Phto by Pharma

No one knows the precise number of these brazen thefts because shippers of the goods are not required to report the crimes, but experts say the crimes have been increasing every year, especially over the past three years. The U.S. Food and Drug Administration thinks it’s a major issue and has sounded alerts to all players who manufacture, ship, store or sell these regulated items.

It’s not just the cash value of the larceny that’s at issue. Security experts from FDA, insurance investigators and state health departments are worried about the contraband being contaminated by mishandling; or mixed and sold with counterfeit drugs.

“There have been several cases where patients experienced adverse reactions from stolen drugs, reactions that were most likely due to improper storage and handling. We do not want to see this increase in thefts continue,” Michael Chappell,
 FDA’s acting Assistant Commissioner for Regulatory Affairs wrote in a letter to manufacturers, wholesalers and trade associations last week.

He reminded those whose shipments of FDA-regulated items were targeted by the thieves that these crimes threaten the public health because a product that has been taken from the “legitimate supply chain poses potential safety risks to consumers.”

In March alone, FDA reported several major thefts:

• On March 14, Eli Lilly and Company reported one of the largest known drugs thefts.  Cases of antidepressants and anti-psychotics were stolen from a Lilly distribution center located in Enfield, Conn., when thieves cut through a warehouse roof and rappelled down, deactivated a sophisticated alarm, picked up drugs valued at about $75 million and fled.
• The day before,  5,000 cases of Mead Johnson Nutrition’s infant formula products were stolen from a truck stop in Richwood, Ky.
• On March 3,  generic over-the-counter products worth $400,000 were stolen from a truck near Dallas.

It is not just the cargo movers and warehouse that are targeted.

Last year, Orlando, Fla., police busted 21 people for stealing millions of dollars of baby formula – worth $25 to $46 a can – off the shelves of grocery, drug, big-box and discount stores in four counties. What’s worse, according to police statements at the time, the thieves changed the expiration dates on many of the cans before selling them at flea markets and on eBay.

Some of the stolen loot is intercepted by Customs agents and major U.S. ports, but more frequently nefarious brokers will offer the bogus goods on the internet.

The biggest worry is that these stolen products, once reintroduced into the legitimate supply chain, are often accompanied by counterfeit products or products with improperly extended expiration dates.

It’s a frequent occurrence, says Benjamin England, a former FDA special agent and FDA lawyer, who now runs a consulting group called FDAimports.

He explains how the con is run: “Say I steal 250 bottles of an AIDS drug, but sell 500 bottles into the market, with the additional bottles being counterfeit or relabeled with an extended expiration date,” says England. “The stolen product acts as cover for the counterfeit or expired product.” (England said he saw this quite frequently when he was a federal investigator in Miami.)

Many of the criminal gangs in this line of work have concluded that it’s safer than pushing heroin and cocaine.

For a longer version of this story see what I wrote today for AOLNews.

National Honey Board

“The objective of the meeting will be a frank discussion of issues affecting the domestic honey industry, primarily transshipment of foreign honey and adulteration of honey,” said a note to all participants from the National Honey Packers & Dealers Association.

The meeting comes as federal investigators and the offices of the U.S. attorney in at least four states continue to search for  packing companies, honey brokers and importers allegedly involved in facilitating or purchasing intentionally mislabeled or bogus honey.

The crime, which some major suppliers say may involve 50 percent or more of all imported honey, centers on foreign hucksters and shady importers taking cheap, but abundant Chinese honey, moving it to a country with a reputation for a quality product, changing the country-of-origin on the shipping papers and then marketing the bogus load to brokers in the U.S.

There are two reasons for this illegal global bait-and-switch. First, the U.S. has set a tariff on each pound of Chinese honey brought into the U.S. – higher than any other nation – to protect domestic honey producers from the cheaper Chinese honey flooding the market.

But more importantly, Chinese honey often contains traces of an illegal animal antibiotic called chloramphenicol.  This drug, purchased from India, was first used years ago to stem an epidemic of disease that was laying waste to most of  China’s bee colonies.

The drug still taints most of the Chinese honey, some importers say and the Food and Drug Administration and the Canadian government found the contaminate in imported honey in January.

For the rest of this story, see what I wrote today for AOLNews.com.

Special agents from the Food and Drug Administration and Immigration and Customs Enforcement charged Francisca Josefina Lopez and Jorge Alexis Ochoa Lopez with introducing four shipments adulterated or tainted food products into interstate commerce.

The cheese, valued at $322,000 was imported from Nicaragua between December 2009 and March 2010, said a statement by the FDA.

Testing in the large FDA laboratory in Atlanta documented that three of the four shipments were contaminated with a food pathogen called Staphylococcus aureus. The fourth shipment was not pasteurized as the importers claimed on customs paperwork.

The onset of Staphylococcal food poisoning can be very rapid, the FDA says, depending on individual susceptibility to the toxin, the amount of contaminated food eaten, and the general health of the victim

The defendants operated from a company known as The Lacteos Factory in Northwest Miami and reportedly developed an elaborate scam to conceal the hazardous cheese.

On April 1, 2010, Customs & Border Protection inspected a cargo container at the Port of Miami, which had been returned to the seaport from Lacteos, with documents stating the cheese was refused and was being returned to Central America.

But, CBP Inspectors discovered that the top layer of cartons on each pallet contained small bricks of cheese, as labeled, but the bulk of the cargo contained in the lower tiers of boxes contained only buckets of waste water. As a result, the majority of the four-hundred eleven cartons of cheese from the entry were missing

Subsequently, a search warrant was executed at the Lacteos Factory, which revealed that the three other shipments of the cheese product had been sold to over 30 customers, despite the food still being customs hold, which meant the cheese could not be legally sold.

Apparently, one customer conducted independent testing of the cheese, found it to be contaminated with the bacteria and returned the product. Despite that, the cheese was repackaged and sold to other customers.

The Food, Drug & Cosmetic Act states a food is deemed to be adulterated, among other reasons, if it bears or contains any poisonous or deleterious substance which may render it injurious to health.

Felony convictions under the FDA law carry possible sentences of up to three years in prison and fines of up to $250,000 for each violation. In addition, if the pair is convicted of the anti-smuggling violations, they can also face a sentence of up to five years in prison and fines of up to $250,000 for each violation, and forfeiture of the smuggled goods.

Photo Spice Co.

After months of research, the Government Accountability Office told Congress it was concerned about a well-known loophole in the Food and Drug Administration regulations that for decades has concerned consumer and public health advocates.

It deals with a often controversial exception to the FDA’s practice of demanding rigorous analysis of the contents of processed food. Immunity from the FDA’s scrutiny is bestowed with the four word designation of “generally regarded as safe.”

What this means is that food manufacturers who want to include an additive in a food product are often spared having to spend hundreds of thousands of dollars in safety tests and can save years in getting something on to store shelves.

The GAO determined that:

• FDA generally doesn’t know about most of these GRAS determinations because companies are not required to inform the agency.
• FDA has not taken steps that could help ensure the safety of additives listed as GRAS.
• Food products may contain numerous ingredients, including GRAS substances, making it difficult, if not impossible, for public health authorities to attribute a food safety problem to a specific GRAS additives.
• FDA does not systematically reconsider the safety of GRAS substances as new information or new methods for evaluating safety become available.

The investigators also noted that while FDA has issued guidance to minimize the potential for conflicts of interest among its own staff who look at the safety of GRAS substances, it has not issued any restrictions for companies to use with their hired scientific experts.

“There is a relatively small community of experts qualified to sit on the GRAS designation panels and, inevitably, these experts may have corporate or financial affiliations that could bias their decisions,” the report said.

The investigators said it was almost impossible to link adverse effects to GRAS additives because their presence in food is rarely known outside those who produced it.

GAO said that the food safety agency told it that complaints and public concerns could prompt them to reconsider the safety of a GRAS substance.

Yet the FDA’s actions present a different picture.

More than 40 years ago, the GRAS-labeled artificial sweetener cyclamate was banned after allegations of serious health effects. That was pretty much it for decades.

A more serious debate over another GRAS additive is going on today and is generating repeated demands from unions, public health experts and others for another ban.

The substance is diacetyl, a chemical butter flavoring that has killed a handful of workers and sickened hundreds of others in microwave popcorn plants, bakeries, candy makers and other food processors.

What angers worker and food safety specialists even more is that many manufacturers say they have switched to a substitute for the old lung-destroying flavoring additive that government researchers have determined contains just as much or more diacetyl than the old concoction.

It too is listed as GRAS and the FDA knows it, but has done nothing.

Over the past 50 years, thousands of spices, artificial flavors, and binders, vitamins and minerals, and preservatives have been declared as GRAS. These substances are added to enhance a food’s taste, texture, nutritional content, or shelf life.

These safety designations started in 1958, when Congress blessed GRAS by amending the Federal Food, Drug, and Cosmetic Act to say that the safety of an additive “does not need to be established with absolute certainty.”  Rather, the Act said that a scientific panel selected by the manufacturer can rule that no harm will result from the intended use of an additive.

But in reality, the only ones who know whether not the additives are actually safe is the company and its own analysts or the outside labs they hire.

Thousands of exemptions are granted by food industry trade groups. For example, the largest, the Flavor and Extract Manufacturers Association, has bestowed GRAS on more than 2,600 additives since 1960.

The GAO expressed added concern over two specific areas – imported additives, where the level of safety consideration is often completely unknown and the growing use of GRAS designation in engineered nanomaterial in food.

In responding to the report, the FDA says it agreed with many of the faults that GAO documented but said that the agency would have to seek authority from Congress in order to require all companies to inform it of their designation of additives as GRAS.

If that were to happen, FDA said, it could place an added burden on food producers and tax FDA’s resources.

The GAO investigation was requested by two democrats, Iowa Sen. Tom Harkin of and Connecticut Rep. Rosa DeLauro.

Here is  a link to an AOLnews version of this story.

We went though this last year with contaminated peanuts from the Georgia and Texas plants of Peanut Corporation of America.

PCA recalled the tainted goobers, but the ripple effect spread for weeks as hundreds of manufacturers pulled thousands of products made with the pathogen-containing nuts off store shelves throughout North American.

It’s not peanuts this time, but rather a flavoring agent called hydrolyzed vegetable protein. As unappetizing as the name sounds, it is used as a flavoring agent in thousands of gravies, sauces, soups, salad dressings and snacks.

The source of the tainted concoction is Basic Food Flavors, Inc., an international supplier of flavor and seasoning agents.   The FDA conducted an investigation of the company’s Las Vegas, Nev., production plant after a customer who purchased the flavoring had it analyzed and found it contained Salmonella.

As the FDA did with the peanuts and does with many other recalled foods, the agency has to wait until the downstream producers of these consumer products realize that the food they’re selling may also be contaminated.

The federal food detectives say they don’t have enough investigators or a structure that permits them to identify and chase all the ingredients in the processed food that’s manufactured and sold in this country.

For more details on this recall see the story I wrote on AOLnews.com.

Well, it may be happening again, but this time with red pepper.

Food safety cops from three federal agencies and the state of Rhode Island say they have linked salmonella-infected, Italian-style sausage and salami to a crushed red pepper sold by Wholesome Spice, a Brooklyn, N.Y., wholesale distributor.

According to the Centers for Disease Control, more than 238 people in 44 states and Washington, D.C., have been sickened by the pathogen Salmonella Montevideo, which reportedly contaminated meat products made, packaged and sold by Daniele International Inc.

The poison-food specialists said that public health officials in multiple states and the Centers for Disease Control in Atlanta compared foods eaten by 41 ill people to another 41 with no sign of illness. This mini-epidemiological study identified Daniele meats as a possible source of illness and the pepper­–both black and red–as the host of the salmonella.

The Rhode Island producer, whose meats are sold under different brand names, has recalled about  1.5 million pounds of Italian-style sausage along with different types of ready-to-eat, pepper-coated meats.

But now, the CDC says the spice merchant is trying to recall 25-pound boxes of crushed red pepper it sold from April to last month due to possible Salmonella contamination.

The company has not said how much of the crushed red pepper was sold, but the 25-pound bulk packages, which were sold throughout the Northeast U.S., are often repackaged by others into consumer-size portions for home use or, like the peanuts, added to an unknown number of other commercially sold food products.

Late last month, Rhode Island officials reported finding Salmonella in two open containers of black pepper that Daniele had bought from Wholesome Spice. Two weeks later, officials found the pathogen in another load of black pepper but said this was purchased from a Chinese distributor.

For the appetizer: San Antonio Bay oysters polluted with Noroviruses. For the main course: grilled beef infected with E. coli from contaminated tenderizing needles; chicken with Campylobacter or imported ham with Listeria monocytogenes. Then there’s a side dish of stuffing loaded with salmonella-contaminated hazelnuts. And for those watching their weight: a popular nutritional drink fouled with the food poison Bacillus cereus.

Even the family pet wasn’t forgotten.  Its pigs ears and beef hooves were laced with salmonella.

All those item were recalled in December by the federal government or were the subjects of warnings by food safety experts. And 2010 isn’t shaping up to set a safer table, according to some of the country’s leading food safety experts.

That’s not the message from the government’s three big players in the war against dangerous food — the Food and Drug Administration, the Department of Agriculture and the Centers for Disease Control. All predict the food supply will be safer because of new safeguards being pushed by the Obama administration.

Less than two months after taking office, the president announced the creation of the Food Safety Working Group and promised more resources to safeguard the nation’s food supply.

“Many of the laws and regulations governing food safety in America have not been updated since they were written in the time of Teddy Roosevelt,” Obama said at that time.

“There are certain things that only a government can do. And one of those things is ensuring that the foods we eat …are safe and don’t cause us harm,” said Obama.

The USDA’s Food Safety Inspection Service and the FDA are trying to improve product traceability, both forward and back, in the production chain, with the goal of being able to respond quicker to outbreaks, said Caleb Weaver, USDA’s press secretary.

Agriculture Secretary Tom Vilsack wants his agency to “further reduce the incidence of food-borne pathogens and the number of food-borne-related deaths to zero,” Weaver added.

However, some managers and field investigators in the same agencies have views much closer to those of food safety activists. They predict that the very powerful food industry lobbyists, especially for the meat producers, will go down swinging and screaming to thwart meaningful food safety reform.

If you want to see what the food safety experts are worried about, here is a link to the rest of my story on AOL News’ Sphere.com

In fact, it appears it never went away, despite promises from the food industry.

So what is the Obama Administration going to do about it? Nothing meaningful, at least for another year, it said this week, stunning unions, members of Congress, public health activists and physicians who have pleaded for government action to protect workers and consumers from the butter flavoring.

Two years ago this month, the nation’s leading popcorn purveyors proclaimed that they’d done away with the chemical culprit diacetyl, believed to be the harmful element in the food flavoring.

But now, government health investigators are reporting that the “new, safer, butter substitutes” are, in some cases, at least as toxic as what they replaced.

Even the top lawyer for the flavoring industry said his organization has told anyone that would listen that diacetyl substitutes are actually just another form of diacetyl.

“We’ve been very clear to flavor manufacturers, food companies and regulators that these so-called substitutes are diacetyl,” said John Hallagan, General Counsel for the Flavors and Extracts Manufacturers Association.

Hallagan told me this week that his trade association discouraged food manufacturers from using these materials and calling their products “diacetyl-free.” But he quickly admitted that his group has no legal authority to prohibit their use.

That’s up to the food manufacturers.”

But those companies refused to discuss the source of the butter flavoring in their products. But their food scientists and flavorists openly debate it at professional meetings as they sought their peer’s opinions on the value of starter distillates and trimers they were using to achieve the rich butter flavors that consumers love so much.

But federal health investigators, many of whom had chased the dangerous additive for years, had concluded that these butter surrogates may be unsafe.

“The inclusion of these alternative substances neither eliminate diacetyl nor assure safety for workers,’’

physicians from the National Institute of Occupational Safety and Health – Drs. Kathleen Kreiss and Nancy Sahakian – wrote earlier this year. Their agency has led the way in chasing which flavoring agents were sickening factory workers.

On the same trail was Dr. Daniel Morgan, with the Respiratory Toxicity Group at the National Institute of Environmental Health Sciences.   On Monday he told me he had found the same danger in one of the principle components of the butter substitute – a concoction called 2,3-pentanedione.

“It caused the same injuries in test animals as diacetyl and our preliminary data indicates the toxicity is close to identical,” Morgan said.

“We don’t really know what industry is using as a substitute in these ‘diacetyl-free’ items. But, if 2,3-pentanedione was being used, it’s being done without toxicity data.”

The disease from exposure to diacetyl – bronchiolitis obliterans – is debilitating and potentially fatal. It irreversibly destroys the small airways in the lung. The only hope for many is a hard-to-get single or double lung transplant.

It was almost ten years ago, the holiday season, that Dr. Allen Parmet, a really sharp occupational medicine doc, used his experience treating victims of a rocket fuel accident to figured out that workers at a Missouri microwave popcorn plant were having their lungs destroyed by some chemical used at the facility.

A team from NIOSH quickly pointed to diacetyl as the likely villain.

Over the years, unions, congress, scores of physicians and scientists and occupational health experts called on OSHA to take action.

In June 2006, Rep. Hilda Solis, a Democrat who represented the Los Angeles district where two stricken flavoring plant workers lived, reacted to media reports on their illness and demanded that that OSHA do more to protect workers.

“”These illnesses and deaths are preventable,” Solis said at the time. “Further inaction is inexcusable.”

Public health advocates told themselves that when Democrats took over the health and safety agencies the Bush regulations-are-bad-era would vaporize. One measurement  was going to be how quickly the Obama team addressed something diacetyl.

Well, this week the new Labor Secretary, who now happens to be Hilda Solis, addressed it.

She released her plans for worker health and safety, mentioning several specific hazards, including diacetyl.

But instead of expediting carefully crafted rules for diacetyl and worker safety, she ordered another year of bureaucratic review of diacetyl’s health effects.

You’ve got to wonder what really happened to Solis’ great concern for workers exposed to diacetyl.

For a longer version of this story, check out what I wrote on AOL News – Sphere.com.