Raw is risky, for pets and humans

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

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

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

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 http://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

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

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.

Hire me: Looks like youse could use some editors

US: FDA takes steps to build a stronger workforce

Scott Gottlieb

https://blogs.fda.gov/fdavoice/index.php/2017/11/fda-takes-steps-to-build-a-stronger-workforce/

I’m a Canadian, U.S. and Australian citizen (and maybe UK too), my scientific c.v. doesn’t suck, so I’ll work anywhere (and I’m cute with puppies, 15 years ago).

FDA faces challenges related to building and maintaining a diverse, talented, and dedicated professional workforce. The agency’s responsibilities increasingly demand a staff with specialized skills; and our own process sometimes doesn’t fully support our ability to recruit and retain the people we need. Congress has given FDA new resources and authorities to build and maintain our talented workforce. But the agency still needs to do more to expand on these opportunities and solidify our workforce.

A few months ago, I announced that FDA is taking action to build a stronger workforce by making key process improvements related to hiring and retention. Our people are the agency’s most important asset. We need to invest in our approach to how we hire and retain our staff.

To achieve this goal, we’ve established an FDA Hiring Initiative to reimagine the agency’s hiring practices and procedures with the goal of attracting, recruiting, hiring and retaining professionals who will support FDA’s mission. As part of that initiative, I requested a comprehensive evaluation of our hiring practices and procedures.

Today, FDA is releasing the Initial Assessment of FDA Hiring and Retentionreport. This comprehensive survey identifies the root causes of our current challenges and provides a roadmap for our future.

Building and retaining talented staff is critical to FDA’s ability to meet our public health mission. We’re launching a comprehensive effort to streamline our hiring practices with a focus on recruiting and retaining a world-class workforce. As a first step, FDA will hold a public meeting later this month to share the results of the report, our thinking for overhauling the hiring process, and to solicit public comment.

We’ll also be getting feedback from FDA staff since our people have the best perspective on the challenges they see recruiting the best and brightest people, and keeping them at FDA.

We also intend to conduct a hiring pilot early next year that will leverage the key findings from the initial assessment and that will modernize and streamline hiring practices by using new IT tools and eliminating unnecessary processes. The pilot will focus on the end to end hiring process beginning with the day the need for new staff is identified to the day a candidate is hired. It will directly align our administrative hiring procedures with the scientific objectives of our programsThe new, more efficient approach in the pilot will focus on hiring several critical occupations in the medical product areas to support commitments of the Prescription Drug User Fee Act (PDUFA) VI and the Biosimilar User Fee Act (BsUFA) II.

As part of the initiative, we’ve established a Scientific Staffing team that will focus on recruiting scientists and conducting proactive outreach to professional associations and academia. Our scientific recruitment team will develop digital and social media tools, which will provide FDA with modern recruitment and outreach techniques. These efforts, combined with the successes of the hiring pilot, will yield a future state of efficient, consistent, processes that helps us get the right people in the right roles to achieve results.

The soul of FDA and our public health mission is our people. Retaining the people who help us achieve our successes is as important as recruiting new colleagues to help us meet our future challenges. 

 

Eating too much black licorice is harmful, FDA warns

I’ve never liked licorice, especially the black stuff.

Reminds me of a grandparent’s decaying hard candy dish.

The U.S. Food and Drug Administration is, according to Ashley May of USA Today, warning consumers not eat large amounts of black licorice.

The candy, made from a shrub usually found in Greece, Turkey and Asia, contains a compound (glycyrrhizin) that can lower a person’s potassium levels, FDA experts say. So, eating too much could cause heart problems, high blood pressure, swelling and sluggishness, an FDA advisory reports.  

Last year, the FDA heard of at least one case of black licorice causing health problems, according to the advisory. 

Especially for those 40-years-old and older, eating two ounces of black licorice a day for at least two weeks could throw off heart rhythms. 

30 sick: Salmonella linked to tuna

Marissa Harshman of the Spokesman-Review writes Clark County Public Health officials in Washington state were among the first to identify a nationwide salmonella outbreak linked to tuna loins and tuna steaks.

Locally, the case began with five reports of illness to Clark County Public Health in late August. Since then, the outbreak has grown to 30 cases in seven states and led to a recall of a California-based company’s tuna products.

The outbreak includes six confirmed and two presumed cases in Clark County, said Dr. Alan Melnick, Clark County health officer.

The investigation is continuing at the national level by the Food and Drug Administration and the Centers for Disease Control and Prevention.

“The fact that little, old Clark County was able to be one of the first people to pick up on this ongoing outbreak really highlights the strengths of this system we’ve developed,” said Madison Riethman, an applied epidemiology fellow at Clark County Public Health, during a county health board meeting Wednesday.

And what did little old Clark County do to publicize the outbreak, go public to try and prevent others getting sick.

The first rule of public health is, as encapsulated by Riethman, make public health look good.

Local health officials first learned of a possible outbreak on Aug. 29, when local laboratories reported five cases of salmonella, a bacteria that causes illness with symptoms such as diarrhea, fever and abdominal cramps. Typically, the department gets three to eight reports each month, Riethman said.

“The fact that we got five in one day was a big red flag,” she said.

Fancy food ain’t safe food: New York edition

One of New York’s most expensive restaurants is in some trouble with the Food and Drug Administration over its fresh fish.

John Tozzi of Bloomberg writes that Masa, which earned three Michelin stars for its $595 tasting menu (before drinks and tax), received a warning letter from the FDA dated Oct. 16 alleging violations of federal rules that govern seafood imports. “Your fresh trevally and fresh Katsuwonus pelamis (Katsuo), also known as skipjack tuna or bonito,” the agency wrote in a letter published online this week, “have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.”

“We take FDA regulations very seriously and, of course, food safety is always a priority. We are working closely with our purveyors in Japan to get this resolved quickly,” said Tina Clabbers, a representative for Masa, in an email.

While the the FDA doesn’t typically regulate individual restaurants, the agency has jurisdiction over seafood importers. Inspectors visited Masa on June 22, according to the letter, which redacted the name of the restaurant’s fish supplier.

The letter doesn’t specify the precise nature of the violation, and a spokesperson in the FDA’s New York district office was not available for comment.