancer, or does the extract cause a risk to humans at all?
To answer these questions, more research is required, said Rider.
“I think it’s better to leave that part of the interpretation from our perspective and just say that considering the findings, which were positive for carcinogenisis in both the male and female rats and mice, that they may be related.”
“Because these supplements are incredibly complex because they’re based on plant materials, we did not do the full toxicokinetic studies that would be needed to make the comparison,” Rider explained.
Toxicokinetics is a way of tracking what happens to a substance in the body.
So far, another research team at NTP has conducted an analysis of the liver tumors that developed in the mice. The results of that study showed that the liver tumors that grew in mice given ginkgo extract were different from those that arise spontaneously in mice.
Researchers reported a “marked differences between these tumors and those arising spontaneously in the B6C3F1 mouse.”
What Rider can say about her team’s results is that they show a potential connection between ginkgo and cancer, and that the substance should be looked at to see whether it indeed provides more benefit than potential risk.
She points to a 2008 study on the potential effects of ginkgo on memory, for which over 3,000 participants were given either ginkgo extract or a placebo and followed for an average of 6 years, and no difference in memory function was observed between the groups.
“If you’re doing your own personal risk-benefit calculation, you might want to consider the human efficacy studies and our studies as well as the variability seen in the marketplace,” said Rider.
The American Botanical Council questioned the results of the government research, saying that the ginkgo used in the NTP study did not reflect extracts commonly found in the U.S.
“The Chinese ginkgo extract manufactured in Shanghai is not consistent with any compendial botanical and chemical standards for quality as set forth in various official pharmacopeias and does not conform to the well-established chemical profiles, quality, and purity of the leading, clinically tested ginkgo extracts produced by the pioneering Willmar Schwabe Pharmaceuticals of Karlsruhe, Germany, and Indena SpA in Milan, Italy,” said ABC in a statement last week.
However, according to Rider, “The Ginkgo biloba extract used in the current studies was procured from a supplier known to provide material to United States companies.”
Rider said she and her colleagues found a wide variety of compositions among ginkgo supplements sold in the U.S. This may be due to the fact that ginkgo, as a dietary supplement, is not regulated by the U.S. Food and Drug Administration.
With the passing of the Dietary Supplement Health and Education Act of 1994, the responsibility of ensuring the safety of dietary supplements was transferred from FDA to manufacturers.
“Dietary supplements do not need approval from FDA before they are marketed,” says FDA on its website. “A firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products,” continues the agency’s Q & A page on dietary supplements.
In 1997, a Denver-based company petitioned FDA to include ginkgo biloba in its list of ingredients that are “generally recognized as safe,” or GRAS, and are therefore allowed to be used as food additives. But the company withdrew its request in 2000, and ginkgo has still not been approved for use in foods.
The New Mexico Department of Health has confirmed seven Salmonella illnesses associated with live chicks and ducklings that appear to be connected to a multistate outbreak under investigation by the U.S. Centers for Disease Control and Prevention.
Earlier this week, South Dakota and Minnesota confirmed four and three illnesses in the outbreak, respectively. Another six illnesses believed to be caused by live poultry have cropped up in Nebraska, but officials there have not confirmed a connection to the multistate outbreak.
A spokesman for the New Mexico Department of Health confirmed with Food Safety News that the state’s Salmonella illnesses were connected to the multistate outbreak.
A CDC spokeswoman told Food Safety News on Monday that the agency was investigating the outbreak, but was not prepared to make any announcements. As of Thursday, the agency has not made any further statements and it is unclear if more states are affected by the outbreak.
The New Mexico Department of Health warned against allowing live chicks or ducklings in homes, as they may spread harmful bacteria onto household surfaces. Health professionals recommend thoroughly washing hands after handling live poultry, and making sure young children do not snuggle or kiss birds.
Last month, Food Safety News produced a video on safe handling of chicks in anticipation of chick season. Watch that video below:
At least 73 people in 18 states have fallen ill with Salmonella Saintpaul infection thought to be connected to imported cucumbers, according to the U.S. Centers for Disease Control and Prevention.
Fourteen of the patients were hospitalized.
The U.S. Food and Drug Administration placed the firms Daniel Cardenas Izabal and Miracle Greenhouse of Culiacán, Mexico on import alert on April 24. Those cucumbers are no longer believed to be on the market.
The number ill by state is as follows: Arizona (9), California (28), Colorado (1), Idaho (2), Illinois (3), Louisiana (1), Massachusetts (1), Maryland (1), Minnesota (8), Nevada (1), New Mexico (2), North Carolina (1), Ohio (1), Oregon (2), South Dakota (2), Texas (6), Virginia (2) and Wisconsin (2).
Illness onset dates ranged from January 12, 2013 to April 6, 2013. The ill range in age from less than 1 year to 80 years old, with a median age of 23. Sixty percent are female.
Cucumbers are historically not associated with foodborne illness outbreaks. During a massive German E. coli outbreak in the summer of 2011, cucumbers were briefly suspected as the source before the blame was ultimately blamed on fresh sprouts.
In April 2011, a North Carolina company voluntarily recalled cucumbers due to a potential Salmonella risk.
Graphics courtesy of CDC.
Health officials in Wisconsin suspect three patients sickened by the same strain of E. coli O157:H7 contracted their illnesses after consuming raw milk, Wisconsin Department of Agriculture spokeswoman Raechelle Cline told Food Safety News Thursday.
All three patients reside in Manitowoc County, and they include a three year-old child and his or her mother.
Officials are currently testing samples of milk from the suspected dairy and will not identify it unless they prove a connection.
“Raw milk was the most likely commonality we’ve been able to identify,” Cline said.
The illnesses occurred in March, and the officials are unaware of any additional cases.
Health institutions such as the U.S. Centers for Disease Control and Prevention advise against drinking raw milk, as it has not been pasteurized to eliminate potentially harmful pathogens.
Just as the U.S. Department of Agriculture recommended a grant of inspection for what could become the first U.S. horse slaughterhouse following a five-year federal ban, actor Robert Redford has made a public call for banning horse slaughter, via a letter written to horse welfare organization Equine Advocates.
“Horses have always been very important in my life and I feel strongly that they need our protection from any kind of abuse, especially slaughter,” Redford begins. He goes on to compare the treatment of horses in the U.S. to the treatment of dogs and cats, and laments the desire of a “small group of special interests” who want to breed horses to profit from their meat.
“The entire slaughter process is cruel and inhumane and perpetuates abuse and neglect without consequences, in addition to condoning a violation of our nation’s cruelty laws,” he continues. He also highlights the concern that horse slaughter allows for a “swift cover-up” of horse theft.
For now, the future of U.S. horse slaughter remains up in the air, as the Obama Administration has suggested excluding money for inspectors at horse slaughterhouses from the 2014 budget. Beyond that, Congress may choose to extend the five-year ban.
Food Safety News published a report on the potential for horse slaughter to begin in New Mexico yesterday.
Following state-level initiatives on the West Coast, Senator Barbara Boxer (D-CA) and Representative Peter DeFazio (D-OR) on Wednesday introduced legislation that would require the U.S. Food and Drug Administration “clearly label” all genetically engineered (GE) foods, including foods that are made from GE grains and GE salmon, if it is approved by the agency.
The bill, dubbed the Genetically Engineered Food Right-to-Know Act, has ten co-sponsors in the Senate, including Sens. Lisa Murkowski (R-AK), who represents a big salmon state and is supportive of labeling GE salmon, Kristen Gillibrand (D-NY), and Bernie Sanders (I-VT), and nearly two dozen co-sponsors in the House, including Reps. Don Young (R-AK), also a vocal supporter of labeling GE salmon; Chellie Pingree (D-ME); Louise Slaughter (D-NY) and Jim McDermott (D-WA).
While polls have found that nine in ten Americans support labeling, a high profile proposition, Prop. 37, which would have mandated labeling in California failed last year. Washington state is set to put a similar initiative on the ballot next election.
“Americans have the right to know what is in the food they eat so they can make the best choices for their families,” Senator Boxer said in the announcement Wednesday. “This legislation is supported by a broad coalition of consumer groups, businesses, farmers, fishermen and parents who all agree that consumers deserve more – not less – information about the food they buy.”
Rep. Polis said the bill is about “empowering consumers: consumers can chose to eat or not eat GMOs, or to pay more or less for GMOs.” He said he believes consumers have a right to know what they are eating. I believe consumers have a right to know what they are eating so they can make their own informed food choices. I am proud to be working toward more informative food labels.”
More than 60 countries have some form of mandated GE labeling for foods, but in the U.S. labeling has been on a voluntary basis, with a hodge podge of “GMO-free,” or genetically modified organism-free, certifications and independent labels. In the early 1990s, the FDA determined that GE foods were not materially different from their non-GE counterparts and so there was no need to mandate labels, but 20 years later a movement has been built to pressure legislatures to reverse course.
Six children from southern and eastern Nebraska have recently contracted Salmonella infections, and health officials suspect the illnesses may have been linked to baby ducks or chickens.
The state Department of Health and Human Services says it has confirmed six cases of salmonellosis (the disease caused by Salmonella infection) in children ages 1 through 6, according to the Journal Star. One of the victims was hospitalized and later released.
At least five of the children came into contact with ducklings or chicks in the days preceding their illnesses, according to Leah Bucco-White, a spokesperson for the Nebraska HHS, reported the Journal Star.
However, baby poultry have not yet been conclusively identified as the source of the cases, according to Bucco-White.
Symptoms of salmonellosis generally appear between 6 and 72 hours after exposure, and include fever, chills, abdominal cramps, diarrhea, vomiting and muscle aches.
If you think you or your child may have contracted a Salmonella infection, contact your healthcare provider.
Twelve people in Minnesota have fallen ill with Salmonella poisoning after eating unpasteurized, homemade queso fresco, a Mexican-style cheese, according to a joint statement released by the state departments of health and agriculture, and the City of Minneapolis.
At least eight patients were hospitalized after eating the product, and another two were hospitalized from secondary infections after contact with infected individuals. All of those patients have since recovered.
The cases are connected to an individual who distributed the product from their home, as well as making home deliveries and possibly selling the product on a street corner near the East Lake Street area of Minneapolis.
“Anyone who may have purchased or received this product recently should not eat it but should throw it away,” the statement read.
Farm-direct sales of raw milk and unpasteurized dairy products are legal in Minnesota, but state law prohibits those products to be distributed or sold off the farm. Cheese makers must also follow proper food safety regulations, including owning a license.
The state department of health is continuing to investigate the potential for additional illnesses connected to the outbreak.