Wednesday, November 26, 2008

International Formula Council Statement on Melamine and Infant Formulas

/PRNewswire/ -- The International Formula Council* (IFC) today issued the following statement:

"In light of recent reports regarding melamine and infant formula, the International Formula Council and its members reassure parents and health professionals that infant formula manufactured in the United States remains safe and nutritious. Additionally, a U.S. Food and Drug Administration (FDA) spokesperson has stated, 'There's no basis for concern because we're talking about trace levels that are so low ... that there's absolutely no risk.'

"While trace levels of melamine may be found in food as a by-product of processing and packaging, these levels are far below the level deemed safe by numerous other governments including Canada, New Zealand, Hong Kong, the Philippines, Malaysia, and China. Further, these trace amounts are far below the levels recently found in Chinese infant formulas intentionally contaminated with melamine.

"U.S. infant formula products meet the highest standards and specifications; they are manufactured with strict adherence to Good Manufacturing Practices using high-quality ingredients. Each component in the manufacturing process is carefully assessed to ensure that it complies with strict industry standards, and finished products are tested to meet or exceed all FDA standards for infant formula. The IFC and its members are committed to the continued high standards of food safety we have established with the FDA. IFC would also welcome the opportunity to help further implement these standards and quality control testing requirements globally."

* The International Formula Council is an association of manufacturers and marketers of formulated nutrition products, e.g., infant formulas and adult nutritionals, whose members are based predominantly in North America. IFC members are: Abbott Nutrition; Mead Johnson Nutritionals; Nestle Nutrition -- USA; and Wyeth Nutrition.

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Tuesday, November 25, 2008

National Wooden Pallet and Container Association: Environment for Sale

TT Note: Tsk, tsk.

/PRNewswire-USNewswire/ -- The principles of the president of the National Forest Foundation (NFF) Bill Possiel are clearly for sale to the highest donor. The evidence of this is his recent misinformation campaign promoting the use of plastic pallets over wood on behalf of recent contributor Intelligent Global Pooling Systems (iGPS).

"Of all the hardwood logged in the United States, 40 percent is used for pallets which are frequently used only once and then landfilled. Wood pallets are heavy, bulky, and increase shipping costs and energy used in transportation," said NFF President Bill Possiel. "We are proud to work with iGPS to restore our forests and reduce demand for hardwood species, which sequester carbon and provide many other ecosystem benefits."

Reuters, October 7, 2008

The iGPS company has said it will make a contribution to the NFF every time an iGPS pallet is rented over the next two years. That means the more plastic that is unleashed into the environment, the more money for the NFF. They are doing this to offset the damage plastic inflicts on the environment.

Contrast the environmental impact of plastic pallets with wood.

Carbon sequestration is the process by which atmospheric carbon dioxide is absorbed by trees through photosynthesis and stored as carbon in biomass (trunks, branches, foliage, and roots) and soils. Carbon sequestration in forests and wood products helps offset fossil fuel emissions, one of the key drivers of human-induced climate change.

Sustainable forestry practices can increase the ability of forests to sequester additional atmospheric carbon while enhancing other ecosystem services, such as improved soil and water quality. Planting trees, restoring forested ecosystems, and improving forest health are some of the ways to increase forest carbon. Harvesting and regenerating forests can also result in net carbon sequestration in wood products and new forest growth. Investing in forest carbon sequestration projects is a cost-effective way to complement corporate greenhouse gas reductions or allowance purchases.

USDA Forest Service

In other words, while plastic pallets need a carbon offset to mitigate the injury imposed by their product, wood pallets are the offset!

Mr. Possiel's devotion to the organization's bank account over conviction appears to be immense since he not only commended the plastic product corporation, but in so doing he used half-truths and outright falsehoods against the far more environmentally favorable wood pallet industry.

-- Half-Truth: "Of all the hardwood logged in the United States, 40
percent is used for pallets..."


That is true, but what he failed to add is the fact that wood pallets are a byproduct using wood that is rejected by housing and furniture makers for aesthetic reasons yet strong and durable enough for transport and shipping platforms. If the plastic pallet industry were to gain the market advantage they seek, the wood currently used for wood pallets would become wood waste.

-- Falsehood: Mr. Possiel said that wood pallets are frequently used only
once and then landfilled. There are more than 1.2 billion pallets in
service in the United States each day. They are collected, sorted,
repaired and returned to service by the largest pallet pool in the
world. That pool is comprised of more than 5,000 independently owned
and operated white wood pallet companies across the country. It is an
informal pool, yet awe-inspiring in its efficiency.


With wood pallets comprising 83% of the market, they are recognized throughout the supply chain as a commodity far too valuable to simply discard as refuse. Pallets are bought by shippers, sold to recyclers by retailers, repaired and resold to shippers. That cycle occurs over-and-over.

-- Falsehood: When pallets can no longer be repaired to a standard that
will ensure protection of the goods being shipped and safety of
workers handling the load, the pallets are recycled into new products.
Those products include landscape mulch, animal bedding, boiler fuel,
firewood, and wood stove pellets. The nails from ground pallet chips
are removed through a variety of collection technologies and sold as
scrap metal to be used again.


If a random pallet does end up at a solid waste management facility it is "repurposed" into such things as wood mulch or energy -- it does not go into landfill (source: National Solid Wastes Management Association). The wood pallet has value that is used from cradle to grave.

Mr. Possiel also failed to address the fact that the business model and success of companies like iGPS depend upon the infrastructure of independent wood pallet recyclers who collect, sort and return the pallets. If these wood recycling companies were to go out of business, plastic pallets would become one-way pallets unless iGPS and other pallet management firms were to purchase, maintain and fuel trucks and facilities around the country dedicated to pallet collection. Obviously this would skyrocket the cost of these already exorbitant plastic pallets.

Mr. Possiel is not serving the interests of the NFF when he allows himself to become the mouthpiece of iGPS. As the late U.S. Senator Daniel Patrick Moynihan said, "Everyone is entitled to his own opinion, but not his own facts." The facts clearly support wood pallets as the environmental choice.

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Monday, November 24, 2008

New Consumer Health Guide -- 'Pass Up the Poison Plastic, The PVC-Free Guide for Your Family & Home' Released Just in Time

New Consumer Health Guide -- 'Pass Up the Poison Plastic, The PVC-Free Guide for Your Family & Home' Released Just in Time for the Holiday Shopping Season

/PRNewswire-USNewswire/ -- A new guide released today just in time for the holiday shopping season empowers parents and consumers worried about toxic chemicals in toys, baby products, and the home to find safer products. Pass Up the Poison Plastic -- the PVC-Free Guide for Your Family & Home lists the most common consumer products made out of polyvinyl chloride (PVC) plastic and suggests safer PVC-free options. PVC, also known as vinyl, is the worst plastic for our health and environment, releasing dangerous chemicals that can cause cancer. The Center for Health, Environment and Justice (CHEJ), who coordinates a national campaign to phase out PVC, released the new guide. It can be downloaded for free at www.besafenet.com/pvc.

It also includes the top ten reasons for purchasing PVC-free products, quick tips for avoiding PVC, a listing of common household products that may contain PVC, information about other toxic plastics to avoid, a cheat sheet to common plastic acronyms, information on simple actions consumers can take for safer products and a healthier environment, and more.

"We need to take personal responsibility for the health and environmental impacts of the products we purchase," said Mike Schade, co-author of the guide and PVC Campaign Coordinator for the Center for Health, Environment and Justice. "We've created this new guide to empower consumers to find safer solutions to PVC, the most toxic plastic for our health and environment. We can help build consumer consciousness and demand for safer, healthier products by purchasing PVC-free products."

PVC products often contain dangerous toxic additives such as phthalates, lead, and organotins, which can leach out and pose avoidable dangers to consumers. Many toxic toys recalled over the past few years were made out of PVC. In the summer of 2008, Congress enacted legislation to ban phthalates in children's toys, but they are still allowed in all other PVC products in the home, despite their known hazards. A number of studies have identified correlations between phthalates in PVC products and asthma in children and adults.

A number of major retailers, including Target, Sears Holdings, Wal-Mart, JCPenneys, and IKEA have enacted major policies to reduce or phase out PVC products and/or packaging.

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Sunday, November 23, 2008

Major Retailer Agrees to Pay $500,000 Civil Penalty for Failure to Report Hazardous Outdoor Candles

The U.S. Consumer Product Safety Commission (CPSC) announced today that IKEA North America Services LLC, of Plymouth Meeting, Pa., has agreed to pay the government a $500,000 civil penalty. The penalty, which has been provisionally accepted by the Commission, settles allegations that the company failed to immediately report incidents about defective outdoor candles.

CPSC alleged that IKEA failed to report to the government in a timely manner that outdoor candles sold by the firm could unexpectedly flare up and pose fire and burn injury hazards to consumers, when they attempted to extinguish the candles by blowing them out.

IKEA sold about 133,000 six-pack sets of the outdoor candles in the United States between February 2001 and July 2005. The firm also sold an additional 1.3 million candle sets internationally. During that time, the firm received at least 32 reports worldwide of unexpected flare-ups, including fire, scorching and twelve reported injuries, including minor to serious burns. In May 2006, CPSC and IKEA announced the recall of the candles.

Federal Law requires manufacturers, distributors and retailers to report to CPSC immediately after obtaining information reasonably supporting the conclusion that a product contains a defect, which could create a substantial product hazard or create an unreasonable risk of serious injury or death.

In agreeing to settle the allegations, IKEA North America Services denies that it knowingly violated federal law.

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Saturday, November 22, 2008

Warning: Hazardous to Your Lungs

TT Note: Just another thought on the long term effects of willingly adding toxic chemicals to your body in the name of fun. Read and learn.

Chronic drinking isn’t just bad for the liver, it’s hazardous to the lungs....

The Hidden Truth about Alcohol
By Valerie Gregg

Read the story.

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Friday, November 21, 2008

Is your Christmas Tree making You Ill

TT Note: There's no doubt live trees in the house can aggravate allergies and asthma. The allergists in Fayette County recommend no live trees for homes whose occupants have allergies. Washing down the artificial tree as an attempt to lesson mold spores is a great idea.

24-7-- Could it be your Christmas tree that's making you sick? Recent studies tend to support that theory. It seems that Christmas trees, either real or artificial can be a source of mold or allergens that can be the cause of those "sniffles" you seem to have at this time of the year.

In a recent study, mold spores in an apartment had a normal range of 500-700 spores per cubic meter. When the Christmas tree was added, the spores measured about 800 spores per cubic meter of air for the first three days. By day 14 the spores count had increased to 5,000 spores per cubic meter. If you have asthma or are prone to sinus infections you are likely to have a problem. The longer you leave the tree up the worse the contamination.

An artificial tree, stored in the attic or basement for a year can pose many of the same problems. It can acquire pollens, dust or mold. Taking the tree outdoors and washing it down can help. But that isn't always possible due to cold temperatures of the season.

Minnesota based WorldWide Oxide markets and EPA approved GREEN mold preventer Vital Oxide. Vital Oxide is totally safe, is odorless, and contains no harmful VOC's states company spokesman Tom Heller. Simply spray Vital Oxide onto the tree every few days during the season, and the mold or allergen problem will not be a factor in your home states Heller. Because Vital Oxide is odorless, you will not have to worry about some cover-up scent destroying your Christmas ambiance.

For more information on the studies visit the WorldWide Oxide web site at http://www.worldwideoxide.com.

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Tuesday, November 18, 2008

National Report Ranks Georgia 50th in Protecting Kids from Tobacco

TT Note: Where do the kids smoke? So many areas are smoke free these days and I have to admit I like the fresher air. Maybe Georgia should consider collecting two dollars from the tobacco companies for every dollar the companies spend in advertising in the state. Perhaps convenience stores will have to tighten their own rules and regulations for selling cigarettes to minors. Just a thought.

/PRNewswire-USNewswire/ -- Ten years after the November 1998 state tobacco settlement, Georgia ranks 50th in the nation in funding programs to protect kids from tobacco, according to a national report released today by a coalition of public health organizations.

Georgia currently spends $3.2 million a year on tobacco prevention programs, which is 2.7 percent of the $116.5 million recommended by the U.S. Centers for Disease Control and Prevention (CDC).

Other key findings for Georgia include:
-- The tobacco companies spend more than $444 million a year on marketing
in Georgia. This is 139 times what the state spends on tobacco
prevention.
-- Georgia this year will collect $393 million from the tobacco
settlement and tobacco taxes, but will spend less than 1 percent of it
on tobacco prevention.


The annual report on states' funding of tobacco prevention programs, titled "A Decade of Broken Promises," was released by the Campaign for Tobacco-Free Kids, American Heart Association, American Cancer Society Cancer Action Network, American Lung Association and the Robert Wood Johnson Foundation.

"Georgia is one of the most disappointing states when it comes to funding programs to protect kids from tobacco," said Matthew L. Myers, President of the Campaign for Tobacco-Free Kids. "On this 10th anniversary of the tobacco settlement, we call on Georgia's leaders to raise the state cigarette tax and use some of the new revenue to increase funding for tobacco prevention. Tobacco prevention is a smart investment that reduces smoking, saves lives and saves money by reducing tobacco-related health care costs."

Georgia's current cigarette tax of 37 cents per pack is 43rd in the nation and well below the national average of $1.19 per pack. Scientific studies have found that increasing cigarette prices is one of the most effective ways to prevent kids from smoking and encourage smokers to quit.

On Nov. 23, 1998, 46 states settled their lawsuits against the nation's major tobacco companies to recover tobacco-related health care costs, joining four states (Mississippi, Texas, Florida and Minnesota) that had reached earlier settlements. These settlements require the tobacco companies to make annual payments to the states in perpetuity, with total payments estimated at $246 billion over the first 25 years. The states also collect billions of dollars each year in tobacco taxes.

The new report finds that most states have broken their promise to use a significant portion of their tobacco money to fund programs to prevent kids from smoking and help smokers quit.

According to the report, the states in the last 10 years have received $203.5 billion in revenue from the tobacco settlement and tobacco taxes. But they have spent only 3.2 percent of this tobacco money - $6.5 billion - on tobacco prevention and cessation programs.

Other findings of the report include:
-- In the current year, no state is funding tobacco prevention at
CDC-recommended levels, and only nine states fund their programs at
even half of the CDC recommendation.
-- 41 states and the District of Columbia are funding tobacco prevention
programs at less than half the CDC-recommended amount. These include
27 states that are providing less than a quarter of the recommended
funding.
-- Total funding for state tobacco prevention programs this year, $718.1
million, amounts to less than three percent of the $24.6 billion the
states will collect from the tobacco settlement and tobacco taxes. It
would take just 15 percent of this tobacco revenue to fund tobacco
prevention programs in every state at CDC-recommended levels.


The report warns that the nation faces two immediate challenges in the fight against tobacco use: complacency and looming state budget shortfalls. First, while the nation has made significant progress over the past decade in reducing smoking, progress has slowed and further progress is at risk without aggressive efforts at all levels of government. Second, the states are expected to face budget shortfalls in the coming year as a result of the weak economy. The last time the states faced significant budget shortfalls, they cut funding for tobacco prevention programs by 28 percent between 2002 and 2005. The cutbacks are a major reason why smoking declines subsequently stalled, and states should not make the same mistake again.

The report found that there is more evidence than ever that tobacco prevention programs work to reduce smoking, save lives and save money by reducing tobacco-related health care costs. Washington State, which has been a national leader in funding tobacco prevention, has reduced smoking by 60 percent among sixth graders and by 43 percent among 12th graders since the late 1990s. A recent study found that California's tobacco control program saved $86 billion in health care costs in its first 15 years, compared to $1.8 billion spent on the program, for a return on investment of nearly 50:1.

In Georgia, 18.6 percent of high school students smoke, and 11,300 more kids become regular smokers every year. Each year, tobacco claims 10,300 lives and costs the state $2.25 billion in health care bills.

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Friday, November 14, 2008

Got the No Drixoral Drips

Fall has arrived and so has my seasonal cold. I've been using the wonder drug of my choice for close to 20 years when I get all stuffed up. Ah, the agony of the cold season is upon us.

I limped up to the pharmacy counter just the other day to restock my supply of Drixoral. In between my nose blowing and sniffles, I asked the pharmacist for my wonder drug. Nope. Can't do it.

What? No Drixoral? Has there been a run on the only decongestant that really works for me? He said it hasn't been available in months.

So, I blew my noise and went home to my trusty computer to see if there was a problem or if it was just that particular pharmacy. Arrrrgggghhhhh.

Blogs everywhere say "No Drixoral." After the tears stopped, and I blew my now doubly stuffed nose, I went to the site of the manufacturer, Schering Plough.

Their excuse? And I quote- "We are in the process of changing our manufacturing location for our product. Although multiple solutions are being pursued, it is unlikely product will be available in 2009. We apologize for any inconvenience this may have caused. We can offer several alternatives in the meantime."

Sorry. Don't buy it. This great big pharmaceutical company would have us believe that they didn't cross all their t's and dot their i's with the FDA BEFORE they changed production sites. I don't think so. Come on. Now they say it is not likely there will be most likely be no Drixoral until 2010? Yeah. Right.

They recommend using a lesser drug. A drug that works- but doesn't work as well as my beloved Drixoral.

Come on, Schering gurus, be brave and give all suffering Americans the truth. Will you give us our nasal stuffiness relief in the formulation that is proven to work so well? Or will you succumb to government pressure to reformulate it so it doesn't work worth a hoot? By golly, we already are forced to sign away our first born and our inheritance just to get some decent decongestants.

Please save our stuffy noses. Please give us back our wonder drug, Drixoral. Please help me lose my drips.

Thursday, November 13, 2008

Equifax Unveils Online Identity Card

PRNewswire-FirstCall/ -- Equifax Inc. (NYSE:EFX) unveiled today the Equifax online identity card or I-Card, with a beta test of a first-of-its-kind digital identity management solution that is designed to make online transactions easier and more secure for both consumers and businesses.

Information cards (I-cards) are the online equivalent of a driver's license, passport or similar ID and allow consumers to "click-in" to web and e-commerce sites that accept the I-card and conduct online transactions with greater security and control and without having to fill in forms or remember multiple passwords. It is anticipated that this ease-of-use and security will, over time, facilitate relationships between consumers and businesses by reducing the need for companies to retain customers' personal identification information, which could also result in the reduction of risks posed by data breaches.

Equifax is partnering with Parity, a leader in user-centric identity management, to offer the Equifax I-Card that enables people to verify their identity online. People who obtain the Equifax I-Card will also be offered Parity's Azigo I-card management software to enable one-click sign-in and identity verification. Consumers can get their Equifax I-Card free of charge at https://equifaxicards.com/ for use exclusively at a proof-of-concept site (http://watch-this.com/).

I-cards are a new technology standard for user-controlled release of personal information online. As the technology is adopted, people will be able to create and collect I-cards that contain personal data such as their profile, purchase preferences, payment, or verified identity information. They will manage their I-cards by using software such as Parity's Azigo I-card "selector" and will release their personal data to accepting web sites they trust with a single click.

"With fraud and identity theft on the rise, companies need better, more secure ways to conduct transactions online and take their identity management practices to the next level," said Steve Ely, president, Equifax Personal Information Solutions. "The launch of the Equifax I-Card is part of our commitment to build an identity management ecosystem that leverages the industry's latest technologies and data to help businesses address compliance needs and lower fraud rates."

"The Equifax I-Card is an important first step in the evolution of the information card ecosystem," said Jack Connors, President of Parity. "Information cards create the ultimate win-win: people get greater control and security with a vastly superior online experience, and businesses save money, reduce fraud, and get better customer information."

The Equifax I-Card is part of the growing trend to provide increased anonymity and security for a consumer's financial and credit information online. Equifax is working with Parity to help deliver this solution. It also used its premier authentication solution, eIDverifier (TM), as well as multiple data sources for identity verification along with open source technology that is endorsed by The Information Card Foundation (ICF), an industry consortium of consumer, data and technology companies.

The Equifax I-Card is among the first commercial I-card-based products to launch from members of ICF, a not-for-profit organization dedicated to developing a simpler and more secure digital identity on the Internet. Led by Deutsche Telecom, Equifax, Google, Intel, Microsoft, Novell, Oracle PayPal and Parity, the ICF promotes the rapid build-out and adoption of Internet-enabled digital identities using information cards.

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Wednesday, November 12, 2008

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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Johnson and Johnson--Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall Of Infants' Mylicon Gas Relief Dye Free Drops

Johnson & Johnson • Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON® GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately.

The two lots of Infants' MYLICON® GAS RELIEF DYE FREE drops non-staining 1 oz. bottles included in the recall are:

71683791111-1
Lot SMF007
Exp 09/10
Infants' Mylicon® Gas Relief Dye Free Non-Staining Drops 1 oz.

71683791111-1
Lot SMF008
Exp 09/10
Infants' Mylicon® Gas Relief Dye Free Non-Staining Drops 1 oz.

Consumers can find the lot numbers on the bottom of the box containing the product and also on the lower left side of the sticker on the product bottle.

Consumers who purchased Infants' MYLICON® GAS RELIEF DYE FREE drops non-staining included in this recall should immediately stop using the product and contact the company at 1-800-222-9435 (Monday – Friday, 8:00 a.m. – 8:00 p.m. EST) or via the internet at www.mylicon.com for instructions regarding how to dispose of the product and request a replacement or refund.

Infants' MYLICON® drops are sold over-the counter, in retail stores and pharmacies, as an anti-gas medicine to relieve the discomfort of infant gas frequently caused by air swallowing or by certain formulas or foods.

The recall does not affect any Original Infants' MYLICON® GAS RELIEF products (1/2 oz. or 1 oz. size) or Infants' MYLICON® GAS RELIEF DYE FREE drops non-staining (1/2 oz. size).

The manufacturer has instructed retailers and wholesalers to return their inventories.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm
Regular Mail: Use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 1-800-FDA-0178

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Nestlé Withdraws Nestlé Farinha Lactea Cereal in the United States

Nestlé is withdrawing Nestlé Farinha Lactea cereal in the United States. Nestlé is taking this action as we have learned that the product may contain residual traces of a pesticide not currently approved for use on wheat in the U.S. While the pesticide is approved for use in Brazil and the noted levels are well below Brazilian standards, it is not used on wheat products in the United States and therefore there is no set standard for its presence in cereal. The pesticide is permitted in the United States on grain crops other than wheat.

Nestlé Farinha Lactea cereal is manufactured in Brazil by Nestlé Brazil and sold primarily in Portuguese language communities in the United States. The withdrawal applies to all sizes, varieties and production codes of the product. No other Nestlé products are affected.

Nestlé USA is assisting with the withdrawal of this product from the U.S. market to ensure the continued quality and safety of Nestlé products. Nestlé has not received any illness reports or consumer complaints.

Consumers who have purchased Nestlé Farinha Lactea cereal should not consume the product, and should return it to the store where they purchased it for a full refund.

We encourage consumers with questions about the withdrawal to contact Nestlé Consumer Services at (800) 628-7679.

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Thursday, November 06, 2008

FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer

TT Note: And still the contaminated products from China show up in America.

As part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government today seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio.

The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.

“This action will help prevent this contaminated heparin from finding its way into the marketplace," said Mike Chappell, acting associate commissioner for regulatory affairs, FDA.

Heparin is a blood-thinning drug. An API is a substance or mixture of substances that, when delivered in a finished drug product, directly affects the structure or function of the body. Heparin Sodium USP is an API that may be incorporated into finished drug products. Heparin Lithium is used in certain medical devices including vacutainer blood collection tubes, some in vitro diagnostic assays, and as a coating for capillary tubes. Celsus has distributed Heparin Sodium USP and Heparin Lithium to manufacturers in both the United States and abroad.

OSCS contaminant in injectable drug products containing heparin has been linked to multiple adverse events and deaths initially reported to the FDA in January 2008. Since then, the FDA has put in place a comprehensive inspection and import controls program and has acted to remove from the market heparin materials and products contaminated with OSCS. The seized Celsus heparin – which had entered the United States before the establishment of import controls for the drug – was tested for the presence of OSCS as part of this FDA effort.

To date, the agency has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.

The FDA informed Celsus Laboratories during an April 2008 inspection and again in a May 8, 2008, letter that the company's actions to notify customers about a contaminant in its heparin were insufficient to assure an effective recall. The agency advises manufacturers who may have purchased heparin from Celsus to contact the company to make certain they are not using any heparin from the seized lots because the product does not meet acceptable quality standards.

The FDA has notified Japanese, Canadian, Australian, European Union, and other international authorities of shipments of contaminated heparin from Celsus.

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Wednesday, November 05, 2008

Plantation Pipe Line Will Pay Penalty for Fuel Spills in Va., N.C., Ga.

PRNewswire-USNewswire/ -- Plantation Pipe Line Company, Alpharetta, Ga., has agreed to pay a civil penalty and implement safeguards in order to resolve a Clean Water Act lawsuit over fuel pipeline spills in three states, the Justice Department, the U.S. Environmental Protection Agency (EPA) and state of North Carolina announced.

The company has agreed to pay a $725,000 penalty for discharges of jet fuel and gasoline in Virginia, Georgia and North Carolina, and for inadequate spill prevention safeguards at a Virginia facility. The company also has agreed to implement $1.3 million in new spill prevention safeguards.

"Companies like Plantation Pipe Line that operate oil production infrastructure have a responsibility to ensure the safety and integrity of their operations," said Ronald J. Tenpas, Assistant Attorney General for the Justice Department's Environment and Natural Resources Division. "We continue to work closely with the Environmental Protection Agency to enforce this nation's environmental laws."

"Federal oil pollution prevention requirements, along with regular pipeline upgrades, are designed to prevent the kinds of oil spills that have occurred on Plantation's pipeline system," said Donald Welsh, administrator for EPA's mid-Atlantic region. "The pipeline upgrades required in this settlement will help protect the environment by preventing future spills."

"Oil spills can cause significant harm to the environment," said Jimmy Palmer, EPA Regional Administrator in Atlanta. "EPA will continue to ensure that facilities handling oils follow established procedures to minimize risk to our water and sensitive ecosystems."

The lawsuit cited Plantation for four separate fuel spills from 2000 to 2006, totaling 1,005 barrels (or 42,210 gallons):

-- On Nov. 27, 2006, at least 97 barrels of gasoline leaked from a
Plantation pipeline in Mecklenburg County, N.C., some flowing into Paw
Creek.
-- On Feb. 22, 2003, at least 788 barrels of gasoline spilled from a
pipeline in Hull, Ga., some entering a tributary of East Sandy Creek.
-- On Mar. 13, 2002, at least 20 barrels of jet fuel were discharged from
a pipeline in Alexandria, Va., some flowing to a tributary of Hooff
Run.
-- On Jan. 10, 2000, at least 100 barrels of jet fuel leaked from a
pipeline in Newington, Va., some of which spilled into Accotink Creek.


The lawsuit also cited Plantation Pipe Line for failing to prepare and implement a required spill prevention, control and countermeasure plan for a 420,000-gallon oil storage tank at its Newington, Va., facility.

The settlement requires Plantation to pay a $715,000 penalty to the federal government's Oil Spill Liability Trust Fund and $10,000 to the North Carolina Department of Environment and Natural Resources. In addition, the company will implement $1.3 million in spill prevention safeguards, including upgrades to pipelines and excavating buried valves to improve regular inspection capabilities.

The Clean Water Act prohibits discharges of oil into waterways and coastal areas in quantities that may be harmful to the environment or public health. Oil spills threaten both fresh water and marine environments, harming plant and animal life through physical damage and the toxicity of the oil itself, which may poison exposed organisms. For more information on the effects and cleanups of oil spills, visit: http://www.epa.gov/oilspill.

The proposed consent decree, filed by the U.S. Department of Justice on behalf of EPA and North Carolina, is subject to a 30-day public comment period and final court approval. A copy of the proposed consent decree is available on the Justice Department Web site at www.usdoj.gov/enrd/Consent_Decrees.html.

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