Looking to reduce your exposure to plasticizers in the new year? Contrary to what you might think, shopping organic and avoiding plastic food packaging isn’t a surefire way to avoid harmful chemicals such as BPA and phthalates.
According to new research from Consumer Reports, phthalates and bisphenols — two chemicals linked to various health risks such as diabetes and hormone disruption — are “widespread” among supermarket staples and fast foods, regardless of their packaging and ingredients and whether or not they are certified organic.
Researchers found that 99% of the supermarket and fast foods they tested contained phthalates, also known as plasticizers, which are chemicals that are added to plastics to make them more flexible. In addition, 79% of the food samples contained bisphenol A (BPA), an industrial chemical used in plastic manufacturing, and other bisphenols. Both chemicals have been found in studies to be hazardous to health.
Among the supermarket foods tested, Annie’s Organic Cheesy Ravioli proved to have the most phthalates at 53,579 per nanogram, followed by Del Monte sliced peaches which contain 24,928 phthalates per nanogram and Chicken of the Sea pink salmon, which has 24,321 phthalates per nanogram.
The chemical levels found in those pre-packaged foods proved much higher than even those of several fast-food items CR tested, including McDonald’s Quarter Pounder With Cheese, which has 9,956 phthalates per nanogram and Little Caesars Classic Cheese Pizza (cardboard box) which contains 5,703 phthalates per nanogram. However, researchers found one fast-food favorite, Wendy’s Crispy Chicken Nuggets, had a whopping 33,980 phthalates per nanogram.
Just one product, a can of Polar Seltzer Raspberry Lime, tested negative for phthalates.
CR’s tested 85 foods for three bisphenols and 10 phthalates, as well as some of their common chemical substitutes, analyzing two or three samples of each product. The tested foods included prepared meals, fruits and vegetables, milk and other dairy products, baby food, fast food, meat and seafood, all of which came in various types of packaging, from cans to pouches to foil.
In several studies, phthalates have been linked to reproductive disorders and genital abnormalities, the National Research Council said in a 2008 report. Research on BPA, links the chemical to high blood pressure, Type 2 diabetes and cardiovascular disease, according to Mayo Clinic.
Sparse and outdated regulations
Previously thought to make their way into pre-packaged foods exclusively through packaging, plastic chemicals can leach into food products in a number of ways, Consumer Reports found. Phthalates can get into foods through tubing, conveyor belts and gloves used during food processing, as well as get into meat and produce through contaminated water and soil, according to CR.
Safety activists have long argued for a federal ban on the use of plasticizers in food packaging and processing, but have been mostly unsuccessful.
In 2023, the Food and Drug Administration rejected a petition calling for a ban on the use of phthalates in food packaging and food processing. Few regulations restricting the use of phthalates exist and current thresholds for bisphenol A (BPA) and some other phthalates, are considered outmoded by many experts.
“Many of these thresholds do not reflect the most current scientific knowledge, and may not protect against all the potential health effects,” CR scientist Tunde Akinleye, who oversaw the tests, said in the report. “We don’t feel comfortable saying these levels are okay. They’re not.”
Also, there’s a larger picture to be considered, he noted. Given our cumulative exposure to phthalates which are found in so many of the products we use and foods we eat each day, Akinleye says it is hard to quantify what levels of phthalates should be considered “safe” in any one single product.
“The more we learn about these chemicals, including how widespread they are, the more it seems clear that they can harm us even at very low levels,” he said.
Elizabeth Napolitano is a freelance reporter at CBS MoneyWatch, where she covers business and technology news. She also writes for CoinDesk. Before joining CBS, she interned at NBC News’ BizTech Unit and worked on the Associated Press’ web scraping team.
Federal officials are urging Ozempic users to check the legitimacy of their medications because of counterfeit versions of the popular diabetes drug that have been sold through legitimate sources.
The Food and Drug Administration has seized “thousands of units” of counterfeit Ozempic 1 milligram injections in an investigation that is ongoing, it said Thursday in a consumer alert. The drugs have been linked to five reports of illness, but none of the cases were serious, the notice shows.
Counterfeit Ozempic drugs are identifiable by the numbers on their cartons.
U.S. Food and Drug Administration
Ozempic products with lot number NAR0074 and serial number 430834149057 on the box are counterfeit products and should not be used, the FDA warned.
The bogus drugs’ ingredients, quality and safety are not yet known, the FDA said. Ozempic-maker Novo Nordisk and the FDA are testing the seized products, according to the notice.
The illegitimate products come with pen labels, cartons, fact sheets and needles that are also counterfeit, the notice shows. The needles pose an infection risk to consumers because it remains unclear whether or not they are sterile, Novo Nordisk said Thursday in a statement.
Amid the shortages, fraudsters have sold illegitimate Ozempic-like products to pharmacies, masquerading as medical wholesaler employees. It remains unclear whether the fakes are authentic products that are being diverted from foreign markets or whether they are being produced by scammers within the U.S.
The FDA last month revealed three people had been hospitalized after taking suspected counterfeit products containing semaglutide, the active ingredient in Ozempic.
The FDA is advising retail pharmacies to buy authentic Ozempic only through authorized distributors and for patients to get it only through state-licensed pharmacies.
Consumers can report suspect Ozempic packages by calling 800-332-1088 or by contacting a state complaint coordinator.
Elizabeth Napolitano is a freelance reporter at CBS MoneyWatch, where she covers business and technology news. She also writes for CoinDesk. Before joining CBS, she interned at NBC News’ BizTech Unit and worked on the Associated Press’ web scraping team.
Thanks for reading CBS NEWS.
Create your free account or log in for more features.
Living with diabetes, Carlton “PeeWee” Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream.
The pump, manufactured by device maker Medtronic, connected plastic tubing to an insulin reservoir, which Gautney set to release doses of the vital hormone over the course of the day. Gautney, a motorcycle enthusiast, worked as a dispatcher with the police department in Opp, Alabama.
The 59-year-old died suddenly on May 17, 2020, because — his family believes — the pump malfunctioned and delivered a fatal overdose of insulin.
“There’s a big hole left where he was,” said Gautney’s daughter, Carla Wiggins, who is suing the manufacturer. “A big part of me is missing.”
The wrongful-death lawsuit alleges the pump was “defective and unreasonably dangerous.” Medtronic has denied the pump caused Gautney’s death and filed a court motion for summary judgment, which is pending.
Carlton “PeeWee” Gautney Jr., a dispatcher with the police department in Opp, Alabama, died at age 59 in May 2020. His family alleges in a lawsuit that the Medtronic MiniMed insulin pump he relied on malfunctioned and killed him from an overdose of insulin. Daughter Carla Wiggins (left) is fighting the device company in court in Florida. The company has denied the pump caused the man’s death and is seeking to dismiss the case.
Carla Wiggins
The pump Gautney depended on was among more than 400,000 Medtronic devices recalled, starting in November 2019, after the company said in a recall notice that damage to a retainer ring on the pump could “lead to an over or under delivery of insulin,” which could “be life threatening or may result in death.”
As the recall played out, federal regulators discovered that Medtronic had delayed acting — and warning patients of possible hazards with the pumps — despite amassing tens of thousands of complaints about the rings, government records show.
Over the past year, KFF Health News has investigated medical device malfunctions including:
And even a dental device, used on patients without FDA review, that lawsuits alleged has caused catastrophic harm to teeth and jawbones. CBS News co-reported and aired TV stories about the hip and dental devices.
The investigation has found that most medical devices, including many implants, are now cleared for sale by the FDA without tests for safety or effectiveness. Instead, manufacturers must simply show they have “substantial equivalence” to a product already in the marketplace — an approval process some experts view as vastly overused and fraught with risks.
“Patients believe they are getting an implant that’s been proven safe,” said Joshua Sharlin, a former FDA official who now is a consultant and expert witness in drug and medical device regulation. “No, it hasn’t,” Sharlin said.
And once those devices reach the marketplace, the FDA struggles to track malfunctions, including deaths and injuries — while injured patients face legal barriers trying to hold manufacturers accountable for product defects.
In a statement to KFF Health News, the FDA said it “has a scientifically rigorous process to evaluate the safety and effectiveness of medical devices.”
“Too little, too late”
The FDA approved the MiniMed 670G insulin pump on Sept. 28, 2016, after its most stringent safety review, a little-used process known as premarket approval.
In a news release that day, Jeffrey Shuren, who directs the FDA’s Center for Devices and Radiological Health, lauded the device as a “first-of-its-kind technology” that would give patients “greater freedom to live their lives” and to monitor and dispense insulin as needed. The pump was tested on 123 patients in a clinical trial over several months with “no serious adverse events,” the release said. Shuren declined to be interviewed.
The FDA’s enthusiasm didn’t last. In November 2019, Medtronic, citing the ring problem, launched an “urgent medical device recall” of the pumps, which it expanded in late 2021.
During an inspection at Medtronic’s plant in Northridge, California, FDA officials learned the company had logged more than 74,000 ring complaints between 2016 and the November 2019 recall. More than 800 complaints weren’t investigated at all, according to the FDA, which sharply criticized the company in a December 2021 warning letter.
Medtronic is facing more than 60 lawsuits filed by injured patients and their families and the company believes it may be hit with claims for damages from thousands more patients, the company disclosed in an August Securities and Exchange Commission filing.
Medtronic pumps that allegedly dispensed too much, or too little, insulin have been blamed for contributing to at least a dozen patient deaths, according to lawsuits filed since 2019. Some cases have been settled under confidential terms, while others are pending or have been dismissed. Medtronic has denied any responsibility in response to the lawsuits.
In one pending case, a Las Vegas man using the pump allegedly fell into an “insulin-induced coma” that led to his death in 2020. In another 2020 case, a 67-year-old New Jersey resident collapsed at her home, dying later the same day at a local hospital.
The recall notice Medtronic sent to a 43-year-old Missouri man’s home arrived a few days after police found him dead on his bedroom floor, his family alleged in a lawsuit filed in August. “Simply too little, too late,” the suit reads. The case is pending, and Medtronic has yet to file an answer in court.
Medtronic declined to answer written questions from KFF Health News about the pumps and court cases. In an emailed statement, the company said it replaced pump rings with new ones “redesigned to reduce the risk of damage” and “fulfilled all pump replacement requests at no cost to customers.”
The 1976 federal law that mandated safety testing for high-risk medical devices also created a far easier — and less costly — pathway to the marketplace. This process, known as a 510(k) clearance, requires manufacturers to show a new device they plan to sell has “substantial equivalence” to one already on the market, even if the prior product has been recalled.
Critics have worried for years that the 510(k)-approval scenario is too industry-friendly to protect patients from harm.
In July 2011, an Institute of Medicine report concluded that 510(k) was “not intended to evaluate the safety and effectiveness of medical devices” and said “a move away from the 510(k) clearance process should occur as soon as reasonably possible.”
More than a decade later, that hasn’t happened, even amid mounting controversy over the clearance of hundreds of devices that employ artificial intelligence.
The FDA now clears about 3,000 low- to moderate-risk devices every year through 510(k) review, which costs the device maker a standard FDA fee of about $22,000. That compares with about 30 approvals a year through the stricter premarketing requirements, which cost nearly $500,000 per device, according to FDA data. Diana Zuckerman, president of the National Center for Health Research, said even many doctors don’t realize devices cleared for sale typically have not undergone clinical trials to establish their safety.
“Doctors are shocked to learn this,” she said. “Patients aren’t going to know it when their doctors don’t.”
In response to written questions from KFF Health News, the FDA said it “continues to believe in the merits of the 510(k) program and will continue to work to identify program improvements that strengthen the safety and effectiveness of 510(k) cleared devices.” The FDA keeps a tight lid on data showing which devices manufacturers choose to demonstrate substantial equivalence — what the agency refers to as “predicate” devices.
“We can’t get detailed data,” said Sandra Rothenberg, a researcher at the Rochester Institute of Technology. “It’s very hard for researchers to determine the basis on which substantial equivalence is being made and to analyze if there are problems.”
Rothenberg cited the history of “metal-on-metal” artificial hip implants, which under 510(k) spawned many new brands — along with a disastrous toll of patient injuries. The implants could release metal particles that damaged bone and led to premature removal and replacement, a painful operation. Just four of these hip devices have been the target of more than 25,000 lawsuits seeking damages, court records show. In early 2016, the FDA issued an order requiring safety testing before approving new metal-on-metal hip devices.
Alarm bells
Two former Medtronic sales executives in California argue in a whistleblower lawsuit that the 510(k) process can be abused.
According to the whistleblowers, the FDA approved the Puritan Bennett 980, or PB 980, ventilator in 2014 based on the assertion it was substantially equivalent to the PB 840, an earlier mechanical ventilator long viewed as the workhorse of the industry.
Medtronic’s subsidiary company Covidien made its claim even though the device has completely different “guts” and operates using software and other “substantially different” mechanisms, according to the whistleblowers’ suit.
In response, Medtronic said it “believes the allegations are without merit and has moved to dismiss the case.” The case is pending.
The whistleblowers argue the PB 980 ventilator was plagued by dangerous malfunctions for years before its recall in late 2021.
One ventilator billowed smoke in an intensive care unit while the whistleblowers were told by one hospital that “the wheels for the ventilator cart may actually fall off the ventilator during transport,” according to the suit.
Batteries could die without warning, kicking off a scramble to keep patients alive; monitor screens froze up repeatedly or otherwise went on the blink; and, in several cases, alarm bells warning of a patient emergency rang continuously and could be quieted only by unplugging the unit from the wall socket and pulling out its batteries, according to the suit.
The December 2021 recall of the PB 980 cited a “manufacturing assembly error” that the company said may cause the ventilator to become “inoperable.”
Medtronic said in an email that the ventilator “has helped thousands of patients around the world,” including playing a “critical role in the global response to the COVID-19 pandemic.”
Late warnings
The FDA operates a massive database, called MAUDE, to alert regulators and the public to emerging device dangers. The FDA requires manufacturers to advise the agency when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm. These reports must be submitted within 30 days unless a special exemption is granted.
But FDA officials acknowledge that many serious adverse events go unreported — just how many is anybody’s guess.
Since 2010, the FDA has cited companies more than 5,000 times for not handling, reviewing, or investigating complaints properly, or for not reporting adverse events on time. For instance, the FDA cited an Ohio company that made electric beds and other devices more than 15 times for failing to properly scrutinize complaints or report adverse events, including the death of a patient who allegedly became trapped between a bedrail and mattress, agency records show.
In about 10% of reports, more than a year or two elapsed from when a death or serious injury occurred and when the FDA received the reports, a KFF Health News analysis found. That works out to nearly 60,000 delayed reports a year.
Experts and lawmakers say the FDA needs to find a way to detect safety problems quicker.
Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) have tried for years to persuade the agency to add unique device identifiers to Medicare payment claim forms to help track products that fail. In an email statement to KFF Health News, Grassley called that a “commonsense step we can take up front to mitigate risk, improve certainty and save money later.”
The FDA said it is working to “strike the right balance between assuring safety and fostering device innovation and patient access.” Yet it noted: “Additional resources are required to establish a fully functioning active surveillance system for medical devices.” For now, injured patients suing device companies often cite the volume of adverse event reports to MAUDE, or FDA citations for failing to report them, to bolster claims that the company knew about product malfunctions but failed to correct them.
In one case, a New York man is suing manufacturer Boston Scientific, claiming injuries from a device called the AMS 800 that is used to treat stress urinary incontinence.
Though Boston Scientific says on its website that 200,000 men have been treated successfully, the lawsuit argues complaints piled up in MAUDE year after year and no action was taken — by the company or by regulators.
The number of complaints filed soared from six in 2016 to 2,753 in 2019, according to the suit. By far, the largest category involved incontinence, the condition the device was supposed to fix, according to the suit. Boston Scientific did not respond to a request for comment. The company has filed a motion to dismiss the case, which is pending.
By the FDA’s own count, more than 57,000 of some 74,000 complaints Medtronic received about the MiniMed insulin pump’s retainer rings were reported to the agency. The FDA said the complaints “were part of the information that led to the compliance actions.” The agency said it “approved design and manufacturing changes to the retainer ring to correct this issue” and “has reviewed information confirming the effectiveness of the modification.”
“What is the threshold for the FDA to step in and do something?” said Mara Schwartz, who is a nurse, diabetes educator, and pump user. “How many deaths or adverse events does there have to be?”
In 2020, she sued Medtronic, alleging she suffered seizures when the pump mistakenly delivered an overdose of insulin. Medtronic denied her claims, and the case has since been settled under confidential terms.
Private eyes
Some countries don’t trust the device industry to play such a key role in oversight.
Australia and about a dozen other nations maintain registries that measure the performance of medical devices against competitors, with an eye toward not paying for care for a substandard device.
That’s not likely to happen in the United States, where no device or drug manufacturer must demonstrate its new product is better than what’s already for sale.
Product liability lawsuits in the U.S. often cite troubling findings from overseas. For instance, registries in Australia and other countries pinpointed durability problems with the Optetrak knee implants manufactured by Florida device company Exactech years before a major recall. Exactech has declined comment.
The Australian surveillance network also detected deficiencies with the Medtronic PB 980 ventilator, prompting the country’s health authority to suspend its use for six months until Medtronic completed training for health care workers and took other steps to improve it, court records show. Medtronic told KFF Health News that it had “worked closely” with the Australian group to resolve the problems. “We take patient safety very seriously and have processes to identify quality issues and determine appropriate actions,” Medtronic said.
Registries have gained some traction in America. But so far, they typically have been controlled, and sometimes funded, by industry and medical specialty groups that share their findings only with doctors.
One private registry managed by the Society of Thoracic Surgeons, called Intermacs, tracks death and injury rates at 180 hospitals in the United States certified to implant a mechanical heart pump known as an LVAD. Some patients might find that information helpful, but it’s not available to them.
“Exciting features”
While the FDA clears thousands of devices for use based on the “substantial equivalence” premise, manufacturers often tout “new and exciting features” in their advertising and other marketing, said Alexander Everhart, a researcher at the Washington University School of Medicine in St. Louis.
These marketing campaigns have long been controversial, especially when they rely partly on wining and dining surgeons and other medical professionals to gain new business, or when surgeons have financial ties to manufacturers whose products they use. Orthopedic device makers have funneled billions of dollars to surgeons, including fees for consulting, doing medical research, or royalties for their role in fine-tuning surgical tools and techniques, even promoting the products to their peers.
Marketing campaigns directed at prospective patients may receive little scrutiny. The FDA has “limited resources to actively monitor the volume of direct-to-consumer advertising,” according to a Government Accountability Office report issued in September. From 2018 to 2022, the FDA took 255 enforcement actions involving advertising claims made for devices, according to the GAO report.
Legal barriers
While manufacturers can advertise devices directly to patients, courts may not hold them accountable for communicating possible risks to patients.
Consider the case of Richard Greisberg, a retired electronics business owner in New Jersey. He sued Boston Scientific in 2019, years after having a Greenfield vena cava filter implanted. The device is intended to prevent blood clots that develop in the lower body from traveling into the lungs, which can be deadly.
Greisberg argued that the device had migrated in his body, causing pain and other symptoms and damage that took years to identify. Representing himself in court, he tried to argue that nobody had told him that could happen and that if they had done so he wouldn’t have agreed to the procedure.
He lost when the judge cited a legal doctrine called “learned intermediary.” The doctrine, which is recognized in many states, holds that manufacturers must warn only physicians, who are presumed to have the knowledge to understand a medical device’s risks and relay them to patients.
The court ruled that a 27-page manual the manufacturer sent to the physician who implanted it, which included details about possible risks, was adequate and tossed the case.
Greisberg, 81, felt sucker-punched. “They never gave me any warning about what could happen down the road,” he said in an interview. “I never had a chance to have my day in court.”
The family of PeeWee Gautney also faces challenges pursuing the insulin pump lawsuit.
Gautney died in a motel room in Destin, Florida, a day after riding his Harley-Davidson to the Panhandle beach town on a weekend jaunt. The MiniMed pump was still strapped to his body, according to a police report.
Medtronic had sent Gautney a form letter in late March 2020, less than two months before he died, advising him to make sure the ring was locking in place correctly. A week later, he wrote back, telling the company: “It’s fine right now,” court records show.
Wiggins, 33, his daughter, who is also a neonatal respiratory therapist, said she believes a crack in the retainer ring caused it to release too much insulin, which her dad may not have recognized.
“It should never be put on the patient to determine if there is a problem,” Wiggins said.
Medtronic has denied the pump failed and caused Gautney’s death. The FDA approved the device knowing patients faced the risk of it administering wrong doses, but believed the benefits outweighed these risks, Medtronic argued in a motion for summary judgment in September. The motion is pending.
Medtronic also cited a legal doctrine holding that Congress granted the FDA sole oversight authority over devices receiving premarket approval, which preempts any product defect claims brought under state laws. Manufacturers have drawn on the preemption defense to sidestep liability for patient injuries, and often win dismissal, though federal courts are split in applying the doctrine.
Wiggins hopes to beat those odds, arguing that the December 2021 FDA warning letter reveals that Medtronic violated safety and manufacturing standards.
Her lawyer, Scott Murphy, said that insulin pumps are “really wonderful” devices for people with diabetes when they work right. He argues that the FDA records confirm that Medtronic significantly downplayed its pump’s hazards.
“The risks get minimized and the benefits exaggerated,” he said.
KFF Health News, formerly known as Kaiser Health News (KHN), is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.
Coca-Cola is recalling 2,000 cases of Diet Coke, Sprite and Fanta Orange soda cans because they may contain “foreign material.”
The recall comprises 12-packs of 12-ounce cans, including 1,557 packs of Sprite, 417 of Diet Coke and 14 of Fanta Orange. The cases were distributed in Alabama, Mississippi and Florida, an FDA filing shows.
It remains unclear what the potential “foreign material” could be and what risks, if any, it poses to consumers. The FDA did not immediately respond to CBS MoneyWatch’s request for comment.
The recall includes:
Diet Coke 12-packs marked with lot numbers JAN2924MBD3 and UPC 49000028911 and have a best-by date of Jan. 29, 2024.
Fanta Orange 12-packs with lot numbers UL2924MBD3 and UPC 49000030730.
Sprite 12-packs with lot numbers JUL2924MBD3 and UPC 49000028928.
Recalled Fanta and Sprite both have a best-by date of July 29, 2024.
Elizabeth Napolitano is a freelance reporter at CBS MoneyWatch, where she covers business and technology news. She also writes for CoinDesk. Before joining CBS, she interned at NBC News’ BizTech Unit and worked on the Associated Press’ web scraping team.
Thanks for reading CBS NEWS.
Create your free account or log in for more features.
The Food and Drug Administration is warning consumers not to use or purchase any products from the supplement brand called Neptune’s Fix after receiving multiple reports of severe reactions, including seizures and hospitalizations. The FDA says it is testing samples for illegal and harmful ingredients.
Neptune’s Fix supplements purport to contain tianeptine, an opioid alternative prescribed as an antidepressant in some Latin American, Asian and European countries. Tianeptine is not approved for use in the U.S.
The FDA has previously warned about this “potentially dangerous” substance, which the agency says has been linked to addiction and deadly overdoses.
The FDA is warning consumers to not purchase or use Neptune’s Fix products, or any other product with tianeptine, which is not approved in the U.S.
FDA
Now authorities worry other substances may also be mixed into these products, which are being sold illegally online and in retailers like gas stations and vape or smoke shops.
News of the FDA’s testing comes less than a month after health officials in New Jersey warned they had identified a cluster of poisonings linked to tianeptine products including Neptune’s Fix.
More than half of the patients suffered seizures after ingesting the products, the state’s health department said. Some required hospitalization. Others showed up at hospitals with a variety of other serious symptoms, including hallucinations and vomiting.
It is unclear which states have reported issues with Neptune’s Fix to FDA or how long the agency’s testing of the products will take.
An FDA spokesperson did not immediately respond to a request for comment.
“Gas station heroin”
Authorities have moved to crack down on other tianeptine supplements in recent years, after the CDC reported in 2018 that poison control centers had been fielding a growing number of calls over tianeptine abuse and withdrawal from use of the drug.
Nicknamed “gas station heroin” due to its wide availability in convenience stores and other small retailers, several states have taken steps to curb sales of the drug. Other brands of tianeptine the FDA has previously warned about include Za Za and Tianna Red.
Federal prosecutors have also gone after companies for smuggling and selling tianeptine products in the U.S.
Emergency rooms have reported surges in reports of users struggling over withdrawal from the drug in recent years, including after efforts to pull the product from store shelves.
Unlike typical antidepressants, the drug works by binding to the body’s mu opioid receptors, causing effects that mimic opioid toxicity and withdrawal. Similar to other opioids, naloxone has been used to manage tianeptine overdoses.
“We were having to put a lot of people in the intensive care units (ICUs) because the withdrawal symptoms were so bad and often included delirium requiring high doses of sedating medications,” Dr. William Rushton, head of the University of Alabama’s Medical Toxicology program, said in a post by the university.
Alexander Tin is a digital reporter for CBS News based in the Washington, D.C. bureau. He covers the Biden administration’s public health agencies, including the federal response to infectious disease outbreaks like COVID-19.
Peaches, plums and nectarines distributed by HMC Farms and sold nationwide as recently as last week are being recalled due to an outbreak of listeria that has resulted in 11 illnesses, including one death and 10 hospitalizations, federal safety regulators said Monday.
“Investigators are working to determine if any additional fruit or products made with this fruit may be contaminated,” the U.S. Centers for Disease Control and Prevention stated in a food safety alert.
Kingsburg, California-based HMC Farms is recalling peaches, plums and nectarines sold between May 1 and November 15 of this year as well as as during the same period in 2022, the company said in a notice posted Friday by the Food and Drug Administration. The FDA found listeria in testing a sample of HMC Farms peaches in late October, the CDC said.
Sold around the U.S. by retailers including Walmart and Sam’s Clubs, the recalled fruit may be contaminated with listeria monocytogenes, an organism that can cause serious and at times fatal infections.
As of Nov. 17, the people sickened in the listeria outbreak reside in seven states: California, Colorado, Florida, Illinois, Kansas, Michigan and Ohio, according to the CDC. One person died in California and another became sick while pregnant and had preterm labor, the agency noted.
Listeria infections can cause serious, and sometimes fatal, illness in young children, frail or elderly people, as well as others with weakened immune systems, according to the CDC. Healthy people may experience symptoms including high fever, severe headache and stomach pain. The organism can also cause miscarriages and stillbirths.
Image of fruit recalled by HMC Farms due to listeria concerns.
U.S. Food and Drug Administration
U.S. Food and Drug Administration
Image of recalled product.
U.S. Food and Drug Administration
The recalled fruit was sold in 2-pound bags branded “HMC Farms” or “Signature Farms,” or as individual fruit that has a “USA-E-U” code and a number, as follows:
Yellow peach: 4044 or 4038
White peach: 4401
Yellow nectarine: 4036 or 4378
White nectarine: 3035
Red plum: 4042
Black plum: 4040
The recall does not include organically grown fruit, the company and CDC noted (See images of all of the recalled fruit products here).
Consumers should check their homes, including their freezers, for the recalled fruit and discard it, agency said. Anyone with questions can call the company at (844) 483-3867, Monday-Friday from 8 a.m. to 8 p.m. Eastern time.
Pharmacy chain CVS Health said it is pulling some of its most popular cold and cough medications from store shelves, weeks after advisers to the Food and Drug Administration deemed a common ingredient ineffective.
CVS told CBS MoneyWatch that it will no longer sell products that only contain phenylephrine as an active ingredient at its pharmacy stores.
“We are removing certain oral cough and cold products that contain phenylephrine as the only active ingredient from CVS Pharmacy stores,” the company said in a statement to CBS MoneyWatch.
“Other oral cough and cold products will continue to be offered to meet consumer needs,” CVS added.
CVS said it is aware of the FDA Advisory Committee’s position on oral phenylephrine and is committed to complying with all applicable laws and regulations. It is pulling the decongestants voluntarily.
Oral phenylephrine is found in Dayquil, Mucinex Sinus-Max, Sudafed PE Sinus Congestion, Theraflu and other popular medications sold at pharmacies across the U.S.
“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” Dr. Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine, said last month.
Decongestants with phenylephrine account for roughly $1.8 billion in annual sales, according to the FDA.
It’s unclear if other pharmacies will follow suit and remove drugs in which phenylephrine is the only active ingredient. Walgreens did not say if it will stop selling the medications, telling CBS MoneyWatch that it “follows FDA regulations.”
“We are closely monitoring the situation and actively partnering with the Walgreens Office of Clinical Integrity and suppliers on appropriate next steps,” a spokesperson told CBS MoneyWatch.
Rite Aid did not immediately reply to a request for comment.
—The Associated Press contributed to this report.
Thanks for reading CBS NEWS.
Create your free account or log in for more features.
About 6,500 cases of cantaloupes from Eagle Produce’s Kandy Brand have been recalled across 19 states and Washington, D.C., over concerns they could be contaminated with salmonella.
Be the first to know
Get browser notifications for breaking news, live events, and exclusive reporting.
The label for the diabetes drug Ozempic — which has become popular for weight loss — now acknowledges reports of blocked intestines following use of the medication. The change comes after the Food and Drug Administration greenlighted a series of updates from drugmaker Novo Nordisk for its product.
Ozempic now joins other products in this booming class of so-called GLP-1 agonist medications which acknowledge increased reports of what doctos call ileus, or a blockage in the intestines.
Weight loss drug Wegovy, which is also an injection of semaglutide manufactured by Novo Nordisk, acknowledges reports of ileus on its label as well, as does Mounjaro, a diabetes medication from Eli Lilly.
However, the FDA stopped short of directly blaming the potentially life-threatening condition on the drug.
“Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure,” the label reads.
The FDA has received 8,571 reports of gastrointestinal disorders after use of semaglutide medications, which includes both Ozempic and Wegovy, according to data published by the regulator through June 30.
Ileus is specifically mentioned as a reaction in 33 cases listed on the FDA’s dashboard of people taking semaglutide, including two deaths.
Both Novo Nordisk and Eli Lilly are facing a lawsuit over claims that the medications can cause a similar condition called gastroparesis, or paralysis of the stomach, which stops food from reaching the small intestine despite there being no blockage.
Spokespeople for Novo Nordisk and the FDA did not immediately respond to a request for comment.
The Food and Drug Administration declined on Tuesday to approve neffy, an epinephrine nasal spray from drugmaker ARS Pharmaceuticals, keeping the first needle-free option for Americans to treat severe allergic reactions off the market pending more trial data.
ARS had expected the FDA to approve neffy for use in adults and children who weigh more than 30 kilograms, or around 66 pounds. The spray would have required a prescription, similar to EpiPens and other epinephrine injections that are currently used to treat anaphylaxis.
Epinephrine is crucial in an emergency to treat potentially life-threatening allergic reactions. The new spray, if eventually approved, would provide a welcome alternative for many families of children with severe allergies who’d rather avoid needles.
ARS Pharmaceuticals’ neffy epinephrine nasal spray, which is still pending FDA approval.
ARS PHARMACEUTICALS
According to ARS, the FDA regulators decided Tuesday that more data was needed to evaluate the safety of repeated doses of the nasal spray before it could be approved. FDA advisors had suggested in previous guidance issued in May that the additional data could be gathered in a trial after the drug was brought to market, so the drugmaker voiced disappointment over the Tuesday decision.
“We are very surprised by this action and the late requirement at this time to change the repeat-dose study from a post-marketing requirement, which we had previously aligned on with FDA, to a pre-approval requirement, particularly given the positive Advisory Committee vote,” said ARS Pharma co-founder, president and CEO Richard Lowenthal in a statement late Tuesday. “We are deeply disappointed that this action further delays the availability of neffyfor the millions of people who are at risk of a potentially life-threatening severe allergic reaction. Patients and caregivers are waiting for neffy, and we aim to complete the newly requested trial as quickly as possible to meet the needs of patients.”
“Major barriers limit the rapid use of epinephrine in a community setting. Many patients fear needles and many are not comfortable with self-injection. There is also the impracticality of carrying the current available devices,” Lowenthal told a panel of the FDA’s outside advisers at a meeting in May to weigh the product.
Lowenthal told the committee that the company planned to provide the product in a “slim neffy carrying case” that carries two sprayers each.
As many as 85% of patients who face severe allergies would be willing to carry epinephrine around with them daily if neffy was an option, Lowenthal said their surveys suggested, up from around 55% with current options.
“If they don’t have it with them, it’s a moot point. They don’t deliver, they don’t have drug, they go to the hospital,” said Lowenthal in May.
The drugmaker says neffy nasal spray works by delivering a dose of epinephrine to patients facing allergy attacks using two other technologies already used in other FDA-approved products. One is the substance dodecylmaltoside, licensed from drugmaker Neurelis, which it says “enhances drug absorption” through mucous membranes, which are cells that line the airways from the nose to the lungs. Neurelis has used this ingredient, branded as Intravail, in a spray of their own to treat epilepsy.
The other is a sprayer device sold by Aptar Pharma that is already used in a number of products. It’s the same type of sprayer used by the Narcan-brand nasal sprays of naloxone, which are used to treat drug overdoses and were recently greenlighted by the FDA for over-the-counter sales.
Despite the availability of some generic alternatives, some Americans continue to face steep price tags for annual purchases of the currently available epinephrine injection devices. Brand name EpiPen and its generic alternatives can cost some families more than $200 per year, which has led some states to explore caps on epinephrine prices.
More epinephrine nasal sprays are also in the pipeline. Drugmaker Bryn Pharma has touted promising results from its experimental epinephrine nasal spray Utuly, which they say could outperform current injectors.
Is it as effective as an injection?
The FDA’s rejection of neffy pending more trial data was just the latest delay for ARS’ bid to bring the drug to market.
The company had previously said the FDA could decide on approval of neffy by mid-2023. But ARS disclosed in June that the FDA had told the company it would need until September to decide on the approval. The extra time was needed to finish “labeling and post-marketing commitment discussions” raised after the FDA advisory committee meeting on neffy, the company said.
A majority of the FDA’s Pulmonary-Allergy Drugs Advisory Committee ended up voting in May to back the neffy’s benefits outweighing its risks, after wrestling with a number of questions around whether the spray might be less effective than current injections.
“Following the strong endorsement of our clinical data for neffy at the May PADAC meeting, there was limited time to address any final questions and complete labeling,” Lowenthal had said in a release.
While epinephrine is widely accepted by experts as effective at treating severe allergic reactions, use of the chemical — purified adrenaline that dates back to the early 20th century — predates the existence of the FDA. That means epinephrine’s original use for treating anaphylaxis came about without clinical trials to directly prove that it works, as well as to better understand what measurements of the drug in the body are required for it to be effective.
The original EpiPen was approved in 1987 without clinical trials or detailed data on how the drug is absorbed or its effects on the body, the FDA says.
Clinical trials to prove that delivering epinephrine as a spray works as well as an injection would be difficult to run ethically, FDA officials acknowledged.
Instead, ARS Pharmaceuticals ran a variety of studies to generate so-called “surrogate” data aimed at figuring out whether its spray could likely be as effective as injections.
Those included dosing subjects exposed to seasonal allergens, as well as measuring concentrations of the drug in their body, which generated some conflicting data. Comparisons with measurements from epinephrine injections also led to varied results.
“I really want this product to work. I mean, we definitely benefit from a needle-less means of delivering epi. And I think the sponsor has done a nice job trying to find that balance. That said, I think we’re using weak surrogate data to assure ourselves,” Lewis Nelson, a member of the FDA committee, said at the May meeting.
Nelson echoed other committee members in praising the company and FDA’s approach to solving some of the substantial variabilities seen with other epinephrine injections. But he also said he thought more data would be needed in order to approve the drug.
“I really would hate to learn, without some better clinical data, that we recommend approval of a product on the basis of surrogate data that’s inconsistent and somewhat confusing and, ultimately because of that, patients are harmed,” he said at the meeting.
Nestlé has recalled its Toll House Chocolate Chip Cookie Dough Bar because the snacks may contain wood fragments.
The recall, announced by the U.S. Food and Drug Administration Thursday, is limited to two batches of the Toll House Chocolate Chip Cookie Dough “break and bake” Bar produced on April 24 and 25.
The FDA has not received any reports of illnesses or deaths related to the product but decided to recall the product “out of an abundance of caution” following “a small number” of calls from consumers, according to the notice.
Nestlé has recalled its Toll House Chocolate Chip Cookie Dough Bar because the snacks may contain wood fragments.
verybestbaking.com (by Nesté)
The recall includes Toll House Chocolate Chip Cookie Dough with batch codes 311457531K and 311557534K with corresponding “best by” dates 8/22/23 and 10/23/23.
FDA
Nestlé toll house recall batch codes
The recall includes Toll House Chocolate Chip Cookie Dough with batch codes 311457531K and 311557534K with corresponding “best by” dates 8/22/23 and 10/23/23. Consumers who have purchased the affected cookie dough bars should not eat the potentially contaminated dough, but return the product to the store where it was purchased to get a replacement or refund, the manufacturer said.
The recall does not affect any other varieties of Nestlé Toll House refrigerated cookie dough in “break and bake” bars, rolls, tubs or any other Nestlé Toll House product, including Edible cookie dough.
Nestle did not immediately respond to CBS MoneyWatch’s request for comment.
Customers can contact Nestlé USA at 1-800-681-1678 for more information.
Thanks for reading CBS NEWS.
Create your free account or log in for more features.
Thousands of Tydemy brand birth control pills have been recalled, the Food and Drug Administration warned Tuesday, after testing by drugmaker Lupin Pharmaceuticals found that two lots they made of the tablets might have lower effectiveness.
Recalled batches of the Tydemy pills — a combination prescription contraceptive of estrogen and progestin — are of two specific lot numbers listed on the FDA’s website.
The FDA says the products were distributed nationwide to pharmacies and supermarkets from June 2022 through May 2023.
A total of 4,179 boxes have been recalled, according to the FDA’s database, which amounts to about 350,000 tablets that might be less effective at stopping pregnancy.
People who are currently taking recalled lots of the drugs are urged to continue taking their pills but immediately seek out an alternative from their doctor.
“Lupin advises patients to continue taking their medication. Patients should immediately contact their health care provider for advice regarding an alternative contraceptive method,”the FDA said in its warning.
The agency added that Lupin has voluntarily recalled the affected lots at the wholesale level.
Why the pills might be less effective
Drugmakers routinely do what’s called “stability” testing to ensure that medications they produce are still good to use out to their expiration dates.
Lupin Pharmaceuticals says that batches of Tydemy fell short after 12 months, with too low levels of an inactive ingredient called ascorbic acid used in making the tablets, as well as too high of “a known impurity.”
“Lupin is recalling these two batches because if there were a significant reduction in the amount of inactive content (ascorbic acid), this could potentially impact the effectiveness of the product which could potentially result in unexpected pregnancy,” the company said.
So far, Lupin says they have received “no reports of adverse events related to either recalled batches” from the current recall of birth control pills.
The FDA says it encourages doctors or patients who had an issue with the tablets to report it to the agency online or by fax.
It is unclear what led to the so-called “out of specification” issue, or if more batches might be affected. A spokesperson for Lupin Pharmaceuticals did not respond to a request for comment.
The recall is not the first for the drugmaker, which claims to be the “third-largest pharmaceutical company in the U.S. by prescriptions.”
Late last year, Lupin recalled batches of blood pressure medication Quinapril after finding impurities. An inspection of a facility run by the company in March turned up a range of shortcomings, including failing to run down the root causes behind several “out of specification” test results.
“Deviation investigations are not thoroughly investigated by your firms and appropriate actions are not taken to prevent recurrence,” the FDA’s inspectors wrote in that case.
The FDA has approved a birth control pill to be sold without a prescription for the first time in the United States, a milestone that could significantly expand access to contraception. What do you think?
“It will be a nice six months until the Supreme Court bans this.”
Helena Rogers, Control Center Specialist
Ingenious Forms Of Birth Control Used In Ancient Times
“I’m proud to be alive for such a watershed moment in the history of fucking.”
The U.S. Food and Drug Administration has approved the first over-the-counter birth control pill, allowing Americans to buy a daily oral contraceptive without a prescription.
Opill, the progestin-only pill from drugmaker Perrigo, will provide an option for obtaining oral contraceptives without needing to first see a health care provider, in hopes of reducing barriers to access, according to the FDA’s news release, which notes that almost half of the 6.1 million pregnancies in the U.S. each year are unintended.
“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a news release Thursday morning. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”
In a press briefing following the FDA’s decision, Frederique Welgryn, Perrigo’s global vice president of women’s health, called the approval “a historic moment and a revolutionary change in contraceptive access and reproductive health.”
How does Opill work?
Opill is made up of norgestrel, a kind of “progestin-only” birth control pill that was first approved as safe and effective to be prescribed by doctors in the 1970s. This is different from other birth control pills that are largely prescribed today, which are newer “combined” formulations that also use estrogen.
Hormone-based pills, which have all required a prescription until now, have long been the most common form of birth control in the U.S., the Associated Press reports. Tens of millions of women have used them since the first pills came on the market in the 1960s.
Is Opill safe?
The FDA says Opill is “safe and effective” when used properly. The guidelines include taking the pill at the same time every day; not using it along with another hormonal birth control product, including IUDs (intra-uterine devices); and avoiding medications that interact with it, which could decrease its efficacy.
“Opill should not be used by those who have or have ever had breast cancer,” the FDA’s release adds. “Consumers who have any other form of cancer should ask a doctor before use.”
According to the FDA, the most common side effects of Opill include:
Irregular bleeding
Headaches
Dizziness
Nausea
Increased appetite
Abdominal pain
Cramps or bloating
When will Opill be available?
The company is expected to start shipping the pill early next year, the AP reported, and there will be no age restrictions on sales.
The FDA says the drug will be available in drug stores, convenience stores and grocery stores, as well as online.
How much will Opill cost?
Welgryn did not provide over-the-counter pricing information in Thursday’s briefing, but said it was Perigo’s mission to make it “affordable and accessible to people who need it.”
While over-the-counter medicines are generally cheaper than prescription drugs, they aren’t typically covered by insurance.
Welgryn said the company is hoping to change that approach by insurers, but did not have an estimated timeline for coverage, noting that it will “take time.”
Alex Tin and the Associated Press contributed to this report.
WASHINGTON—Calling the influencer-backed beverage a serious public health concern, a visibly erect Sen. Chuck Schumer (D-NY) called on the FDA Monday to investigate the 72-hour erection he had experienced as a result of drinking Logan Paul’s Prime energy drink. “Buyers and parents need to understand the risks involved with having a three-day stiffy that’s as hard as a mallet,” said the Senate Minority Leader, who winced as he pulled at his pants from behind the podium, confirming that his erection remained unchanged despite repeated efforts to take a cold shower, masturbate, and make love to his wife, Iris. “After drinking just one can of this stuff last week, I still feel the effects of arousal, to the point that I cannot physically urinate without leaning over the toilet. It’s just throbbing down there, and I’m worried it’s here for good. Durbin took a sip, too, and look at him—he can’t even sit down. This beverage, marketed simply as a ‘hydration supplement’ has no business being on U.S. shelves. I am begging the FDA: Please, for the love of God, investigate my penis.” At press time, Schumer was overheard explaining to the Senate Ethics Committee that his bulging erection was not sexual, but rather a physiological response to blue raspberry flavoring.
Chattanooga, Tennessee — Carol Noon has an aggressive form of endometrial cancer. It’s treatable, but there is no time to waste.
Due to a drug shortage, she told CBS News “there’s no guarantee” that the life-saving chemotherapy drugs she needs will be available throughout the course of her treatment.
The night before her second dose of chemotherapy, the 61-year-old Noon received a call from her doctor to inform her that the hospital had run out of her treatment. Thankfully, Noon got her dose a week later.
“I think it’s an emotional rollercoaster,” Noon said. “It’s very frustrating to know that there’s a standard of care, these two generic drugs, and I can’t get them.”
She said her doctors are “frustrated. “We’re not sure what the next steps are. And we’re just hoping there’s gonna be treatment available.”
Patients like Noon are given carboplatin and cisplatin, generic medications that aren’t profitable for manufacturers to produce— and few are made in the U.S.
Since the start of the COVID-19 pandemic, the international supply chain for cancer medications has been strained and the situation has become dire. Food and Drug Administration inspectors found “widespread problems” at a factory in India that makes more than half of the U.S. supply of cisplatin.
In March, the FDA reported that Pluvicto — a drug used to treat advanced prostate cancer — is in short supply. Pluvicto is only manufactured in Italy.
And the issue isn’t just limited to cancer drugs. A report also released in March by the Senate Homeland Security Committee found that 295 drugs were in short supply in the U.S. last year, marking a five-year high.
“We had to make some decisions about who we were going to prioritize during this difficult time,” said oncologist Dr. Kari Wisinski with the University of Wisconsin Health, who told CBS News she had never seen a shortage this serious.
“The question is, could people die because of this shortage?” Wisinksi asked. “I think it all depends on how long it occurred. If we experienced a prolonged shortage of chemotherapy, then yes, I do think people could die.”
In response, the FDA last month temporarily began importing cisplatin from a Chinese drug manufacturer Qilu Pharmaceutical, which is not FDA approved.
“Someday, I’m gonna die,” Noon said. “I really would rather not die because these standard generic drugs weren’t available to me. And I can’t imagine being in that position and questioning what happened, my family having that doubt and my friends having that doubt. Was it the cancer, or was it that there was not enough chemotherapy and it got rationed.”
Better think twice before consuming any foods this summer made from frozen strawberries.
The Food and Drug Administration has added more brands to a growing list of frozen strawberry products being recalled nationwide.
Willamette Valley Fruit Co. on Sunday announced it is voluntarily recalling potentially contaminated frozen strawberry products sold under various brands at Walmart, Costco and HEB stores across 32 states.
The recall comes in response to the federal agency’s ongoing investigation into hepatitis A infections linked to frozen organic strawberries imported from Baja California, Mexico.
The recalled products were distributed via the following retailers:
Walmart: Great Value Sliced Strawberries, Great Value Mixed Fruit, and Great Value Antioxidant Blend distributed to select Walmart stores in in Arkansas, Arizona, California, Colorado, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, North Dakota, Nebraska, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Utah, Virginia, Wisconsin, West Wyoming from Jan. 24, 2023 – June 8, 2023.
Costco Wholesale Stores: Rader Farms Organic Fresh Start Smoothie Blend distributed to Costco Wholesale stores in Colorado, Texas, California, and Arizona from Oct. 3, 2022 – June 8, 2023.
HEB: Rader Farms Organic Berry Trio distributed to HEB stores in Texas from July 18, 2022 – June 8, 2023.
Rader Farms Organic Berry Trio distributed to HEB stores in Texas from July 18, 2022 – June 8, 2023 is part of the latest recall of frozen organic strawberries imported from Baja California, Mexico.
FDA.gov
So far, nine people across three states have fallen sick from the outbreak, with three of those affected becoming so sick that they were hospitalized, the FDA reported.
Hepatitis A is a highly contagious liver infection caused by the hepatitis A virus. It is spread through close contact with infected individuals or by consuming foods or beverages contaminated with the virus, according to the CDC.
The virus can cause mild to serious illness, lasting from a few weeks to several months. Symptoms can include abdominal pain, fatigue, jaundice, dark urine and pale stool.
The FDA urged consumers not to eat the frozen strawberries.
“Consumers are urged to check their freezers for the recalled product, not to consume it and either discard the product or return it to the store for a refund,” the agency said in a recall announcement.
Those who may have consumed affected products are advised to consult a health care professional or local health department immediately to determine if a vaccination is appropriate. Consumers can visit www.fda.gov for more information on hepatitis A.
The FDA has included a list of the affected package serial numbers on its website.
Thanks for reading CBS NEWS.
Create your free account or log in for more features.
The FDA issued a new warning about some of the popular diabetes drugs being used for weight loss after the agency “received adverse event reports after patients used compounded semaglutide.” That’s the generic name for medications like Ozempic and Wegovy. New York endocrinologist Dr. Florence Comite joins CBS News to discuss the risks of taking off-brand versions.
Be the first to know
Get browser notifications for breaking news, live events, and exclusive reporting.
The U.S. Food and Drug Administration has set limits for inorganic arsenic in apple juice, but Consumer Reports argues that the level is still too high and could harm children who consume the popular drink.
The FDA on Thursday announced it is setting the limit of 10 parts per billion as an allowable amount of inorganic arsenic in apple juice, noting that it has identified some apple juice products with levels about that amount.
But Consumer Reports is taking issue with the limit, arguing that it is still too high and could pose a health risk to children. Arsenic can enter apple juice through a number of ways, including arsenic-based pesticides, naturally high levels of arsenic in soil or water or through industrial activities that impact the environment, the FDA noted in its report on its recommendation.
The limits set by the FDA “are too high, and would leave children vulnerable to serious health issues, including damage to the brain and nervous system, which can lead to learning and behavioral problems,” said Brian Ronholm, director of food policy for Consumer Reports, in a statement.
The FDA didn’t immediately return a request for comment.
A nearly decade-long sampling of apple juice found a mean arsenic level of 4.6 ppb, the FDA noted in its report. But some samples had arsenic levels as high as 44 ppb.
Arsenic in apple juice poses a higher risk to children because they drink more of the liquid relative to their body weight than adults. Research suggests a link between “adverse neurodevelopmental effects” in children and infants and exposure to the chemical element, the FDA noted.
Because of the potential harm to children, the level for arsenic should be set at 3 ppb in apple juice, Consumer Reports said.
In a 2019 report, Consumer Reports found that some popular fruit juices may contain heavy metals including lead, arsenic and cadmium. That test found that all but one juice had arsenic levels below the FDA’s 10 ppb limit, while 58% had an amount below 3 ppb.
Thanks for reading CBS NEWS.
Create your free account or log in for more features.
A team of Food and Drug Administration staff revealed Friday that they have a number of reservations over a drugmaker’s request to become the first in the U.S. to sell birth control pills without a doctor’s prescription. The company, HRA Pharma, is seeking permission for over-the-counter sales of norgestrel tablets, a kind of daily birth control that would be marketed as Opill.
Among the concerns is that some people might not be able to correctly figure out whether it would be safe and effective for them to take the drug. And a key study submitted to the agency included “improbable” results that the FDA worries may “call into question the reliability of all of the actual use data” from it.
The federal review team’s unease, detailed in a 130-page document published by the FDA, comes ahead of a joint meeting scheduled for two agency panels next week to weigh the request.
This illustration provided by Perrigo in May, 2023, depicts proposed packaging for the company’s birth control medication Opill.
Perrigo via AP
After presentations Tuesday from a range of experts, as well as the FDA and HRA Pharma, the agency plans to ask the two advisory groups — the Nonprescription Drugs Advisory Committee and Obstetrics, Reproductive and Urologic Drugs Advisory Committee — to discuss and vote around their concerns.
While the FDA is not legally required to approve drugs based on their advisory committee votes, the agency says the meetings play a key role in advising staff wrestling with tricky questions posed by drug company submissions.
Study issues
Draft discussion questions for the meeting suggest the FDA could ask HRA Pharma to try and repeat its “actual use study” simulating consumers actually taking the drug home and using it, as if it was an over-the-counter birth control product.
The first of these studies run by the company ran aground early, the FDA says, “due to technical failures in the daily use of the electronic diary” and other issues with data collection.
Results from a second attempt were ultimately submitted to the agency, dubbed Adherence with Continuous-Dose Oral Contraceptive Evaluation of Self-Selection and Actual Use or ACCESS.
But the FDA says it found some participants in ACCESS reporting taking more tablets than they were actually given, potentially undermining the reliability of the entire study.
There are also concerns that too many Americans may not follow the directions for safe and effective use. That worry is further complicated by scarce data on adolescents using the drug.
As one risk, some participants with current or previous breast cancer — who should not take norgestrel because it can stimulate tumor growth — “failed to correctly deselect” from taking the pills in both the ACCESS study and a separate targeted study.
Norgestrel’s efficacy was also called into question. Since it was first approved in 1973 under the brand name Ovrette, norgestrel has since been superseded in the American market by newer birth control options.
Unlike combined oral contraceptives, norgestrel “relies more stringently on taking the tablet at approximately the same time each day.” Recent approvals have revealed that contraceptives may also be less effective in overweight or obese people, the FDA said.
“Given that this product was approved in the 1970s and the paucity of data in today’s target population of reproductive females in the United States, real-world effectiveness of this product in the United States remains ill-defined,” the reviewers wrote.
Expanding access
The FDA team acknowledged that direct consumer access to birth control pills could substantially reduce barriers that Americans face in getting contraception, bypassing the need for doctor’s appointments to get prescriptions.
It could also cut down on Americans shelling out for less effective “nonhormonal, use-as-needed contraceptive choices” that are currently available in over-the-counter in stores, they said.
“Providing patients with OTC access to the birth control pill is an easy call from a public health perspective as the health risks of pregnancy vastly outweigh those of oral contraceptive use,” Dr. David Aizuss said in a statement released by the American Medical Association last year, urging the FDA to expand access to birth control pills without age restrictions.
HRA Pharma, in a press release by its parent Perrigo, had touted its submission to the FDA last year as “a groundbreaking moment in contraceptive access and reproductive equity in the U.S.”
The committee had initially been scheduled to meet last November to discuss the product, branded as Opill by HRA Pharma.
But the company disclosed last year that the FDA had postponed the meeting, as well as pushing back its target to decide on approval by three months.
