FDA warns against certain uses of asthma drug terbutaline for preterm labor

The U.S. Food and Drug Administration is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor due to the potential for serious maternal heart problems and death. In addition, oral terbutaline tablets should not be used for prevention or treatment of preterm labor. The FDA is requiring the addition of a Boxed Warning and Contraindication to the drug prescribing information (labeling) to warn against these uses.

Terbutaline is FDA-approved to prevent and treat narrowing of the airways (bronchospasm) associated with asthma, bronchitis, and emphysema. The drug is used off-label for obstetric purposes, including treating preterm labor and treating uterine hyperstimulation. Terbutaline has also been used in an attempt to prevent recurrent preterm labor. There is no evidence, however, that use of terbutaline to prevent preterm labor improves infant outcomes. Serious adverse events, including maternal deaths, have been reported with such use in pregnant patients.

“Women should be aware that serious and sometimes fatal side effects have been reported after prolonged use of terbutaline in pregnant women,” said Scott Monroe, M.D., director of FDA’s Division of Reproductive and Urologic Products. “It is important for patients and health care professionals to consider all the potential risks and known benefits of any drug before deciding on its use.”

The FDA is aware that administration of terbutaline by injection to pregnant women is used in hospital settings in certain urgent situations. The FDA warning relates to safety concerns about the prolonged use of terbutaline injection beyond 48-72 hours, and against any use of oral terbutaline in pregnant women for prevention or treatment of preterm labor.

The decision to require a Boxed Warning and Contraindication is based on the FDA’s review of post-market safety reports of heart problems and even death associated with terbutaline use for obstetric indications, as well as data from medical literature documenting the lack of safety and effectiveness of terbutaline for preventing preterm labor, and animal data suggesting potential risks. Based on this information, the FDA concluded that the risk of serious adverse events outweighs any potential benefit to pregnant patients for either prolonged use of terbutaline injection beyond 48-72 hours or use of oral terbutaline for prevention or treatment of preterm labor.

These changes to the drug labeling are consistent with statements from the American College of Obstetricians and Gynecologists discouraging use of terbutaline for preventing preterm labor.

There are multiple generic versions of terbutaline oral tablets and injectable formulations available. The brand name products were previously discontinued by the companies that made them.

The FDA encourages patients to talk to their health care professional if they have concerns about any treatment they are receiving. Patients and health care professionals should report any side effects from the use of terbutaline to the FDA’s MedWatch adverse event reporting program at www.fda.gov/MedWatch1.

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FDA says Tessalon liquid cough capsules pose risk for young children

The U.S. Food and Drug Administration is warning that accidental ingestion of Tessalon (benzonatate) by children younger than 10 years can result in serious side effects or death.

Tessalon, approved by the FDA to treat symptomatic relief of cough in patients older than 10, may attract younger children because of the drug’s candy-like appearance – a round, liquid-filled gelatin capsule. The safety and effectiveness of benzonatate in children younger than 10 years has not been established.

“Benzonatate should be kept in a child-resistant container and stored out of reach of children," said Carol Holquist, R.Ph., director of FDA’s Division of Medication Error Prevention and Analysis. “The FDA encourages health care professionals to talk with their patients and those caring for children about the risk of accidental ingestion or overdose.”

A review of the FDA’s Adverse Event Reporting System database from 1982 through May 2010 identified seven cases of accidental ingestion associated with benzonatate in children younger than 10. Five of the cases resulted in death in children ages 2 years and younger. Overdose with benzonatate in children younger than 2 years has been reported following accidental ingestion of only one or two benzonatate capsules.

Common adverse events reported in the overdose cases included cardiac arrest, coma, and convulsion. Signs and symptoms of overdose can occur within 15-20 minutes of ingestion. Some of the deaths reported in children have been within hours of the accidental ingestion.

The FDA is also adding a new Warning and Precaution section to the benzonatate drug label to warn health care professionals about accidental ingestion resulting in overdose and death in children younger than 10.

Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of benzonatate to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.

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FDA Warning Letters issued to four makers of caffeinated alcoholic beverages

The U.S. Food and Drug Administration today warned four companies that the caffeine added to their malt alcoholic beverages is an “unsafe food additive” and said that further action, including seizure of their products, is possible under federal law.

The companies receiving Warning Letters and their products are:

• Charge Beverages Corp.: Core High Gravity HG, Core High Gravity HG Orange, and Lemon Lime Core Spiked
• New Century Brewing Co., LLC: Moonshot
• Phusion Projects, LLC (doing business as Drink Four Brewing Co.): Four Loko
• United Brands Company Inc.: Joose and Max

FDA’s action follows a scientific review by the Agency. FDA examined the published peer-reviewed literature on the co-consumption of caffeine and alcohol, consulted with experts in the fields of toxicology, neuropharmacology, emergency medicine, and epidemiology, and reviewed information provided by product manufacturers. FDA also performed its own independent laboratory analysis of these products.

“FDA does not find support for the claim that the addition of caffeine to these alcoholic beverages is ‘generally recognized as safe,’ which is the legal standard,” said Dr. Joshua M. Sharfstein, Principal Deputy Commissioner. “To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern.”

Experts have raised concerns that caffeine can mask some of the sensory cues individuals might normally rely on to determine their level of intoxication. The FDA said peer-reviewed studies suggest that the consumption of beverages containing added caffeine and alcohol is associated with risky behaviors that may lead to hazardous and life-threatening situations.

The agency said the products named in the Warning Letters are being marketed in violation of the Federal Food, Drug, and Cosmetic Act (the FFDCA). Each Warning Letter requests that the recipient inform the FDA in writing within 15 days of the specific steps that will be taken to remedy the violation and prevent its recurrence. If a company does not believe its products are in violation of the FFDCA, it may present its reasoning and any supporting information as well.

If the FDA believes that the violation continues to exist, the agency may pursue an enforcement action that could include seizure of the products or an injunction to prevent the firm from continuing to produce the product until the violation has been corrected.

FDA’s action today follows a November 2009 request to manufacturers to provide information on the safety of adding caffeine to their products.

FDA is aware that on November 16, Phusion Projects, LLC, the maker of Four Loko, announced its intention to remove caffeine and other stimulants from its drinks. FDA views this announcement as a positive step. FDA has not yet heard officially from the company about this announcement, including how quickly it will remove present product from circulation and how quickly it will reformulate its product. FDA intends to work with Phusion Projects, LLC and the other manufacturers to assure their products meet safety standards.

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FDA: Potentially harmful stimulant found in Slimming Beauty capsules

The U.S. Food and Drug Administration today advised consumers who have Slimming Beauty Bitter Orange Slimming Capsules not to use the product. FDA warns that Slimming Beauty Bitter Orange Slimming Capsules contain the active pharmaceutical ingredient sibutramine, a prescription-only drug which is a stimulant. Sibutramine is not listed on the product label and could harm consumers, especially those with cardiovascular conditions.

FDA lab tests reveal that the product contains excessive amounts of sibutramine that may be dangerous to people who have a history of cardiovascular disease, because it can lead to elevated blood pressure, stroke, and heart attack.

Consumers who are otherwise healthy and who take the amount of sibutramine found in Slimming Beauty capsules can experience anxiety, nausea, heart palpitations, a racing heart, insomnia, and elevated blood pressure. Sibutramine also may interact with other medications and can cause serious side effects.

Sibutramine is a powerful stimulant that should not be used without a prescription due to the safety risks associated with it.

Slimming Beauty is being sold over the Internet by Beautiful Health Inc., formerly LL Health and Beauty. Slimming Beauty sample packets also have been distributed by individuals at community events. The product and the sample packets are falsely labeled as “100% Herbal.” The sample packet label is misleading because it indicates that it is a natural vitamin and calcium capsule for use in children as young as 2 years old.

The FDA has determined that Slimming Beauty sample packets were distributed at the 40th Annual Mexican Independence Day Parade in Chicago, on Sept. 12, 2010. The agency is aware of several reports of serious side effects from the use of this product including elevated blood pressure, headaches, vomiting, and insomnia.

Consumers and health care professionals are encouraged to report adverse events related to the use of Slimming Beauty capsules to the FDA's MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm or by phone at 800-FDA-1088 (800-332-1088).

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FDA Warns Consumers to Avoid TimeOut Capsules

The U.S. Food and Drug Administration is warning consumers not to take TimeOut Capsules because it contains an active drug ingredient that can dangerously lower blood pressure. The product is marketed as a dietary supplement for sexual enhancement.

TimeOut is labeled as “100% natural” and consumers may mistakenly assume the product is harmless and poses no health risk. TimeOut is distributed on Internet sites and online marketplaces as 2,500 mg capsules.

Consumers who have TimeOut Capsules should stop using them immediately. Sexual enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or death.

The FDA analyzed TimeOut and determined that it contains hydroxythiohomosildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Like sildenafil, this chemical may interact with prescription drugs such as nitrates, including nitroglycerin, and cause dangerously low blood pressure. When blood pressure drops suddenly, the brain is deprived of an adequate blood supply which can lead to dizziness or lightheadedness.

To date, the FDA is not aware of any adverse events associated with the use of this product.

The FDA advises consumers who have experienced any negative side effects from sexual enhancement products to consult a health care professional and to safely discard the product. Consumers and health care professionals should report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online.

During the past several years, the FDA has found many products marketed as dietary supplements for sexual enhancement that can be harmful to consumers because they are adulterated with ingredients in FDA-approved drugs or variations of these ingredients.

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FDA Warns of Possible Dangers from Portable Foot-Tanning Device

The U.S. Food and Drug Administration is warning consumers about the risk of ultraviolet radiation overdose with the Tootsie Tanner portable foot tanning device.

Use of the tanning device can lead to an overdose of ultraviolet radiation because its labeling recommends an improper duration of exposure to radiation and the device has an inadequate timer. The labeled exposure schedule indicates that the device may be used for 30 minutes, and the timer control permits 30 minutes exposure. Based on FDA testing, the maximum exposure time for this device is 20 minutes.

The device fails to provide prominent warnings about the need for protective eyewear. Use of this product according to the labeling could result in an overdose of ultraviolet radiation, which may cause immediate and delayed serious eye and skin injuries.

The FDA has issued a warning letter to the device manufacturer and distributor, IPCH, located in Sugarland, Texas. Since issuing the warning letter, the FDA learned that IPCH is no longer in business. Thus, the device will not be replaced or updated with the correct labeling. Refunds will not be available for the estimated 3,000 devices sold.

The FDA recommends that users of this device, which include tanning salon owners and operators, stop using this device, remove the lamps and safely discard all components of the device according to local environmental protection standards.

Although the FDA has received no adverse event reports to date, the agency is concerned about the risk of eye and skin injuries from an overdose of ultraviolet radiation.

Consumers may report serious adverse events (side effects) with the device to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax, or phone.

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U.S. Appeals Court Reinstates Claim That Controversial Diet Drug Redux Should Never Have Been Offered to American People

/PRNewswire/ -- An Ohio Federal Court of Appeals ruling issued yesterday is reinstating the late victim's claim that the recalled diet drug Redux (commonly called fen-phen) linked to her death should never have been marketed to the American people by Wyeth due in part to its pre-approval concerns about potentially lethal side effects. The Court, in remanding the case to the trial court, held that Federal drug regulations do not preempt Ohio negligence claims, and indicated that the Supreme Court's 2009 landmark pharmaceutical manufacturer preemption decision (Wyeth v. Levine) may apply beyond inadequate warning-label claims.

Benjamin H. Anderson, Esq., of Anderson Law Offices, LLC of Cleveland, Ohio, counsel for the plaintiff, said, "Mary Buchanan, like so many others, turned to a drug to help her lose weight and as a result she lost her life. She and her surviving family members deserve justice; this is an important decision in her case and for the harms and losses she sustained, as well as the many millions of Americans taking prescription medications who have long been concerned about drug companies being shielded from appropriate state negligence laws. Significantly, the appeals court has also reinstated and remanded to the trial court our claim for punitive damages."

In reversing key sections of the trial court's finding for the defendant on summary judgment in Wimbush v. Wyeth et.al., 6th Cir. No. 09-3380, the three-judge appeals panel held that the trial judge erred in concluding that the U.S. Food and Drug Administration (FDA) preempted the Buchanan family's negligence claims that the drug should never have been made available to Americans given Wyeth-Redux's known health risks, particularly Primary Pulmonary Hypertension (PPH). Mrs. Buchanan, a hard-working and dedicated 66- year-old nurse from Maple Heights, Ohio who took the weight-loss drug during 1996 and 1997, lost her life to PPH in 2003 within a few months after filing the complaint. The drug company, which spent more than $50 million marketing the wildly popular and profitable drug after its launch in April 1996, pulled it on September 15, 1997 at the request of the FDA and under mounting criticism by independent researchers and reports in respected medical journals.

Though Redux was only on the market for a relatively short period, to date it is estimated that Wyeth has paid thousands of victims of Redux and its predecessor, Pondimin - and/or their survivors - more than $20 billion in damages. In evaluating the potential side effects of Redux, researchers noted that PPH is a devastating pulmonary disease for which there is still no cure, and the associated heart-valve problems may and often did require high-risk heart surgery. The controversial, high-risk diet drug had previously been evaluated and pulled from pharmacies overseas and it was banned in some individual states before the total recall.

In its decision, the appeals Court stated, "...we are not persuaded that it is always impossible to comply with both state law duties and FDA regulations in the process leading up to FDA approval." It added, "...we cannot agree with the district court's conclusion as, not only is there a presumption against preemption, but the case law supports the conclusion that Congress did not intend to preempt state tort law claims when it passed the Food, Drug, and Cosmetics Act (FDCA)."

In a footnote, it commented "...the overwhelming take-away from the Levine majority opinion is that state tort law has historically played a substantial role in the regulation of drug manufacturers and that Congress has never indicated an intent to change this role. Thus, while Levine did leave open the possibility that there may be some state law claims that would conflict with the FDA's regulatory authority and function, the claim at issue in Levine was not one of them. We do not believe that Buchanan's pre-approval negligence claims are, either."

Attorney Anderson, commenting on the interpretation of the Levine ruling in the case, said, "Drug companies are now on notice that they cannot lie to and conceal from the FDA crucial information in the pre-approval process and then expect to be held harmless once their drugs are responsible for causing pain, suffering and, as in Mrs. Buchanan's case, death."

The Court affirmed the dismissal of the balance of the plaintiff's claims, and Attorney Anderson said he will evaluate with appellate counsel Paul Flowers, Esq., and Mrs. Buchanan's family all appropriate legal options.

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FDA Warns Consumers of Serious Harm from Drinking Miracle Mineral Solution (MMS)

/PRNewswire/ -- The U.S. Food and Drug Administration is warning consumers not to take Miracle Mineral Solution, an oral liquid solution also known as "Miracle Mineral Supplement" or "MMS." The product, when used as directed, produces an industrial bleach that can cause serious harm to health.

The FDA has received several reports of health injuries from consumers using this product, including severe nausea, vomiting, and life-threatening low blood pressure from dehydration.

Consumers who have MMS should stop using it immediately and throw it away.

MMS is distributed on Internet sites and online auctions by multiple independent distributors. Although the products share the MMS name, the look of the labeling may vary.

The product instructs consumers to mix the 28 percent sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration.

MMS claims to treat multiple unrelated diseases, including HIV, hepatitis, the H1N1 flu virus, common colds, acne, cancer, and other conditions. The FDA is not aware of any research that MMS is effective in treating any of these conditions. MMS also poses a significant health risk to consumers who may choose to use this product for self-treatment instead of seeking FDA-approved treatments for these conditions.

The FDA continues to investigate and may pursue civil or criminal enforcement actions as appropriate to protect the public from this potentially dangerous product.

The FDA advises consumers who have experienced any negative side effects from MMS to consult a health care professional as soon as possible and to discard the product. Consumers and health care professionals should report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.

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FDA Advisory: Avoid Unintentional Exposure of Children and Pets to Evamist

/PRNewswire/ -- The U.S. Food and Drug Administration is warning that inadvertent exposure to Evamist through skin contact with patients using this product has the potential for adverse effects in children and pets.

Evamist contains estradiol, an estrogen hormone, and is used in women to reduce hot flashes during menopause. The drug is sprayed on the skin between the elbow and wrist, on the inside of the forearm. The FDA currently is reviewing reports of adverse events in children and pets who were inadvertently exposed to this topical estrogen product.

"Women using Evamist need to be aware of the potential risks to children who come in contact with the area of skin where this drug is applied," said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III. "It is important that people know to keep both children and pets away from the product to minimize exposure."

Evamist was FDA approved in 2007. From July 2007 to June 2010, FDA received eight post-marketing cases of unintended exposure to Evamist in children ages 3 years to 5 years. Adverse events reported in unintentionally exposed children include premature puberty, nipple swelling and breast development in females, and breast enlargement in males. Since 2007, two reports of secondary exposure to Evamist in dogs also have been received by FDA's Center for Veterinary Medicine. Pets exposed to Evamist may exhibit signs such as mammary/nipple enlargement and vulvar swelling.

Patients using Evamist should not allow children to make contact with the area of the arm where Evamist is sprayed and should wash the child's skin with soap and water as soon as possible if contact does occur. Pets also should not be allowed to lick or touch the arm where Evamist is sprayed as small pets may be especially sensitive to the estrogen in this product. If direct contact with the arm where Evamist was sprayed cannot be avoided, it is recommended that women wear a garment that covers the area where the drug was applied.

At this time, it is unknown whether unintended exposure can occur with other topical estrogen products. The FDA is continuing to review adverse event reports and evaluate ways to reduce unintended exposures to these products.

Consumers and health care professionals should report any side effects from Evamist by using the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.

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FDA Warns Consumers to Avoid Magic Power Coffee

The U.S. Food and Drug Administration is warning consumers that Magic Power Coffee, an instant coffee product marketed as a dietary supplement for sexual enhancement, contains an active drug ingredient that can dangerously lower blood pressure.

Consumers who have Magic Power Coffee should stop using it immediately. Sexual enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or even death.

In the case of Magic Power Coffee, the FDA collected and analyzed the product and determined that the product contains hydroxythiohomosildenafil. This is a chemical similar to sildenafil, the active ingredient in Viagra. Hydroxythiohomosildenafil, like sildenafil, may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. Consumers and health care professionals should be aware of this problem and the health hazard it presents.

When blood pressure drops suddenly, the brain is deprived of an adequate blood supply, which can lead to dizziness or lightheadedness.

"Because this product is an instant coffee labeled as an ‘all natural dietary supplement,’ consumers may assume it is harmless and poses no health risk," said Deborah M. Autor, director of FDA’s Center for Drug Evaluation and Research, Office of Compliance. "In fact, Magic Power Coffee can cause serious harm.”

To date, the FDA is not aware of any adverse events associated with the use of this product.

The product is distributed on Internet sites and online auctions by multiple independent distributors participating in an online multi-level marketing scheme. It is sold in a 2-serving box and a 12-serving carton containing six 2-serving boxes.

The FDA advises consumers who have experienced any negative side effects from sexual enhancement products to consult a health care professional and to safely discard the product. Consumers and health care professionals should report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm

During the past several years, the FDA has found many products marketed as dietary supplements for sexual enhancement that contain undeclared active ingredients of FDA-approved drugs, analogs of approved drugs or other compounds that do not qualify as “dietary ingredients.”

“The FDA is committed to protecting public health and stopping the illegal marketing of unapproved drugs,” said Autor. “We support vigorous law enforcement and criminal prosecution of violators of safe drug laws.

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FDA Warns Public of Continued Extortion Scam by FDA Impersonators

/PRNewswire/ -- The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of an international extortion scam.

The criminals call the victims -- who in most cases previously purchased drugs over the Internet or via "telepharmacies" -- and identify themselves as FDA special agents or other law enforcement officials. The criminals inform the victims that purchasing drugs over the Internet or the telephone is illegal, and that law enforcement action will be pursued unless a fine or fee ranging from $100 to $250,000 is paid. Victims often also have fraudulent transactions placed against their credit cards.

The criminals always request the money be sent by wire transfer to a designated location, usually in the Dominican Republic. If victims refuse to send money, they are often threatened with a search of their property, arrest, deportation, physical harm, or incarceration.

"Impersonating an FDA official is a violation of federal law," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. "The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment."

FDA special agents and other law enforcement officials are not authorized to impose or collect criminal fines. Only a court can take such action, with fines payable to the U.S. Treasury.

Anyone receiving a telephone call from a person purporting to be an FDA or other law enforcement official who is seeking money to settle a law enforcement action for the illegal purchase of drugs over the Internet should refuse the demand and call the FDA's Office of Criminal Investigations Metro Washington Field Office at (800) 521-5783 to report the crime.

In addition to posing as FDA officials, criminals have posed as special agents of the DEA, FBI, U.S. Secret Service and U.S. Customs Service as well as U.S. and Dominican prosecutors and judges. In response, the FDA, in conjunction with various federal, state, and local agencies, is actively pursing criminal charges.

The FDA also reminds consumers to use caution when purchasing prescription drugs over the telephone or the Internet. In addition to the increased risk of purchasing unsafe and ineffective drugs from Web sites operating outside the law, there is the danger that personal data can be compromised. For more on FDA's concerns about unlawful drug sales on the Internet, see http://www.fda.gov/oc/buyonline/faqs.html.

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Toxic Chemical bisphenol A Still Not Banned By FDA; Schumer, Gillibrand Call for Ban; Govt Official Warns Public

/PRNewswire/ -- Environmental health advocates hope that U.S. FDA will make its promised announcement about health hazards of bisphenol A (BPA), a synthetic sex hormone linked to cancer, behavioral changes, reproductive harm and other illnesses, in time for Christmas.

Sarah Janssen, MD, PhD, staff scientist, Natural Resources Defense Council: "Just as you rely on your doctor for medical advice, FDA must rely on the advice of scientific experts. Dozens of independent scientists, including the Director of NIEHS, have recommended avoiding BPA exposure. FDA should heed their guidance and ban BPA in food packaging."

Janet Nudelman, Breast Cancer Fund: "Scientific evidence shows there's no safe level of BPA exposure. The FDA should immediately ban BPA in polycarbonate food containers and require labeling of cans containing BPA."

Urvashi Rangan, PhD, toxicologist with Consumers Union, whose recent study revealing BPA in canned foods was cited by Senators Schumer and Gillibrand: "Consumers can't know how much BPA is in any can of food. The current safety limit for BPA is outdated, using traditional toxicology that doesn't apply to BPA and other endocrine disruptors. BPA has demonstrated adverse effects at very low doses."

"Restrictions on BPA are in place in Connecticut, Minnesota, Chicago, three New York counties, and legislation has been introduced in 21 states," according to Sarah Uhl from Coalition for a Safe and Healthy Connecticut.

Bobbi Chase Wilding of Clean New York is pregnant: "Women of child bearing age and babies are put in danger because this toxic chemical is in products we use. Recent studies find BPA in the bodies of pregnant women and health care providers. FDA must protect us and not delay."

Mike Schade, Center for Health, Environment & Justice. says, "Some local and state governments have banned sales of BPA-contaminated products, and retailers are taking them off their shelves. The FDA needs to act now."

"As we celebrate the Christmas season, we are reminded of Jesus' commitment to those in poverty. We hope that the FDA will take measures to ensure that canned food is BPA-free through the use of safe alternatives in the future," says Chloe Schwabe from the National Council of Churches.

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Buyers Steer Clear Of Cashed-In Clunkers

(NAPSI)-Nearly 700,000 used cars were traded in and sent to be scrapped under the federal Car Allowance Rebate System, or "Cash for Clunkers." But how many of those autos actually made it to the scrap yard? Experts say it could pay for used car buyers to ask just that.

Some now warn that although it is illegal to resell any car traded in under the Cash for Clunkers program, many of the used cars that were supposedly scrapped may in fact be resold around the country.

Protecting Yourself

Fortunately, there are ways for car buyers to protect themselves. For instance, working with the National Highway Traffic Safety Administration (NHTSA), Carfax recently added the vehicle identification number (VIN) of every car included in the Cash for Clunkers program to its database.

The information is available for free at www.carfax.com/clunkers. After plugging in the 17-digit VIN, the free check alerts buyers and sellers to any vehicle that was supposed to be scrapped as part of the initiative. The company's vehicle history reports also include the clunker information in addition to other important facts about a car's past--facts that a seller may be unaware of or choose not to reveal. Carfax Reports can indicate if a car was in a flood, fire or wreck or if its odometer may have been illegally rolled back.

It's also smart for shoppers to give a car a visual inspection and have the car inspected by a trusted mechanic before they buy. A few things to look for:

•Make sure the seller's name and the vehicle identification number matches on all documents and the car itself.

•Be aware of malfunctioning air bag indicator lights. The light should turn on briefly when you start the engine and then turn off.

•Cracked wires or interior rust; cars that were once under water will rot from the inside out. Wet wires become brittle and metal bolts and brackets will start rusting when they dry out.

Learn More

For more information on the Cash for Clunkers program and guidelines, visit www.cars.gov. For more information on vehicle history reports, visit www.carfax.com.

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Beware When Shopping Going-Out-Of-Business Sales

(SPM Wire) Going-out-of-business sales can mean huge discounts, but Better Business Bureau is warning shoppers to beware of false deals.

"The bargains are not always as advertised at going-out-of business sales and some consumers don't realize they're getting ripped off when they're supposed to be getting a deal," said Steve Cox, BBB spokesperson.

When a large retailer liquidates assets, the sale is undertaken by a liquidator who sets prices and attempts to sell items quickly and at the highest profit. So, some items actually will be marked up.

In 2008, an ABC News report revealed that many items sold during one liquidation sale were marked up as much as 14 percent.

The BBB offers this advice:

Confirm that a deal IS a deal. Some liquidators mark up prices, while a store's competitors sometimes drop prices to compete with liquidation sales.

Use credit cards. Credit cards include consumer protections if the company doesn't deliver on promised goods.

Don't count on customer service. Consumers might be responsible for delivery of large items. Understand all sales are final and you don't have many options if dissatisfied.

Know the warranty status before buying. Warranties are often maintained by manufacturers or third-parties, meaning they still apply if the retailer goes out of business.

Use gift cards ASAP. Businesses in liquidation won't survive long, so don't get stuck with worthless plastic.

For more consumer advice visit www.bbb.org.

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FDA Warns Public of Extortion Scam by FDA Impersonators

The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials.

Several instances have been reported to the FDA of calls enticing consumers to purchase discounted prescription drugs by wiring funds to one of several locations in the Dominican Republic. No medications are ever delivered. A subsequent call is received from a fraudulent "FDA special agent" informing the consumer that a fine of several thousand dollars is required to be sent to an address in the Dominican Republic to prevent incarceration or other legal action.

"Impersonating an FDA official is a violation of federal law," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. "The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment. FDA officials always present identification in person when conducting official business."

Consumers should note that the fraudulent calls appear to be from telephone numbers located within the United States, but are in fact from either ported voice-over-the-Internet-protocol numbers (calls made directly from a computer and moved or "ported" to other computers to avoid detection) or cellular phones. Reports to FDA describe the callers as having Hispanic accents.

The scheme most likely began with the theft of personal information from consumers who previously purchased drugs via the Internet or telephone or who were victims of credit card fraud.

The FDA is investigating and complaints or information regarding this scheme should be reported to the FDA Office of Criminal Investigations at (800) 521-5783.

The FDA reminds consumers to purchase prescription drugs only from licensed pharmacies located in the United States. Information about the proper purchase of on-line medicine can be found at: http://www.fda.gov/consumer/features/drugsonline0707.html.

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CPSC and Carter's Advise Parents of Rashes Associated with Heat Transferred, or "Tag-less," Labels

The U.S. Consumer Product Safety Commission (CPSC) and Carter's, Inc., of Atlanta, Georgia, are advising parents and caregivers that they have received reports that a small percentage of babies and infants have developed rashes on the upper back after wearing Carter's clothing with heat-transferred, or "tag-less," labels.

This advisory applies to Carter's Fall 2007 product line. The Fall 2007 line utilizes a label on the inside back of the garment that has a raised surface with a solid, rather than a stenciled, background. This advisory does not apply to previous and current product lines, which utilize labels with stenciled backgrounds.

The garments, which were made in various countries, were sold at Carter's own retail stores and at department and national chain stores.

If your child develops a rash on the upper back after wearing garments that have a "tag-less" label with a solid background, you should stop using these garments. If the rash persists or worsens, you should contact your pediatrician. For additional information, visit Carter's website at http://www.carters.com/corporate/tagless_message.aspx, contact Carter's toll free at 1-888-282-4674 or by email at contactus@carters.com

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“Private Browsing” Not So Private

TT Note: Interesting. Be aware that private browsing only protects you on your computer and not from prying eyes outside your computer. Read on to learn more.

(BUSINESS WIRE) --Microsoft announced last week that the upcoming Internet Explorer 8 would include the rumored “private browsing” mode, designed to conceal a user’s activities from other users of the same PC. A privacy mode is already a feature of Apple’s Safari browser, and a similar technology is available in Mozilla’s Firefox, as well as the newly announced Google Chrome. Private browsing mode utilizes techniques that automatically delete search history, page cache, and browsing history so the next user can’t see where you’ve been or what you’ve been up to.

Unfortunately, this mode does nothing to provide real privacy from hackers, spyware, and network-based attacks that pose significant and growing threats to users’ finances and identities.

“The private browsing mode avoids embarrassment, and prevents your spouse from learning about the surprise gift you’re researching for them,” says Ray Dickenson, Authentium’s CTO. “But it doesn’t prevent the disclosure of your usernames, passwords, credit card numbers, and other personal information to criminals. While we applaud the feature as a valuable tool for users, we’re concerned the name will only exacerbate the current explosion of digitally cultivated identity theft by fooling users into thinking they’re protected.”

Authentium, maker of the leading secure browsing companion SafeCentral, cautions users not to trust these privacy features as a means of protection from fraud.

“Whether using Safari, Firefox, or the upcoming Internet Explorer 8, users need to be aware that the private browsing mode is for local protection only, and is not a deterrent against identity theft,” says Corey O’Donnell, Vice President of Marketing for Authentium. “While I can’t suggest a better name, we’re certainly concerned that the private browsing moniker will give users a false sense of security and put them at increased risk when conducting transactions online. Independent of our goals and mission of providing advanced protection with our SafeCentral service, we feel it’s important to alert the public about the actual functions of this feature.”

Authentium issued the warning in conjunction with the recent announcement and posted notifications to its antivirus customers and security partners via the corporate blog. Authentium is attempting to ensure that the security community, including its roster of high-profile partners, was prepared to respond to customer inquiry on the feature.

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FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes

TT Note: We've been following this story for several days and have been watching as the health threat grows. This is the latest information released late this afternoon.

The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes.

FDA recommends that consumers not eat raw red Roma, raw red plum, raw red round tomatoes, or products that contain these types of raw red tomatoes unless the tomatoes are from the sources listed below. If unsure of where tomatoes are grown or harvested, consumers are encouraged to contact the store where the tomato purchase was made. Consumers should continue to eat cherry tomatoes, grape tomatoes, and tomatoes sold with the vine still attached, or tomatoes grown at home.

On June 5, using traceback and other distribution pattern information, FDA published a list of states, territories, and countries where tomatoes are grown and harvested which have not been associated with this outbreak. This updated list includes: Arkansas, California, Georgia, North Carolina, South Carolina, Tennessee, Texas, Belgium, Canada, Dominican Republic, Guatemala, Israel, Netherlands, and Puerto Rico. The list is available at www.fda.gov/oc/opacom/hottopics/tomatoes.html#retailers. This list will be updated as more information becomes available.

FDA’s recommendation does not apply to the following tomatoes from any source: cherry, grape, and tomatoes sold with the vine still attached.

FDA recommends that retailers, restaurateurs, and food service operators not offer for sale and service raw red Roma, raw red plum, and raw red round tomatoes unless they are from the sources listed above. Cherry tomatoes, grape tomatoes, and tomatoes sold with the vine still attached, may continue to be offered from any source.

Since mid April, there have been 145 reported cases of salmonellosis caused by Salmonella Saintpaul nationwide, including at least 23 hospitalizations. States reporting illnesses linked to the outbreak include: Arizona, California, Colorado, Connecticut, Idaho, Illinois, Indiana, Kansas, New Mexico, Oklahoma, Oregon, Texas, Utah, Virginia, Washington, and Wisconsin. Salmonella Saintpaul is an uncommon type of Salmonella.

Salmonella can cause serious and sometimes fatal infections particularly in young children, frail or elderly people, and those with weakened immune systems. Healthy persons often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, the organism can get into the bloodstream and produce more severe illnesses. Consumers who have recently eaten raw tomatoes or foods containing raw tomatoes and are experiencing any of these symptoms should contact their health care provider. All Salmonella infections should be reported to state or local health authorities.

FDA recognizes that the source of the contaminated tomatoes may be limited to a single grower or packer or tomatoes from a specific geographic area. FDA also recognizes that there are many tomato crops across the country and in foreign countries that will be ready for harvest or will become ready in the coming months. In order to ensure that consumers can continue to enjoy tomatoes that are safe to eat, FDA is working diligently with the states, the Centers for Disease Control and Prevention, the Indian Health Service, and various food industry trade associations to quickly determine the source of the tomatoes associated with the outbreak.

FDA is taking these actions while the agency continues to investigate this outbreak with state and federal partners. Such actions are a key component of FDA’s Food Protection Plan, a scientific and risk-based approach to strengthen and protect the nation’s food supply.

FDA will continue to issue updates as more specific information becomes available.

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FDA Warns Consumers Not to Use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular (also known as Shangai

Toxic Note: I know that none of OUR readers would EVER buy or use any of these products, you're too smart to try unregulated drugs off the Internet without checking 'em out first. But, just on the off-chance someone out there is considering it (after all, someone must be buying it or they wouldn't be making it to sell...), here's the info from the FDA:

These products are illegal drugs and contain undeclared active ingredients in prescription erectile dysfunction drugs

The U.S. Food and Drug Administration (FDA) is advising consumers not to buy or use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular, also marketed as Shangai Chaojimengnan, products.

These products, which originate in China, are being marketed for the treatment of erectile dysfunction (ED) and for sexual enhancement. Although labeled as dietary supplements, these products do not qualify as dietary supplements because they contain undeclared active ingredients of FDA-approved prescription drugs for erectile dysfunction. The products are thus drugs that are illegal because they lack FDA approval.

The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions. Because they may have been advised against taking ED drugs, they may seek out products like these because they are marketed as "all natural" or as not containing the active ingredients in approved, prescribed ED drugs. Additionally, because the manufacturing source of the active ingredients in these products is unknown, consumers should be aware that the safety, efficacy, and purity of these ingredients can not be validated.

"Products like these put consumers at considerable risk because they contain undeclared active ingredients in FDA approved drugs that require a prescription to obtain," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research (CDER). "An unsuspecting consumer with underlying medical issues may buy and take these products without knowing that they can cause serious drug interactions."

FDA performed chemical testing of the products that revealed that Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, and Lady Shangai contain sildenafil, the active ingredient in Viagra, an FDA-approved drug for erectile dysfunction. Shangai Regular, also marketed as Shangai Chaojimengnan, contains an unapproved substance with a structure similar to sildenafil that may cause similar side effects and drug interactions. Neither sildenafil nor the analog of sildenafil is listed as an ingredient on the label of any of these products.

FDA advises consumers who have used any of these products to discontinue use and consult their health care providers if they have experienced any adverse events that they feel are related to the use of these products. Consumers and health care professionals can report adverse events to FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm. FDA recommends that consumers should talk to their health care provider about FDA-approved treatments for erectile dysfunction. FDA may take further regulatory actions to protect consumers from these illegal products.

The products are packaged and distributed by Shangai Distributor, Inc. of Coamo, Puerto Rico.