Beware the fungus: FDA says dietary supplements containing live bacteria or yeast could cause problems in immunocompromised persons

The U.S Food and Drug Administration is warning health professionals of the risks associated with the regarding use of dietary supplements containing live bacteria or yeast in immunocompromised persons. A premature infant administered a dietary supplement, ABC Dophilus Powder (Solgar), as part of in-hospital course of treatment, developed gastrointestinal mucormycosis caused by the mold Rhizopus oryzae and died. Rhizopus oryzae mold was found to be present as a contaminant in an unopened container of the ABC Dophilus Powder, which is formulated to contain three species of live bacteria.

abc-dophilus-powderFDA, along with the Centers for Disease Control and Prevention (CDC) and the Connecticut Department of Public Health, are investigating the death of this preterm infant who developed gastrointestinal mucormycosis.  In mid-November, Solgar issued a recall for certain lots of ABC Dophilus Powder and public health warnings were issued advising customers and consumers not to use the recalled product.

FDA is informing healthcare providers that dietary supplements, including those that are formulated to contain live bacteria or yeast, are generally not regulated as drugs by the FDA.  As such, these products are not subject to FDA’s premarket review or approval requirements for safety and effectiveness, nor to the agency’s rigorous manufacturing and testing standards for drugs, including testing for extraneous organisms.

 

 

Over 300 sickened: State knew Chobani yogurt was tainted months before recall, FDA says

Whether it’s food, automobiles, consumer goods, whatever – selling deficient product and trying to cover it up usually backfires.

chobani.yogurtPeople and corporations are found out over time: so suck it up and go public early and often.

In response to continual mold problems, Chobani, the Greek yogurt people, made staff changes at its Twin Falls plant and corporate headquarters in New York, hired one new public relations firm and one advertising firm during the recall, and fired Nicki Briggs and “other in-house PR staffers” in November after “a broad refocusing of its resources.”

Chobani official said those PR changes had nothing to do with the mold outbreak and resulting recall.

Chobani may have been focusing on the wrong problem.

MagicValley.com reports the Idaho Department of Agriculture saw moldy yogurt during a routine inspection at Chobani two months before the company issued a voluntary recall, says a U.S. Food and Drug Administration report obtained by the Times-News under a Freedom of Information Act request.

The state denies the FDA claim.

More than 300 people got sick after consuming the moldy Greek yogurt from Twin Falls.

The state inspection was conducted in July. But not until September did Chobani issue a voluntary recall of 35 varieties of its tainted yogurt, advising the public it was contaminated with Mucor circinelloides, a mold commonly associated with yogurt production.

A report summarizing five separate inspections by the FDA in September gives this account of the state’s inspection:

“In July the routine Grade A sampling and testing samples taken by the Idaho Department of Agriculture (ISDA) from the Chobani Idaho Inc. production were visually noted, by the laboratory technician, that surface defects were present and additional testing was conducted noting a yeast like growth developing in the yogurt samples.”

chobani-recall-2013-updateThe FDA inspections also prompted Chobani to clean various pieces of equipment at the Twin Falls facility. After some “minor deficiencies” were reported, the FDA did not issue a mandatory recall or take further action.

ISDA spokeswoman Pamela Juker said state regulators never took note of any mold during the July inspections, and she’s unsure where the FDA got its information.

“All of the raw and finished product-testing results met the requirements of the Pasteurized Milk Ordinance,” Juker said. “All of the tests we’ve done met the requirements.”

Chobani repeatedly has declined to provide details on the issue. But Weber Shandwick, a third-party public relations firm, emailed a company response Wednesday.

“Our goal is to ensure our Idaho facility is not just a leader in size, but also in cleanliness, quality and safety,” a Chobani official wrote. “To accomplish this, we have brought in significant resources and are working with internal as well as outside experts to put together one of the most advanced food safety and quality systems in our industry.”

Uh-huh.

And I prefer science as an enhancement of nature.

Neptune (me, not exactly as shown) to halt production until FDA documents correction of unsanitary practices

Neptune Manufacturing prepares, processes, packs, holds and distributes ready-to-eat smoked and salt-cured (pickled) fish and fishery products including pickled herring, smoked steelhead trout, smoked turbot/halibut, smoked whitefish, smoked salmon and smoked mackerel. The company sells its ready-to-eat products wholesale to customers located in southern California and Las Vegas.

neptuneThe U.S. Food and Drug Administration has conducted seven inspections of the facility since 2006. Each time, FDA investigators found similar unsanitary conditions. (The Act refers to unsanitary conditions as insanitary.) FDA investigators found the pathogenic bacterium Listeria monocytogenes (L. mono) on four occasions at the facility. FDA investigators also found a failure to control for Clostridium botulinum (C. bot) growth and toxin formation on at least three occasions.

L. mono is a foodborne pathogen that can cause serious illness or even death in vulnerable groups such as newborns, elderly adults and those with impaired immune systems. C. bot, a bacterium that can grow in seafood products, causes botulism, which is rare but can cause paralysis and death without prompt treatment. The purpose of food safety regulations is, in part, to prevent the growth and spread of L. mono, C. bot and other microorganisms that cause foodborne illness.

“When a company and its owners repeatedly violate the same food safety procedures, their failure to improve their processes and clean up their facility endangers the public,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “The FDA will take necessary action to protect the food supply from adulteration.”

No illnesses have been reported to date associated with Neptune Manufacturing, Inc. products. Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.

poseidon neptuneOn December 1, a federal judge from the U.S. District Court for the Central District of California entered a consent decree of permanent injunction against Neptune Manufacturing, Inc., of Los Angeles, and its owners, Alexander Goldring, Peter Oyrekh and Semyon Krutovsky.

The consent decree requires Neptune and its owners to stop processing and distributing their smoked and pickled seafood products until they have taken specific steps to bring their operation into compliance with the Federal Food, Drug, and Cosmetic Act (“the Act”).

I always go to the gas station for a sandwich: Detroit-based company distributing tainted sandwiches

The U.S. government wants to stop a Detroit company from distributing ready-to-eat sandwiches which, the government says, are tainted and could be a health hazard to those who eat them.

Scotty-s-Foods-sandwich-jpgA civil complaint has been filed on behalf of the FDA claiming Scotty’s Incorporated’s sandwiches are manufactured “under insanitary conditions.”

“Moreover, the company has failed to implement a written Hazard Analysis and Critical Control Point (HACCP) plan for handling seafood and minimizing the potential for harmful contamination in the company’s ready-to-eat tuna sandwiches,” reads a statement from the Justice Department.

The sandwiches can be purchased in vending machines and at gas stations or convenience stores.

The FDA inspected Scotty’s facilities at 3426 Junction Street in Detroit, where the company prepares, packs, holds, and distributes ready-to-eat sandwiches, and also processes seafood, specifically tuna for tuna sandwiches. According to the complaint, the inspection between Jan. 14 and Feb. 6, 2014 found the sandwiches “have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.”

View: PDF of civil complaint against Scotty’s

US FDA will send more inspectors to China office

Food safety is the responsibility of those who produce food.

Government is there to ensure minimal standards are met.

trade.food.nov.14The best will always far exceed government standards.

But, countries need help, so the U.S. Food and Drug Administration will dispatch more inspectors to China to help ensure the quality of exports, making its China office the largest one overseas.

As early as next year, staff at the China office will be boosted to 21 from the current four, and nine of them will be responsible for food safety, said Christopher J. Hickey, FDA China director. Currently there are only two in food safety, while the rest are in charge of drugs and medical devices.

China is the fourth-largest exporter of food to the US.

Meanwhile, citing a globalized food and drug supply chain, China is also considering sending safety inspectors to the US, said Wu Yongning, chief scientist from the China National Center For Food Safety Risk Assessment.

Wu said that given China’s sheer size, the increase of US FDA inspectors would allow more on-site inspections of particularly high-risk producers.

Michael R. Taylor, deputy commissioner for foods at the Food and Drug Administration, said the staff increase is “important for us as that permits us to work more closely with our Chinese counterparts to become knowledgeable about practices here.”

“We can work with both the Chinese government and the industry to explain our requirements and provide trading support for those exporting to the U.S. to comply with our standards,” he said.

Priorities include agriculture, farm produce, seafood and animal drugs, he noted.

FDA alleges food safety violations at New Bedford scallop plant

The US Food and Drug Administration (FDA) found “serious” food safety violations at a seafood processing facility operated by Massachusetts-based M&B Sea Products, the FDA said in a warning letter to the company.

raw.scallops.dillions.aug.09Refrigerated, reduced-oxygen packaged raw scallops at the facility have been “prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health,” the FDA said in the Aug. 26 letter.

John Murray, president of the New Bedford-based company, did not respond to requests for comment from Undercurrent News on Tuesday. Mutahar Shamsi, director of the FDA’s New England district, declined to comment on an open case.

Recent research on third-party audits

Ronald Doering, the first president of the Canadian Food Inspection Agency and the only one I can remember, writes in his Food Law column:

ron.doeringUntil recently there has been little serious research on the most significant food safety advance in the last decade, a develop­ment that has been entirely outside the realm of public law — the extraordinary growth of third-party supplier audits. There are now over 500 food safety audit firms, many of which have global operations.

The Food Safety Service Providers, an industry association representing nine leading private food safety audit firms, asserts that its members alone conduct more than 200,000 audits and inspections in more than 100 countries each year. It has been estimated that in the U.S. the scale of private food law auditing activity is now 10 times larger than that of the federal government, more than all federal and state efforts combined. Two recently published academic studies provide inter­esting insights into several aspects of this important new area of food law.

Audits and Inspections Are Never Enough: A Critique to Enhance Food Safety (Food Control, vol. 30, issue 2) by Douglas Powell et al. identifies the many limitations of third-party audits and doc­uments several cases of major foodborne illness outbreaks linked to food proces­sors that have passed third-party audits. Audits need to be supplemented by other measures such as microbial testing, and companies must have in-house capacity to meaningfully assess the audit results. Third-party audits are part of “a shift in food safety governance away from government regulation and inspection towards the development of private food safety standards.” This study represents a cogent caution to the audit industry that they must improve their systems, and a warning to the food industry that audits are never enough.

doug.ron.2.jan.13In the latest Wisconsin Law Review American law professors Timothy D. Lytton and Lesley K. McAllister (Oversight in Private Food Safety Auditing: Addressing Auditor Conflict of Interest, 2014) provide the first comprehensive analysis of one of the most serious problems with private food safety auditing — auditor conflict of interest. Auditors are paid by the company being audited. Suppliers have an interest in finding the cheapest and least intrusive audit that will provide a certificate, and auditors have a financial incentive to reduce the cost and rigour of audits to get business in a very competitive environment. This study analyzes several oversight mechanisms that have been developed to mitigate the conflict problem, but concludes that at this time there are still too few financial incentives to assure more rigorous auditing.

Considering how few inspections are actually carried out by the Food and Drug Administration (FDA) relative to the number of businesses it is responsible for, it is ironic that the U.S. has been so reluctant to embrace more fully the advantages that third-party audits represent. Perhaps this is because President Obama is so beholden to consumer activist groups that do not trust the in­dustry, believe that only FDA inspectors can stop big bad food companies from poisoning consumers, and who refuse to recognize that it is private audits that are increasingly the drivers of enhanced food safety. Obama has declared that it is the state that has the primary responsibility for food safety, and the former FDA com­missioner dismissed audit schemes as being merely “a business strategy, not a public health strategy.”

In Canada we have always recognized that while it is a shared effort, practically and legally it is food producers that have the primary responsibility for food safety. Industry recognized some years ago that they couldn’t meet this responsibility adequately just by complying with gov­ernment regulations — that they could protect their brand from recalls, minimize foodborne illness law suits, source ingredi­ents widely and trade internationally only if, among other things, they insisted on warranty agreements from suppliers and that these were backed up by independent third-party audits. There are many legal and other problems with these relatively new instruments at this still early stage in their development, but they’ve come a long way in the last 10 years.

Finding ways to better integrate public law-based food safety regulations with private law-based certification systems may prove to be one of our more inter­esting challenges in the decade ahead.

Blessed are the cheese makers (except those that have an import alert)

Following the don’t-age-on-wood-boards-uh-just-kidding incident earlier this year, the U.S. FDA are again raising the hackles of cheese purveyors. This time over an import alert.

According to Janet Fletcher of the L.A. Times Daily Dish, an FDA-issued alert on certain manufacturers of raw milk cheeses due to presumed insanitary conditions is keeping some top-selling cheeses off of baguettes.

In early August, these cheeses and many more landed on an FDA Import Alert because the agency found bacterial counts that exceeded its tolerance level. Cheeses on Import Alert can’t be sold in the U.S. until the producer documents corrective action and five samples test clean, a process that can take months.hqdefault

Of course, French creameries haven’t changed their recipes for any of these classic cheeses. But their wheels are flunking now because the FDA has drastically cut allowances for a typically harmless bacterium by a factor of 10.

The limits for nontoxigenic E. coli were cut from 100 MPN (most probable number) per gram to 10 MPN. These are bacteria that live in every human gut; they are typically harmless and we coexist happily. But the FDA considers them a marker for sanitation: If a cheese shows even modest levels of nontoxigenic E. coli, the facility that produced it must be insufficiently clean.

Dennis D’Amico, an assistant professor at the University of Connecticut whose specialty is dairy microbiology, says this premise is flawed.

“There was no health risk in all the years we operated at 100 MPN,” says David Gremmels of Oregon’s Rogue Creamery, which produces several raw-milk blues. “We look at this as an arbitrary change.”

Gremmels and others say they felt blindsided by the revised FDA guidelines, learning about them only when European cheeses began being held. The agency hasn’t offered any scientific support for the altered E. coli allowance, prompting unease about its decision making.

The stepped-up testing creates headaches for companies like Gourmet Imports, a Los Angeles cheese importer and distributor.

“In the past year, we’ve had delays on things you never would have imagined would be held before,” reports general manager Alex Brown. Even Parmigiano-Reggiano, a well-aged, low-moisture cheese unlikely to have microbial issues, was recently held for testing.

“It’s the safest cheese on the planet,” Brown says.

An import alert allows FDA to ask for more data (micro or inspection from an exporting country) and according to the Alert page, This import alert represents the Agency’s current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public.

After a bit of digging I found a 2009 FDA Staff Compliance Policy Guide Sec. 527.300 Dairy Products – Microbial Contaminants and Alkaline Phosphatase Activity (CPG 7106.08) that states:

The presence of Escherichia coli in a cheese and cheese product made from raw milk at a level greater than 100 MPN/g (Most Probable Number per gram) indicates insanitary conditions relating to contact with fecal matter, including poor employee hygiene practices, improperly sanitized utensils and equipment, or contaminated raw materials. The presence of Escherichia coli at levels greater than 10 MPN/g in a dairy product, other than a cheese or cheese product made from raw milk, also indicates insanitary conditions. The presence of Escherichia coli at levels greater than 10 MPN/g in a dairy product made from pasteurized milk indicates that contamination occurred after pasteurization.

Any government agency needs to clearly and effectively communicate risk-based decisions, (especially changes) and provide the evidence to back a particular decision.

Food additives on the rise as FDA scrutiny wanes

The explosion of new food additives coupled with an easing of oversight requirements is allowing manufacturers to avoid the scrutiny of the Food and Drug Administration, which is responsible for ensuring the safety of chemicals streaming into the food supply.

fda.gras.approvedAnd in hundreds of cases, the FDA doesn’t even know of the existence of new additives, which can include chemical preservatives, flavorings and thickening agents, records and interviews show.

“We simply do not have the information to vouch for the safety of many of these chemicals,” said Michael Taylor, the FDA’s deputy commissioner for food.

The FDA has received thousands of consumer complaints about additives in recent years, saying certain substances seem to trigger asthmatic attacks, serious bouts of vomiting, intestinal-tract disorders and other health problems.

At a pace far faster than in previous years, companies are adding secret ingredients to everything from energy drinks to granola bars. But the more widespread concern among food-safety advocates and some federal regulators is the quickening trend of companies opting for an expedited certification process to a degree never intended when it was established 17 years ago to, in part, help businesses.

A voluntary certification system has nearly replaced one that relied on a more formal, time-consuming review — where the FDA, rather than companies, made the final determination on what is safe. The result is that consumers have little way of being certain that the food products they buy won’t harm them.

“We aren’t saying we have a public health crisis,” Taylor said. “But we do have questions about whether we can do what people expect of us.”

‘Natural’ helps sell $40 billion worth of food in the U.S. every year—and the label means nothing

Nothing makes Americans buy a food product quite like the fabulously ambiguous word “natural.”

chobani.yogurtThe top 35 health claims and food labels include words most anyone who has been to a supermarket in the past five years should recognize—ones like “natural,” yes, but also “organic,” and “fat free,” and “carb conscious,” and “100 calories.”  These phrases helped the food industry sell more than $377 billion worth of masterfully marketed food items in the United States during the past year, according to data from market research firm Nielsen.

The list of lucrative food labels is long, and, at times, upsetting.

Many of these labels are pasted onto food packages for good reason. It’s imperative, after all, that consumers with celiac disease be able to tell which food items are gluten free, or that those with milk allergies be able to tell which are made without lactose.

But some are utterly meaningless. Take food labeled with the word “natural,” for instance. Actually, remember it, because it’s probably the most egregious example on supermarket shelves today. The food industry now sells almost $41 billion worth of food each year labeled with the word “natural,” according to data from Nielsen. And the “natural” means, well, nothing. The US Food and Drug Administration (FDA) doesn’t even have an official definition or delineation of what “natural” actually means. The only thing the FDA has regarding the word is this statement, on its website:

From a food science perspective, it is difficult to define a food product that is ‘natural’ because the food has probably been processed and is no longer the product of the earth. That said, FDA has not developed a definition for use of the term natural or its derivatives. However, the agency has not objected to the use of the term if the food does not contain added color, artificial flavors, or synthetic substances.

market.naturalIt’s hardly the only misleading adjective the food industry is swinging around these days. The word organic, while a bit less nebulous, still means a good deal less than one might think. Several others, including ones that reference antioxidants, proteins, calcium and other vitamins and minerals, are confusing consumers by tricking them into believing certain food products are healthier than they actually are, a recent study found. And the trend is only likely to get worse. Many of the top grossing food labels are still growing—and fast.