Potential Contamination Leads to Lettuce Recall

According to the U.S. Food and Drug Administration on September 29, 2011, True Leaf Farms, located in California, is voluntarily recalling 90 cartons of chopped romaine because of the potential of contamination with Listeria monocytogenes. The recalled product was shipped between September 12 and 13 to an institutional food service distributor in Oregon who further distributed it to at least two additional states, Washington and Idaho. The romaine affected by this recall has a “use by date” of 9/29/11.

Listeria monocytogenes is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The recalled bags of romaine were packed in True Leaf Farms cardboard cartons and distributed by Church Brothers, LLC, and shipped between September 12 and 13, 2011. All bags carry a “use by date” of 9/29/11. Produce affected by the recall was labeled as follows:

  • 2# bags, chopped romaine – Bag and box code B256-46438-8

Photos of the recalled product can be viewed at www.churchbrothers.com/recall. This recall includes only chopped romaine as described above.

FDA notified the company today that a sample taken as part of a random check from a single bag of chopped romaine tested positive forListeria monocytogenes. True Leaf Farms is working with FDA to inform consumers of this recall. In addition, the company is working with its food service distribution customers to ensure that other romaine products that may be implicated are pulled from the market.

Anyone who has in their possession the recalled romaine as described above should not consume it, and should either destroy it or call Church Brothers, LLC for product pickup.

Consumers with questions or who need information may call Church Brothers, LLC, the sales agent for True Leaf Farms, at 1-800-799-9475, or may visit www.churchbrothers.com for updates.

A Diminished Reputation for Johnson & Johnson

According to the Washington Post, Johnson & Johnson, based in New Brunswick, N.J., has announced about two dozen recalls since September 2009, involving well over 300 million bottles of nonprescription medicines, plus some prescription drugs (including Topamax, some HIV drugs and epilepsy drugs), contact lenses, faulty blood glucose test strips and artificial hips. Reasons for the unprecedented number of recalls have ranged from nauseating odors on packaging and incorrect levels of active ingredients to contaminants in medicines and painful hip replacements that wore out prematurely and required replacement.

J&J has said some of the recalls were precautionary, but the repeated cases have damaged its once-stellar reputation.

Three J&J factories came under intense scrutiny by the Food and Drug Administration, including one in Fort Washington, Pa., that was shut down in spring 2010. Company officials earlier this year said they were arranging to have the recalled products made in other factories, but the shifts required advance FDA approval.J&J plans to put Tylenol Cold & Flu Severe caplets back on store shelves. This is one of many products that have been recalled. At least one other recalled product, grape-flavored children’s Tylenol, already has come back on the market.

Working toward Endocrine Disrupters Product Recalls

Americans are exposed to thousands of toxic chemicals every day. Over the past 70 years, more than 80,000 chemicals have been released into the environment. Some are harmless, but over 200 chemicals have never been studied to assess their effect on human health.

Endocrine disrupters are one category of chemicals that have been linked to harmful side effects in humans and animals. They are found in everyday consumer products; including, herbicides, sports and baby bottles, cigarettes, electrical appliances, textiles, cosmetics, fragrances and medical devices. They have been linked to a multitude of serious outcomes for women, men and children, including early puberty, shortened lactation, breast cancer, miscarriage, impaired fertility, as well as other harmful health conditions.

Endocrine Disrupters Defined

Endocrine disrupters are substances that interfere with the synthesis, secretion, transport, binding, action, or elimination of natural hormones in the body that are responsible for development, behavior, fertility and maintenance of homeostasis (normal cell metabolism). These disruptions can cause cancerous tumors, birth defects, and other developmental disorders. Any system in the body controlled by hormones, can be derailed by endocrine disrupters. The critical period of development for most organisms is between the transition from a fertilized egg into a fully formed infant. As the cells begin to grow and differentiate, there are critical balances of hormones and protein changes that must occur. Therefore, a dose of disrupting chemicals can do substantial damage to a developing fetus.

Examples of endocrine disrupters include Atraxine (heavily used herbicide), BPA (commonly used in some plastic products, canned foods and infant formulas), cigarette smoke, PBBs (used as a flame retardant) and phthalates (compounds used in cosmetics, fragrances and medical devices).

Preventing Exposure

In 1976, the Toxic Substances Control Act (TSCA) was enacted to give the Environmental Protection Agency (EPA) the power to require information from chemical companies, assess the safety of products and regulate their use if they were found the be dangerous. Many believe the TSCA has not lived up to that potential. On February 3, 2011, the United States Senate Committee on Environment and Public Works  held a hearing entitled Assessing the Effectiveness of U.S. Chemical Safety laws. The committee acknowledged in this hearing that TSCA has limited organizational capacity and resources.

When passed into law, TSCA approved more than 60,000 chemicals that were in existence prior to 1976; only 200 of the original 60,000 chemicals have been tested for safety; some uses of only 5 of these toxic substances have been restricted. Today there are more than 80,000 chemicals on the market, which have never been fully assessed for toxic impacts on human health and the environment. TSCA allows chemical manufacturers to keep the ingredients in some chemicals secret — nearly 20 percent of the 80,000 chemicals are secret, according to EPA.

The FDA has created an “Endocrine Disrupters Knowledge Base” document to serve as a resource for research and regulatory scientists to foster the development…” The FDA has also worked to limit the use of some consumer products that contain endocrine disrupters. However, without effective testing methods, thousands of products are still sold on today’s American market that contain harmful endocrine disrupters.

Working Toward Recalls

The opportunity to fix what some call the broken federal chemical safety system continues to ripen. Virtually all parties now agree that the nation’s chemical safety law must be modernized. Several factors are driving Congress to finish its work to overhaul the 35-year old Toxic Substances Control Act.

On April 14, 2011, Sen. Frank Lautenberg (D-NJ) introduced the Safe Chemicals Act (S. 847), which would take meaningful steps to protect American families from harmful chemicals.

If congress is successful in its work to adjust the TSCA, it is likely the FDA will be able to recall many of the dangerous products currently on the market.

Surgical Mesh Dangers Require More from the FDA?: Recalls in Demand

According to Time Magazine, thousands of women have been seriously damaged by a surgical mesh implant operation to treat problems following childbirth.

Pelvic organ prolapse occurs when one of the pelvic organs, most commonly the bladder, slips from its regular location to press against the vagina, causing pain and discomfort. This occurs when the muscles and ligaments that should hold the organs in place are weakened or stretched. Most often a pelvic organ prolapse takes place after childbirth, or after a hysterectomy.

Doctors can use surgical mesh to repair those weakened tissues. Implants are put in to reinforce the vaginal wall, or to support the urethra to prevent urine leakage. MedPage Today, a news service for physicians, reports that at least 100,000 such procedures were performed in the U.S. in 2010.

However, in July, the FDA reported that: “[S]erious complications associated with surgical mesh for transvaginal repair of [pelvic organ prolapse] are not rare. Furthermore, it is not clear that transvaginal [pelvic organ prolapse] repair with mesh is more effective than traditional non-mesh repair in all patients [...] and it may expose patients to greater risk.”

Specifically, the mesh implant can cause:

  • erosion through vaginal epithelium
  • infection
  • pain
  • urinary problems
  • recurrence of prolapse and/or incontinence

Public Citizen petitioned the FDA in late August to recall these surgical mesh products immediately and impose more stringent approval requirements in the future. In response, the FDA has proposed to re-classify non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of POP to class III  medical devices, which would intensify the approval process for future products, and require post-marketing approval evaluations.

However, the FDA also appears ready to allow a grace period for manufacturers of current mesh product to keep them on the market and require companies to conduct further studies. According to Public Citizen, the further studies of the current mesh product would be highly unethical because there is sufficient data showing that these products are ineffective and harmful, and there should be no further delay in removing these products from the market.

Dr. Daniel S. Elliot, a urologic surgeon specializing in female urology and POP at the Mayo Clinic in Rochester stated, “a grace period allowing continued marketing of these devices would recklessly endanger women.”

The FDA has yet to further respond to Public Citizen’s urges for a recall, but has just met with an advisory panel recently and is presently considering whether to classify the mesh devices as “high risk.”

More Recalls for Honda

According to the International Business Times, Honda is recalling over 940,000 cars worldwide from its Fit, CR-V (2006) and CR-Z (2011) lines. The massive recall is the second for Honda in recent weeks. In August, Honda recalled 2.3 million cars to fix a transmission issue. Honda had pulled ahead last year when Toyota faced massive recalls issues and even had to appear before Congress to answer questions about its response to safety questions, but now a run of bad news has plagued Honda.

Pertaining to the Fit and CR-V recalls, the company stated a design flaw can allow residue from window cleaners to build up, and that over that time can degrade the switch’s electrical contracts and potentially cause a fire. 

Separately, Honda has recalled the CR-Z due to a software glitch that could allow the motor under some conditions to rotate in the opposite direction from the transmission’s gear, potentially allowing the car to roll backwards when the transmission is in forward gear.

Honda has been on a bit of a losing streak lately. In addition to the recalls, Honda received a scathing “Consumer Reports” review for its 2012 model year Civic compact car, perennially a bestseller for the Japanese automaker. The magazine headline n its Aug. 1 issue said” “2012 Honda Civic LX: Scores too low for Consumer Reports to recommend.”

Edmund’s Inside Line, via an e-mail from Honda’s spokesman, speculates the Fit models sold in the United States are not effected by this recall. However, both the CR-V and CR-Z models effected by the recall were sold in the United States. Honda said no injuries or deaths have been reported related to the defects. Owner notification of the CR-Z and CR-V recall in the U.S. will begin in late September. Owners can contact Honda by calling 800-999-1009 and selecting option 4.

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