THE FOOD LAW BLOGGER

The Food Law Blogger explores food litigation, including cases involving foodborne illness and labeling disputes, as well as key regulatory developments at the U.S. Food and Drug Administration and U.S. Department of Agriculture. Ping Josh Long with story ideas at jlong@vpico.com.

Consumer Group Seeks to Eviscerate New USDA Poultry Inspection System

Josh Longhttp://www.foodproductdesign.com/Blogs/Food-Law-Blogger/2014/09/Consumer-Group-Seeks-to-Eviscerate-New-USDA-Poult.aspx

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A consumer rights group wants a federal court to vacate a new poultry inspection system adopted by an agency within the U.S. Department of Agriculture.

The regulations, finalized this summer by the Food Safety and Inspection Service (FSIS) and taking effect on Oct. 20, would give chicken and turkey slaughterhouses the green light to “dramatically increase their slaughter line speeds, while threatening public health and introducing unwholesome poultry into interstate commerce," Food & Water Watch contends in the lawsuit.

The new inspection system violates the Poultry Products Inspection Act because it eliminates mandatory inspection requirements and the regulations were finalized before the opportunity for public comment, according to the suit, which was filed on Sept. 11 in the U.S. District Court in Washington, D.C. The lawsuit also contends the regulations are arbitrary and capricious.

FSIS did not immediately respond on Thursday, Sept. 19, to a request for comment.

On July 31, the food-safety agency announced a new poultry inspection system that it said imposes new requirements to control Salmonella and Campylobacter and would prevent up to 5,000 foodborne illnesses annually. Under the inspection system, poultry companies will review carcasses for defects, a move FSIS said will free up its inspectors to focus on food-safety examinations.

The poultry industry expressed support for the new inspection system before the regulations were finalized. Rather than being confined to examining the dead birds for physical defects such as bumps and bruises, FSIS inspectors will have flexibility to search for causes of foodborne illnesses such as Salmonella, said Keith Williams, vice president of communications and marketing with the National Turkey Federation, in a phone interview earlier this year. According to a powerpoint presentation from FSIS, such sorting activities largely relate to the marketability of the carcasses rather than food safety.

Consumer and labor groups argued the proposal would compromise food safety and exacerbate the burden on inspectors who already suffer carpel tunnel syndrome and other ailments. Responding to public comments on its proposal, FSIS said the finalized regulations would cap at 140 birds per minute maximum line speeds, remaining consistent with current programs. FSIS had proposed increasing the number of inspections to 175 chickens per minute with one FSIS inspector on the line and one FSIS inspector off the line.

Before FSIS adopted the new regulations, government inspectors examined every carcass, according to Food & Water Watch. The lawsuit estimates the new system will lead to a reduction of as many as 770 federal inspectors.
“USDA’s new system will harm consumers and reverse 100 years of effective government regulation of the meat industry," said Wenonah Hauter, executive director of Food & Water Watch, in a statement. “It’s essentially a return to Upton Sinclair’s The Jungle. It’s a huge step backwards for our food safety system."

But USDA said it has learned a great deal about managing pathogens such as Salmonella since it began inspecting poultry more than a half century ago, requiring a more modern approach. FSIS has refuted criticism that fewer inspectors will compromise food safety, citing data from a pilot program showing “greater compliance with sanitation and HACCP regulations, carcasses with lower levels of visible fecal contamination, and equivalent or lower levels ofSalmonella contamination."

“These positive results were able to be achieved with fewer inspectors overall, but more inspectors deployed to more meaningful food safety-based activities," FSIS said in a Q&A on “Poultry Slaughter Modernization."

Under the new system, all poultry facilities must conduct microbiological testing at two points in their production process to demonstrate that they are controlling two common pathogens, Salmonella and Campylobacter. FSIS said it is the first time such requirements have been imposed.

FOOD SAFETY: FDA faces challenges overseeing fecal transplant safety

• Science

FDA faces challenges overseeing fecal transplant safety

MATTHEW PERRONE

Washington — The Associated Press

Published Thursday, Jun. 26 2014, 3:48 PM EDT

Last updated Thursday, Jun. 26 2014, 4:00 PM EDT

Imagine a low-cost treatment for a life-threatening infection that could cure up to 90 per cent of patients with minimal side effects, often in a few days.

It may sound like a miracle drug, but this cutting-edge treatment is profoundly simple — though somewhat icky: take the stool of healthy patients to cure those with hard-to-treat intestinal infections. A small but growing number of physicians have begun using these so-called fecal transplants to treat Clostridium difficile, commonly referred to as C-diff, a bacterial infection that causes nausea, cramping and diarrhea. The germ afflicts a half-million Americans annually and kills about 15,000 of them.

But fecal transplants pose a challenge for the Food and Drug Administration, which has decided to regulate the treatment as an experimental drug. Stool transplants don’t fit neatly into the agency’s standard framework. And while regulators have shown flexibility in their approach, some critics say the mere presence of government oversight is discouraging many doctors from offering transplants. That’s led some patients to seek out questionable “do-it-yourself” websites, forums and videos.

Most researchers agree that the FDA’s concerns are warranted. Patients can contract HIV, hepatitis and other viruses and parasites from fecal matter that is not properly screened. Additionally, there are no long-term studies on potential side effects of stool transplantation.

FDA officials declined to be interviewed for this story, but said in a written response that the fecal transplantation “shows promise in treating C. difficile infection that has not been responsive to other therapies.”

Indeed, with many patients no longer responding to potent antibiotics, fecal transplants have emerged as an effective therapy against drug-resistant strains of the C-diff superbug. The procedure works because the healthy bacteria found in donors’ feces can help fight off foreign infections.

“We’re dealing with something that is pretty close to miraculous,” says Dr. Lawrence Brandt of New York’s Montefiore Medical Center, who has performed over 200 fecal transplants.

Most products reviewed by the FDA spend years in testing before they are submitted to the agency, usually by large drug or medical device developers. Fecal transplants have followed a different path.

In recent years, a handful of doctors have published small case studies on their use of stool to treat C-diff, with many reporting cure rates of about 90 per cent. In January 2013, the New England Journal of Medicine published the first rigorous, head-to-head study showing that fecal transplants were superior to antibiotics for patients with recurring C-diff.

The FDA announced last May that it would regulate stool transplants as an experimental drug, meaning doctors could only perform transplants under an FDA-approved research application. The so-called investigational new drug application must include detailed information on the drug to be tested, the study design and safeguards to protect patients. Assembling a single application can take months or years, even for large drugmakers.

Doctors pushed back, saying the requirement would force them to turn away desperate patients.

“FDA and some others are concerned about the long-term effects,” Brandt said. “But my point was these people are getting ready to die now. They are not going to survive long enough to develop the diseases you’re afraid they’re going to get.”

A few weeks later, the FDA revised its position, saying it would not enforce the requirement for doctors treating patients with drug-resistant C-diff — provided donors are properly screened and patients are informed that fecal transplants are still experimental.

But regulating stool samples as a drug presents other challenges. While it’s easy to limit access to experimental drugs, everyone has access to stool. And with detailed instructions available on websites like thepowerofpoop.com, there’s nothing to stop patients from trying the procedure at home — especially if they can’t find a doctor to perform it.

“Some of these patients are very desperate and they’re not going to take no for an answer,” says Dr. Michael Edmond of Virginia Commonwealth University, who has performed fecal transplants for patients who travel from as far away as Ohio.

Catherine Duff of Carmel, Indiana, says she had no choice but to help herself. In April 2012, she was suffering through her seventh C-diff. infection, going to the bathroom 20 to 30 times a day and making multiple trips to the hospital due to dehydration.

“My quality of life had gotten to the point where I was beginning to think that it might be better to die,” says Duff, 58.

Duff asked three different physicians if she could try a fecal transplant, but none were willing to perform the procedure. Her gastroenterologist did offer to test her husband’s stool to make sure it wasn’t contaminated.

Using instructions found online, Duff and her husband created a solution from his stool sample, mixing it with saline in a blender and administering it via an enema bottle. Four hours later, Duff said she felt good enough to get up and go for a walk.

Today, Duff runs a non-profit group, the Fecal Transplant Foundation, which aims to raise awareness of the procedure and help patients. Duff says she gets up to 15 emails a day from patients looking for a doctor or a donor. Some even ask if they can use a stool sample from their infants or pets.

Duff says the unresolved status of FDA’s oversight discourages more doctors from offering the treatment. “There are so many doctors who are suspicious that the FDA could change their mind at any given moment and decide to not exercise discretion,” Duff says.

According to a list maintained by the foundation, only about 100 physicians offer fecal transplants in the U.S. There is no one method for performing the procedure. Some doctors liquefy the stool and drip it into the patient’s colon via colonoscopy. Others use a tube that runs from the nose down into the stomach.

With so few providers available, proponents of stool transplantation have come up with innovative solutions. One big hurdle is the high cost of screening a stool sample, which can run up to $1,500 per sample. Insurance typically doesn’t cover testing the stool sample because donors are usually healthy without signs of sickness.

Since October 2013, a Boston-based “stool bank” has managed to bring costs down to about $250 per treatment by screening samples in bulk. To date, OpenBiome has shipped over 300 stool samples in ready-to-use frozen preparations to 39 hospitals.

But in March, the FDA released an updated proposal for regulating fecal transplants, saying doctors should only use stool from a donor who is “known” to either the patient or their physician. Some doctors and patients worried the proposal, if finalized, would shutter OpenBiome and a handful of other stool banks, which use anonymous donors and ship to providers hundreds of miles away.

But OpenBiome founder, Mark Smith, says his group continues operating after having several productive discussions with the FDA. Smith says regulators have encouraged him to set up a formal study in which hospitals that work with OpenBiome will contribute data on the safety and effectiveness of fecal transplants.

“They understand the importance of making treatment available for patients today, while making sure there is adequate oversight of the risks,” Smith says. “We’re actually totally on the same page.”

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Stakes Are High for Peanut Corp. of America Defendants in Criminal Trial

Stakes Are High for Peanut Corp. of America Defendants in Criminal Trial

Josh Long

May 14, 2014 - Blogs

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 The U.S. Justice Department has secured the cooperation of two key witnesses in a felony criminal prosecution against executives of the defunct Peanut Corporation of America, a peanut processor and manufacturer whose gross annual sales once totaled $30 million.

Daniel Kilgore and Samuel Lightsey served as operations managers at a peanut plant in Blakeley, Georgia, which was tied to a Salmonella outbreak that caused more than 700 illnesses and nine deaths in 2008 and 2009.

Last week, Lightsey pleaded guilty to a number of charges filed against him and faces several years behind bars under a plea agreement with federal prosecutors. He and Kilgore have agreed to cooperate with the government in a criminal trial that is pending against three other defendants, two of whom are brothers: Stewart Parnell, the owner and president of PCA; and his sibling, Michael, who worked as a food broker on behalf of the company.

In a 76-count indictment unveiled last year, federal authorities contend the former officials mislead customers about the presence of Salmonella in peanut products that were sold to them, fabricating documents that stated shipments of peanut products contained no pathogens when no tests were conducted or lab results showed the presence of Salmonella. The former officials also have been accused of lying to U.S. Food and Drug Administration (FDA) inspectors following a widespread outbreak that caught lawmakers' attention.

The Salmonella Typhimurium outbreak was traced back to PCA's plant in Blakeley, and was linked to 714 reported illnesses in 46 states and nine deaths in Idaho, Minnesota, North Carolina, Ohio and Virginia, according to the Centers for Disease Control and Prevention (CDC). The government contends the PCA officials failed to ensure the plant was sanitary and prevent cross-contamination between raw and cooked products.

Jury Trial Pending
W. Louis Sands, a U.S. District Judge, is scheduled to preside over a jury trial on July 14 in Albany, Georgia against the Parnells, who each have been charged with mail and wire fraud, the introduction of adulterated and misbranded food into interstate commerce with the intent to defraud or mislead and conspiracy. The U.S. Attorney’s Office for the Middle District of Georgia also charged Stewart Parnell with obstruction of justice. A third defendant, Mary Wilkerson, a former PCA receptionist, officer manager and quality assurance manager, is set to go to trial alongside the Parnells on several charges, including obstruction of justice.

The criminal case could go to a jury five years after lawmakers with the House Energy and Commerce Committee looked into the cause of the outbreak. Documents obtained by the Subcommittee on Oversight and Investigations tended “to show a company that was more concerned with its bottom line than the safety of its customers," said Rep. Henry Waxman, the California Democrat, at the outset of the Feb. 11, 2009 hearing.

For instance, Waxman referenced an email from Stewart Parnell that stated, in part, “the cost is costing us huge $$$$$". That email was fired off to Lightsey and another PCA official, David Voth, on Oct. 6, 2008 after Lightsey revealed the previous month that products tested positive for Salmonella, including 320 cases of a lot that had been shipped to two customers, Fieldbrook and Kerry Ingredients.

“In this case, the scope of the outbreak is not as important … as the conduct of the people who were involved and that’s what really is at question," said David Plunkett, a senior staff attorney with the Food Safety Program for the Center for Science in the Public Interest, in a phone interview.

Prosecutors have painted the defendants as participants in a long-standing scheme to defraud their customers, who ranged in size from small, family-owned operations to multibillion-dollar food giants.

If the Parnells decide to roll the dice before a jury, they will be tried together. The brothers requested separate trials, arguing that their defenses were “antagonistic and mutually exclusive," according to prosecutors. But a judge denied the request, said Pam Lightsey, a spokeswoman for the U.S. Attorney’s Office.


Former Plant Managers Witnesses for Prosecution
The defendants who pleaded guilty aren’t exactly getting a sweetheart deal.

The government agreed to recommend a prison sentence of no more than six years for Lightsey and no more than 12 years for Kilgore. The potential prison sentences are staggering especially in a case of foodborne illness. For instance, Lightsey faces a maximum prison sentence of 20 years each on three counts, five years each on two other counts and three years each on two remaining counts.

Both men agreed to cooperate with the government and conceded that a number of allegations leveled against them in the indictment are true. The admissions of guilt put the remaining defendants, particularly the Parnells, in a difficult spot. As an example, Kilgore admitted the government’s allegation in Paragraph 29 that he and the brothers shipped peanut paste to a customer without submitting a sample from the lot for microbiological testing but instead submitted a false certificate of analysis. Among the allegations that Lightsey acknowledged are true: that Stewart Parnell had directed him to release a product that had originally tested positive for Salmonella but tested negative on a retest.
Such allegations, if corroborated on the witness stand by Kilgore and Lightsey, could persuade a jury that the brothers intended to defraud their customers and could care less whether or not their peanut products contained pathogens like Salmonella.

Proving intent is a necessity—and a highly contested matter—in a case of fraud. Thanks to the plea agreements with Kilgore and Lightsey, the government knows it can call the former plant managers and obtain their testimony demonstrating such bad intent, said Ronald Friedman, a former criminal federal prosecutor for 22 years and current co-chair of Lane Powell’s White Collar Criminal Defense, Regulatory Compliance and Special Investigations Practice Group.

“They [Kilgore and Lightsey] are going to mouth all those bad allegations about bad intent. ‘This was intentional. We meant to do this. This was a conspiracy,’" said Friedman, who examined the indictment and other court documents before commenting.

Friedman, who has no connection to the case, thinks it’s less likely the Parnells will deny the falsification of documents and other evidence of fraud that the indictment references. Instead, they may testify the fraud occurred without their knowledge.

“Yah this happened. Yah false tests were provided. Yah this was a terrible thing," Friedman anticipates the defendants arguing, “but we didn’t know about it."

That could be a hard sell to the jury particularly for Stewart Parnell, who owned and ran the company as president. Especially when considering allegations in the indictment under the title “Overt Acts", which if corroborated by the plant managers, tend to show his knowledge and participation in the scheme. Consider a Sept. 15, 2004 shipment of peanut products by Stewart Parnell and Kilgore to a customer; lab results later indicated the products tested positive for Salmonella, yet neither man notified the customer about the pathogen, according to the indictment. If Kilgore affirms the veracity of that allegation in open court, and testifies that Parnell was notified that the products tested positive for the pathogen, it’s going to be hard for PCA’s president to plead ignorance.

But he may raise a separate defense at trial other than simply being in the dark about the illicit operations in Blakeley. A purported expert for the defense, Joseph Conley, claims Parnell suffered from ADHD or attention deficit hyperactivity disorder.  According to court documents filed on March 11, 2014, Parnell has sought to offer Conley’s testimony to show he “did not commit the alleged crimes because he never factually acquired the knowledge necessary to form any intent about the actions alleged by the government." The prosecution, through a separate expert, claims Conley’s methods are unreliable and he shouldn’t be allowed to testify.
Sands, the federal judge, hasn’t yet ruled on whether or not Conley can testify at trial as an expert.

Government’s Cites Lies
The Justice Department claims this is not your run-of-the-mill case of foodborne illness.

Not only did some PCA officials fabricate documents upon which customers relied, they lied to or misled FDA inspectors who visited the plant in January 2009 following the outbreak, according to prosecutors.
“When those responsible for producing or supplying our food lie and cut corners, as alleged in the indictment, they put all of us at risk," said Stuart F. Delery, who heads the Justice Department’s Civil Division, in a statement at the time the indictment was announced.

At least some victims want the Parnells to be held accountable for the outbreak.

Bill Marler, a renowned food-safety lawyer who represented five of the nine individuals who died and dozens of victims who fell ill from contaminated peanut products, remembers a congressional investigation in which two of his clients who had lost parents to the outbreak testified.

“It was a time when Mr. Lightsey and Mr. Parnell took the 5th Amendment," Marler said. “It was pretty powerful."
Marler said a number of his clients communicated with the U.S. Attorney’s Office from spring 2009 through 2012. “My clients were frustrated that Parnells weren’t being prosecuted," he recalled.

Then on Feb. 21, 2013, prosecutors announced the 52-page indictment against the brothers, Lightsey and Wilkerson.

Plunkett of the Center for Science in the Public Interest expressed hope that the case would send a message to the food industry and serve as a deterrent against egregious behavior that compromises food safety.

 “You want that deterrent effect and I would hope certainly that would be one of the outcomes of this," he said. “I think by and large the industry gets that … If they are not keeping safety as their No. 1 priority, there are consequences."

Pouch Packaging Sector to Reach $9.4 Billion by 2018

Pouch Packaging Sector to Reach $9.4 Billion by 2018

Judie Bizzozero

May 06, 2014 - Blogs

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It’s been a little more than one year since Capri Sun took a beating over research conducted at Indiana State University that discovered five different types of mold in the popular kids’ drink. The research project was triggered after reports of consumers finding fungal mats in the beverages hit the mainstream media, causing consumer outcry for more transparency.

The fungal growth occurred because Capri Sun does not contain preservatives, and both Kraft Foods (the maker of Capri Sun) and scientists were quick to point out that for the majority of people, other than being grossed out, the fungal mats pose no harm to humans except possibly for patients who are immune-compromised or have some other underlying diseases. Kraft’s website stated that the mold was a result of breaches in packaging and a lack of preservatives in the drink.

So why is this important more than a year later? Over the past month, I have noticed Capri Sun ads touting new pouch packaging with clear bottoms—clearly a move by Kraft to convey more transparency. According to Kantar Media, Capri Sun spent millions to the development of the clear panel, and nearly doubled its marketing budget to $45 million over last year.

According to the company’s website, “We made the change for several reasons. Moms across the country told us they like that Capri Sun juice drinks are made with no artificial preservatives, colors or flavors, but wanted the ability to see inside the pouch. The clear bottom makes it easy to verify that the Capri Sun kids love contains all the goodness moms expect and nothing they don’t."

So why didn’t Kraft just scrap the pouch packaging? The answer: Because pouch packaging clearly presents food and beverage makers with a number of advantages.

In fact, demand for pouches in the United States will reach $9.4 billion by in 2018, fueled by above average gains for stand-up pouches stemming from sustainability, function, and marketing advantages over alternative packaging media, according to a new report from Freedonia.
Advances for stand-up pouches will be well above those of most other packaging types, resulting from growing interest among packaged goods companies. This interest is based on savings achieved in shipping costs due to the lighter weight and lower material use of stand-up pouches compared to rigid containers. Also supporting gains will be the ability of stand-up pouches to differentiate products on store shelves due to their use of high-quality graphics. In addition, heightened use of reclosing and dispensing components will increase the competitiveness of pouches against rigid containers.

According to the report, in flat pouches, the fastest growth will be seen in four-side-seal pouches, driven by rising demand in medical and pharmaceutical markets, and in food applications, such as meat, poultry, seafood, sauces and condiments. Flat pouch advances will also be supported by improved barrier structures and the incorporation of such convenience features as resealable closures, spouts, and tear notches.

Spouted pouches are expected to register double-digit growth through 2018, driven by expanding use of pouches in general, along with the functionality and convenient dispensing afforded by spouts. Baby food, sauces and condiments, and other processed food applications will offer solid opportunities for spouted pouches. In fact, spouted pouches for baby food provide advantages in terms of portability and convenience as they enable self feeding. Rapid advances are also expected in the beverage market as spouted pouches become more common with alcoholic beverages, premixed cocktails, sports drinks and energy drinks.

Food and beverage markets accounted for 80 percent of pouch demand in 2013. Stand-up pouch demand will outpace that of flat pouches based on their combination of performance, strong shelf appeal, user friendliness, and sustainability qualities due to their lighter weight and reduced material use. Value gains also will be fueled by heightened demand for larger sized pouches, spouted pouches, pouches with carrying features, and pouches that use self-venting films to enable steam cooking of contents in the package.

Through 2018, the fastest-growing food and beverage applications for pouches will be pet food and meat, poultry, and seafood.

FOOD ADDITIVES: The Top 10 Evil Food Additives

The Top 10 Evil Food Additives

By: Emily Lockhart on Friday, January 24th, 2014 @ 9:21 am 

2

If you live in North America, it’s difficult to avoid processed cereals, snacks, and processed convenience foods in your diet. However, a diet high in processed foods exposes your body to a swarm of evil food additives, all of them artificially engineered and all of them bad for your health.

When you can, opt for fresh foods. However, when you can’t avoid processed convenience, here are the top ten evil food additives to look out for…

1. High Fructose Corn Syrup

High fructose corn syrup (or HFCS) is not only a mouthful to say, it’s also pretty treacherous on the waistline as well, making up the bulk of empty calories in processed foods, and HFCS is an ingredient in pretty much all of them! Not only does this additive—found primarily in processed snacks, breads, salad dressings, cereals, and candy—raise LDL cholesterol (bad) levels; it aids weight gain, and contributes to type 2 diabetes.

2. Trans Fat

The dreaded trans fat got a lot of attention a few years back prompting consumers to scour shelved foods for this (literally) heart-stopping substance. However, almost all deep-fried fast foods contain the bad fat that causes increased LDL (or bad) cholesterol levels, and in turn leading to heart disease, diabetes, chronic inflammatory disorders, and strokes. Look for trans fats in any deep fried goodies, chips, crackers, baked treats, or any foods made with margarine or partially hydrogenated vegetable oil.

3. Aspartame

Aspartame, which is the chemical combination of E951, is rife in diet, no fat, and sugar free-labeled soda, gum, sweets, cereal, yogurt, and a plethora of other convenience foods and beverages. While it may mask itself as a dieters ally, Aspartame is a neurotoxin and carcinogen, which basically means that it’s a toxic sweet poison that’s been linked to brain tumors, diabetes, multiple sclerosis, Alzheimer’s, anxiety disorders, and migraines.

4. Food Dyes

Blue #1 and #2 (or E133), red #40 (or E124), yellow #6 (or E110), and yellow tartrazine (or E102)—most of these common, artificial food dyes have been banned in European countries for causing brain and behavioral issues, thyroid and adrenal cancer, and chromosomal damage. If you take the time to read the box, you’ll find them hidden in North American sweet snack foods, boxed macaroni and cheese, cereal, soda, energy drinks, and ice cream.

5. Monosodium Glutamate

MSG, the popular amino acid that’s so flavor-enhancing that it literally makes you see spots. I’m not kidding; this popular excitotoxin—added to soups, salad dressings, and restaurant entrees—will eventually cause disorientation, impaired vision, headaches, and neurological damage if consumed in excess.

6. Sodium Nitrate

Sodium nitrate has put a black smear on processed lunchmeats—like bacon, ham, hot dogs, and other processed meats—for its carcinogenic on the human digestive system. Sure, it adds to the preservation time and boosts color in these foods, but it also causes liver and pancreatic damage.

7. Potassium Bromate

A common additive that “fluffs” or boosts the volume of bread products made with refined, white flour, potassium bromate might give that crusty roll extra softness in the middle. However, trace amounts of potassium bromate led to several cancer diagnosis when it was fed to animals during food testing studies.

8. Sulfur Dioxide

Sulfur additives (or E220) is considered so toxic that the U.S. Federal Drugs Administration (FDA) actually banned its use in soda, beer, juice, vinegar, and dried fruits. Once sprayed on raw fruits and vegetables for preservation at the grocery store, sulfur dioxide has been linked to causing hypotension, conjunctivitis, asthma, bronchitis, emphysema, and cardiovascular disease.

 

9. Sodium Sulfite

The preservative also listed as E221 (or sulfites) on wine and foods containing processed dried fruit, is a prime cause of food sensitivities and associated headaches, rashes, and asthma. Those with severe allergies can actually suffer anaphylaxis (or restricted airways) and death due to consuming foods containing sulfites.

10. BHA and BHT

Butylated hydroxyanisole (BHA) and butylated hydrozyttoluene (BHT) are commonly added to foods to prevent spoilage as far as taste and color. You’ll find this mood-altering, cancer-causing additive in boxed cereals, chewing gum, some frozen meats, jello, and potato chips made with vegetable oils or snacks made with shortening and lard.

 

FOOD ADDITIVES: How Safe are the Ingredients?

The Truth About 7 Common Food Additives

How safe are the ingredients in your food?

Reviewed by Kathleen M. Zelman, MPH, RD, LDBy Martin Downs, MPH
WebMD Feature

If, like many Americans, you stock your pantry with processed foods, you may worry about how safe food additives really are.

Over the years, the safety of many food additives, from food dyes to trans fats, has come into question. A scare over a food additive may linger in our minds long after researchers find that there's actually no cause for alarm. It can take years, or even decades, to find out the truth, and sometimes the case is never really closed.

To help you figure out what’s safe, WebMD took a look at the latest research on seven of the most controversial food additives. Here’s what we found:

1. Artificial coloring

What it is

Artificial food colors are chemical dyes used to color food and drinks.

Foods that have it

Many types of processed foods, beverages, and condiments have artificial coloring in them.

Why it's controversial

Artificial food color is suspected of causing increased hyperactivity in children. Also, the dye Yellow No. 5 has been thought to worsen asthma symptoms. (In the 1970s, the FDA famously banned Red Dye No. 2 after some studies found that large doses could cause cancer in rats.)

What the research shows

In 2007, a British study published in The Lancet concluded that consuming artificial coloring and preservatives in food can increase hyperactivity in kids. Scientists have been studying the link between food additives and hyperactivity in children for more than 30 years, with mixed results. But the results of the 2007 study compelled the European Food Standards Agency to urge companies to voluntarily remove artificial coloring from food products. The FDA, however, hasn't changed its opinion on the use of FDA-approved artificial food colors, which it considers safe when used properly.

Reports suggesting that the food color Yellow No. 5 might aggravate some people's asthma symptoms date back to the 1950s. But in most controlled studies, Yellow No. 5 has not been shown to have a significant impact on asthma, according to a review of all known studies, which is updated every year.

How you find it on the label

The following artificial colors are approved for use in food products and must be listed as ingredients on labels:

• FD&C Blue No. 1 (brilliant blue FCF)       
• FD&C Blue No. 2 (indigotine)
• FD&C Green No. 3 (fast green FCF)       
• FD&C Red No. 40 (allura red AC)           
• FD&C Red No. 3 (erythrosine)
• FD&C Yellow No. 5 (tartrazine)
• FD&C Yellow No. 6 (sunset yellow)
• Orange B (restricted to use in hot dog and sausage casings)

2. High fructose corn syrup continued...

Foods that have it

High fructose corn syrup is a common additive in many kinds of processed foods, not just sweets. Most non-diet soft drinks are sweetened with high fructose corn syrup.

Why it's controversial

Some experts have proposed that people metabolize high fructose corn syrup in a way that raises the risk of obesity and type 2 diabetes more than sugar made from sugar cane. Much of the controversy stems from the observation that obesity in the United States and consumption of high fructose corn syrup increased at the same time.

What the research shows

"It's just sugar," says Marion Nestle, PhD, a professor of nutrition and public health at New York University. "Biochemically, there's no difference."

The high fructose corn syrups commonly used to sweeten foods and drinks are 55-58% fructose and 42-45% glucose. Sucrose (cane sugar) is a double sugar made of fructose and  glucose. Digestion quickly breaks down cane sugar and high fructose corn syrup into fructose and glucose.

"There's a little bit more fructose in high fructose corn syrup, but not a lot," Nestle says. "It doesn't really make any difference. The body can't tell them apart."  The American Medical Association recently stated that there is scant evidence to support the idea that high fructose corn syrup is any worse than cane sugar and that consuming too much sugar of either kind is unhealthy.

How you find it on the label

High fructose corn syrup can be found in the list of ingredients on a food label.

3. Aspartame

What it is

Aspartame is an artificial sweetener known by various brand names, including Equal and NutraSweet.

Foods that have it

Aspartame is a commonly used additive for sweetening diet soft drinks.

Why it's controversial

Various health concerns have been raised about aspartame since it was introduced in 1981. Most recently, it has been suspected of causing cancer. There have been reports of aspartame causing seizures, headaches, mood disturbances, and reduced mental performance. A study published in 2005 suggested that aspartame could cause leukemia and lymphoma in rats. Another study, published in 1996, argued that an increase in the rate of brain tumors in the United States could be related to consumption of aspartame.

What the research shows

Dozens of studies in people and animals have tested for effects possibly related to aspartame. The majority of these studies show that things such as headaches, seizures, and mental and emotional problems didn't occur with aspartame more often than with placebo, even at doses many times higher than anyone would likely ever consume. Large epidemiological studies haven't found a link between aspartame and cancer. A study of about 500,000 people, sponsored by the National Cancer Institute, compared those who drank beverages containing aspartame with those who didn't. It found that people who drank increasing amounts of beverages containing aspartame did not have a greater risk for lymphomas, leukemias, or brain cancer. Another study looked at data from a large survey done by the National Institutes of Health. The survey included detailed information on 1,888 cases of leukemia or lymphomas and 315 cases of brain cancer. The researchers found no link between aspartame consumption and those cancers.

"For more than three decades, research has found aspartame to be safe, and today it is approved for use in more than 100 countries," says Robert E. Brackett, PhD, spokesman for the Grocery Manufacturers Association, a lobbying organization in Washington, D.C. "In fact, the U.S. Food and Drug Administration has confirmed the safety of aspartame 26 times over a period of 23 years, with the most recent confirmation in April 2007."

How to find it on the label

Look for aspartame in the list of ingredients.

4. Monosodium glutamate (MSG)

MSG by itself looks like salt or sugar crystals. It is a form of the naturally occurring chemical glutamate. Glutamate doesn't have a flavor of its own, but it enhances other flavors and imparts a savory taste. Tomatoes, soybeans, and seaweed are examples of foods that have a lot of glutamate naturally. Some scientists say that glutamate, also known as "umami," is the fifth essential flavor that the human palate can detect, in addition to sweet, salty, bitter, and sour.

Foods that have it

MSG is an additive used in many foods.

Why it's controversial

Many people claim to have bad reactions when they eat food seasoned with MSG. In the late 1960s, people started talking about "Chinese restaurant syndrome," alleging that food prepared with MSG at Chinese restaurants made them sick.

What the research shows

Many studies over the past four decades have tested the idea that some people may be sensitive to MSG. Most scientists today agree that if there is such a thing as a sensitivity or allergy to MSG, it's extremely rare. Studies haven't found any regular pattern of symptoms that could be typical of a reaction to MSG. Also, people are more likely to have symptoms if they're given MSG crystals than if they eat the same amount of MSG mixed with food.

"It's very hard for me to believe that there's a problem with it," Nestle says. Nevertheless, some still swear that they have bad reactions to MSG. "People who think they have problems with it should avoid it," she says.

How you find it on the label

Some food labels come right out and say that a product contains added MSG. But there are other ingredients that may contain MSG such as "hydrolyzed soy protein" and "autolyzed yeast."

5. Sodium benzoate

What it is

Sodium benzoate is a food additive used as a preservative.

Foods that have it

Sodium benzoate is used in a variety of processed food products and drinks.

Why it's controversial

It's suspected that sodium benzoate, in addition to artificial food color, may increase hyperactivity in some children. Sodium benzoate in soft drinks may also react with added vitamin C to make benzene, a cancer-causing substance.

What the research shows

The 2007 Lancet study that linked additives with increased hyperactivity included the preservative sodium benzoate.

In 2006 and 2007, the FDA tested a sample of almost 200 beverages from stores in different states that contained sodium benzoate and vitamin C. Four of the beverages had benzene levels that were above federal safety standards. The drinks were then reformulated by manufacturers and later deemed safe by the FDA. The agency points out, however, that the tests were limited and that it's still not known how much benzene consumers could be exposed to from beverages.

How you find it on the label

Sodium benzoate is listed among the ingredients on a product label.

6. Sodium nitrite

Sodium nitrite is an additive used for curing meat.

Foods that have it

Sodium nitrite is usually found in preserved meat products, like sausages and canned meats.

Why it's controversial

There is a theory that eating a lot of sodium nitrite might cause gastric cancer.

What the research shows

There is evidence that sodium nitrite could have been to blame for a lot of the gastric cancers that people had in the past. Until the early 1930s, gastric cancer caused the most deaths of all cancers in the United States. After that, more Americans began to use modern refrigeration and ate less cured meat. Also, producers started to use much less sodium nitrite in the curing process around that time. As these changes took place, deaths from gastric cancer also dropped dramatically.

This theory has been debated for decades, and it is still an open question.

How you find it on the label

Sodium nitrite will be listed as an ingredient on the labels of food products.

7. Trans fat

What it is

Trans fats are created when manufacturers add hydrogen to vegetable oil. Trans fats are food additives in the sense that they're mainly added to the food supply by manufacturing processes, although small amounts of trans fats are present naturally in animal fat.

Foods that have it

These "partially hydrogenated oils" are used most often for deep-frying food, and in baked goods. Margarine and vegetable shortening may also be made with partially hydrogenated oil.

Why it's controversial

Trans fats are believed to increase the risk of heart disease and type 2 diabetes.

What the research shows

Most scientists now agree that eating trans fats can be very harmful to health. Trans fats have been found to lower people's HDL (good) cholesterol and raise LDL (bad) cholesterol. The American Heart Association recommends getting less than 1% of your daily calories from trans fats.

How you find it on the label

Product labels are now required to list the amount of trans fat in a serving. Partially hydrogenated oil may also be listed as an ingredient.

But many fried foods and baked goods that are laden with trans fats are served in restaurants, and they don't come with nutrition labels. To avoid trans fats, it's best to limit your overall daily fat intake.

"Usually, when you increase the total amount of fat you consume, you increase the amount of trans fat as well," says Benjamin Caballero, MD, a professor at the Center for Human Nutrition at the Johns Hopkins Bloomberg School of Public Health. If you reduce your total fat intake from 13% of your daily calories (which he says is typical for Americans) to less than 10% (which is recommended), you probably won't exceed the limit on trans fat.

"There are so many controversial studies about ingredients that are a little more emotionally mediated by one study showing it harmful and another study showing it not harmful, and then people say, ‘What am I to do?’”

"You're going to get more nutrient bang for your buck to eat less refined foods when you can," says Christine Gerbstadt, MD, RD, a spokeswoman for the American Dietetic Association.