Sprouts still suck: FDA sampling shows sprouts a problem

There’s a reason Walmart and Costco and Kroger stopped selling raw sprouts: they suck, meaning that, like raw milk, they cause a disproportionate percentage of illness based on low consumption rates.

The U.S. Food and Drug Administration wrote in a recent report sprouts are especially vulnerable to pathogens given the warm, moist and nutrient-rich conditions needed to grow them. From 1996 to July 2016, there were 46 reported outbreaks of foodborne illness in the U.S. linked to sprouts. The U.S. outbreaks accounted for 2,474 illnesses, 187 hospitalizations, and three deaths (and, tragically, many more in Canada, Australia, Japan and Europe).

A table of sprout-related outbreaks is available at http://barfblog.com/wp-content/uploads/2016/02/Sprout-associated-outbreaks-2-23-16.xlsx.

From the executive summary:

The U.S. Food and Drug Administration (FDA) set out to collect and test sprouts in 2014 as part of a new proactive and preventive approach to deploying its sampling resources with the ultimate goal of keeping contaminated food from reaching consumers.

The new approach, detailed in the Background section of this report (page 4), centers on the testing of a statistically determined number of samples of targeted foods over a relatively short period of time, 12 to18 months, to ensure a statistically valid amount of data is available for decision making. This approach helps the agency determine if there are common factors – such as origin, season, or variety – associated with pathogen findings.

The FDA issued the sprouts assignment in January 2014 under its new sampling model. The assignment targeted sprouts at three points in the production process (seeds, finished product and spent irrigation water), with the aim of collecting and testing 1,600 samples to determine the prevalence of select pathogens in the commodity. As background, the FDA designed its sampling plan such that if contamination of one percent or greater was present in the commodity, the agency would detect it. The FDA monitored the assignment closely to gather lessons learned and make changes to its sampling procedures if needed to address trends or food safety issues. About one year into the assignment, the FDA decided to stop its collection and testing at 825 samples because it had already collected samples on more than one occasion from many of the sprouting operations known to the agency and its state partners. The sample set acquired was sufficient for the FDA to estimate the bacterial prevalences in the commodity with a 95 percent confidence interval of 0% to 2% for a one percent contamination rate.

The FDA tested only domestically grown sprouts for this assignment because virtually all sprouts eaten in the United States are grown domestically due to the commodity’s delicate nature and relatively short shelf-life. Of note, the industry features a preponderance of relatively small operations.

The FDA tested the sprout samples for three pathogens: Salmonella, Listeria monocytogenes and Escherichia coli (E. coli) O157:H7. Based on the test results, the FDA found the prevalence of Salmonella in the finished product sprouts to be 0.21 percent. The agency also found that the prevalence of Salmonella in seeds (2.35%) was significantly higher than in finished product (0.21%) and in spent irrigation water (0.54%). Based on the test results, the FDA found the prevalence of Listeria monocytogenes in the finished product to be 1.28 percent. There was no significant difference in the prevalence of Listeria monocytogenes based on point in the production process. None of the samples tested positive for E. coli O157:H7. The agency did not test seed for E. coli O157:H7 due to limitations associated with the test method.

Among the FDA’s other findings, the agency found most of the positive samples at a small number of sprouting operations. Specifically, the FDA found violative samples at eight (8.5%) of the 94 sprouting operations visited for purposes of this assignment. The fact that the agency found multiple positive samples at some of these operations underscores the need for sprouting operations to comply with the agency’s Produce Safety Regulation (published November 2015), which seeks to prevent outbreaks of foodborne illness and improve sprout safety.

To address the positive samples, the FDA worked with the firms that owned or released the affected product to conduct voluntary recalls or to have their consignees destroy it, and then followed up with inspections. Of particular note, this sampling assignment helped detect and stop an outbreak of listeriosis while it still entailed a small number of cases, as described in the Public Health Impact section of this report (page 14). This assignment also prompted six product recalls.

The FDA will continue to consider microbial contamination of sprouts and how best to reduce it. Such contamination remains a concern to the FDA given the aforementioned outbreak and the recalls initiated. Going forward, the FDA intends to inspect sprouting operations to ensure they are complying, as applicable, with the Produce Safety Rule, which includes new requirements for sprouts growers. The agency has no plans to conduct additional large-scale sampling of sprouts at this time but may sample the commodity in accordance with its longstanding approach to food sampling, which centers on (but is not limited to) the following criteria:

  • A firm has a previous history of unmitigated microbial contamination in the environment (e.g., human illness, recalled or seized product, previous inspectional history, or environmental pathogens without proper corrective actions by the facility), or
  • Inspectional observations that warrant collection of samples for microbiological analyses.

The complete report is available at https://www.fda.gov/downloads/Food/ComplianceEnforcement/Sampling/UCM566981.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Impossible Burger, regulatory gaps, and money. Always money

I want hamburgers temperature-verified to 160F.

Blood is a terrible indicator.

Stephanie Strom of the NY Times writes that one of the chief selling points of the Impossible Burger, a much ballyhooed plant-based burger patty, is its resemblance to meat, right down to the taste and beeflike “blood.”

Those qualities, from an ingredient produced by a genetically engineered yeast, have made the burger a darling among high-end restaurants like Momofuku Nishi in New York and Jardinière in San Francisco, and have attracted more than $250 million in investment for the company behind it, Impossible Foods.

Bill Gates is an investor.

That makes me want to run to my Mac.

The genetically engineered yeast thingy is just thrown in there to raise alarm.

My 1985 daily squash partner, Andy, was working on genetically engineered yeast for wine back in the day. Our bottling parties were legend.

Now, its secret sauce — soy leghemoglobin, a substance found in nature in the roots of soybean plants that the company makes in its laboratory — has raised regulatory questions.

Impossible Foods wants the Food and Drug Administration to confirm that the ingredient is safe to eat. But the agency has expressed concern that it has never been consumed by humans and may be an allergen, according to documents obtained under a Freedom of Information request by the ETC Group as well as other environmental and consumer organizations and shared with The New York Times.

“F.D.A. believes the arguments presented, individually and collectively, do not establish the safety of soy leghemoglobin for consumption,” agency officials wrote in a memo they prepared for a phone conversation with the company on Aug. 3, 2015, “nor do they point to a general recognition of safety.”

Impossible Foods can still sell its burger despite the F.D.A. findings, which did not conclude soy leghemoglobin was unsafe. The company plans to resubmit its petition to the agency.

Impossible Foods is finding out what happens when a fast-moving venture capital business runs headlong into the staid world of government regulation.

In the case of Impossible Foods, the debate centers on its use of soy leghemoglobin, which the company’s engineered yeast produces and forms an important ingredient behind the business.

The company was started in 2011 by Pat Brown, a chemist at Stanford University. His approach, involving genetics, microbiology and cutting-edge chemistry attracted venture capitalists also eager to find plant-and lab-based replacements for hamburgers and chicken wings.

Impossible Foods sought to woo top chefs with a splashy sales pitch about how the burger mimicked the aroma, attributes and taste of real beef. When soy leghemoglobin breaks down, it releases a protein known as heme, giving it that meatlike texture.

Within three years of its founding, Impossible Foods landed big-name investors like Khosla, Mr. Gates and the Hong Kong billionaire Li Ka-Shing. This month, Temasek Holdings, Singapore’s sovereign wealth fund, joined an investment round that added $75 million to the company’s coffers.

“I love V.C.s and particularly the ones that invested in us,” Mr. Brown said at a TechCrunch conference in May, referring to venture capital firms. “But it’s truly astonishing how little diligence they do in terms of the actual science that underlies some tech companies.”

The F.D.A.’s approval is not required for new ingredients. Companies can hire consultants to run tests, and they have no obligation to inform the agency of their findings, a process known as self-affirmation.

Impossible Foods adhered to that procedure, concluding in 2014 that soy leghemoglobin was safe. But it went further, seeking the regulator’s imprimatur.

“We respect the role the F.D.A. plays in ensuring the safety of our food supply, and we believe the public wants and deserves transparency and access to any information they need to decide for themselves whether any food they might eat is safe and wholesome,” Rachel Konrad, a spokeswoman for Impossible Foods, wrote in an email.

The F.D.A., however, wanted the company to show the ingredient was safe specifically for humans. It told Impossible Foods to establish the safety of the more than 40 other proteins that make up part of its soy leghemoglobin. F.D.A. officials said the company’s assessment of the potential for the ingredient to be an allergen was deficient.

“This product has been touted as the ‘secret sauce’ in the Impossible Burger,” said Jim Thomas, program director at the ETC Group, the Canadian environmental organization that started the Freedom of Information request. “Now we know that the F.D.A. had questions about it, but it was put on the market anyway.”

Ms. Konrad defended the burger, writing it “is entirely safe to eat” and “fully compliant with all F.D.A. regulations.” She said the company was “taking extra steps to provide additional data to the F.D.A. beyond what’s required.”

Impossible Foods, she said, has tested its ingredient on rats fed “well above” the amount of soy leghemoglobin in its burger. Ms. Konrad said the company’s expert panel had determined those tests also demonstrated the ingredient was safe, and that the company would thus resubmit its petition for F.D.A. confirmation this month.

This is a novel food, and makes Canada’s approach to regulation of food safety sane, for a while.

1 dead, 46 sick: Multistate outbreak of Salmonella Kiambu linked to Maradol papayas

Mangos, I love; papayas, not so much.

The U.S. Centers for Disease Control and Prevention (CDC), public health and regulatory officials in several states, and the U.S. Food and Drug Administration (FDA) are investigating a multistate outbreak of Salmonella Kiambu infections.

A total of 47 people infected with the outbreak strain of Salmonella Kiambu have been reported from 12 states.

Twelve ill people have been hospitalized. One death has been reported from New York City.

Illnesses started on dates ranging from May 17, 2017 to June 28, 2017. Ill people range in age from less than 1 year to 95, with a median age of 27. Among ill people, 67% are female. Among 31 people with available information, 18 (58%) are of Hispanic ethnicity. Among 33 people with available information, 12 (36%) report being hospitalized. One death was reported from New York City.

Epidemiologic and laboratory evidence collected to date indicates that Maradol papayas are a likely source of this multistate outbreak.

CDC recommends that consumers not eat, restaurants not serve, and retailers not sell Maradol papayas until we learn more.

If you aren’t sure if the papaya you bought is a Maradol papaya, you can ask the place of purchase. Restaurants and retailers can ask their supplier.

When in doubt, don’t eat, sell, or serve them and throw them out.

Wash and sanitize countertops as well as drawers or shelves in refrigerators where papayas were stored.

This investigation is ongoing. CDC will provide updates when more information is available.

Atypical BSE in Alabama cow

The U.S. Department of Agriculture (USDA) announced an atypical case of Bovine Spongiform Encephalopathy (BSE), a neurologic disease of cattle, in an eleven-year old cow in Alabama.  This animal never entered slaughter channels and at no time presented a risk to the food supply, or to human health in the United States.

USDA Animal and Plant Health Inspection Service’s (APHIS) National Veterinary Services Laboratories (NVSL) have determined that this cow was positive for atypical (L-type) BSE.  The animal was showing clinical signs and was found through routine surveillance at an Alabama livestock market. 

BSE is the form that occurred primarily in the United Kingdom, beginning in the late 1980’s, and it has been linked to variant Creutzfeldt-Jakob disease (vCJD) in people. The primary source of infection for classical BSE is feed contaminated with the infectious prion agent, such as meat-and-bone meal containing protein derived from rendered infected cattle. Regulations from the Food and Drug Administration (FDA) have prohibited the inclusion of mammalian protein in feed for cattle and other ruminants since 1997 and have also prohibited high-risk tissue materials in all animal feed since 2009.

Atypical BSE is different, and it generally occurs in older cattle, usually 8 years of age or greater. It seems to arise rarely and spontaneously in all cattle populations.

This is the nation’s 5th detection of BSE.  Of the four previous U.S. cases, the first was a case of classical BSE that was imported from Canada; the rest have been atypical (H- or L-type) BSE.

More Hep A means more human shit where fish swim

REO Speedwagon was a terrible band.

The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), are assisting state and local officials in assessing the risk of hepatitis A virus exposure from contaminated frozen tuna sourced from Sustainable Seafood Company, Vietnam, and Santa Cruz Seafood Inc., Philippines. If unvaccinated consumers have consumed the recalled product within the last two weeks, post-exposure prophylaxis may help prevent hepatitis A virus infection.

Prior to FDA’s announcement, Hilo Fish Company alerted its customers and distribution partners directly to let them know about the company’s voluntary recall of certain tuna products on May 18. The FDA received records from the company or its distribution partners indicating that they sold frozen tuna to the establishments listed on the FDA’s website. The FDA is working with Hilo and other distributors to ensure that the companies remove product from the market. The table containing the names of establishments have been updated.

It is the responsibility of the Hilo Fish Company to notify its customers about the voluntary recall. It is also the responsibility of any company that received a recall notice from Hilo Fish Company to notify its customers. The establishments identified on the FDA’s website should have received a notice from Hilo Fish Company or their direct supplier. If they have not, they should reach out to their suppliers for more information. Any company that has questions about the voluntary recall or has affected product and did not receive notice should contact the FDA at 1-800-SAFEFOOD.

We don’t need no education: Why PR flunkery fails

I could never do PR.

It’s so much about swallowing whole.

I’ve done it, I’ve applied for jobs, but it makes me feel nauseous.

In a Cormey-Team America way.

My grandfather – the original Homer — was the asparagus baron of Canada.

100 acres that he sold at the door in Alliston, Ontario (that’s in Canada) in the 1960s and 70s, and my cousin is making a living with 40 acres outside Cambridge, Ontario (also in Canada – Barrie’s Asparagus).

There’s this guy at the University of Guelph who has been doing the PR thing for decades. I once asked his boss, a good scientist, do you know how much bullshit this guy is spinning?

And he said yeah, but that was what the system required.

Swallow whole.

(Oh, and to my Ontario farmer friends, I understand it’s been a bit wet. Adapt).

But this isn’t about asparagus.

It’s about the weird perversion that a bunch of groups have to educate consumers.

The U.S. just went through the dumbest electoral cycle in its history, and people want to be educated?

No it’s the rise of idiocracy.

In the past week, the U.S. Food and Drug Administration got $3 million to educate consumers about genetically engineered foods, Cargill unveiled its Non-GMO Project partnership, which is stupid beyond belief (and knowing that Cargill’s Mike Robach, vice-president, corporate food safety, quality & regulatory is chair of the Global Food Safety Initiative’s board of directors makes me question the value of any food safety audit ever sanctioned by GFSI), and the National cattlemen’s Beef Association has produced “two fact sheets on beef production and processing, available to consumers seeking more information about their steaks and other cuts, and how they got to the plate,” to educate consumers makes me want to scream.

How can you have any pudding if you don’t eat your meat?

Whenever a group says the public needs to be educated about food safety, biotechnology, trans fats, organics or anything else, that group has utterly failed to present a compelling case for their cause. Individuals can choose to educate themselves about all sorts of interesting things, but the idea of educating someone is doomed to failure. And it’s sorta arrogant to state that others need to be educated; to imply that if only you understood the world as I understand the world, we would agree and dissent would be minimized.

There’s a shitload of academic literature about the value of story-telling, about providing information rather than educating, withholding judgement, but these assholes can’t help themselves.

They know better.

Waste money.

My farmer relatives who interact with people daily know a whole lot more than you.

Audits and inspections are never enough: A critique to enhance food safety

30.aug.12

Food Control

D.A. Powell, S. Erdozain, C. Dodd, R. Costa, K. Morley, B.J. Chapman

http://www.sciencedirect.com/science/article/pii/S0956713512004409?v=s5

Abstract

Internal and external food safety audits are conducted to assess the safety and quality of food including on-farm production, manufacturing practices, sanitation, and hygiene. Some auditors are direct stakeholders that are employed by food establishments to conduct internal audits, while other auditors may represent the interests of a second-party purchaser or a third-party auditing agency. Some buyers conduct their own audits or additional testing, while some buyers trust the results of third-party audits or inspections. Third-party auditors, however, use various food safety audit standards and most do not have a vested interest in the products being sold. Audits are conducted under a proprietary standard, while food safety inspections are generally conducted within a legal framework. There have been many foodborne illness outbreaks linked to food processors that have passed third-party audits and inspections, raising questions about the utility of both. Supporters argue third-party audits are a way to ensure food safety in an era of dwindling economic resources. Critics contend that while external audits and inspections can be a valuable tool to help ensure safe food, such activities represent only a snapshot in time. This paper identifies limitations of food safety inspections and audits and provides recommendations for strengthening the system, based on developing a strong food safety culture, including risk-based verification steps, throughout the food safety system.

Truffle oil fingered: 159 sickened with Salmonella at Fig & Olive in 2015

In the summer of 2015, some 150 people were stricken with Salmonella at uppity Fig and Olive restaurants in Washington, D.C. and Los Angeles.

The salmonella outbreak shut down the City Center, DC location for six days in Sept. 2015. The Food and Drug Administration and local health authorities never definitively determined the exact source of the salmonella, but truffle mushroom croquettes were a common denominator among Fig & Olive diners who got sick. Components of the dish were pre-prepared at a Long Island City commissary that supplied Fig & Olive’s restaurants around the country with already-made sauces, dressings, and more, and has since been closed.

Six months and a round of layoffs later, one former mid-level executive told Jessica Sidman of Washington City Paper, “They’re an image conscious-first company. They don’t care about the guest. They care about their image, and they care about the bottom line … It’s just not a good company.”

The U.S. Centers for Disease Control has now weighed in on the source of the Salmonella – without naming the restaurant.

During July–September 2015, a total of 159 patrons reported gastrointestinal illness after eating at a single District of Columbia restaurant. Forty-one persons (40 restaurant patrons and one employee) were infected with an indistinguishable Salmonella Enteritidis strain on the basis of pulsed-field gel electrophoresis (XbaI pattern JEGX01.0008). Results from a case-control study using restaurant patron data identified a novel food vehicle, truffle oil, as the likely source of Salmonella Enteritidis infection in this outbreak. Approximately 89% of case-patients reported eating truffle oil–containing items, compared with 57% of patrons who did not report gastrointestinal illness (p<0.001).

Public health officials and consumers should be aware that truffle oil has been implicated as the likely source of a Salmonella Enteritidis outbreak and could possibly harbor this pathogen. Timely engagement of the public, health care providers, and local and federal public health officials, is particularly critical for early recognition of outbreaks involving common foodborne pathogens, such as Salmonella Enteritidis.

Chicago sets a food safety standard, then ignores it

The Chicago Tribune reports that inspections are government stethoscopes. They detect leaky roofs, Cobb salads that can tear up our insides, faulty elevators and buildings that are firetraps.

restaurant-inspectionAbout those Cobb salads.

The Chicago Department of Public Health requires “high risk” food establishments, such as restaurants, school and hospital kitchens and day care centers to be inspected twice a year. In 2015, fewer than half of them got two inspections, city Inspector General Joseph Ferguson recently reported. Grocery stores are supposed to get an annual inspection, but nearly 1 in 5 were not visited by sanitarians last year. Bars and convenience stores are supposed to be inspected once every two years, but fewer than 1 in 4 got a visit from inspectors in 2014 and 2015.

The explanation is simple: not enough inspectors. The city has 38 full-time inspectors to handle a workload that the IG says would take 94.

Would you like ranch or Imodium on that Cobb salad?

Foodborne illness affects 48 million people every year in the U.S., according to the Centers for Disease Control and Prevention — hospitalizing at least 128,000, killing 3,000, and making countless others miserable.

Chicago’s food safety inspection rules follow state guidelines, which are based on recommendations from the U.S. Food and Drug Administration. But the city routinely falls short of those standards. For years, the city and state have agreed to “corrective action plans” that allow Chicago to continue to receive local health protection grants from the Illinois Department of Public Health. In 2015, that amounted to $2.5 million.

That raises some questions: Are twice-a-year restaurant inspections necessary to protect people from foodborne illness or not?

Why should consumers have confidence in food safety standards that state health officials consider negotiable?

Does Chicago need more inspectors, or more realistic rules?

If twice-a-year inspections are needed, then the city has an obligation to provide the staffing to conduct them. If they’re not needed, then there are better uses for scarce public dollars. The city needs to figure out which of those things is true, instead of leaving rules on the books and breaking them repeatedly. Taxpayers deserve to know their money is being used wisely, and diners deserve to know their local eateries are following safe food-handling procedures.

It’s not the first time the city has failed to carry out its own inspections regimen. In 2012, the Tribune reported that nearly two-thirds of the city’s elevators had not been inspected the previous year as required. Some of the buildings were downtown, where the city dealt with a backlog by allowing property owners to hire their own inspectors to check elevators. But many building managers didn’t get the inspections done, and the city largely let them off the hook, the Tribune found. Very few of the non-compliant building owners were fined, and the city failed to follow up with its own inspectors, an expense that could have been passed on to the owners.

The fees and fines paid by food service establishments don’t cover the cost of the required inspections — and in any case, that money goes into the city’s corporate fund, which pays for all sorts of programs and services. That money could be dedicated to the Department of Public Health to pay for inspections, though the city would have to find efficiencies in its operating budget to make up for the lost dollars. The city also could charge more for inspections and licenses, or raise the fines for violators, to help cover the costs.

But Ferguson makes an excellent point: The city first needs to determine whether it’s necessary to add 56 inspectors to its payroll. That means working with state health officials to craft an inspections regimen that ensures food safety and is cost-effective, and to codify those standards. The IG’s report recommends consulting with food safety experts — government agencies, NGOs and academic institutions — to come up with a science-based inspection schedule.

By keeping a rule on its books that it doesn’t enforce, the city is not being straight with Chicagoans. Meaningful food safety standards, adequately enforced, will give a hungry public the confidence to chow down.

 

Going public: FDA not liable for $15 million in damages sought by tomato grower for food safety warning error

I remember. I was in Quebec City with a pregnant Amy when all this went down. Doing hour-long iradio interviews where midnight callers asked about aliens and Salmonella.

tomato

Michael Booth of the National Law Journal reports the U.S. Food and Drug Administration cannot be held liable for financial damages suffered by farmers when it issues emergency, but erroneous, food safety warnings, the U.S. Court of Appeals for the Fourth Circuit has ruled.

In its Dec. 2 ruling, the Fourth Circuit refused to allow a South Carolina tomato farmer to seek more than $15 million in damages from the federal government under the Federal Tort Claims Act after the FDA issued a warning that an outbreak of Salmonella Saintpaul was caused by contaminated tomatoes, when it was later determined that the outbreak was caused by contaminated peppers imported from Mexico.

A South Carolina tomato farm, Seaside Farm on St. Helena Island, sued the federal government, claiming that the incorrect warnings issued by the FDA, beginning in May 2008 and later corrected, cost it $15,036,294 in revenue. The Fourth Circuit agreed with a trial court that the FDA was acting within its authority to issue emergency food safety warnings based on preliminary information in order to protect public health.

“We refuse to place FDA between a rock and a hard place,” wrote Judge J. Harvie Wilkinson for the panel, sitting in Richmond.

“One the one hand, if FDA issued a contamination warning that was even arguably overbroad, premature, or of anything less than perfect accuracy, injured companies would plague the agency with lawsuits,” he said.

“On the other hand, delay in issuing a contamination warning would lead to massive tort liability with respect to consumers who suffer serious or even fatal consequences that a timely warning might have averted,” Wilkinson said.

Judges Paul Niemeyer and Dennis Shedd joined in the Dec. 2 ruling.

The medical crisis arose on May 22, 2008, when the New Mexico Department of Health notified the Centers for Disease Control and Prevention (CDC) that a number of residents had been diagnosed as having Salmonella Saintpaul, a strain that causes fever, diarrhea, nausea and, if left untreated, death. Soon after, similar reports came in from Texas.

The CDC determined that a “strong statistical” analysis determined that the illnesses were caused by people eating raw tomatoes. By June 1 of that year, CDC was investigating 87 illnesses in nine states.

tomato-irradiationThe FDA then issued a warning to consumers in New Mexico and Texas. By June 6, 2008, however, reported cases grew to 145 incidents in 16 states. In New Jersey, three people were reported to have been diagnosed with the illness. On June 7, the FDA issued a blanket nationwide warning telling consumers that they should be wary of eating raw tomatoes. (New Jersey tomatoes were not implicated, since they do not ripen until later in the season.)

The warning listed a number of countries and states, including South Carolina, that were not included and were not implicated, but those states were not listed in media reports. Eventually, 1,220 people were diagnosed as having Salmonella Saintpaul.

Raw tomatoes were not the cause of the illnesses, however. The contamination was traced to imported jalapeño and serrano peppers imported from Mexico.

Seaside Farm, which had just harvested a large crop of tomatoes, sued in May 2011. The farm claimed the erroneous FDA warning about tomatoes cost it $15 million-plus damages in revenue.