Tag Archives: fda

Minnesota is leading the rest of country in banning germ-killer triclosan

Minnesota’s first-in-the nation ban on soaps containing the once ubiquitous germ-killer triclosan takes effect Jan. 1, but the people who spearheaded the law say it’s already having its desired effect on a national level.

The federal government caught up to Minnesota’s 2014 decision with its own ban that takes effect in September 2017. Major manufacturers have largely phased out the chemical already, with some products being marketed as triclosan-free.

And it’s an example of how changes can start at a local level.

“I wanted it to change the national situation with triclosan and it certainly has contributed to that,” said state Sen. John Marty, an author of Minnesota’s ban.

Triclosan once was widely used in anti-bacterial soaps, deodorants and even toothpaste. But studies began to show it could disrupt sex and thyroid hormones and other bodily functions, and scientists were concerned routine use could contribute to the development of resistant bacteria. And University of Minnesota research found that triclosan can break down into potentially harmful dioxins in lakes and rivers.

The group Friends of the Mississippi River and its allies in the Legislature, including Marty, got Gov. Mark Dayton to sign a ban in 2014 that gave the industry until Jan. 1, 2017, to comply.

In September, the FDA banned triclosan along with 18 other anti-bacterial chemicals from soaps nationwide, saying manufacturers had failed to show they were safe or more effective at killing germs than plain soap and water. However, the FDA allowed the use of some triclosan products such as Colgate Total toothpaste, saying it’s effective at preventing gingivitis.

Marty and Trevor Russell, the water program director for Friends of the Mississippi River, acknowledged they can’t take direct credit for the FDA’s action because that rulemaking process began in 1978, though it didn’t finalize the rule until after a legal battle with the Natural Resources Defense Council.

However, the Minnesota men hope their efforts helped turn opinions against the chemical and are confident the state’s ban helped prod manufacturers to accelerate a phase-out that some companies such as Procter & Gamble and Johnson & Johnson had already begun.

Most major brands are now reformulated, said Brian Sansoni, spokesman for the American Cleaning Institute, a lobbying group. Soaps containing triclosan on store shelves are likely stocks that retailers are just using up, he said.

Russell noted he recently found Dial liquid anti-bacterial hand soap at two local Wal-Marts, two supermarkets and a Walgreens.

The industry is now submitting data to the FDA on the safety and effectiveness of the three main replacements, benzalkonium chloride, benzethonium chloride and chloroxylenol.

“Consumers can continue to use these products with confidence, like they always have,” Sansoni said.

By going first, Russell said, Minnesota can identify any issues with implementing the ban and share it with the rest of the country.

The Minnesota Department of Health will remind consumers and businesses of the ban’s start.

Will Trump cut healthy school lunches, food labels and safety inspections?

Will Donald Trump remake school lunches into his fast-food favorites of burgers and fried chicken when he’s president?

Children grumbling about the rules for  healthier school lunches rules championed by first lady Michelle Obama may have reason to cheer Trump’s election as the billionaire businessman is a proud patron of Kentucky Fried Chicken and McDonald’s. And he’s promised to curb federal regulations.

The Obama administration has made healthier, safer and better labeled food a priority in the last eight years, significantly raising the profile of food policy and sometimes drawing the ire of Republicans, farmers and the food industry. The first lady made reducing childhood obesity one of her signature issues through her “Let’s Move” campaign.

In addition to the healthier rules for school lunches, the administration ushered a sweeping food safety law through Congress, pushed through several new food labeling regulations, started to phase out trans fats, added calorie labels to menus and suggested new limits on sodium in packaged foods. The White House has also fended off efforts in the Republican Congress to trim the nation’s food stamp program.

“Food advocates are already nostalgic for the Obama era and will be playing defense for the next four years,” says Sam Kass, a former White House senior adviser on nutrition and personal chef for the Obamas.

A look at some of the food regulations that could be scrapped — or tweaked — in the new administration:

MAKING SCHOOL MEALS UNHEALTHY AGAIN

Trump himself hasn’t weighed in on regulations for school lunches. But Republicans, school nutrition directors and some in the food industry have balked at parts of the administration’s rules that set stricter fat, sugar and sodium limits, among other standards, on foods in the lunch line and beyond. While many students and schools have now gotten used to the healthier foods, some still complain that the standards are costly and difficult to meet.

“I would be very surprised if we don’t see some major changes on the school lunch program” and some other food issues, said Rep. Robert Aderholt of Alabama, the Republican chairman of the House subcommittee that oversees Agriculture Department spending.

Aderholt, who sits on Trump’s agriculture advisory committee, says the Obama administration’s approach was “activist driven” and people who voted for Trump are looking for a more common-sense approach.

Legislation is pending in both the House and Senate to revise some of the standards, and will likely be considered again next year. USDA could also make some changes on its own.

One of many names that have been floated as a possible agriculture secretary is Sid Miller, the Texas Agriculture Commissioner who repealed a state ban on deep fryers and soda machines at schools. Miller recently got in trouble when he used a profanity on Twitter to describe Democrat Hillary Clinton; he blamed a staffer and the tweet was deleted.

FOOD SAFETY A HASSLE TO FARMERS

In September, the Trump campaign pitched rolling back food safety regulations in a fact sheet, arguing they are burdensome to farmers and criticizing increased inspections of food manufacturing facilities as “overkill.” The sheet referred to the “food police” at the Food and Drug Administration. The campaign later deleted the proposal from its website.

Congress passed new food safety regulations in 2010, a year after a salmonella outbreak linked to a Georgia peanut company killed nine people. Michael Taylor, former FDA deputy commissioner for foods who oversaw the food safety rules, says it wouldn’t be popular with consumers to roll them back.

“Consumers are only getting more focused on safety, health and wellness,” Taylor says.

Trump himself is a self-professed germaphobe who prefers eating at fast-food restaurants because he believes they have higher food safety standards.

FOOD STAMPS

Congressional Republicans have been examining food stamps since the program’s cost grew to almost $80 billion annually after the recession. Participation and costs have dipped since its 2013 high, but conservatives have suggested tightening eligibility standards or increasing work requirements. House Speaker Paul Ryan has for years championed an overhaul to the program.

Democrats in the Senate have consistently objected to any changes, and will still wield influence. But they won’t have the backing of a Democratic White House.

OTHER FOOD POLICY

Many other laws are either already in place or close to it, including a revised “nutrition facts” panel on the back of food packages, with a new line breaking out added sugars, a labeling law for genetically modified foods and calorie labeling on restaurant and supermarket menus.

In many cases, the rules are a result of compromise with industry. Kass says that pulling back may just create more cost and uncertainty for businesses.

“Unwinding things is really hard, especially when most of them have been implemented and industry has moved on,” Kass says.

He predicts most of the regulations will stay, but that there will be little additional progress. Ongoing administration efforts to reduce sodium in food and antibiotics in meat could be casualties.

Margo Wootan, a lobbyist on nutrition issues for the Center for Science in the Public Interest, says advocates will continue to be aggressive at the state and local levels, hoping change will bubble up.

“The public is more interested than ever in nutrition and will continue to press companies,” she says.

 

Questions, concerns arise over FDA’s ‘Botox Police’

On April 5, 2012, a criminal investigator from the Food and Drug Administration named Robert West charged into an oncology clinic in Greenville, Tennessee.

West was chasing a lead that Dr. Anindya Sen and his wife, the clinic’s office manager Patricia Posey Sen, purchased an unapproved Turkish version of the cancer drug Avastin.

But “Cowboy Bob,” as some defense attorneys call him, did not realize his interview was caught on the clinic’s surveillance cameras. West told Posey Sen she was guilty of buying counterfeit drugs and looked like a “deer in the headlights,” court records say.

Without a warrant or permission, he and an FBI agent rifled through cabinets, seizing drugs that appeared to have foreign, non-FDA approved packaging. At one point, West snatched a drug out of a nurse’s hands as she treated a chemotherapy patient.

A U.S. judge later said West’s tone was “ominous and threatening” and that his statement about the drugs being counterfeit “apparently was not the truth.” West’s search was declared illegal, and the evidence was deemed inadmissible at the Sens’ criminal trial in December 2013.

Earlier that year, managers at the FDA’s Maryland-based Office of Criminal Investigations, or OCI, had promoted West to senior operations manager, where he oversaw hundreds of similar investigations. Last year, he was promoted to special agent in charge in Miami. In February, he taught a class to new agents on how to pursue similar probes.

West declined interview requests.

West’s approach in Tennessee and FDA managers’ eagerness to reward him open a window into a collision unfolding inside the historically staid U.S. drug agency, pitting investigators who object to what they see as cowboy tactics against a small cadre of managers who control the opening of investigations.

FDA leaders, including West, Special Agent in Charge of the headquarters office Thomas South and OCI Director George Karavetsos, are pursuing an agenda that has opened a divide over the office’s handling of criminal investigations, interviews and records show.

Prosecutors are declining to pursue many FDA cases, citing a lack of prosecutorial merit, criminal intent or strong evidence, Reuters found in a review of more than 170 letters detailing why the Department of Justice declined cases. The letters, obtained under the Freedom of Information Act, appear to bolster critics’ claims of agency overreaching.

From fiscal 2008 to 2015, more than half of OCI cases – 53 percent – were closed without action. By contrast, at the Environmental Protection Agency in the same period, 71 percent of opened cases spurred criminal charges. At the Internal Revenue Service’s criminal unit, 68 percent of initiated investigations resulted in charges. The FDA criminal investigation office had more cases closed without action than it had arrests, Reuters found.

Some FDA agents complain they have turned into the “Botox Police” – chasing down every doctor who purchased authentic versions of the popular anti-wrinkle drug that were labeled for use in other countries, an exercise producing few prosecutions.

Large pharmaceutical companies sometimes refer cases to the FDA or help the agency investigate targets, and some doctors ensnared in the dragnet say the investigations ultimately help drug makers charge top dollar in the United States.

In one example, Botox maker Allergan referred a case to the FDA against an unlicensed Virginia distributor accused of illegally selling Botox, court records show – helping the agency land convictions. Another time, a former OCI agent-turned security official for a drug maker conducted his own undercover work before sharing his findings with the FDA.

The FDA said its focus differs from other agencies, with a mandate to protect public health, and that it follows leads from all sources –agents, the public and industry. “The public health risks of unapproved drugs from foreign sources outweigh any potential cost savings,” the FDA said in a statement.

In an interview, Karavetsos said statistics are not a good benchmark to measure OCI’s success. Protecting public health will “always trump the criminal investigation,” said Karavetsos, who became OCI director in January 2015.

He points to successful prosecutions, including one against the former Peanut Corporation of America president who sold Salmonella-tainted peanuts, and another involving a fatal meningitis outbreak in Massachusetts.

Through an FDA spokesman, South declined comment.

UNKNOWN OFFICE, BIG POWER

The 280-unit Office of Criminal Investigations, with an annual budget of $77.3 million, is a little-known corner of the FDA created in the 1990s in response to a generic drug scandal.

The FDA agents carry guns and only investigate criminal violations, though the unit is housed inside the agency’s civil regulatory arm, the Office of Regulatory Affairs. Historically, many agents were hired from the Secret Service.

FDA leaders say they are trying to better align OCI’s priorities with agency centers that set policy over areas including food, drugs and tobacco. They are setting investigative goals and revamping training and hiring – changes, they say, that may be causing growing pains.

“Before the realignment, the decision-making about what types of cases OCI would take was less centralized than it is now,” said Howard Sklamberg, deputy commissioner for the FDA’s Office of Global Regulatory Operations and Policy.

Current and former FDA agents say managers push cases that lack legal merit at the expense of others with more potential that were not pursued, including probes involving steroids, the street-level sale of counterfeit painkillers and the importation of drugs like Kratom, a plant used as an alternative to opioids.

Agents say they are instructed to focus primarily on cases involving the “legitimate supply chain.” In the United States, the majority of drugs move through one of three major wholesale distributors – McKesson, Cardinal Health and AmerisourceBergen Corp.. OCI headquarters wields complete control over which cases to pursue.

Most agents who spoke for this article did so anonymously. Reuters obtained letters written by several agents describing tensions and low morale.

“The vast majority of referrals I received from within OCI, especially from Headquarters, involved conduct that did not even rise to the level of a knowing crime,” former FDA special agent Ken Petroff wrote in a March letter to FDA Commissioner Robert Califf. “Some of the referrals involved no crime at all yet I was ordered to spend (waste) time on these cases.”

Petroff sent the letter, he said, to share concerns about waste and management within FDA. Four months later, Associate Commissioner for Regulatory Affairs Melinda Plaisier replied, “I appreciate the information you have provided.”

DEAD-END INVESTIGATIONS

One example of the fissure emerging within the FDA: a push by headquarters to investigate the use of imported unapproved drugs by doctors, such as Botox, an injectable cosmetic made by Allergan to reduce wrinkles.

The Botox cases are part of a larger effort to crack down on what are known as foreign unapproved medical products – so-called “FUMP” cases. A drug is deemed foreign unapproved if it is manufactured without FDA oversight or lacks labels approved by the agency. The designation doesn’t necessarily mean the drug is counterfeit or harmful.

Concerns about the agency’s handling of Botox cases emerged as early as 2013. In one field office, a psychologist sent to defuse internal tensions heard complaints of “micromanagement” of cases and of Botox inquiries wasting “valuable agent time” and antagonizing relations with U.S. attorneys, documents show.

The Botox initiative has produced few tangible results, but has rankled agents who say they are little more than “Botox Police” or the “ATF”— Allergan Task Force. Some complain the crackdown protects pharmaceutical companies’ drug prices more than consumers.

“In the European Union, price controls govern the amount they can charge,” attorney Kevin Marino said in a 2014 trial defending a client acquitted of illegally shipping Botox. “Here in the United States, apparently the last bastion of capitalism in the world, they can charge whatever they please.”

Investigations into doctors who purchase foreign unapproved cosmetic products are unlikely to prompt prosecutors to press charges, records and interviews show. There is little demonstrable harm to public health or the national purse since taxpayer-funded insurance programs do not accept claims for Botox unless it has been prescribed for an approved medical purpose.

And, the majority of the Botox seized by the OCI was later found to be legitimate products made by Allergan but labeled for use in other countries, according to some 140 FDA lab reports examined by Reuters.

Allergan calls the manufacture and sale of counterfeit Botox a “significant threat.” Unauthorized suppliers may not store it at the proper temperature, decreasing its effectiveness and triggering “adverse effects,” Allergan said.

The company “frequently” receives reports about unauthorized sellers and refers them to law enforcement when necessary, a spokesman said.

Letters drafted by agents and sent to U.S. Attorney’s Offices detail why the bulk of the FDA’s Botox prosecutorial referrals were declined.

The Nevada U.S. Attorney’s Office rejected a case against a doctor who twice purchased foreign-made Botox for his wife. Other prosecutors declined cases because the Botox was authentic, small amounts were purchased, and no insurance claims were submitted.

Still, agents are instructed by managers in the office’s headquarters in Rockville, Maryland, to interview every doctor suspected of purchasing foreign unapproved drugs and upload their findings into a non-public FUMP database used to mine for criminal targets. “There are no assurances that unapproved products from foreign sources are safe or effective,” the FDA said.

Another investigation that faltered: a nationwide undercover sting championed by Karavetsos in 2015 involving the purchase of a variety of dietary supplements marketed for weight loss, sexual performance and strength building sold at retail chains including GNC, The Vitamin Shoppe, and Vitamin World.

Though agents bought about $16,000 in supplements, the investigation produced no prosecutions because the supplements all came back with a clean bill of health from the FDA’s lab, documents obtained by Reuters show.

“Wasting investigative resources on cases that go nowhere raises concerns about the responsible use of tax dollars,” said Senate Judiciary Chairman Charles Grassley, R-Iowa.

Karavetsos described the probe as a proactive investigation.

MISDEMEANORS AND QUESTIONS

Unlike Europe, the U.S. does not impose price controls on pharmaceuticals. This makes costly drugs like Botox popular in America’s “gray market,” where distributors divert drugs with foreign labels into the United States and sell them to doctors at a discount.

“There is a reason why a doctor in the United States is incentivized to buy foreign-sourced Botox,” said Andrew Ittleman, a defense attorney with Fuerst Ittleman David & Joseph PL. “All of this relates to… the lack of price controls and Allergan trying to control its market.”

The FDA launched a mission to interview doctors who buy foreign-sourced clinical drugs, hoping to halt fraud in the supply chain. But the effort brought limited success.

The FDA’s push was sparked when a fake version of Roche’s cancer drug Avastin infiltrated the supply chain. Distributors offered to sell the drugs at cheaper prices to oncologists who operate sole practices and had no power to negotiate discounts.

A Roche spokeswoman said the company learned of the issues from a Swiss wholesaler in December 2011; the FDA contacted the company in January 2012 after learning counterfeit vials were shipped to the U.S.

From 2011 to 2015, FDA investigations into foreign unapproved oncology drugs led to criminal charges against suppliers and distributors as well as more than two dozen doctors, nurses, office managers and clinics who bought the drugs and billed them to federal insurance programs.

Yet most doctors, nurses and office managers were charged with less serious misdemeanor violations of the Federal Food, Drug and Cosmetic Act, which makes it a crime to introduce or receive a counterfeit, adulterated or misbranded drug into interstate commerce.

The FDA is the lead federal agency enforcing violations of the law, with FUMP cases among its investigative priorities.

After devoting more than 218,000 man hours on FUMP investigations from 2012-2015, many cases were declined for prosecution or closed. Of 878 investigations opened from 2009 through Aug. 1, 2016, 110 convictions resulted and 437 cases were closed without action, records show.

In an irony, many doctors criminally prosecuted had purchased real versions of the drugs that were misbranded, while some who actually bought fake Avastin were not charged.

The Roche spokeswoman did not directly respond to a question about the disparate prosecutorial treatment, but said the company supports the government’s efforts.

In two California cases, doctors who purchased counterfeit Avastin reached civil settlements. In Arizona, doctors whose patients suffered adverse reactions to counterfeit Avastin were not charged due to “the lack of interest” by prosecutors, records show.

Karavetsos defended the efforts, saying each U.S. attorney’s office has unique priorities and OCI is focusing on high-volume purchasers and repeat offenders.

“We don’t have the luxury to play Russian roulette with the consumers in the United States,” he said.

Charging doctors with misdemeanor violations has sparked debate.

Doctors are typically not trained to identify misbranded packaging, yet can be convicted of a misdemeanor if they unintentionally buy a misbranded drug. An FDA expert once testified he didn’t learn how to identify foreign unapproved labels until he joined the agency. West, in a 2013 email to field managers, admitted having a hard time detecting misbranded medical devices.

A drug can fall afoul of branding rules over small details. Those failing to display “RX only” or containing foreign writing on the outer package or insert could skirt rules.

Often, prosecutors cited a lack of criminal intent in turning down FDA cases.

“You don’t have to be a philosopher king to understand there is an elemental unfairness in holding someone criminally liable for conduct of which they had no knowledge or intent,” said Richard Callahan, U.S. Attorney for the Eastern District of Missouri.

Callahan said he strives to bring felony charges, but on rare occasion files misdemeanors in hopes of using the charges to build larger cases.

To be sure, some doctors ignore red flags.

One in Tennessee got a two-year prison term after he ignored nurses’ concerns that some of the drugs he bought had foreign languages on the labels; he had the drugs shipped to a storage building to avoid detection. Karavetsos said the FDA has nearly a dozen active cases into doctors who continued buying drugs after warnings.

But many doctors say they did not knowingly break the law.

A CASE IN TEXAS

One is Dr. Eduardo Miranda, an oncologist treating primarily impoverished patients in Laredo, Texas.

The drugs Miranda bought were made by the real manufacturers, but labeled for use in other countries. No patients were harmed.

Miranda said he ordered from a company called Quality Special Products because he was facing a shortage of an anti-nausea drug. QSP also offered a discount.

In 2009, an FDA agent confronted Miranda and accused him of ordering from QSP to make more money. Later, with TV cameras rolling, agents wearing bulletproof vests and carrying guns raided his office while patients awaited care.

Miranda stopped purchasing from QSP and created a new compliance program. In 2013, the U.S. Attorney for the Southern District of Texas prosecuted Miranda. He pleaded guilty to a misdemeanor of introducing a misbranded drug into interstate commerce.

“I think I was used by them to make a statement,” Miranda said. “They didn’t care that I was the only clinic providing care for indigent patients.”

Miranda is trying to appeal a 13-year ban from participating in federal health programs. In a nod to the role Miranda plays in his community, the Health and Human Services Inspector General carved out an exemption allowing him to continue billing the government as long as he remains in Laredo. Separately, the Texas medical board declined to fine him.

Miranda pays $17,000 in monthly restitution to Medicare, Medicaid and Blue Cross Blue Shield. Drug maker Sanofi petitioned for restitution on top of that, saying it lost $300,000-plus in profit because Miranda did not pay the U.S. market rate. The judge rejected that argument.

Sanofi takes “threats to patient safety” seriously and seeks restitution “as an additional deterrent,” a spokeswoman said.

Miranda’s attorney, Russell Soloway, said the case sends another message: “The laws and regulations are set up to safeguard the … big drug supply companies.”

Some legal experts believe the law should differentiate between clear criminal conduct, such as selling watered-down products, versus buying the same drugs cheaper.

“You would hope they would focus on people endangering the public health,” said Kevin Outterson, a professor of health law at Boston University.

SHIFTING FOCUS

After the discovery of bogus Avastin, OCI initially focused on tracking down doctors who purchased foreign unapproved cancer medications.

In 2013, the focus shifted. That year, Rockville managers dispatched investigators to interview 1,100 doctors suspected of buying foreign unapproved drugs from Medical Device King, a licensed wholesale distributor in Great Neck, New York, internal records show.

Former OCI agent Jim Dahl, then a security official for drug maker Eisai, conducted undercover purchases of the anti-nausea drug Aloxi from Medical Device King and shared his findings with the FDA, later testifying for the government.

Dahl, now a board member for the non-profit Partnership for Safe Medicines, said Eisai was motivated by patient safety. “If we find a crime, we refer it to the government,” he said.

As agents made their rounds, they encountered many doctors who had only purchased Botox or medical devices. Some got less than $1,000 worth of drugs.

Special Agent in Charge South instructed agents to conduct surprise visits to doctors’ offices, refer each for prosecution and seek asset forfeitures, an April 2013 email shows. Agents often entered offices without warrants.

Thomas Kubic, president of the non-profit Pharmaceutical Security Institute, sees value in agents visiting doctors. “You don’t know if it is genuine or counterfeit,” he said.

Only a handful of doctors have faced prosecution for buying foreign, unapproved Botox.

One, Anoushirvan Sarraf, was convicted at trial in 2014 on felony charges in connection with illegally importing and purchasing Botox from Gallant Pharma, an unlicensed Virginia supplier the FDA began investigating in 2009 after complaints from Allergan. Jonathan Simms, Sarraf’s attorney, said his client denied being part of a conspiracy.

In the same case, court testimony shows, the FDA asked Allergan to help it find a doctor who would go undercover, though the effort failed. Other drug makers hired their own private investigators to make undercover purchases and shared the results with the FDA. Drug companies “very frequently” send complaints to OCI, an FDA agent testified.

West unveiled plans to launch the FUMP database in an April 2013 email to field managers, saying it would help gather intelligence. “These cases are not ‘stupid’ as an agent recently stated,” wrote West, who is retiring this month.

In June 2013, an FDA employee lodged a complaint with the HHS Inspector General, saying the Botox cases drained resources. The complaint detailed the hours spent chasing doctors who bought small quantities, and said managers chided agents raising questions.

Nothing came of the complaint, the former employee said.

THE CASE IN TENNESSEE

In Tennessee, the Sens won a victory in convincing a judge to suppress evidence from West’s search. Dr. Sen and his wife faced multiple misdemeanor counts for buying foreign unapproved drugs. Office manager Posey Sen faced felony charges, including allegations she lied to West.

The jury acquitted Posey Sen of all felony charges. It convicted the Sens of misdemeanors involving introducing misbranded drugs into interstate commerce.

The convictions did not stand for long.

The Sens appealed, but before their case was heard, the Justice Department announced in December 2014 it would vacate the convictions. The DOJ declined to provide Reuters documents detailing its rationale.

Still, the DOJ has pursued civil charges against Dr. Sen, records show, and the government withheld about $1 million in reimbursements tied to the drugs. The Sens had to fight to convince HHS to let them participate in federal insurance programs.

Dr. Sen is again treating patients.

Posey Sen described the case as a “horrible ordeal.” At one point during her arraignment, she said, West swabbed her mouth for a DNA sample. “He personally did the DNA testing on me,” she said.

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FDA: People overdosing on anti-diarrhea drugs

Federal health officials are investigating sometimes-deadly overdoses with common anti-diarrhea drugs, a bizarre manifestation of the nation’s drug abuse problem.

The primary ingredient in prescription Imodium and similar over-the-counter drugs is intended to control diarrhea. But abusers sometimes try to achieve heroin-like highs by taking massive doses, up to 300 milligrams at once, according to cases in the medical literature. Recommended doses range between 8 milligrams and 16 milligrams per day.

The Food and Drug Administration warned doctors and patients Tuesday that the drugs can cause potentially deadly heart problems when taken at higher-than-recommended levels. The agency has received 31 reports of people hospitalized due to the heart problems, including 10 deaths over the last 39 years. The agency’s database is not comprehensive and many drug overdoses are not reported to the government.

But national poison centers reported a 71 percent increase in calls involving loperamide-containing drugs between 2011 and 2014, according to a journal article published last month in the Annals of Emergency Medicine.

The paper’s authors recommended restricting over-the-counter sales of the anti-diarrhea drugs, similar to other easily abused medications like pseudoephedrine, the decongestant that can be processed into methamphetamine.

FDA regulators said in an online posting that they are monitoring the issue and considering next steps.

Reports of abuse are rising amid an epidemic of addiction and abuse involving opioids, a family of drugs that includes narcotics like heroin and legal prescriptions like morphine and oxycodone. In some cases, opioid abusers will attempt to wean themselves off those drugs by substituting the anti-diarrhea drugs.

In 2014, more than 47,000 drug overdoses were recorded in the U.S., with opioids accounting for 61 percent of that total, according to the Centers for Disease Control and Prevention. Federal and state authorities have been trying to reduce opioid abuse for years, though overdose deaths have continued to rise.

 

 

Senate Republicans fail to stop GMO labeling

Senate Republican efforts to stop mandatory labeling of GMO foods have stalled with the demise of the Dark Act.

The Senate, on a 48-49 vote in mid-March, fell short of the necessary numbers to move ahead on legislation that would have barred states from requiring the labeling. Vermont is set to require such labels this summer, and other states are considering similar laws.

The procedural vote is a setback for the food industry, which has lobbied to block Vermont’s law.

The industry argues that genetically modified organisms, or GMOs, are safe and the labels could be costly for agriculture, food companies and consumers. Congressional Republicans have opposed a patchwork of state laws and worked to find a solution on the issue before Vermont’s law kicks in.

Genetically modified seeds are engineered in laboratories to have certain traits, such as resistance to herbicides. The majority of the country’s corn and soybean crop is now genetically modified, with much of that going to animal feed. Corn and soybeans also are made into popular processed food ingredients such as high-fructose corn syrup, corn starch and soybean oil. The food industry says about 75 percent to 80 percent of foods contain genetically modified ingredients.

The Food and Drug Administration says they are safe. But advocates for labeling say not enough is known about their risks. Among supporters of labeling are many organic companies that are barred by law from using modified ingredients in their foods.

Those advocates have been fighting state by state to enact the labeling, with the eventual goal of a national standard.

Compromise sought on GMO labeling

Republican senators were hoping to find compromise with Democrats who have supported mandatory labeling. The chairman of the Senate Agriculture, Nutrition and Forestry Committee, GOP Sen. Pat Roberts of Kansas, tweaked the bill that advanced from his committee this month to require the Agriculture Department to measure whether food companies were using voluntary labels. If not enough companies were doing so in three years, the department would require the labeling.

But that wasn’t enough for most Democrats.

Michigan Sen. Debbie Stabenow, the top Democrat on the committee, said she worked until late Tuesday night to try to find agreement with Roberts. She said she agrees that GMOs are safe, but “a growing number of American consumers want to know more about the food they eat. And they have the right to know.”

She said she believes that it is still possible to find compromise on the issue and she is still talking to Roberts about the legislation.

The House passed a bill blocking the state laws last year.

FDA to ease restrictions on blood donations by gay men

Federal health officials are lifting the nation’s 32-year-old lifetime ban on blood donations from gay and bisexual men, but major restrictions will continue to limit who can donate.

The Food and Drug Administration announced it will replace the blanket ban with a new policy barring donations from men who have had sex with a man in the previous year. While the one-year-ban has been criticized by activists it matches policies in other countries, including Australia, Japan and the U.K.

Gay rights activists said the new policy is a “step in the right direction,” but falls short.

“It continues to stigmatize gay and bisexual men,” said David Stacy, of the Human Rights Campaign, the largest U.S. gay rights group. “It simply cannot be justified in light of current scientific research and updated blood screening technology.”

Monday’s policy shift was first announced in late 2014 and followed years of outreach by medical groups and gay rights groups who said the blanket ban no longer made sense. FDA officials signaled their agreement on Dec. 21, saying in a statement the change is “backed by sound science and continues to protect our blood supply.”

The lifetime ban was put in place during the early years of the AIDS crisis and was intended to protect the blood supply from what was a then little-understood disease. But many medical groups, including the American Medical Association, argued that the policy was no longer supported by science, given advances in HIV testing.

All U.S. blood donations are screened for HIV, the virus that causes AIDS. But there is a roughly 10-day window between initial infection and when the virus can be detected in the bloodstream. The American Red Cross estimates the risk of getting an HIV-positive blood donation is 1 in 1.5 million for U.S. patients. About 15.7 million blood donations are collected in the U.S. each year.

In 2006 the Red Cross, the American Association of Blood Banks, and America’s Blood Centers called the ban “medically and scientifically unwarranted.”

The FDA concluded that moving to a one-year abstinence requirement would not change the safety of the U.S. blood supply, based on data from Australia and other sources.

On the current blood donor questionnaire, men are asked if they have ever had sex with another man since 1977 — the start of the AIDS epidemic in the U.S. Potential donors who answer positively are barred from donating blood. The new questionnaire, as outlined by the FDA, would ask men if they have had sex with another man in the last 12 months.

Blood sculpture draws attention to FDA ban on gay donors

An art installation opening in New York City draws attention to a federal ban on blood donations from gay and bisexual men.

“Blood Mirror” by Jordan Eagles uses blood donated by nine gay and bisexual men. It’s encased in resin. 

It’ll be shown at Trinity Church on Wall Street from through Dec. 1, which is World AIDS Day.

Eagles says he wanted to create the 7-foot-tall interactive sculpture to show the blood could have been used to save lives.

The Food and Drug Administration instituted a lifetime ban on blood donations from gay men in 1983 in response to the AIDS crisis. This year, it proposed an updated policy allowing donations from gay men if they remained celibate for a year.

“Blood Mirror” was previously on view at the American University Museum in Washington, D.C.

Dietary supplements send 23,000 to hospitals each year in US

Many claim to be natural, which may sound safe, but dietary supplements send 23,000 Americans to hospital emergency rooms each year, a new federal study estimates.

The riskiest ones are weight-loss and energy-boosting products, says the report, published in the New England Journal of Medicine.

Here are some details:

POPULAR PILLS

The market is flush with pills and powders. Supplement products have increased dramatically, from about 4,000 types in 1994 to more than 55,000 in 2012, the report says. Roughly half of all U.S. adults say they have used at least one in the past month, most commonly vitamins. Dietary supplements do not have to have federal Food and Drug Administration approval before they are sold, nor do they get the kind of testing prescription drugs do. The FDA can order a product off the market if it is found to be unsafe.

THE STUDY

Reliable information on serious side effects from supplements is hard to come by. Researchers at the U.S. Centers for Disease Control and Prevention and at the FDA studied emergency room records from 2004 through 2013 at 63 hospitals considered to be nationally representative. Based on 3,667 cases they found, they estimated there are about 23,000 ER visits each year for health problems related to supplements, and that about 2,154 lead to hospitalization.

BIGGEST TROUBLEMAKERS

Products for weight loss or increased energy accounted for the most ER visits. These products caused 72 percent of problems involving chest pain or irregular or too-fast heartbeats, and they were the culprits in more than half of visits among patients ages 5 to 34. Bodybuilding and sexual-enhancement products also led to cardiac symptoms in many seeking ER help.

THE SUPPLEMENT INDUSTRY’S VIEW

“They sound like big numbers but they really aren’t,” Steve Mister, president of the trade group Council for Responsible Nutrition, said of the ER visits. “The risks are so, so small” when you consider the millions of people who use the products, he said.

ADVICE

Ask your doctor before taking any supplements. Some can interfere with other medicines, and certain vitamins, especially in high doses, are known to be harmful, such as beta-carotene and vitamin A for smokers.

On the WebStudy: http://www.nejm.org/doi/full/10.1056/NEJMsa1504267

Popular foods taking on new hues without artificial dyes

Mozzarella cheese at Panera restaurants won’t be as glaringly white.

Banana peppers in Subway sandwiches won’t be the same exact shade of yellow.

Trix cereal will have two fewer colors.

Food makers are purging their products of artificial dyes as people increasingly eschew anything in their food they don’t feel is natural. But replicating the vivid colors Americans expect with ingredients like beets and carrots isn’t always easy.

In fact, General Mills couldn’t find good alternatives for the blue and green pieces in Trix, so the company is getting rid of those colors when the cereal is reformulated later this year. The red pieces — which will be colored with radishes and strawberries — will also look different.

“We haven’t been able to get that same vibrant color,” said Kate Gallager, General Mills’ cereal developer.

The shift away from artificial dyes represents the latest chapter for food coloring in the United States, which has had a rocky history. As recently as 1950, the Food and Drug Administration said children became sick after eating an orange Halloween candy that contained a dye. The agency eventually whittled down its list of approved color additives after finding several had caused “serious adverse effects.”

Now, more companies say they are replacing artificial dyes with colors made from fruits, vegetables and spices, which are widely considered “natural,” although the FDA doesn’t classify them that way.

But these present more challenges than artificial dyes.

In addition to costing more, colors from fruits and vegetables can be sensitive to heat and acidity. And since they’re used in higher doses to achieve boldness, tweaks to other parts of recipes may be needed. Such adjustments can be tricky for companies that manufacture on massive scales.

Still, companies want to court people like Heather Thalwitzer, a 31-year-old homemaker in Melbourne, Florida. Thalwitzer avoids artificial colors because she wants her 6-year-old son to eat quality food and she said red dye has been linked to “mania.”

She has tried alternatives like naturally colored sprinkles from Whole Foods, which her husband thinks taste like fish. But she can get along without such products. One year, she made cupcakes topped with a single blueberry for her son’s birthday.

There are times when Thalwitzer makes exceptions, such as when her son is at a friend’s party.

“I’ll let him have the birthday cake,” she said. “But I’ll cringe.”

THE EVOLUTION OF NATURAL

Part of the challenge with colors from natural sources is that the range of hues has been limited.

Blues, for instance, weren’t widely available the U.S. until 2013. That’s when the FDA approved a petition by candy maker Mars Inc. to use spirulina extract as coloring in gum and candy.

The alga can now also be used in ice creams, drink mixes and other products.

“That was a big thing for us,” said Stefan Hake, CEO of the U.S. division of natural color maker GNT.

At the company’s office in Tarrytown, N.Y., Hake demonstrated how to get blue from spirulina by pouring a liquefied version of it through a coffee filter to isolate the right color components.

The approval of spirulina extract also opened up the world of greens, which can be made by mixing blue and yellow. It turns out plants like spinach brown in heat and aren’t ideal for coloring.

Getting approval for a new color source can take years, but it’s one way companies can fill out their palette of natural hues. In coming weeks, an industry group plans to submit a petition to use the carthamus in safflower for yellow, according to color maker Sensient Technologies.

“It’s just one more that might be another crayon in the crayon box,” said Steve Morris, Sensient’s general manager of food colors for North America.

Sensient also developed a “deodorizing process” to remove flavors from ingredients. That allowed it to introduce an orange for beverages made from paprika.

Morris declined to detail the company’s process. But since the ingredient is not “fundamentally changing the form,” he said the ingredients are still within FDA guidelines of permissible color sources. 

Sensient said three-quarters of its new projects for clients in North America involve natural colors. Globally, its sales of colors — natural and synthetic — comes to about $300 million.

COLORING INSIDE THE LINES

There are seven synthetic colors approved for broad use in foods. But these dyes can be mixed to create a wide range of colors. The colors are made by synthesizing raw materials from petroleum, according to the FDA.

Synthetic colors still dominate in the United States, but some cite a study linking them to hyperactivity in children in calling for them to be phased out. Lisa Lefferts at the Center for Science in the Public Interest also says artificial colors can be used in deceptive ways.

“They mask the absence of ingredients,” she said.

Tropicana’s Twister in Cherry Berry Blast flavor, for instance, list apple and grape juice concentrates, but no cherries or berries. A synthetic color gives it the appearance of having the latter fruits.

Of course, colors also are used to make foods more appealing and send visual signals about the ingredients they contain. Subway says it will stop using a synthetic dye in its banana peppers, but will maintain their bright yellow look with turmeric.

Some say a switch to natural color sources isn’t yet possible because it might turn off customers, although they’re looking into how to change.

“We have to deliver bold colors and flavors, or people will stop buying,” said Will Papa, chief research and development officer at Hershey, which makes Jolly Ranchers, Twizzlers and Reese’s.

Mars, which makes M&M’s and Skittles, said it isn’t yet using the spirulina extract it petitioned to have approved.

Not everyone thinks getting rid of artificial colors hinges on finding exact matches with natural alternatives. Panera is betting people won’t mind that its mozzarella cheese might have a yellowish hue after the removal of titanium dioxide. For cookies with candy-coated chocolates, the natural colors Panera is testing are also duller.

Over time, people will get used to the more muted hues of foods with natural ingredients, said Tom Gumpel, Panera’s head baker.

“You have to remove some of your expectations,” he said.