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Food Safety Guidelines: Voluntary Product Recall vs. Mandatory Recall

product recallIf food and food products become unsafe, they can be withdrawn from the market either by voluntary recalls or via a mandatory recall issued by the Federal government. But what’s the difference between the two?

Simply put, a voluntary recall can be effected by either the company which made the product or U.S. regulatory authorities. A mandatory recall is issued by the U.S. government.

Both types of recalls depend on receiving reports from affected citizens or businesses.

Recalls by the U.S. government: degree of public risk at issue

The U.S. Food and Drug Administration (FDA) has the authority to regulate the safety of medical devices, prescriptions, and some foods. Other government authorities, such as the U.S. Department of Agriculture (USDA), are responsible for food safety as well.

If food becomes unsafe for the public, the U.S. Food and Drug Administration (FDA) has the authority to issue either a voluntary product recall or a mandatory recall.

There are three stages of FDA recall. The demarcation between them is the amount of public risk the food poses. The stages are:

Class I Recall – Immediate and Significant Danger of Death or Injury

The Class I recall means that the FDA has determined there to be a significant and immediate danger of death or serious injury from using the product. In a Class I Recall, the FDA issues a plan for the manufacturer to completely recall the product. The plan needs to be trackable, to ensure that all stores and other sales sites have eliminated the product from inventory and that purchasers have been alerted to stop using the product and get it out of their homes.

Class II Recall – Risk of Death or Serious Injury

A Class II recall means that risk of death or serious injury from the product exists, but it is not immediate. As in Class I, the FDA issues a plan for the manufacturer and consumers.

Class III Recall – Products Available That Violate FDA Regulations

A Class III recall is issued when danger is not imminent or there may not be health-related concerns, but products are available that are in violation of FDA regulations. In 2010, for example, the FDA issued a Class III recall of a children’s medication whose production process had led to plastic in the bottles. While not food, it illustrates the scope of a Class III recall.

Generally, the FDA issues recall plans and stipulations and relies on responsible parties — the product manufacturers, stores, and suppliers, among others — to comply with the plan. However, if they do not comply, the FDA has the authority to issue a mandatory recall.

Food recalls by a company

Companies who receive reports that their products are causing danger, ill effects, or death among the public can also put a voluntary recall plan into effect. They can also voluntarily recall products if they discover defects in the processes used to develop or manufacture the product, before or after it is shipped to outlets.

Essentially, there are two types of company-initiated recalls. The first is termed “market withdrawal.” This can be done if a product does not violate FDA regulations, but is unsafe. The company both removes any outstanding product on the market and fixes any violation.

The second is recall done by the firm itself. This may be done if the company, for example, realizes a product poses danger and moves to eliminate the danger before the FDA issues a recall.

Companies also undergo product recalls in conjunction with an FDA plan, under the three classifications discussed above.

Types of recalls can change according to circumstances. In the 2013 case of Chobani yogurt, for example, the product was determined to have a type of mold that had the potential to make people sick. Chobani first used a market withdrawal, and then moved to a recall.

Talk to a product recall attorney today

Ellis Law Firm has been protecting people’s rights from corporations in southern California for more than 20 years. If you or a loved one has been harmed by a food or by food-borne illness because a food was manufactured or sold unsafely, we can help.

Call us today to discuss product liability or negligence. Your consultation with one of our experienced and knowledgeable product liability lawyers comes at no charge to you. Call 1-800-INJURED today.

Additional California food recall resources:

  1. “FDA Publishes Draft Guidance on Mandatory Recall Authority.” Food Safety News. May 7, 2015. http://www.foodsafetynews.com/2015/05/fda-publishes-draft-guidance-on-mandatory-recall-authority/#.WOVhbDvys9A
  2. Recalls and Alerts. Foodsafety.gov. https://www.foodsafety.gov/recalls/index.html
  3. U.S. Food and Drug Administration. FDA Basics. “What Is a Recall?” https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194885.htm

Garden Hoses: Another Source of Dangerous Lead

A drink from the garden hose, a run through the sprinkler on a hot day, a wading pool full of cool clear water-these are some of the great joys of childhood. But is the water that’s coming through the garden hose safe?

Recent studies have found that many garden hoses contain unsafe levels of lead that can leech into the water that runs through the hose. Lead has been found to cause developmental delays, muscle problems and other health issues in children.

One study by “Consumer Reports” magazine found that water sitting inside a hose that has been left in direct sun can have more than 100 times the government’s maximum levels of lead for water that is considered drinkable.

Why Are Hoses Dangerous?

The lead problem seems to stem from the fact that many hoses are made of a plastic called polyvinyl chloride (PVC). Lead is often used to stabilize PVC and keep it from deteriorating as quickly. Since garden hose water is not meant to be directly consumed by humans, the government does not currently prohibit sales of PVC hoses.

Some studies suggest, however, that even watering vegetables and other foods with a PVC hose could cause people to ingest elevated levels of lead. Tests of garden soil in many areas show elevated lead levels. To avoid lead contamination, buy a hose that is not made with PVC. Several manufacturers offer PVC-free garden hoses.

If you or a family member has suffered from medical problems related to lead poisoning, and you believe the contamination originated from a garden hose or any other source, consult an experienced attorney familiar with the problems associated with lead poisoning.

Los Angeles Food Poison Attorney – What To Do If You’ve Been Food Poisoned?

The Oxford English Dictionary defines “poison” as “a substance that is capable of causing the illness or death of a living organism when introduced or absorbed.”

The legal definition of the term is “any product or substance that can harm someone if it is used in the wrong way, by the wrong person, or in the wrong amount.”

The medical condition of poisoning is even broader: It can be caused by substances that are not even legally required to carry the label “poison.”

Therefore, can food become poisonous? Of course it can if it is infected, tampered with or altered in any way that causes it to become detrimental to its consumer. In fact, that’s what we call “food poisoning.”

But what about the genetic engineering, tampering or alteration of our food supply? If it causes bodily harm, even over the long haul, could that be considered poisoning?

I call again to the stand Dr. George Wald, a Nobel laureate in physiology or medicine and one of the first scientists to speak out about the dangers of genetically engineered foods. He explained: “Recombinant DNA technology (genetic engineering) faces our society with problems unprecedented, not only in the history of science, but of life on the Earth. … Now whole new proteins will be transposed overnight into wholly new associations, with consequences no one can foretell, either for the host organism or their neighbors. … For going ahead in this direction may not only be unwise but dangerous. Potentially, it could breed new animal and plant diseases, new sources of cancer, novel epidemics.”

food poisoning infographic

Last week, I discussed the dangers of genetic engineering to crop seeds and other foods. As a response, one of the readers of “C-Force,” my weekly health and fitness column, asked, “What do you think are the best ways to avoid GMOs when they aren’t even labeled on food ingredients?”

Let me tell you how I responded.

First, contact your governmental officials, and ask them to endorse or support legislation that requires food companies to start listing whether their products use GMOs.

At least 14 states have introduced legislation on genetically modified ingredient labeling, but most face government gridlock. So take action, and keep foods safe (non-genetically engineered) by contacting your state and federal representatives — as well as the Food and Drug Administration and the U.S. Department of Agriculture — and tell them to legislate that genetically modified ingredients be labeled on every package.

Ask your federal representatives to support the new federal labeling bill, the Genetically Engineered Food Right-to-Know Act, which would require the food industry to label all genetically engineered foods and ingredients. In addition, tell your representatives that corn and cotton must not be deregulated, because without strict controls, genetically engineered crops will encroach on non-genetically engineered crops, contaminating them and rendering the organic crops as nonorganic.

The biggest question is: How can we best avoid genetically modified ingredients in our food and elsewhere?

Here are the best ways that I’ve discovered from GMO and nutrition specialists and resources:

Salmonella, e. coli and listeria are among the pathogens that can contaminate food, leaving the people who consume it sick – sometimes seriously, suffering from a severe illness that can include long-term health consequences. A serious bout of food poisoning can also leave a victim with significant medical expenses, lost wages and other problems.

Food poisoning causes about 48 million people to get sick, 128,000 hospitalizations, and up to 3,000 deaths each year, according to the Centers for Disease Control (CDC). Salmonella alone, one of the most common forms of food poisoning, accounts for medical costs and lost work time of about $1 billion.

Everything from tainted lettuce, contaminated meat and even defective children’s snack foods has been implicated in large- scale food poisoning outbreaks.

Contamination

Bacteria and viruses can contaminate food in many ways. Poor sanitation or preparation is a key way. For example, food handlers who do not wash their hands after using the bathroom or who have infections themselves can cause food-borne illnesses. Manufacturers that do not maintain sanitary conditions at factories or packing plants can cause food poisoning. Fruits and vegetables can become contaminated with bacteria while still in the fields as a result of exposure to animal waste. Improperly packaged food stored at the wrong temperature also promotes contamination.

Bacteria that Frequently Cause Food Poisoning

Bacteria are one of the most common causes of food borne illnesses, which each type offering its own host of adverse reactions and consequences. A wide range of tainted food can pose danger, including peanut butter, meat, seafood and lettuce. Salmonella – which is transmitted by undercooked foods, such as eggs, poultry, dairy products, and seafood – is a common type of food poisoning; it can cause a moderate illness with nausea, vomiting, cramps/diarrhea, and headaches, which may return a few weeks later in the form of arthritis (joint pains). Salmonella can, however, become a life-threatening malady for people with impaired immune systems (such as those with kidney disease or HIV/AIDS, as well as those on chemotherapy for cancer).

E. coli O157:H7 is one of hundreds of strains of the bacterium Escherichia coli. Although most strains are harmless, this particular one infects about 73,000 and causes some 61 deaths in the United States each year. E. coli causes moderate to severe illness that begins as watery diarrhea, but progresses into bloody diarrhea. The more virulent E. coli O15:H7 can cause kidney failure and death (about 3-5% of all cases). It is transmitted by eating raw or undercooked hamburger, unpasteurized milk or juices, or contaminated well water.

Listeria is a bacterium found in soil, vegetation, raw milk, meat, poultry, cheeses (particularly the soft mould-ripened varieties) and salad vegetables. Listeria symptoms can vary from a mild flu-like illness to meningitis and septicemia. In pregnant women, Listeria can cause a miscarriage or the birth of an infected child, and even require an abortion. Other people at risk of a bad strain are those with compromised immune systems, including the very young and the very old.

Viruses that Cause Food Poisoning

Viruses are a major cause of food borne illnesses. In many instances, viruses contaminate food because food industry workers do not take precautions to insure a sanitary environment. One such virus that can be passed in this manner is the Norwalk Virus, which causes a mild illness that induces nausea, vomiting, diarrhea, stomach pain, headache, and low-grade fever. It is the most common viral cause of adult food poisoning and is transmitted from water, shellfish, and vegetables contaminated by feces, as well as from person to person.

Hepatitis A is another virus that can be transmitted via food. Hepatitis A causes mild illness with sudden onset of fever, loss of appetite, and feelings of tiredness; these usually are followed by jaundice, which is a yellowing of the eyes and skin. In extreme cases, Hepatitis A can cause one to need a liver transplant; it also can cause death. It is transmitted from person to person by fecal contamination of food. In the past, infected waiters have passed Hepatitis A on to restaurant patrons. The largest Hepatitis A outbreak in U.S. history occurred in 2005 at Chi-Chi’s Mexican Restaurant in Pennsylvania. More than 500 people contracted Hepatitis A – three of whom died –after eating at the restaurant. The outbreak was linked to tainted green onions.

Rotavirus is another virus that can be passed through contaminated food. Rotavirus causes moderate to severe illness, with vomiting, followed by watery diarrhea and fever. It is the most common cause of food poisoning in infants and children and is transmitted from person to person by fecal contamination of food and shared play areas.

Food Poisoning can Have Long-Term Adverse Health Effects

A bout of food poisoning can cause serious long-term health problems; some victims will still be dealing with the consequences of food borne illnesses months and even years after the initial illness.

E. coli victims sometimes require kidney transplants. They may also have scarred intestines, which can cause lasting digestive difficulty. Even e. coli patients who supposedly recovered can eventually experience long-term health problems. About 10 percent of e. coli sufferers develop a serious complication called hemolytic uremic syndrome, or HUS, where their kidneys and other organs fail.

Salmonella also has potential long-term health consequences. Some victims of Salmonella will develop a disease called Reiter’s Syndrome, a difficult-to-treat form of reactive arthritis that causes severe joint pain, irritation of the eyes, and painful urination. Reiter’s Syndrome can plague its victims for months or years, and can lead to chronic arthritis. Certain strains of shigella and yersinia bacteria, which are far more common abroad than in the U.S., can also trigger Reiter’s Syndrome.

About 1 in 1,000 sufferers of campylobacter, a diarrhea-causing infection spread by raw poultry, develop the far more serious Guillain-Barre syndrome within a month or so. Their body attacks their nerves, causing paralysis that usually requires intensive care and a ventilator to breathe. It is estimated that about a third of the nation’s Guillain-Barre cases have been linked to previous instances of campylobacter, even if the diarrhea was very mild, and they typically suffer a more severe case than patients who never had food poisoning.

Get Help from a Professional Food Attorney

If you think you or a loved one are eligible for a tainted food lawsuit, please contact Ellis Law online or at 1800.INJURED and have your case evaluated by one of our qualified personal injury attorneys. The food poisoning attorneys at our firm are committed to helping victims of food borne illnesses receive the compensation they deserve.

–Educate yourself and your loved ones about GMOs from credible articles, books or videos, such as those mentioned on the websites below or YouTube’s “Genetically Modified Organism (GMO) — Myths and Truths.”

–Keep up-to-date about anti-GMO trends, legislation and action items by frequenting websites such as the one for the Center for Food Safety, another great GMO watchdog organization (http://www.centerforfoodsafety.org).

–Buy certified-organic and local foods. USDA organic and Non-GMO Project Verified products cannot intentionally include GMO ingredients.

The USDA explains: “The use of genetic engineering, or genetically modified organisms (GMOs), is prohibited in organic products. This means an organic farmer can’t plant GMO seeds, an organic cow can’t eat GMO alfalfa or corn, and an organic soup producer can’t use any GMO ingredients. To meet the USDA organic regulations, farmers and processors must show they aren’t using GMOs and that they are protecting their products from contact with prohibited substances, such as GMOs, from farm to table.”

The “Non-GMO Project Verified” label is the only third-party non-GMO verification program in North America. Its website (https://www.nongmoproject.org/) explains, “Since its incorporation in 2007, the Project has grown into a collaboration of manufacturers, retailers, processors, distributors, farmers, seed companies and consumers.”

–Avoid at-risk ingredients that are now largely (roughly 90 percent) produced using GMOs, including soybeans, canola, cottonseed, corn and sugar from sugar beets. Unless sugar is labeled as organic or pure cane, it likely contains sugar from genetically modified sugar beets.

The Chicago Tribune reported, “These crops (mentioned above) often are added to processed foods as oils, sweeteners and soy proteins but also can be part of amino acids, aspartame, ascorbic acid, sodium ascorbate, vitamin C, citric acid, sodium citrate, ethanol, flavorings (natural and artificial), hydrolyzed vegetable protein, lactic acid, maltodextrins, microbial growth media, molasses, monosodium glutamate, sucrose, textured vegetable protein, xantham gum, vitamins and yeast products, according to the Non-GMO Project.”

Regarding most fruits and vegetables, the Non-GMO Shopping Guide further explains: “Very few fresh fruits and vegetables for sale in the U.S. are genetically modified. Novel products such as seedless watermelons are NOT genetically modified. Small amounts of zucchini, yellow crookneck squash and sweet corn may be GM. The only commercialized GM fruit is papaya from Hawaii — about half of Hawaii’s papayas are GM. Even if the fruit or vegetable is non-GMO, if it is packaged, frozen or canned, there may be GM additives.”

–Buy only dairy products labeled “certified organic,” “No rBGH or rBST” or “artificial hormone-free,” because some source cows are fed genetically modified feed or injected with genetically modified bovine growth hormone.

–Support and patronize grocers (and commend their management) that offer lines of organic products and eliminate GMO ingredients from their product shelves. For example, Target, H-E-B, Giant Eagle and Meijer recently joined more than 55 other food retailers — including Trader Joe’s, Whole Foods, Aldi, Marsh and Hy-Vee — in agreeing not to sell genetically engineered fish in their stores. Whole Foods and Trader Joe’s claim that all their store-brand items originate from non-GMO ingredients.