Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Friday, March 27, 2026

California lawmaker launches bill to highlight healthier foods in grocery stores

A California bill would give non-ultraprocessed food a seal and 
premium placement on grocery store shelves. (Unsplash photo)
A California lawmaker is promoting a bill that would give non-ultraprocessed foods a “California Certified” seal of approval and premium grocery shelf space to help educate consumers about which foods are the healthiest, report Nicole Norman and Rachel Bluth of Politico. "The legislation is the latest in a broader war on unhealthy food."

On a federal level, the Food and Drug Administration and USDA continue to tease out a national definition for ultraprocessed food. But California lawmakers created their own ultraprocessed food definition in October 2025, which labels ultraprocessed food as "any food or beverage that contains flavor or color enhancers and that is high in saturated fats, sodium or specific added sugars or sweeteners," Norman and Bluth write.

Educating American consumers about the health risks of ultraprocessed foods and removing them from the national diet are "both popular and bipartisan," Politico reports. "It’s a cause popularized at the federal level by Health and Human Services Secretary Robert F. Kennedy Jr. and his Make America Healthy Again movement."

Unsurprisingly, companies that make ultraprocessed foods are ramping up their opposition to new laws that decrease their market share of U.S. grocery budgets. Norman and Bluth write, "National manufacturers argue that regulatory burdens drive up the price for consumers and that state regulations on ingredients 'risk undermining the system.'"

California's approach, which labels healthy food, is a new twist on the labeling ultraprocessed food debate. Over the past decade, Latin countries have passed laws that require "warning" labels or color-coded nutritional labels on the front of boxes or wrappers. 

In 2024, the FDA began considering requiring food labels that "might flag certain health risks, such as high levels of salt, sugar or saturated fat," The Wall Street Journal reports. According to its website, the FDA is currently "proposing a rule that would require a front-of-package (FOP) nutrition label on most packaged foods to provide accessible, at-a-glance information to help consumers quickly and easily identify how foods can be part of a healthy diet."

Friday, February 27, 2026

U.S. infant formula needs an overhaul, but progress has been slow

More than half of U.S. babies rely on formula for 
nutrition for at least the first 6 months of life.
U.S. baby formula is currently under review by the Food and Drug Administration, an examination considered long overdue by many health professionals, nutrition experts and parents. The FDA plans to "release [its] study results in April examining contaminants in formula and suggested the current list of required nutrients is outdated," reports Sabrina Siddiqui of The Wall Street Journal

It's estimated that more than half of babies born in the U.S. rely on infant formula as their primary form of nutrition, with families that are lower income, of color, or rural more likely to use formula

 

Through the "Operation Stork Speed” initiative, Health and Human Services Secretary Robert F. Kennedy Jr. has said he's making a U.S. baby formula overhaul a priority; however, supporters of formula changes believe the promised overhaul has been slow getting off the ground. Siddiqui writes, "Industry representatives and pediatric experts who have consulted. . . on the initiative say communication has slowed and visibility into the process has been limited."


Formulas fed to American babies today have come under scrutiny for containing seed oils, sugar, corn syrup, arsenic and heavy metals. Parent advocacy groups have often pushed for formula recipes to mirror those used in Europe.

But U.S. formula manufacturers defend their use of seed oils "because they provide key fats babies need to grow, including linoleic acid — a nutrient that is also found in breast milk and required in all formulas," Siddiqui explains. Many scientists and physicians contend that it would be difficult to replace seed oils, which are also used in European formulas, and have long been regarded as safe.

Friday, August 22, 2025

Quick hits: Radioactive shrimp; soybean farmers seek deal; tractor pulls; veggie-flation; 515-mile lightning strike

Radioactive shrimp were recalled as a precautionary
measure. (ABC video graphic)
Earlier this week, the FDA issued an urgent recall for Indonesian shrimp sold at Walmart that may contain radioactive materials. "Certain Great Value raw frozen shrimp products sold at Walmart are being recalled due to possible contamination with Cesium-137, a radioactive isotope," reports Erin Keller of the Independent. FDA shrimp recall details are here.

With their fall harvests almost ready, American soybean farmers sent the Trump administration a letter asking for a trade deal with China. "China, the world's largest soybean buyer, is turning to Brazilian cargoes amid trade tensions with the U.S. and ongoing negotiations," reports Leah Douglas of Reuters. "The country has not pre-purchased soybeans from the upcoming U.S. harvest, an unusual delay that has worried traders and farmers. . . . China bought 54% of U.S. soybean exports in the 2023-2024 marketing year, worth $13.2 billion."

Langford's tractor pull has increased in popularity since
beginning in 1946. (Photo by Zach Jaworski, NPR)
Annual tractor and truck pulls have grown into major events for some rural communities. Little Langford, New York, hosts its tractor pull for two days every August. "Spectators gather on wooden bleachers flanking a long dirt runway, forming an arena that seats 4,000 people — more than the surrounding area's total population," reports Zach Jaworski of NPR. Richard Love, one of the officials at this year's Langford pull, told Jaworski, "It's non-stop action and it's just kind of a big party here." Jaworski adds, "This event in Langford has been held annually since 1946."

After U.S. Department of Labor agents zeroed in on the Marino family farm in New Jersey and uncovered a paperwork violation, they shackled the family's business with administrative red tape, fines and a ruling from a DOL court. Finally, after years of litigation, "a panel of independent federal judges unanimously ruled DOL’s actions in violation of the Constitution. . . and the Marinos were vindicated," reports Chris Bennett of Farm Journal. But the DOL's damage remains -- the Marino family farm that operated for 125 years is gone. Joe Marino told Bennett, "I never thought honesty and facts wouldn’t matter in America, but that’s what happened."
Chart by Axios, from Bureau of Labor data
As U.S. consumers watch the prices for essentials continue to fluctuate, produce costs could become the next budget worry. "Wholesale prices for fresh veggies soared by a record amount last month, foreshadowing a possible spike at the grocery store soon," reports Ben Berkowitz of Axios. "The Producer Price Index for July rose at the fastest clip in three years, far more than economists expected. . . . Per Bureau of Labor Statistics data, it's also the largest monthly increase ever recorded in a summer month (June-August), in figures that go back to 1947." 
A visualization of the megaflash that extended 515 miles, roughly the distance from Dallas to Kansas City, Mo. (Photo by Michael Peterson, GTRI via The Wall Street Journal)

The raw energy released in an average lightning bolt could power a small town for an entire day. With that in mind, consider the energy released during a recently detected lightning flash that zipped along the Great Plains in 2017. It was a "record-setting strike that lasted more than seven seconds and stretched 515 miles, from eastern Texas almost to Kansas City, Mo.," reports Eric Niiler of The Wall Street Journal. "The massive size of the megaflash, which touched ground in five states in 2017, was revealed by a new analysis of satellite imagery from the National Oceanic and Atmospheric Administration. . . . The average lightning strike is between 2 and 10 miles long."

Tuesday, May 07, 2024

CDC wants to research avian bird flu on dairy farms, but many state officials and farmers don't want their help

Dairy farmers want to avoid being labeled an 'avian flu
hotspot.' (Adobe Stock photo)
Dairy farmers don't want Centers for Disease Control and Prevention researchers on their farms even if they're tracking down avian flu. While the dairy industry's opposition to CDC intervention makes it harder for investigators to understand how long and far H5N1 has traveled within dairy herds and work to contain it, farmers and some agriculture officials are claiming federal government overreach, report Meredith Lee Hill, David Lim and Marcia Brown of Politico.

Texas is one state where CDC investigators have not been invited to research because its health department can't find any farms to host them. Politico reports, "The resistance of dairy farmers is emblematic of the trust gap between key agriculture players in red and blue states and federal health officials — one that public health experts fear could hamper the nation's ability to head off the virus' threat to humans."

When the federal government suggested deploying research teams onto dairy farms, state agricultural leaders deflected the need for in-person CDC visits. Hill, Lim and Brown explain, "Democratic, as well as Republican, state officials shared those reservations, including that state and local health officials should continue to lead the response on the ground. Some have also pressed for the Department of Agriculture and its animal health experts to have more say in the process."

Dairies don't want CDC researchers poking around because they don't want to be "identified as a virus hotspot," and they don't want their workers, who are often undocumented, to be scrutinized. Politico reports, "Given that reality, state agriculture officials have specifically pushed for any interviews with farmworkers to be voluntary and conducted off the farms at a different site."

While the CDC is working to find a middle ground where it can work directly with dairy farmers, some states are working on their own measurement tools. Politico reports: "Idaho is one of several states working on a shortened version of the CDC's lengthy questionnaire, with the goal of developing a uniform survey that can be administered nationally, said the state's epidemiologist, Dr. Christine Hahn."

Tuesday, April 11, 2023

Over-the-counter naloxone will help stop overdoses; rural communities in N.Y. report success with involving citizens

Rural places can already provide Narcan rescue boxes. (PBS image)
If you could, would you save someone from a fatal drug overdose? Most people would answer, "Yes." In the coming months, that chance will become a reality. The Food and Drug Administration has cleared the path for the prescription nasal spray naloxone, know by the brand name Narcan, to be sold over the counter. Narcan reverses opioid overdoses and has already made its way to many rural communities. "Overdose epidemic touches every part of the country, but rural areas have special challenges, like fewer providers who treat people with substance-use disorders and long wait times when people call for help after an overdose. That underscores the importance of Narcan," reports William Brangham for PBS NewsHour.

Real-life examples are a scary and vivid. Julia Wilson of  Cato, N.Y, pop. 2,500, retold her experience with Narcan: "My dad comes running in my room, and he's like: 'Something's happening at the neighbor's house. And so I was like, 'Yes, very funny.' He goes: 'No, I'm serious, I think there's an overdose.'. . .I look out the window and see this man lying on the floor in a shed. And I can see two people trying to do CPR on him. . . . I run back into my room, grab my Narcan kit and get in there. And this man, he's just laying there, not responding. . . . I check for a pulse. He didn't have one. I just put one dose in his nose. He still wasn't breathing. . . . I put in the other dose. When I seen him sit up, it was kind of just like a — like, all I could think was just wow."

PBS's William Brangham reports, "Julia learned what to do in a health class called 'Bones, Bodies and Bandages'." Teacher Donna Cappellano told him, "This is a skill. And kids love hands-on things. And so this is just one other avenue to keep yourself healthy or to — or to be able to help a friend. If you know that you can do something to help somebody and you can get the skill, do it because, otherwise, you're going to feel — you're just going to feel bad that you didn't help."

In Auburn, N.Y., Monika Salvage runs "Healing Cayuga," a county program to fight addiction and overdoses. She told Brangham, "Obviously, it's still important for first responders to come and to have that follow-up care. But those few minutes are really important. And it's even more critical in rural areas, where it's not just a few minutes until first responders arrive."

Cayuga County's outreach includes community advocates. "This county's pied piper is Wally Meyers. Going door to door, Meyers preaches and teaches overdose prevention to anyone who will listen," Brangham reports. "Meyers tries to make sure that government buildings and private businesses have Narcan kits on the wall. They're free, available to anyone who opens up the box. . . . Healing Cayuga has put more than 3,000 Narcan kits into the community. At least 113 people here have been revived by bystanders with Narcan. . . . Since 2020, even as fatalities hit new highs all over the country, in this rural county, they are down by a stunning 43 percent."

Randy Smith is also a community mentor who offers peer support. "Smith ended up in jail  after developing a fierce addiction to painkillers. . . He offers moral and practical support to people who are just starting their recovery," Brangham reports. "Now he's leading a women's support group. . . . Nationwide, women in rural areas are more likely to die of an overdose than women in cities. Smith knows the challenge is keeping people alive long enough that they can find their way to a new path. And that takes everybody pitching in."

Wednesday, August 31, 2022

FDA authorizes coronavirus booster shots that target Omicron subvariants; here's what you need to know

Today the Food and Drug Administration "authorized the first redesign of coronavirus vaccines since they were rolled out in late 2020, setting up millions of Americans to receive new booster doses targeting Omicron subvariants as soon as next week," report Noah Weiland and Sharon LaFraniere of The New York Times. "The agency cleared two options aimed at the BA.5 variant of Omicron that is now dominant: one made by Pfizer and its German partner BioNTech for use in people as young as 12, and the other by Moderna, for those 18 and older." The boosters also target the BA.4 subvariant.

People are eligible for the new booster only if they are fully vaccinated, and if it's been at least two months since they got their latest booster or finished the initial two-shot series. Older formulations of the booster will no longer be authorized for people aged 12 and over, the Times reports. The new boosters are now being shipped out and could be available locally as soon as this week.

Fewer and fewer people take advantage of boosters each time a new one is offered, perhaps out of weariness over the pandemic or because they feel sufficiently protected by the initial vaccination. However, FDA officials say the booster could help curb infections and deaths during the winter months, when numbers tend to be higher, the Times reports.

"An average of about 90,000 infections and 475 deaths are recorded every day around the United States, almost three years into a pandemic that has killed more than a million Americans and driven a historic drop in life expectancy," the Times reports. "But there are also hopeful signs. Even with high case counts, fewer than 40,000 people are currently hospitalized with the virus, a decrease of 10 percent since early August and far fewer than during the Delta-driven surge last summer or the Omicron-fueled wave last winter. Deaths have also remained somewhat flat in recent weeks, a sign that vaccines are helping to prevent the worst outcomes of Covid-19."

Tuesday, August 30, 2022

FDA isn't using its power to stop the sale of hundreds of vaping products that it's ordered off the shelves, Stat reports

Food and Drug Administration photo
Even though the U.S. Food and Drug Administration has ordered hundreds of flavored, nicotine-heavy vaping products off of the market, "Vape companies are regularly flouting the FDA’s orders. They’re making, stocking, and selling the illicit goods. And the agency is just letting it happen," Nicholas Florko and Elissa Welle report for Stat, the medicine-and-science publication of The Boston Globe 

The authors write that while the FDA has ordered more than 100 vape manufacturers to stop making more than 250 specific flavors and vapes, "We found scores of companies across the country that are defying the FDA's demands." And despite having "sweeping legal authorities" to crack down on vape companies that ignore its bans, "ranging from levying seven-figure fines to physically pulling products off shelves," the Stat investigation found that the FDA has never used those powers, according to its own data. And in several cases, "It’s even dropped cases against companies that it knows are still selling illegal products." 

The FDA declined Stat’s request for an interview with Commissioner Robert Califf or the head of the FDA’s Center for Tobacco Products, Brian King, but a spokesperson implied that the agency may soon get tougher against companies that ignore its orders, Stat reports.

Vape shops argue that the FDA’s orders aren’t clear enough, and that until they are more so, they'll keep selling the products. The shops “are doing their best, despite a complete lack of clarity or transparency from the agency, to piece together what products are still legally able to be sold,” Amanda Wheeler, president of American Vapor Manufacturers, told Stat.

The writers say their investigation is likely an underestimation of the issue, since they only analyzed warning letters sent to companies that formally asked the agency for permission to sell their products, and then had that request denied and did not focus on the hundreds more companies that received warning letters for never asking the FDA for permission at all.

Thursday, May 19, 2022

Formula roundup: House passes bills to help FDA, expand WIC choices; Biden invokes Defense powers; plant could reopen soon; some infants and children hospitalized

Here are some significant new developments in the baby formula shortage:

Abbott Laboratories reached an agreement Monday to reopen its Sturgis, Michigan plant in the next few weeks, pending federal inspectors' approval. Today Food and Drug Administration commissioner Robert M. Califf told a House appropriations subcommittee that he expects the plant to be open again within two weeks, and begged for more funding so the agency can cope with its workload, Laura Reiley reports for The Washington Post.

"President Biden took urgent action on Wednesday to address the nationwide baby formula shortage, invoking the Defense Production Act to increase production and creating 'Operation Fly Formula' to deploy Defense Department planes and speed formula shipments into the United States from overseas," Annie Karni and Emily Cochrane report for The New York Times. "The White House announced its plan only hours before the House took action of its own, approving an emergency infusion of $28 million for the Food and Drug Administration and a bill to loosen restrictions on what kind of formula can be purchased through the federal food aid program for women and babies."

The $28 million is meant to help the FDA "beef up inspections of formula made at foreign plants and to guard against any future shortages by ensuring the agency is prepared for supply chain disruptions," Nathaniel Weixel and Mychael Schnell report for The Hill. The bill passed on a mainly party-line vote, though 12 Republicans supported the bill in defiance of party leadership.

House Minority Whip Steve Scalise (R-La.) urged House Republicans to oppose the bill, saying it was reckless spending that would provide political cover for the Biden administration while failing to hold the FDA accountable. "House Republicans knocked Democrats for giving money to the FDA without guardrails and without forcing the agency to develop a concrete plan to solve the shortage. At least two House committees are investigating manufacturers and the FDA," Weixel and Schnell report. However, "Democrats argued the FDA does not have enough resources to adequately inspect foreign manufacturers and make sure they meet agency safety standards. The $28 million in emergency funding would make sure the agency can handle those inspections quickly."

A recent Politico investigation found several reasons for the FDA's failure to quickly catch problems at the Abbott plant. The FDA has been underfunded for years, its leaders tend to have far more experience with regulating medications than food, and Trump-era changes in leadership left the agency adrift and—in some cases—caught up in turf wars between feuding officials. All of this happened as the agency was under unprecedented pressure to examine coronavirus vaccines, tests, and treatments.

Meanwhile, some babies and children have already been hurt by the shortage. Doctors in East Texas say they've treated infants who had had seizures after their parents fed them watered-down formula in an effort to stretch their supply. Watered-down formula (or homemade recipes) can endanger babies. And at least two children with intestinal conditions have been treated in a Tennessee hospital because their parents couldn't find the special formula they needed. The formula shortage affects children and even adults with medical conditions that leave them unable to digest regular food. It also disproportionately affects low-wage and other disadvantaged families, Mariel Padilla reports for The 19th. Rutgers University assistant history professor Carla Cevasco spoke with Padilla about the long-standing structural issues that have left low-income families more vulnerable to formula shortages.

Tuesday, May 17, 2022

Abbott reaches agreement with FDA to reopen formula plant

Abbott Laboratories "reached an agreement with the Food and Drug Administration on Monday to reopen the company’s manufacturing plant in Michigan to help ease a nationwide shortage of baby formula, after the facility was closed due to bacterial contamination," reports Spencer Kimball of CNBC. According to the consent decree, Abbott can resume production at its plant in Sturgis, Michigan, within two weeks once the FDA signs off on it, but it will take six to eight weeks after production resumes for formula to hit store shelves.

The FDA ordered the Abbott plant to shut down in February after four infants were sickened from contaminated formula and two died. 

"Under the consent decree to reopen the plant, Abbott has agreed to bring in outside experts to help the facility come into compliance with food safety regulations, according to the Justice Department," Kimball reports. "The outside experts will design a plan for Abbott to reduce the risk of bacterial contamination at the plant and conduct periodic evaluations to make sure the company is in compliance. The process will be under FDA supervision."

In the meantime, the FDA will allow some imported formula meant for foreign markets to enter the U.S., but only after the agency has evaluated whether each manufacturer that applies has a safe and nutritious product. The FDA has been allowing more formula imports meant for the U.S. since February, Kimball reports.

Monday, May 16, 2022

The nationwide shortage of baby formula is probably hitting rural families hardest. Here's what they need to know.

Families nationwide are scrambling to find baby formula amid a widespread shortage. Rural families are likely having an even harder time since there are fewer local places to buy formula, and because families who use federal assistance can only buy certain formulas. It's even more difficult to find certain medically necessary specialty formulas. Here's what you—and your readers—need to know:

What happened: In February the Food and Drug Administration ordered Abbott Nutrition, the nation's leading formula maker, to shut down its plant in Sturgis, Michigan, after four infants were hospitalized with bacterial infections from contaminated formula and two of them died. The FDA issued a voluntary recall on three products (Similac, Alimentum, and EleCare) and warned customers not to use certain specialty formulas produced at the facility, but the warning didn't get much public attention, so parents didn't know to stock up. Formula was already low in stock since at least December because of inflation, supply-chain shortages and product recalls. 

How bad is it? Formula stockpiles in stores are 43 percent lower than normal, compared to 30-40% short in April, says retail data tracker Datasembly. Only about a quarter of children are exclusively breast-fed up to the age of six months, so most parents and caregivers depend at least partially on formula. 

Why not buy another brand? Almost all formula in the U.S. is manufactured domestically because of strict FDA standards, and 90% of the nation's supply comes from four companies. Abbott makes over 40% and Perrigo Nutritionals, Mead Johnson, Gerber (owned by Nestlé) combined account for another 50%. Perrigo makes store-brand formulas for stores such as Walmart, Kroger and Walgreens but that formula can't be purchased by people using federal assistance through the Women, Infants and Children nutrition program, which pays for about half of all formula. In addition, many babies require specialty formulas and can become very sick if they switch.

Why not breastfeed? Many babies who require specialty formulas can also get sick from drinking breast milk. Adoptive families and many others also have difficulty accessing or affording a reliable supply of breast milk, and some survivors of sexual violence may find it traumatizing. Some mothers find it difficult to maintain a steady supply of milk, and others can't breastfeed at all because they must take medications that would taint the milk. Though state and federal laws protect women's right to breastfeed in public—including at work—many women are embarrassed, intimidated, or even discouraged from the practice, and many women are not knowledgeable about the health benefits of breast milk.

Is homemade baby formula a safe alternative? No. Homemade formulas can be too high in sodium, too low in calcium, contaminated, and/or lack critical nutrients. Babies can suffer long-term damage after using homemade formula alternatives or straight cow's milk for even a few days, according to the National Committee on Nutrition for the American Academy of Pediatrics. It's also dangerous to dilute baby formula with too much water. If there is absolutely no other alternative, formula made for toddlers can be ok for a few days for infants who are close to a year of age. 

How long could the shortage last? At least 10 weeks. On Monday the FDA agreed to allow Abbott to reopen its Sturgis plant within two weeks, as long as it passes a safety inspection. After that it will take six to eight weeks for formula to hit store shelves. However, inspectors say there are still problems at the plant. In the meantime, Abbott says it's shipping in formula from its FDA-registered plant in Ireland on a daily basis. The FDA has been allowing more formula imports meant for the U.S. since February, and is now allowing some formula meant for foreign markets to enter the U.S., but only after a safety evaluation.

Could this have been prevented? Growing evidence indicates the FDA failed to act quickly about warnings of safety violations at the Sturgis plant. A whistleblower at the plant warned the FDA in October about safety problems, weeks after the children were hospitalized with bacterial infections, but the agency didn't interview the whistleblower until December and didn't inspect the plant until Jan. 31. That dovetails with a recent Politico investigation that revealed deep-seated issues with the FDA's plant inspections. Current and former employees described the agency as slow to make decisions and lacking enough staff or budget for years to deal with the modern food system even as its regulatory responsibilities have grown.

What the government is doing now: The FDA is expediting and streamlining some of its approval processes to speed up production. The Biden administration and lawmakers from both parties are also urging the Federal Trade Commission and state attorneys general to keep an eye out for price-gouging and increase formula imports to increase the domestic supply. The House Appropriations Committee will hold a hearing this week before introducing an emergency supplemental funding bill to help address the shortage. Late Monday, Abbott and the FDA announced an agreement to reopen the plant, but the company said it would be well over a month before new product ships from the site.
 
What the administration is not doing: Some right-wing politicians and pundits have blamed the Biden administration for the shortage, but no single politician or administration is causing the problem. Biden has also been accused of stockpiling baby formula for undocumented immigrants being detained at the border while American families go without. In fact, the Biden administration is following the law in shipping a limited supply of formula to infants at the border, as the Trump administration did. 

In the meantime, if you need formula, here are some do's and don'ts:
  • Check with your church or local nonprofits to see if they have any.
  • Shop online from reliable sources. 
  • Don't make your own.
  • Don't hoard formula.
  • Network with other families on social media.

Tuesday, February 22, 2022

Pandemic roundup: why Covid can cause stillbirths; peer-to-peer mental health services for farmers; nearly 1 in 5 health-care workers have quit since the beginning of the pandemic

Here's a roundup of recent news stories about the pandemic and vaccination efforts:

It's already well established that stillbirths have increased in many areas with high Covid-19 rates. Now a new study suggests why: A coronavirus infection can invade and destroy the placenta, likely leading to stillbirths, the study says. Read more here.

Nearly a fifth of American health-care workers have quit since the beginning of the pandemic as they get increasingly burned out by the demands of overcrowded hospitals. A portrait of a Minnesota hospital shows what that stress looks like. Read more here.

Worker burnout is only one reason hospitals can't handle the new normal, says one analysis. Rural hospitals especially will continue to lose out: Urban hospitals with deeper pockets will keep poaching rural staff (example: traveling nurses), enabling lucrative elective surgeries. Smaller hospitals will continue to shoulder a disproportionate share of mild-to-moderate Covid-19 patients and will be more likely to have to pause elective surgeries and other non-Covid care. Read more here.

During the Delta variant surge last summer, rural counties with low vaccinations rates were hit the hardest, researchers found. Counties where the coronavirus vaccination rate was below 30% saw nearly double the case rate of counties where vaccination rates were over 50%. Read more here.

The pandemic has increased farmers' need for mental-health services, but many are reluctant to admit they need help. Programs that teach peer-to-peer counseling can be especially effective, but those and other programs may need more funding to remain sustainable. Read more here.

In January, more than 3,000 hospitalized patients became infected with the coronavirus during their stay, more than in any other month of the pandemic, new data show. Read more here.

The Food and Drug Administration delayed its review of Pfizer's coronavirus vaccine for children under 5 years old earlier this month. Sources familiar with the decision now say it's because a few children in the study got breakthrough infections of the Omicron variant after two doses of the vaccine. Since so few people get breakthrough infections, even a handful could be statistically significant. FDA officials and Pfizer agreed it would be better to wait for a larger sample size to assess the vaccine's effectiveness for that age group with both two doses and three doses. Results are expected in early April. Read more here.

Friday, March 19, 2021

USDA hemp rules finalized after much push and pull

The U.S. Department of Agriculture has finished its review of a final rule for industrial hemp production, with an effective date of March 22. The 2018 Farm Bill legalized hemp but sparse regulations led to widespread confusion and problems for producers and processors. The new rule is meant to address those concerns after much feedback from growers, state agencies, and industry groups nationwide.

"The final rule includes provisions for the USDA to approve hemp production plans developed by states and Indian tribes including requirements for maintaining information on the land where hemp is produced, testing the levels of delta-9 tetrahydrocannabinol, disposing of plants not meeting necessary requirements and licensing requirements," Robert Hoban, an attorney who specializes in the cannabis industry, reports for Forbes. "It also establishes a federal plan for hemp producers in states or territories of Indian tribes that do not have their own USDA-approved hemp production plan."

Kentucky Agriculture Commissioner Ryan Quarles, whose feedback about potential problems with the interim final rule resulted in several adjustments to the final rule, said he is encouraged by it, but warned, "Additional challenges remain for the nation’s hemp industry, especially in light of the continued lack of action by the Food and Drug Administration. If this industry is to be successful, we need FDA to deliver clarity on hemp-derived cannabidiol products and their guidance cannot come soon enough."

Monday, February 22, 2021

Pfizer announces its coronavirus vaccine can be stored in regular freezers, opening up more options to rural areas

Pfizer announced Friday that its coronavirus vaccine can be stored in a regular freezer, not the expensive, ultra-cold freezers they originally indicated were necessary. That could mean more vaccine options for rural providers who were unable to afford the new freezers.

"Pfizer submitted data to the Food and Drug Administration showing the vaccine is stable when stored between minus 13 degrees and 5 degrees Fahrenheit, temperatures commonly found in pharmaceutical freezers and refrigerators,"  Jessie Hellmann reports for The Hill. "The company is asking the FDA to update its authorization of the vaccine to allow for vials to be stored at these temperatures for a total of two weeks as an alternative or complement to colder freezers."

The Pfizer and Moderna vaccines are the most prevalent in the U.S., but the Moderna vaccine has been more attractive to rural areas from the start since manufacturers have always indicated it could be stored in a regular freezer. Many rural hospitals, already struggling financially even before the pandemic, said they couldn't afford the $10,000 to $15,000 for one of the ultra-cold freezers.

Monday, December 14, 2020

Some nursing-home residents and workers skeptical of coronavirus vaccine, worry it was approved too quickly

"After 110,000 deaths ravaged the nation’s nursing homes and pushed them to the front of the vaccine line, they now face a vexing problem: Skeptical residents and workers balking at getting the shots," Bernard Condon and Matt Sedensky report for The Associated Press. Some worry that seniors "could be put at risk again by vaccines sped into development in months rather than years. Some who live and work in homes question if enough testing was done on the elderly, if enough is known of side effects and if the shots could do more harm than good."

Public-health officials say the Pfizer vaccine is safe for the elderly. "In an ongoing study of nearly 44,000 people, the U.S. Food and Drug Administration found the vaccine was safe and more than 90% effective across recipients of different ages, including older adults and those with health problems that put them at high risk of Covid-19," Condon and Sedensky report. "But the undercurrent of doubt in nursing homes persists, sometimes fueled by divisive politics, distrust of institutions and misinformation. And so far, the workers are the ones being heard the loudest. . . . Internal surveys by groups including the American Nurses Foundation suggest many workers in long-term care facilities are so concerned about the vaccine they would refuse it."

Though nursing homes account for 40 percent of Covid-19 deaths, less than 1% of the nation's population lives in long-term care facilities, according to The Atlantic's Covid Tracking Project. Nursing homes are a significant vector for spreading the infection in rural areas, but federal rules changed in September relaxed employee-testing requirements for many rural nursing homes. 

Tuesday, October 20, 2020

Two years after nationwide legalization, hemp industry slumping because of patchwork regulations, oversupply

"It’s been nearly two years since the 2018 Farm Bill was signed into law, legalizing industrial hemp production nationwide and fueling hopes of a hemp farming boom. But that hasn’t panned out yet, with growers around the country still struggling to reap the benefits of the burgeoning crop sector," Ryan McCrimmon reports for Politico's Weekly Agriculture. "After millions of acres of hemp were planted in 2019, production is way down this year; many growers gave up because of a steep drop in prices and the lack of a market for their crops."

Another big problem is inconsistent state regulations. "The Agriculture Department has approved hemp programs for 29 states and is negotiating with another 12," McCrimmon reports. "Some state agricultural officials were so unsatisfied with the regulatory framework that USDA proposed last year that they decided not to move forward with hemp initiatives. (Among the biggest complaints are the strict limits on THC that can be present in hemp crops and the stringent testing requirements to certify those levels of the psychoactive chemical.)"

Unclear federal oversight has also hurt the fledgling industry. The Food and Drug Administration "has yet to put forth regulations on cannabidiol, the widely popular compound derived from hemp that’s increasingly found in products from pills to pet foods. The agency’s CBD guidance has been awaiting approval from the White House since July," McCrimmon reports.

One thing hemp farmers have going for them: though they were excluded from an earlier round of federal aid for farmers hurt by the pandemic, the USDA announced in late September that hemp growers could apply for a slice of $14 billion in new relief.

Tuesday, September 01, 2020

First year of nationwide legal industrial hemp cultivation has been a bumpy ride; USDA reopens comment period on rules

UPDATE, Sept. 5: The Department of Agriculture "is reopening the comment period to the interim final rule (IFR) that was published on Oct. 31, 2019, and it has established the U.S. Domestic Hemp Production Program," Successful Farming reports. Comments will be accepted until Oct. 8.

The first year of nationwide legal cultivation of industrial hemp has been a bumpy one, but entrepreneurs and industry analysts say they're optimistic. "Although there are many more licensed hemp growers than there were in 2019, hemp acreage is down by 9 percent, the first year-on-year decrease since Congress allowed hemp pilot and research programs as part of the 2014 Farm Bill," Chuck Abbott reports for the Food & Environment Reporting Network. "Wholesale prices slumped this year due to an oversupply of hemp flowers and biomass. Some farmers were unable to find buyers for their 2019 crop."

The industry has been bedeviled by inconsistent regulations since the 2018 Farm Bill authorized widespread hemp cultivation but left most regulations up to state and local governments. The Food and Drug Administration, meanwhile, has not resolved questions about cannabidiol regulation, deterring many from investing in hemp, Abbott reports. The pandemic, too, has hurt the burgeoning industry just as it has hurt other agricultural sectors and the U.S. economy overall.

Hemp entrepreneur Morris Beegle said the industry has a "bright future," but must overcome obstacles to expand beyond the CBD market and into more whole-plant cultivation for things such as fiber, Abbott reports. "Hemp can also be used in textiles, biocomposites, fuel, and livestock rations, though those uses, which generate lower revenue for hemp biomass, have drawn less attention."

Tuesday, May 26, 2020

Hemp industry, once booming, now on a downward trend as federal government drags feet on regulations

The hemp boom could go bust, despite the early efforts of Senate Majority Leader Mitch McConnell to champion it, Mona Zhang and Paul Demko report for Politico.

After the 2018 Farm Bill legalized widespread hemp cultivation, largely thanks to the Kentucky senator, farmers and manufacturers rushed to get in on the ground floor of the industry, leading to oversupply and low wholesale prices. But patchwork local, state and federal laws have left producers, processors and consumers confused about the legality of hemp and left the door open to snake-oil peddlers who tout hemp-derived CBD as a cure-all without evidence. "All of those factors are hurting the very farmers hemp legalization was supposed to help," Zhang and Demko report.

Meanwhile, a slew of cannabis companies have declared bankruptcy over the past year, including two in McConnell's home state. "Many CBD producers, especially in Kentucky, seemed to be counting on McConnell's influence and FDA regulation," Zhang and Demko report. But McConnell "seems to be missing from the debate in recent months as they clamor for regulatory clarity that could help stave off the economic downturn for the industry."

House Agriculture Committee chair Collin Peterson, D-Minn., introduced a bill in January that would make the FDA regulate CBD products as if they were dietary supplements, "but the chances for such legislation are close to zero in the middle of the public-health crisis," Zhang and Demko report. "Hemp advocates are focused on inserting similar language in a coronavirus package, arguing that it could help boost an industry without additional costs to the federal government." Hemp is not eligible for the $16 billion direct-payment fund for farmers hurt by the pandemic.

Farmers and processors told Politico that it would be unfortunate if quibbles over CBD regulation tanked the hemp industry, since not all hemp is grown for CBD, and the plant has many other uses.