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Friday, August 15, 2008
Manufacturer for Publix Brand Vanilla Wafers Issues a Recall for Undeclared Soy
FOR IMMEDIATE RELEASE -- August 15, 2008 – The manufacturer of Publix Vanilla Wafers is recalling a limited number of 12oz boxes of Vanilla Wafers with a code date of 030409A as they may contain undeclared soy. Persons who have an allergy to soy run the risk of a serious or possible life-threatening allergic reaction if they consume the affected product. The UPC number may be found on the side label below the Nutrition Facts panel:
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Thursday, August 14, 2008
Consumers Have Until September 15 to Apply for Refunds
Consumers Have Until September 15 to Apply for Refunds
Airborne Health, Inc., the Bonita Springs, Florida maker of the popular Airborne Effervescent Health Formula, an effervescent tablet marketed as a cold prevention and treatment remedy, has agreed to pay up to $30 million to settle Federal Trade Commission charges that it did not have adequate evidence to support its advertising claims. The FTC’s lawsuit also names Victoria Knight-McDowell, the former schoolteacher who invented Airborne, and her husband Thomas John McDowell. If the settlement is approved by the court, it will prohibit the defendants from making false and unsubstantiated cold prevention, germ-fighting, and efficacy claims. The monetary judgment will be satisfied by the defendants’ adding $6.5 million to the funds they have already agreed to pay to settle a related private class-action lawsuit, bringing the total settlement fund to $30 million.
“There is no credible evidence that Airborne products, taken as directed, will reduce the severity or duration of colds, or provide any tangible benefit for people who are exposed to germs in crowded places,” said Lydia Parnes, Director of the FTC’s Bureau of Consumer Protection.
The FTC complaint and agreed-upon final order follow settlement last November of the class-action lawsuit, Wilson v. Airborne, Inc. et al., which is pending in federal court in the Central District of California. In that case, the defendants have agreed to pay up to $23.51 million, which will be used for consumer refunds and attorneys’ fees. If the class action suit funds are exhausted, up to $6.5 million in additional funds for consumer redress will become available as a result of the FTC order. One redress administrator will manage both pools of funds and consumers will receive a single refund check.
The Wilson class action settlement provides refunds for purchases of Airborne-branded products (including Airborne Effervescent Health Formula, Airborne On-the-Go, Airborne Power Pixies, Airborne Nighttime, Airborne Jr., Airborne Gummis, and Airborne Seasonal Relief) made between May 1, 2001 and November 29, 2007. More information on the Wilson settlement, eligibility requirements, and procedures for filing a claim online or by mail can be found at www.airbornehealthsettlement.com. Consumers have until September 15, 2008 to apply for a refund for up to six product purchases.
The defendants have marketed Airborne Original Effervescent Formula as a dietary supplement containing 17 ingredients, including vitamins A, C, E, zinc, and selenium. Airborne products have been advertised nationally in print media and on radio and television. They have been sold by grocery stores, drug stores, and mass merchandisers.
According to the FTC’s complaint, there is no competent and reliable scientific evidence to support the claims made by the defendants that Airborne tablets can prevent or reduce the risk of colds, sickness, or infection; protect against or help fight germs; reduce the severity or duration of a cold; and protect against colds, sickness, or infection in crowded places such as airplanes, offices, or schools. The FTC complaint also states that the individual defendants in the case, company founders Victoria Knight-McDowell and Thomas John McDowell, made false claims that Airborne products are clinically proven to treat colds.
If consumer refund claims are not paid on time in the Wilson lawsuit, or if the defendants have not paid at least $23.5 million to settle any other similar class-action lawsuit by December 31, 2009, the defendants must pay the entire $30 million to the FTC, which will administer its own consumer redress program.
In addition to prohibiting the defendants from making claims that are false, misleading, or unsubstantiated by competent and reliable scientific evidence, and providing additional funds for consumer redress, the order authorizes the Commission to monitor the defendants’ compliance with the order.
The Commission vote authorizing the staff to file the complaint and agreed-upon final order was 3-1, with Commissioner J. Thomas Rosch dissenting. These documents were filed in the U.S. District Court for the Central District of California on August 13, 2008. The complaint and agreed-upon final order name the following defendants: Airborne Health, Inc., also doing business as Airborne, Inc. and Knight-McDowell Labs; Airborne Holdings, Inc.; Victoria Knight-McDowell; and Thomas John McDowell, also known as Rider McDowell. The FTC’s complaint and agreed-upon final order can be found at: http://www.ftc.gov/os/caselist/0723183/080814airbornecomplaint.pdf.
NOTE: The Commission files a complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The complaint is not a finding or ruling that the defendant has actually violated the law. The stipulated final order is for settlement purposes only and does not constitute an admission by the defendants of a law violation. A stipulated final order requires approval by the court and has the force of law when signed by the judge.
The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 1,500 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s Web site provides free information on a variety of consumer topics.
Media Contact:
Betsy Lordan
Office of Public Affairs
202-326-3707
Staff Contact:
Christine Lee
Bureau of Consumer Protection
202-326-2095
Airborne Health, Inc., the Bonita Springs, Florida maker of the popular Airborne Effervescent Health Formula, an effervescent tablet marketed as a cold prevention and treatment remedy, has agreed to pay up to $30 million to settle Federal Trade Commission charges that it did not have adequate evidence to support its advertising claims. The FTC’s lawsuit also names Victoria Knight-McDowell, the former schoolteacher who invented Airborne, and her husband Thomas John McDowell. If the settlement is approved by the court, it will prohibit the defendants from making false and unsubstantiated cold prevention, germ-fighting, and efficacy claims. The monetary judgment will be satisfied by the defendants’ adding $6.5 million to the funds they have already agreed to pay to settle a related private class-action lawsuit, bringing the total settlement fund to $30 million.
“There is no credible evidence that Airborne products, taken as directed, will reduce the severity or duration of colds, or provide any tangible benefit for people who are exposed to germs in crowded places,” said Lydia Parnes, Director of the FTC’s Bureau of Consumer Protection.
The FTC complaint and agreed-upon final order follow settlement last November of the class-action lawsuit, Wilson v. Airborne, Inc. et al., which is pending in federal court in the Central District of California. In that case, the defendants have agreed to pay up to $23.51 million, which will be used for consumer refunds and attorneys’ fees. If the class action suit funds are exhausted, up to $6.5 million in additional funds for consumer redress will become available as a result of the FTC order. One redress administrator will manage both pools of funds and consumers will receive a single refund check.
The Wilson class action settlement provides refunds for purchases of Airborne-branded products (including Airborne Effervescent Health Formula, Airborne On-the-Go, Airborne Power Pixies, Airborne Nighttime, Airborne Jr., Airborne Gummis, and Airborne Seasonal Relief) made between May 1, 2001 and November 29, 2007. More information on the Wilson settlement, eligibility requirements, and procedures for filing a claim online or by mail can be found at www.airbornehealthsettlement.com. Consumers have until September 15, 2008 to apply for a refund for up to six product purchases.
The defendants have marketed Airborne Original Effervescent Formula as a dietary supplement containing 17 ingredients, including vitamins A, C, E, zinc, and selenium. Airborne products have been advertised nationally in print media and on radio and television. They have been sold by grocery stores, drug stores, and mass merchandisers.
According to the FTC’s complaint, there is no competent and reliable scientific evidence to support the claims made by the defendants that Airborne tablets can prevent or reduce the risk of colds, sickness, or infection; protect against or help fight germs; reduce the severity or duration of a cold; and protect against colds, sickness, or infection in crowded places such as airplanes, offices, or schools. The FTC complaint also states that the individual defendants in the case, company founders Victoria Knight-McDowell and Thomas John McDowell, made false claims that Airborne products are clinically proven to treat colds.
If consumer refund claims are not paid on time in the Wilson lawsuit, or if the defendants have not paid at least $23.5 million to settle any other similar class-action lawsuit by December 31, 2009, the defendants must pay the entire $30 million to the FTC, which will administer its own consumer redress program.
In addition to prohibiting the defendants from making claims that are false, misleading, or unsubstantiated by competent and reliable scientific evidence, and providing additional funds for consumer redress, the order authorizes the Commission to monitor the defendants’ compliance with the order.
The Commission vote authorizing the staff to file the complaint and agreed-upon final order was 3-1, with Commissioner J. Thomas Rosch dissenting. These documents were filed in the U.S. District Court for the Central District of California on August 13, 2008. The complaint and agreed-upon final order name the following defendants: Airborne Health, Inc., also doing business as Airborne, Inc. and Knight-McDowell Labs; Airborne Holdings, Inc.; Victoria Knight-McDowell; and Thomas John McDowell, also known as Rider McDowell. The FTC’s complaint and agreed-upon final order can be found at: http://www.ftc.gov/os/caselist/0723183/080814airbornecomplaint.pdf.
NOTE: The Commission files a complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The complaint is not a finding or ruling that the defendant has actually violated the law. The stipulated final order is for settlement purposes only and does not constitute an admission by the defendants of a law violation. A stipulated final order requires approval by the court and has the force of law when signed by the judge.
The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 1,500 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s Web site provides free information on a variety of consumer topics.
Media Contact:
Betsy Lordan
Office of Public Affairs
202-326-3707
Staff Contact:
Christine Lee
Bureau of Consumer Protection
202-326-2095
Monday, August 4, 2008
Task Force Says Men Age 75 and Older Should Not Be Screened for Prostate Cancer
Task Force Says Men Age 75 and Older Should Not Be Screened for Prostate Cancer
Men age 75 and older should not be screened for prostate cancer, and younger men should discuss the benefits and harms of the prostate-specific antigen (PSA) test with their clinicians before being tested, according to a new recommendation from the U.S. Preventive Services Task Force. The recommendation and accompanying evidence summary appear in the August 5 issue of the Annals of Internal Medicine.
The Task Force found evidence that screening for prostate cancer provided few health benefits but led to substantial physical harms and some psychological harms in men age 75 and older. In men younger than 75, the Task Force concluded that current evidence is insufficient to assess the balance of benefits and harms of prostate cancer screening. An estimated 218,890 U.S. men were diagnosed with prostate cancer in 2007, and one in six men will be diagnosed in his lifetime.
Screening for prostate cancer is most often performed using PSA tests and digital rectal exams. The PSA test is more likely to detect prostate cancer than the digital rectal exam. However, prostate cancers that are found with a PSA test take years to affect health; most prostate cancers that grow serious enough to cause death take more than 10 years to do so. Since a 75-year-old man has an average life expectancy of about 10 years and is more likely to die from other causes such as heart disease or stroke, prostate cancer screening is unlikely to help men over 75 live longer.
For the same reasons, men younger than 75 with chronic medical problems and a life expectancy of fewer than 10 years are also unlikely to benefit from screening. There are also harms associated with prostate cancer screening, which include biopsies, unnecessary treatment and false-positive results that may lead to anxiety. Complications often result from treating prostate cancer and may include urinary incontinence and impotence. These slow-growing cancers may never have affected a patient's health or well-being had they not been detected by screening.
"Because many prostate cancers grow slowly, early detection may not benefit a patient's health and in some cases may even cause harm," said Task Force Chair Ned Calonge, M.D., M.P.H., who is also chief medical officer for the Colorado Department of Public Health and Environment. "We encourage men younger than 75 to discuss with their clinicians the potential—but uncertain—benefits and the possible harms of getting the PSA test before they decide to be screened."
Current data show that one-third of all men in the United States over 75 are receiving PSA testing. Although most major medical organizations suggest that prostate cancer screening may be discontinued in men with a life expectancy of fewer than 10 years, the Task Force is the first group to define an explicit age cutoff above which screening is likely to be ineffective or harmful. The results of two ongoing clinical trials—the National Cancer Institute's Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial and the European Study of Screening for Prostate Cancer—should help to clarify the potential benefits of screening in men under the age of 75.
The Task Force is the leading independent panel of experts in prevention and primary care. The Task Force, which is supported by AHRQ, conducts rigorous, impartial assessments of the scientific evidence for the effectiveness of a broad range of clinical preventive services, including screening, counseling, and preventive medications. Its recommendations are considered the gold standard for clinical preventive services.
The recommendations and materials for clinicians are available on the AHRQ Web site at http://www.ahrq.gov/clinic/uspstf/uspsprca.htm. Previous Task Force recommendations, summaries of the evidence, and related materials are available from the AHRQ Publications Clearinghouse by calling (800) 358-9295 or sending an E-mail to ahrqpubs@ahrq.hhs.gov. Clinical information is also available from AHRQ's National Guideline Clearinghouse™ at http://www.guideline.gov.
Note to Editors: For men who have been diagnosed with prostate cancer, AHRQ has two new plain-language guides that compare the effectiveness and risks of prostate cancer treatments. More information about the guides is available at http://www.effectivehealthcare.ahrq.gov.
For more information, please contact AHRQ Public Affairs: (301) 427-1855 or (301) 427-1244.
Men age 75 and older should not be screened for prostate cancer, and younger men should discuss the benefits and harms of the prostate-specific antigen (PSA) test with their clinicians before being tested, according to a new recommendation from the U.S. Preventive Services Task Force. The recommendation and accompanying evidence summary appear in the August 5 issue of the Annals of Internal Medicine.
The Task Force found evidence that screening for prostate cancer provided few health benefits but led to substantial physical harms and some psychological harms in men age 75 and older. In men younger than 75, the Task Force concluded that current evidence is insufficient to assess the balance of benefits and harms of prostate cancer screening. An estimated 218,890 U.S. men were diagnosed with prostate cancer in 2007, and one in six men will be diagnosed in his lifetime.
Screening for prostate cancer is most often performed using PSA tests and digital rectal exams. The PSA test is more likely to detect prostate cancer than the digital rectal exam. However, prostate cancers that are found with a PSA test take years to affect health; most prostate cancers that grow serious enough to cause death take more than 10 years to do so. Since a 75-year-old man has an average life expectancy of about 10 years and is more likely to die from other causes such as heart disease or stroke, prostate cancer screening is unlikely to help men over 75 live longer.
For the same reasons, men younger than 75 with chronic medical problems and a life expectancy of fewer than 10 years are also unlikely to benefit from screening. There are also harms associated with prostate cancer screening, which include biopsies, unnecessary treatment and false-positive results that may lead to anxiety. Complications often result from treating prostate cancer and may include urinary incontinence and impotence. These slow-growing cancers may never have affected a patient's health or well-being had they not been detected by screening.
"Because many prostate cancers grow slowly, early detection may not benefit a patient's health and in some cases may even cause harm," said Task Force Chair Ned Calonge, M.D., M.P.H., who is also chief medical officer for the Colorado Department of Public Health and Environment. "We encourage men younger than 75 to discuss with their clinicians the potential—but uncertain—benefits and the possible harms of getting the PSA test before they decide to be screened."
Current data show that one-third of all men in the United States over 75 are receiving PSA testing. Although most major medical organizations suggest that prostate cancer screening may be discontinued in men with a life expectancy of fewer than 10 years, the Task Force is the first group to define an explicit age cutoff above which screening is likely to be ineffective or harmful. The results of two ongoing clinical trials—the National Cancer Institute's Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial and the European Study of Screening for Prostate Cancer—should help to clarify the potential benefits of screening in men under the age of 75.
The Task Force is the leading independent panel of experts in prevention and primary care. The Task Force, which is supported by AHRQ, conducts rigorous, impartial assessments of the scientific evidence for the effectiveness of a broad range of clinical preventive services, including screening, counseling, and preventive medications. Its recommendations are considered the gold standard for clinical preventive services.
The recommendations and materials for clinicians are available on the AHRQ Web site at http://www.ahrq.gov/clinic/uspstf/uspsprca.htm. Previous Task Force recommendations, summaries of the evidence, and related materials are available from the AHRQ Publications Clearinghouse by calling (800) 358-9295 or sending an E-mail to ahrqpubs@ahrq.hhs.gov. Clinical information is also available from AHRQ's National Guideline Clearinghouse™ at http://www.guideline.gov.
Note to Editors: For men who have been diagnosed with prostate cancer, AHRQ has two new plain-language guides that compare the effectiveness and risks of prostate cancer treatments. More information about the guides is available at http://www.effectivehealthcare.ahrq.gov.
For more information, please contact AHRQ Public Affairs: (301) 427-1855 or (301) 427-1244.
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