Tag Archives: FDA

FDA too slow to order food recalls, U.S. watchdog finds

FDA HQ in Maryland

By Julie Steenhuysen

CHICAGO (Reuters) – The Food and Drug Administration is too slow to order companies to recall tainted foods, leaving people at risk of illness and death, a government watchdog said in a review of the agency’s food safety program.

The Department of Health and Human Services’ Office of Inspector General reviewed 30 recalls that occurred between 2012 and 2015, including two in which companies did not recall all affected items until 165 days and 81 days after the FDA became aware of tainted foods. The watchdog issued its report on Wednesday.

“FDA does not have adequate policies and procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls,” the report said. “As a result, consumers remained at risk of illness or death for several weeks after FDA was aware of a potentially hazardous food in the supply chain.”

The watchdog urged the FDA to address the problem immediately.

In a blog post, FDA food safety officials Stephen Ostroff and Howard Sklamberg called the report’s findings “unacceptable” and said the agency is “totally committed” to food safety.

Representative Rosa DeLauro of Connecticut in a statement said it was “mind-boggling” that the FDA does not have policies or procedures to ensure swift voluntary food recalls.

DeLauro, who oversees drug and food safety in her position on the House of Representatives subcommittee responsible for the FDA, pointed to a salmonella outbreak last year in cucumbers, which sickened nearly 900 people, hospitalized 191 and killed six. The outbreak began in July, but it took until September before producers started recalling product.

“Delays like this one – and others found in the report – are completely unacceptable and leave American consumers at risk for illness and death,” DeLauro said.

Ostroff and Sklamberg said the FDA has a plan underway to strengthen compliance and enforcement policies, including both voluntary and mandatory recalls.

But they said recalls must be based on scientific evidence borne out of an outbreak investigation. And while timeframes for recalls need to be set, “they must be done on an individual basis rather than by setting arbitrary deadlines.”

To speed the FDA’s response, Ostroff and Sklamberg said the agency has established a team of experts from different scientific disciplines to oversee outbreak investigations. They also cited FDA’s adoption in 2014 of the use of whole genome sequencing, a more precise technology for determining the genetic fingerprint of foodborne pathogens.

In addition, provisions in the 2011 Food Safety Modernization Act that require companies to minimize food safety risks, and require companies to have a recall plan, will begin to take effect this fall.

(Reporting by Julie Steenhuysen; Editing by Leslie Adler)

New U.S. Food label overhaul to require added sugars detailed

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland

By Lisa Baertlein

(Reuters) – The United States plans a major overhaul of the way packaged foods are labeled, the Food and Drug Administration announced on Friday. Serving sizes will be adjusted to reflect how much people actually eat, and for the first time labels will list added sugars.

These are the first significant changes since the Nutrition Facts label was introduced more than 20 years ago. They come as an increasing number of Americans battle obesity, diabetes and heart disease and will affect roughly 800,000 products from Coca-Cola and ice-cream to soup and spaghetti sauce.

Speaking at a health summit in Washington, first lady Michelle Obama said she was “thrilled” about the new label and said she believes it is going to make “a real difference in providing families across the country the information they need to make healthy choices.” Her “Let’s Move!” initiative aims to increase the health of young people.

Manufacturers have until July 2018 to comply with the new rule. Small businesses with fewer than $10 million in annual sales have an additional year to comply. The FDA, which first proposed the rule in 2014, estimated at the time that the cost to industry of updating the labels would be about $2 billion.

The Grocery Manufacturers Association, which represents the world’s biggest food and drink companies, said the changes were “timely,” as diets and eating patterns have changed dramatically over the past two decades.

“Food and beverage manufacturers have responded by creating more than 30,000 healthier product choices since 2002,” Dr. Leon Bruner, GMA’s chief science officer, said in a statement.

Under the new rules, companies will have to provide details on the amount of added sugar such as corn syrup and white and brown sugar.

The Sugar Association, which represents U.S. sugar cane farmers, refiners, sugar beet farmers and processors, said it was “disappointed” at the requirement to list added sugars on the label and said the FDA had not demonstrated a scientific link between sugar and disease.

Information about calories from fat will be removed because research shows the type of fat is more important than the amount, the FDA said.

The new rules require serving sizes on the label to reflect what, on average, consumers actually eat. About 20 percent of all package labels will be adjusted, the FDA said. Some, such as ice-cream will be adjusted upwards, while others, such as yogurt, will be adjusted downwards.

“What and how much people eat and drink has changed since the last serving size requirements were published in 1993,” the agency said.

HOW WILL CONSUMERS REACT?

It was unclear how much the new label will actually impact consumer behavior.

Professor Jeremy Kees, a nutrition label expert at Villanova University School of Business who has consulted for both the FDA and industry, said he believes the impact will be “relatively small” because the information is on the back of the package.

“I think front of pack labeling has more potential to have a bigger impact on consumers,” he said.

Some changes have already been made, analysts say.

“Carbonated soft drinks have been on the decline before any of this happened,” said Darren Seifer, an analyst at The NPD Group, a market research company. “It might not make it exponentially greater, but it may help sustain it.”

The largest U.S. chocolate maker, The Hershey Company <HSY.N>, said it “will work diligently to make the necessary updates to our Nutrition Facts labels as requested by the FDA.”

In the United States more than one-third of adults and about 17 percent of youth aged 2 to 19 are obese, according to the Centers for Disease Control and Prevention.

Obesity-related conditions include heart disease, stroke, type 2 diabetes and certain types of cancer, some of the leading causes of preventable death. The estimated annual medical cost of obesity in the U.S. was $147 billion in 2008 U.S. dollars, according to Centers for Disease Control.

The FDA estimated the cost to industry of updating the labels at about $2 billion and the benefit to consumers at between $20 billion to $30 billion.

(Additional reporting by Dipika Jain, Sruthi Ramakrishnan, Melissa Fares and Chris Prentice; editing by Phil Berlowitz and Cynthia Osterman)

U.S. environmentalists sue to overturn approval of GMO salmon

An AquAdvantage Salmon is pictured in this undated handout photo provided by AquaBounty Technologies

By Tom Polansek

CHICAGO (Reuters) – U.S. health regulators are facing a lawsuit from a coalition of environmental organizations seeking to overturn the government’s landmark approval of a type of genetically engineered salmon to be farmed for human consumption.

The Center for Food Safety, Food and Water Watch, Friends of the Earth and other groups allege in the lawsuit, filed on Wednesday, that the Food and Drug Administration (FDA) failed to consider all of the environmental risks of the fish when the agency approved it in November.

The FDA also cleared the product, made by Massachusetts-based AquaBounty Technologies, without having the proper authority to regulate genetically engineered animals produced for food, according to the complaint.

The agency declined to comment on the lawsuit on Thursday. Its approval of AquaBounty salmon followed a 20-year review and was the first such approval for an animal whose DNA has been scientifically modified.

AquaBounty is confident the FDA’s approval will stand, Chief Executive Ron Stotish said in a statement. The agency was “extraordinarily thorough and transparent in the review and approval of our application,” he said.

The company has said its salmon can grow to market size in half the time of conventional salmon, saving time and resources.

However, the FDA approval process included “an extremely limited environmental assessment” that did not fully evaluate the potential for AquaBounty salmon to escape from the facilities where they are grown, among other risks, according to the lawsuit.

The legal challenge comes as the U.S. food industry is facing increased pressure from consumers to provide more information about the use of genetically engineered ingredients.

General Mills Inc and other major food companies are rolling out new disclosures on products to comply with a Vermont law that will require labels on foods made with genetically modified organisms, or GMOs.

Major retailers, including Kroger Co and Target Corp, have already said they do not plan to stock AquaBounty salmon on store shelves. It is not yet available for sale.

Activists worry the FDA’s approval of the salmon will serve as a precedent for other genetically engineered food animals.

Their lawsuit seeks to prohibit the FDA from taking further action on the fish or any other genetically engineered animal for human consumption until Congress grants an agency clear authority over such products.

The case is Institute for Fisheries Resources et al v Sylvia Mathews Burwell et al, U.S. District Court, Northern District of California, No. 16-cv-01574.

(Reporting by Tom Polansek; Editing by Richard Pullin and Andrew Hay)

FDA backs expanded use of medical abortion pill

Food and Drug Administration Building

WASHINGTON (Reuters) – The U.S. Food and Drug Administration on Wednesday agreed to allow more access to Danco Laboratories’ abortion pill Mifeprex, likely making it easier and cheaper for women to have an abortion by medication.

The FDA increased authorized use of the pill to 70 days of gestation from the current 49 days, cut the recommended dose of the drug and reduced the number of required visits to a doctor.

The changes are expected to allow greater access to medication abortions, particularly in Texas, North Dakota and Ohio, which have laws that require providers to prescribe the drug according to a more restrictive FDA label in place since 2000.

On Wednesday, the agency updated the Mifepfrex requirements to bring them in line with the most up-to-date scientific studies, which have shown that a third of the dose works as well.

“The FDA label has finally caught up to the evidence based practice in the United States,” said Vicki Saporta, president and chief executive of the National Abortion Federation, an organization of abortion providers. “It has the potential of opening medical abortion care in more rural areas because it does not have to be given by a surgical abortion provider,” she added.

The FDA decision comes amid a heated 2016 presidential race.

Earlier this month, the Supreme Court took up a major abortion case which represents a test for a strategic shift that abortion opponents have taken in recent years: to apply restrictive regulations to abortion doctors and facilities rather than try to ban the procedure outright.

Mifeprex was approved in 2000 to terminate early pregnancy when given in combination with misoprostol, an anti-inflammatory drug that was originally approved to prevent gastric ulcers.

Under the new prescription information on the label, patients will take one 200 mg tablet of Mifeprex on day one instead of three 200 mg tablets. They will take 800 mcg of misoprostol 24-48 hours after taking Mifeprex. Previously they took 400 mcg on day three.

Under the old label, patients were asked to return to their doctor 14 days after taking Mifeprex for an examination. The new label requires that they return between seven and 14 days for an “assessment.”

As far back as 2001, an estimated 83 percent of U.S. providers were no longer using the old FDA-approved regimen, according to the Guttmacher Institute, which backs abortion rights but whose research is used by both sides of the debate.

(Reporting by Toni Clarke, Jilian Mincer and Jon Herskovitz; Editing by Alistair Bell)

Trader Joe’s recalls cashews amid salmonella concerns

A possible salmonella contamination has prompted Trader Joe’s to recall some cashews.

The grocery store chain issued a statement about the recall late last week, saying that one particular kind of Trader Joe’s Raw Cashew Pieces could be contaminated with the bacteria.

The cashews are marked “BEST BEFORE 07.17.2016TF4,” the company said, and were distributed to stores in 30 states across the country, as well as the District of Columbia.

It wasn’t clear exactly how many packages were included in the recall.

Trader Joe’s said it learned of the possible contamination from a supplier, but didn’t elaborate.

A recall notice on the Food and Drug Administration website says Heritage International (USA) Inc. was voluntarily recalling the cashew lot after routine lab tests found salmonella in it.

The bacteria can cause people to fall ill.

Trader Joe’s said it hasn’t received any reports of anyone getting sick from the cashews, though it has stopped selling all Trader Joe’s Raw Cashew Pieces in its stores pending an investigation.

The grocery chain encourages anyone who bought the cashews marked “BEST BEFORE 07.17.2016TF4” to return them for a full refund or throw them out without eating them.

According to the CDC, salmonella sickens about 1.2 million Americans every year. Symptoms include diarrhea, fever and abdominal cramps, and most people fully recover in 4 to 7 days. In extreme cases, though, infections can spread beyond the intestines and become more severe.

The bacteria leads to about 450 deaths and 19,000 hospitalizations every year, the CDC says. Children, older adults and people with weak immune systems are particularly at risk.

FDA Approves First 3D Printed Drug

The U.S. Food and Drug Administration (FDA) has approved the first drug that is created using a 3D printer.

The drug, Spritam, is designed for the treatment of epilepsy according to a statement from the manufacturer Aprecia Pharmaceuticals.

The printed pills were created by what the company calls “ZipDose.”  The printer creates a pre-measured dose that dissolves in the mouth when you consume a liquid.  Tests showed the pill dissolves significantly faster than “fast melt” drugs because the pill is powdered medication bound together by the printer.

“As a result, Spritam enhances the patient experience — administration of even the largest strengths of levetiracetam with just a sip of liquid,” Aprecia said in a statement on Monday. “In addition, with Spritam there is no measuring required as each dose is individually packaged, making it easy to carry this treatment on the go.”

Scientists are hailing the decision by the FDA, saying that the use of 3D printing technology could revolutionize the way medication is given to patients.

The technology could allow doctors to put all of a patient’s medication into a single pill with precise monitoring of the dosages of each medication.  If the doctor needs to make a change, they just change the amount in the printing program for that patient.

Spirtam is the first 3D printed drug approved by the FDA.

Supreme Court Blocks Arizona Abortion Law

The Supreme Court is blocking Arizona from enforcing restrictions on medical abortions while a series of court challenges works through lower courts.

The ruling by the Court upheld a lower court ruling that blocked the rules regulating where women can take abortion-inducing drugs.  Abortion-inducing drugs would also be prohibited after the 7th week of pregnancy instead of the current restriction of the 9th week.

The liberal-leaning 9th Circuit Court of Appeals blocked the state of putting the restrictions in place while the legal challenges are taking place.  North Dakota, Ohio and Texas have similar laws to Arizona.

Abortionist Planned Parenthood says that drug conducted abortions for more than 40 percent of abortions in their abortion centers.

The Arizona restrictions were put into place following the deaths of 8 women who had taken the drugs.  The FDA claims there is no connection between the drugs and the deaths.

North Dakota Court Upholds Abortion Drugs Ban

The North Dakota Supreme Court upheld a state law that limits abortion drugs.

The court reversed the ruling of a lower court judge last year that said the law violated the state constitution.

“Beginning tomorrow morning, there will not be any medication abortions in North Dakota,” said David Brown, an attorney for the Center for Reproductive Rights.

The North Dakota law says that no drugs can be used to induce abortions that are not approved for that use by the FDA.  The North Dakota clinic involved in the lawsuit uses misoprostol as part of their process, which is not approved by the FDA for abortions.  The drug is a treatment for stomach ulcers.

A spokeswoman for the Fargo abortionists say about 20 percent of their abortions each year are done with drugs.

North Dakota Attorney General Wayne Stenehjem praised the court’s decision and said the state will wait to see what the abortionists do before deciding how to proceed with the case

Government Admits More Infectious Diseases In Unsafe Storage

The Food and Drug Administration said that a federal employee who found six vials of the deadly smallpox virus in a cardboard box in a storage room at a Maryland lab also found hundreds of vials of other diseases.

The samples included influenza, rickettsia (which can cause the lethal Rocky Mountain Spotted Fever) and dengue.

FDA official said Wednesday the collection of 327 vials of the various diseases was found at the same time as the smallpox virus vials announced last week.

Testing at the CDC discovered the smallpox viruses in the vial were alive and infectious.

“The fact that these materials were not discovered until now is unacceptable,” said Karen Midthun, of FDA’s director for biologics. “However, upon finding these materials our staff did the right thing – they immediately notified the appropriate authorities who secured the materials and determined there was no exposure.”

The FDA said 32 vials of tissue samples and non-contagious virus were destroyed at the laboratory and the remaining 279 samples were sent to the Department of Homeland Security for storage.

Judge Refuses To Block Arizona Abortion Law

A U.S. District Court judge has refused to block a new set of abortion regulations in Arizona.

The regulations now in effect will require abortionists to follow FDA guidelines for prescribing and dispensing abortion producing drugs such as RU486.  The FDA guidelines prohibit the use of those drugs after the seventh week of pregnancy.

Attorneys for Planned Parenthood has sued to stop the law claiming that requiring abortionists to follow the federal government’s guidelines on the drug would harm women.

Judge David C. Bury ruled that it was still to be seen if the law is an obstacle to abortion but that based on what was presented to the court the measure did not create irreparable harm.

The pro-life Center for Arizona Policy released a statement praising the court’s action saying that the decision upheld a common sense health and safety standard and that it was a victory for anyone who truly cared about the well-being of women.