Tag Archives: Fda

Waiter, is that romaine from Yuma? At least 53 sick across 16 US states with outbreak strain of E. coli O157:H7 linked to lettuce

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David Meyer of Fortune magazine reports the U.S.’s mysterious E. coli outbreak now has a likely culprit: romaine lettuce grown around Yuma, Arizona. And consumers are being given conflicting advice on what to do to protect themselves.

The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) said Wednesday that any consumers in the U.S. who have store-bought chopped romaine lettuce should throw it away. If they want to buy romaine lettuce from now on, they should first check with the store or restaurant that it wasn’t grown in the Yuma region, the agencies said.

However, Consumer Reports has gone a step further, advising people to avoid all romaine lettuce for the time being. Why? Because people may find it difficult to establish for sure that their lettuce does not come from the growing region that’s suspected to be the source.

Niraj Chokshi of the New York Times reported that CDC said in a statement, “If you do not know if the lettuce is romaine, do not eat it and throw it away,” the C.D.C..

The agency was first alerted to the outbreak by health officials in New Jersey, who had noticed an increase in E. coli cases in the state, said Dr. Laura Gieraltowski, an epidemiologist at the C.D.C. After some discussion, it became clear that many of those infected had eaten chopped romaine lettuce at restaurants before getting sick.

Concerned, the agency looked for related cases by checking PulseNet, a national network of laboratories that catalog samples of harmful bacteria from infected patients.

“When we looked back into our PulseNet system we saw that there were other cases in other states with the same DNA fingerprint,” Dr. Gieraltowski said.

The C.D.C. learned that the others infected by that particular strain, E. coli O157:H7, had also eaten chopped romaine lettuce at restaurants before getting sick, she said. It turned over the information to the Food and Drug Administration, which helped trace the outbreak to Yuma, Ariz.

To pinpoint the exact source, though, investigators would need samples of the tainted lettuce. But because of the short shelf life of lettuce and the time it takes for an outbreak to be identified, obtaining such a sample may prove difficult.

However, a cluster of eight illnesses in an Alaska prison may help pinpoint the source.

Dr. Joe McLaughlin, with the Epidemiology Section at the state Department of Health and Social Services, said health officials had responded last week to an outbreak of E. coli O157:H7 bacteria at the Anvil Mountain Correctional Center in Nome, Alaska.

None of the eight patients have died or been hospitalized, in cases which were noticed between April 5 and April 15. All ate “significantly higher” numbers of salads than other people at Anvil Mountain, however, and have shown the same symptoms.

“Our outbreak is the first one I know of that’s been associated nationally with the consumption of whole heads of lettuce rather than chopped lettuce,” McLaughlin said. “What this outbreak suggests is that the source of contamination may actually be at the farm rather than the actual processing of the lettuce.”

Duh.

CDC reports in its latest outbreak update  that information collected to date indicates that chopped romaine lettuce from the Yuma, Arizona growing region could be contaminated with E. coli O157:H7 and could make people sick.

At this time, no common grower, supplier, distributor, or brand has been identified.

Consumers anywhere in the United States who have store-bought chopped romaine lettuce at home, including salads and salad mixes containing chopped romaine lettuce, should not eat it and should throw it away, even if some of it was eaten and no one has gotten sick. If you do not know if the lettuce is romaine, do not eat it and throw it away.

Before purchasing romaine lettuce at a grocery store or eating it at a restaurant, confirm with the store or restaurant that it is not chopped romaine lettuce from the Yuma, Arizona growing region. If you cannot confirm the source of the romaine lettuce, do not buy it or eat it.

Restaurants and retailers should ask their suppliers about the source of their chopped romaine lettuce.

22 sick: Over 200M eggs recalled by Rose Acre Farms

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Rose Acre Farms of Seymour, Indiana, the second largest egg producer in the United States, is voluntarily recalling 206,749,248 eggs because they have the potential to be contaminated with Salmonella Braenderup.

The eggs were distributed from the farm in Hyde County, North Carolina and reached consumers in: Colorado, Florida, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia through retail stores and restaurants via direct delivery.

22 illnesses have been reported to date. 

The affected eggs, from plant number P-1065 with the Julian date range of 011 through date of 102 printed on either the side portion or the principal side of the carton or package.

The voluntary recall was a result of some illnesses reported on the U.S. East Coast, which led to extensive interviews and eventually a thorough FDA inspection of the Hyde County farm, which produces 2.3 million eggs a day. The facility includes 3 million laying hens with a USDA inspector on-site daily. 

Their own PR says 22 sick people, and then, “some illnesses.” Outpouring of corporate empathy there. And the USDA inspector on site means …?

17 sick in 7 states with E. coli O157:H7: Source not yet identified

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CDC, several states, the U.S. Food and Drug Administration, and the U.S. Department of Agriculture’s Food Safety and Inspection Service are investigating a multistate outbreak of Shiga toxin-producing E. coli O157:H7 infections. The investigation is still ongoing and a specific food item, grocery store, or restaurant chain has not been identified as the source of infections. CDC is not recommending that consumers avoid any particular food at this time. Restaurants and retailers are not advised to avoid serving or selling any particular food. CDC will provide more information as it becomes available.

As of April 9, 2018, 17 people infected with the outbreak strain of E. coli O157:H7 have been reported from 7 states. A list of the states and the number of cases in each can be found on the Case Count Map page. Illnesses started on dates ranging from March 22, 2018 to March 31, 2018. Ill people range in age from 12 to 84 years, with a median age of 41. Among ill people, 65% are female. Six ill people have been hospitalized, including one person who developed hemolytic uremic syndrome, a type of kidney failure. No deaths have been reported.

Raw is risky: Fresh herbs can be contaminated

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I’m not a fan of the guac, ever since a hungover former partner spewed vile smelling green stuff at the side of the road decades ago.

And I’m wary of fresh herbs, based on previous outbreaks.

So is the U.S. Food and Drug Administration which on Feb. 23, 2018, revealed details on just how many bacteria are hiding in fresh, store-bought herbs. The agency plans to continue testing herbs through 2019 to thoroughly assess their “rates of bacterial contamination.”

The plan is to test 1,600 samples of items “typically eaten without having undergone a ‘kill step,’ such as cooking, to reduce or eliminate bacteria.” These items include fresh cilantro, parsley, and basil.

This first round of results revealed that of the 139 fresh herb samples tested, four tested positive for salmonella and three contained E. coli bacteria.

The Packer noted the testing found  no pathogens in the U.S. herbs versus imported herbs.

In the same period, the FDA found that three of the 58 U.S.-processed avocado products that were tested had listeria, and one of the 49 imported samples had listeria.

From 1996 to 2015, the FDA linked 2,699 illnesses and 84 hospitalizations to fresh herbs.

The FDA also plans to sample processed avocado for similar reasons – from 2005 to 2015, 525 illnesses were linked to avocados in 12 separate outbreaks. Of 107 avocado and guacamole samples in the initial results, four contained listeria. Avocados, the FDA notes, “have a high moisture content and a non-acidic pH level, conditions that can support the growth of harmful bacteria.”

Raw is risky, for pets and humans

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I have never fed any of my dogs or cats raw pet food.

They may eat each other’s poop, but I control what I can control.

The U.S. Food and Drug Administration is alerting pet owners to a history of four recalls of and multiple complaints associated with Darwin’s Natural and ZooLogics pet foods, manufactured by Arrow Reliance Inc., dba Darwin’s Natural Pet Products, over the period from October 17, 2016 to February 10, 2018. In each instance, the company recalled these products after being alerted to positive findings of Salmonella and/or Listeria monocytogenes in samples of their raw pet food products.

In its most recent recall, on February 10, 2018, Arrow Reliance/Darwin’s Natural recalled ZooLogics Duck with Vegetable Meals for Dogs (Lot #41957) and ZooLogics Chicken with Vegetable Meals for Dogs (Lot #41567) because the products may be contaminated with Salmonella and therefore have the potential to cause salmonellosis in humans and animals. The company states that it only sells its products online through direct-to-consumer sales.

The FDA has investigated six complaints of illness and death in animals that have eaten the recalled products.

Arrow Reliance/Darwin’s Natural has notified its customers directly of the recalls, but has so far not issued any public notification announcing this or any of the previous recalls.

This issue is of particular public health importance because Salmonella can make both people and animals sick.

As part of an ongoing investigation into complaints associated with products manufactured by Arrow Reliance/Darwin’s Natural of Tukwila, WA, the FDA has confirmed that new samples of Darwin’s Natural Pet Products raw pet foods have tested positive for Salmonella. These raw pet foods include ZooLogics Duck with Vegetable Meals for Dogs Lot #41957 and ZooLogics Chicken with Vegetable Meals for Dogs Lot #41567.

The latest recall was triggered by a complaint of an adult dog that had recurring diarrhea over a nine-month period. The dog tested positive for Salmonella from initial testing by the veterinarian and by follow-up testing by the FDA’s Veterinary Laboratory Investigation and Response Network (Vet-LIRN). The Darwin’s Natural raw pet food that the dog had been fed was also positive for Salmonella.

Arrow Reliance/Darwin’s Natural is aware of the dog’s illness and the positive results and initiated a recall on February 10, 2018 by directly notifying its customers via email. The firm has not issued a public recall notice.

Since October 2016, Arrow Reliance/Darwin’s Natural has initiated four recalls and had six reported complaints (some referring to more than one animal) associated with their raw pet food products, including the death of one kitten from a severe systemic Salmonella infection. The Salmonella isolated from the kitten was analyzed using whole genome sequencing and found to be indistinguishable from the Salmonella isolated from a closed package from the same lot of Darwin’s Natural cat food that the kitten ate.

In addition to reports of illnesses associated with Salmonella contamination in the products, the FDA is aware of complaints of at least three animals who were reportedly injured by bone shards in the Darwin’s Natural raw pet food products.

Lettuce grazers rejoice: Consumer Reports says it’s ok to eat romaine lettuce again

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Actually, it was the U.S.  Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) who jointly declared an end to the E coli O157 outbreak after nearly two months of investigation. At least 66 people across the U.S and Canada became ill, 22 were hospitalized, and 2 died during November and December, all linked to consumption of romaine lettuce.

Consumer Reports went along for the ride.

What’s been missing is any response from the leafy greens marketing agency types.

Silence – the LGMA cone of silence — is golden, I guess.

CDC announced on January 25, 2018, that this outbreak appears to be over, because the last case became ill on December 12, 2017. This indicates that the food causing illness is no longer available in the marketplace or consumers’ homes.

Although this outbreak appears to be over, the FDA’s outbreak investigation team is continuing to work with federal, state and local partners to determine what leafy greens made people ill, what people ate, where they bought it, and identify the distribution chain — all with the goal of identifying any common food or points where the food might have become contaminated. To date, no common link has been identified.

Because whole genome sequencing showed that the E. coli O157:H7 strain that resulted in the U.S. illnesses was closely related genetically to the strain that caused illnesses in Canada, the FDA and CDC have been in contact with Canadian food safety authorities throughout this outbreak.

 

Going public: US FDA version

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The purpose of this guidance is to assist and provide recommendations to industry and FDA staff regarding the use, content, and circumstances for issuance of public warnings and public notifications for firm-initiated or FDA-requested recalls under 21 CFR Part 7, Subpart C – Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities.

The guidance also discusses what information should be included in a public warning, as well as the parties responsible for issuing it.

It represents FDA’s current thinking on public warning and notification of recalls under 21 CFR Part 7. 1 This guidance has been prepared by the Office of Strategic Planning and Operational Policy (OSPOP), in the Office of Regulatory Affairs (ORA), in cooperation with the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Veterinary Medicine (CVM), the Center for Tobacco Products (CTP), and the Center for Food Safety and Applied Nutrition (CFSAN) at the U.S. Food and Drug Administration.

This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.

This guidance applies to voluntary recalls of products subject to FDA’s jurisdiction, including any food, drug, and device intended for human or animal use, any cosmetic and biologic intended for human use, any tobacco product intended for human use, and any item subject to a quarantine regulation under part 21 Part 1240. However, it does not apply to radiation emitting electronics which are governed by 21 CFR Part 1003 and 1004.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

Public warning and notification recalls under 21 CFR part 7, subpart C guidance for industry and FDA staff, 17 January 2018

FDA

https://www.fda.gov/downloads/Safety/Recalls/IndustryGuidance/UCM592851.pdf

Going public: Early disclosure of food risks for the benefit of public health

Mar.17

NEHA, Volume 79.7, Pages 8-14

Benjamin Chapman, Maria Sol Erdozaim, Douglas Powell

http://www.neha.org/node/58904

Often during an outbreak of foodborne illness, there are health officials who have data indicating that there is a risk prior to notifying the public. During the lag period between the first public health signal and some release of public information, there are decision makers who are weighing evidence with the impacts of going public. Multiple agencies and analysts have lamented that there is not a common playbook or decision tree for how public health agencies determine what information to release and when. Regularly, health authorities suggest that how and when public information is released is evaluated on a case-by-case basis without sharing the steps and criteria used to make decisions. Information provision on its own is not enough. Risk communication, to be effective and grounded in behavior theory, should provide control measure options for risk management decisions. There is no indication in the literature that consumers benefit from paternalistic protection decisions to guard against information overload. A review of the risk communication literature related to outbreaks, as well as case studies of actual incidents, are explored and a blueprint for health authorities to follow is provided.

 

58 sick, 2 dead, possible link to romaine lettuce

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Over the past seven weeks, 58 people in the U.S. and Canada have become ill and two have died from E. coli O157H7, linked by Canadians to romaine lettuce, probably grown in California, given the timing of illnesses.

On Dec. 11, 2017, the Public Health Agency of Canada did its public duty and notified Canadians that at least 21 people were sick with E. coli O157:H7 and the probable source was romaine lettuce.

A couple of retailers in Canada pulled all romaine lettuce from the shelves, but the others shrugged and said, not enough is known.

By Dec. 28, 2017, the Canadian numbers had jumped to 41 sick and one dead, and the U.S. Centers for Disease Control chimed in to say there were 17 sick in the U.S. with a similar strain but they wouldn’t say it was linked to romaine lettuce, with the Trumpesque language of “CDC is unable to recommend whether U.S. residents should avoid a particular food.”

Outbreaks are hard, but where’s the tipping point between protecting public health and protecting a commodity and all the growers, retailers, involved?

Everyone went off and enjoyed New Year’s, and then people woke up again on Jan. 2, 2018 (happy new year), to be told by the Toronto Star (that’s in Canada) that of the 17 U.S. cases, five people have been hospitalized, one of whom has died. Two have developed hemolytic uremic syndrome.

That’s 58 sick and two dead.

On Jan. 3, 2018, Trisha Calvo of Consumer Reports wrote the group’s food safety types advise “consumers stop eating romaine lettuce until the cause of the outbreak is identified and the offending product is removed from store shelves.”

“Even though we can’t say with 100 percent certainty that romaine lettuce is the cause of the E. coli outbreak in the U.S., a greater degree of caution is appropriate given that lettuce is almost always consumed raw,” says James Rogers, Ph.D., director of food safety and research at Consumer Reports.

“There is not enough epidemiologic evidence at this time to indicate a specific source of the illnesses in the United States,” says Brittany Behm, MPH, a CDC spokesperson. “Although some sick people reported eating romaine lettuce, preliminary data available at this time shows they were not more likely than healthy people to have eaten romaine, based on a CDC food consumption survey.” Health officials, Behm says, take action when there is clear and convincing information linking illness to a contaminated food.

“The FDA should follow the lead of the Canadian government and immediately warn the public about this risk,“ said Jean Halloran, Director of Food Policy Initiatives at Consumers Union, the policy and mobilization division of Consumer Reports.

“The available data strongly suggest that romaine lettuce is the source of the U.S. outbreak,” she says. “If so, and people aren’t warned, more may get sick.”

That got attention, and many media outlets chimed in.

barfblog.com’s Ben Chapman told Rachael Rettner of Live Science that, “[To] say ‘avoid romaine for now,’ I don’t know if I have enough information to agree with that statement,”  Benjamin Chapman, an associate professor and food safety specialist at North Carolina State University.

“Avoiding just romaine may or may not be enough,” because other lettuces or foods could also be affected, Chapman told Live Science. “It could be that there’s a different [food] source of this exact same pathogen,” he said.

Another possibility is that the E. coli strain causing illness in the United States is actually slightly different from the strain in Canada. “We could be looking at two different outbreaks at the same time,” Chapman said.

About four times a day I’ll get a tweet from the Leafy Green Marketing Agreement – the folks who set themselves up after the spinach outbreak of E. coli O157:H7 in 2006 that killed four and sickened 200 – blowing themselves about how great they are, and how their products are so safe.

If you want that kind of PR, then you have to take the hits as well.

LGMA never talks about an outbreak linked to leafy greens (publicly).

To me, they’ve succeeded best at lowering the leafy greens cone of silence and intimidating public health types into delaying reports of outbreaks.

But late on Jan. 4, 2018, LGMA finally made a public statement, below, with my comments.

A group of produce industry associations today issued the following statement to update consumers on a recent e.coli outbreak being investigated in Canada in the U.S.:

It’s E coli. You folks should be well-versed in that.

The U.S. Centers for Disease Control and Prevention has not identified what food likely caused this foodborne illness.  No public agency has contacted any Romaine lettuce grower, shipper or processor and requested that they either stop shipping or recall product already in the marketplace.

Defensive.

Even if this outbreak is actually confirmed to be caused by Romaine lettuce, it’s important to recognize this is a highly perishable product with a limited usable shelf life and it’s highly unlikely a specific affected lot would still be available for sale or in a home refrigerator with the last U.S. illness being reported on December 8th.

Carry on, it’s all gone.

Food safety remains a top priority of leafy greens farmers, shippers and processors and the industry has robust food safety programs in place that incorporate stringent government regulatory oversight.

The Pinto defense. Audits and inspections are never enough, and saying we have government oversight does nothing to build trust with the consuming public, as research shows.

Our leading produce industry associations have and will continue to cooperate fully with public health officials investigating this foodborne illness outbreak.

Play nice in the sandbox.

Anytime we see an outbreak of any foodborne illness, our hearts go out to the victims.

This is what you should have led with. Now it reads like a tack-on.

If the leafy green marketing folks want to be truly transparent, they will make actual inspection data public for mere mortals to review, they will market microbial food safety at retail, and stop stonewalling every time there is an outbreak linked to leafy greens.

I have lots of respect for individual farmers who make a go of it and produce the bounty of produce we enjoy.

I have no respect for self-serving associations with bad soundbites.

A table of leafy green related outbreaks is available at https://www.barfblog.com/wp-content/uploads/2018/01/lettuce-leafy-greens-outbreaks-table-_1-5-18.xlsx

Going public: FDA leaves tainted foods on shelves too long, report finds

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The U.S. Food and Drug Administration is not moving quickly enough to ensure that contaminated food is removed from store shelves, despite being given the necessary authority, federal investigators have concluded.

The inspector general of the Department of Health and Human Services examined 30 of 1,557 food recalls between 2012 and 2015. The investigators found that the F.D.A. did not always evaluate foodborne hazards in a timely manner or ensure that companies initiated recalls promptly, leaving consumers at risk.

Food companies took an average of 57 days to recall items after the F.D.A. was apprised of the potential hazards. One recall did not begin for 303 days, the investigators said.

“Each and every day is important, because every day the product remains on the shelf, consumers are potentially at risk for serious illness or death,’’ said George Nedder, an assistant regional inspector general at Health and Human Services and lead author of the new report.

The F.D.A. has jurisdiction over most of the food supply in the United States, including virtually all processed food. (The Department of Agriculture oversees meat and poultry, and handles recalls of those products.)

About 48 million Americans get sick from food-borne diseases each year, according to the agency. Of those, 128,000 are hospitalized and 3,000 die.

Food recalls are announced frequently, but the vast majority are voluntary. Sometimes a company comes forward to report contamination, adulteration or mislabeling to the F.D.A. Sometimes the agency approaches a manufacturer after learning of a hazard from a state agency or other source.

In the past few months, the F.D.A. has announced recalls of contaminated apple slices (with listeria), biscotti (undeclared nuts) and adobo sauce (salmonella), among other problems.

The report noted numerous failings, among them “deficiencies in F.D.A.’s oversight of recall initiation, monitoring of recalls,” and in collecting and tracking recall data. Investigators also found that the F.D.A. did always not evaluate health hazards in a timely manner.

Many of the problems detailed in the report were the subject of an unusual “early alert memorandum” from the inspector general’s office in June 2016, which warned that “consumers remained at risk of illness or death for several weeks after F.D.A. was aware of a potentially hazardous food in the supply chain.’’

The new report noted that it took the agency 165 days to start a recall of nut butters that may have been tainted with salmonella; 151 days to recall hazelnuts that also suspected of salmonella contamination; 82 days to recall frozen spinach suspected of high levels of cadmium; and 27 days to start a recall of cooked duck eggs carrying the bacteria that cause botulism.

F.D.A. Commissioner Scott Gottlieb said that the agency had taken to heart the inspector general’s earlier warning and had already started to address recall enforcement problems that have persisted for years.

Dr. Gottlieb said that most food recalls occur within four days of a problem being reported, an assertion that Mr. Nedder disputed.

“Delay is deeply concerning to me as well,” Gottlieb, a physician, said in an interview. “I think it’s working a lot better now.”

FDA will also release guidance in the first half of 2018 on what information it can release about where recalled food and diet supplements were sold. A coalition of safety advocates urged Gottlieb in August to release the names of the stores that sell recalled food items, which FDA has claimed is confidential business information. The Agriculture Department releases it, as do other agencies including the Consumer Product Safety Commission.

FDA Commissioner Scott Gottlieb, MD said in a statement (edited below) that, “One of our most important jobs at the U.S. Food and Drug Administration is ensuring the safety of the U.S. food supply. When we learn about a food in the marketplace that may be unsafe, we must act quickly to keep people from getting sick or being harmed. If foodborne illness has already occurred, we also must act quickly to keep more people from becoming ill. The re-issued, final version of the report by the Office of the Inspector General (OIG), which examined our food recall practices over the time period from Oct. 1, 2012 to May 4, 2015, raised some significant concerns for me. While the FDA has addressed many of the findings after the draft version was first released in 2016, we still have more work to do. I take these obligations very seriously. Making sure the FDA has effective recall practices in place, and that we take immediate action to address unsafe foods, are high priorities of mine. Our recall authorities – and how we deploy them – are a cornerstone of our vital, consumer protection mission. …

“Among other steps, the agency will issue guidance on recall communications in the first half of 2018. As one example of the new steps we’re considering, the FDA is examining in what situations it can help consumers get information about the stores and food service locations that may have sold or distributed a potentially unsafe, recalled food, and what company may have supplied the product. If we’re able to disclose this information, consumers would have an easier time knowing if they might have, or have been, exposed to a recalled product that could cause potential risks if it were consumed.”

Here’s some suggestions:

Going public: Early disclosure of food risks for the benefit of public health

Mar.17

NEHA, Volume 79.7, Pages 8-14

Benjamin Chapman, Maria Sol Erdozaim, Douglas Powell

http://www.neha.org/node/58904

Often during an outbreak of foodborne illness, there are health officials who have data indicating that there is a risk prior to notifying the public. During the lag period between the first public health signal and some release of public information, there are decision makers who are weighing evidence with the impacts of going public. Multiple agencies and analysts have lamented that there is not a common playbook or decision tree for how public health agencies determine what information to release and when. Regularly, health authorities suggest that how and when public information is released is evaluated on a case-by-case basis without sharing the steps and criteria used to make decisions. Information provision on its own is not enough. Risk communication, to be effective and grounded in behavior theory, should provide control measure options for risk management decisions. There is no indication in the literature that consumers benefit from paternalistic protection decisions to guard against information overload. A review of the risk communication literature related to outbreaks, as well as case studies of actual incidents, are explored and a blueprint for health authorities to follow is provided.

36 dead: FDA says beware the herb kratom

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The U.S. Food and Drug Administration has issued a strong warning to consumers to stay away from the herbal supplement kratom, saying regulators are aware of 36 deaths linked to products containing the substance.

Laurie McGinley of The Washington Post writes consumers are increasingly using the supplement, which comes from a plant in Southeast Asia, for pain, anxiety and depression, as well as symptoms of opioid withdrawal. The herb also is used recreationally because it produces symptoms such as euphoria.  Proponents say it is a safe way to deal with chronic pain and other ailments, and some researchers are exploring its therapeutic potential, including helping people overcome addictions.

But in a statement, FDA Commissioner Scott Gottlieb said that there is no “reliable evidence” to support the use of kratom as a treatment for opioid-use disorder, and that there are no other FDA-approved uses for kratom.

Rather, he said, evidence shows that the herb has similar effects to narcotics like opioids, “and carries similar risks of abuse, addiction and, in some cases, death.” He said that calls to U.S. poison control centers involving kratom increased tenfold between 2010 and 2015, and that the herb is associated with side effects including seizures, liver damage and withdrawal symptoms.