WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Dove™ SkinVitalizer – Facial Cleansing Massager

Units: About 438,000 units (about 50,000 of which have been purchased by consumers)

Distributor: Unilever, of Trumbull, Conn.

Hazard: The cleansing pillows on this device can loosen or dislodge during use and then the SkinVitalizer can cause minor scratches to the skin.

Incidents/Injuries: Unilever has received 33 reports of cleansing pillows from the SkinVitalizer falling off of the device. Unilever has received nine reports of consumers who have experienced minor scratches while using the product. No serious injuries have been reported.

Description: The recall involves a white hand-held Facial Cleansing Massager wand that is intended for use with Dove Cleansing Pillows. When turned on, the unit vibrates. This notice applies to all units and all codes of the SkinVitalizer. No other Dove products or Dove Facial Cleansing pillows are involved in this recall.

Sold at: Discount department, drug and grocery stores nationwide during February 2006 for about $10.

Manufactured in: China

Remedy: Consumers should immediately stop using the product and contact Unilever for information on receiving a full refund. Unilever will provide all shipping charges for returned SkinVitalizer units.
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WASHINGTON — The Occupational Safety and Health Administration (OSHA) will publish a final standard for occupational exposure to hexavalent chromium in the Feb. 28, 2006, Federal Register. The standard covers occupational exposure to hexavalent chromium (Cr(VI)) in general industry, construction and shipyards.

The standard will be published in accord with the timetable established by the U.S. Court of Appeals for the Third Circuit which in April 2003 ordered OSHA to promulgate a standard governing workplace exposure to hexavalent chromium.

The new standard lowers OSHA’s permissible exposure limit (PEL) for hexavalent chromium, and for all Cr(VI) compounds, from 52 to 5 micrograms of Cr(VI) per cubic meter of air as an 8-hour time- weighted average. The standard also includes provisions relating to preferred methods for controlling exposure, respiratory protection, protective work clothing and equipment, hygiene areas and practices, medical surveillance, hazard communication and recordkeeping.

Hexavalent chromium compounds are widely used in the chemical industry as ingredients and catalysts in pigments, metal plating and chemical synthesis. Cr(VI) can also be produced when welding on stainless steel or Cr(VI)-painted surfaces. The major health effects associated with exposure to Cr(VI) include lung cancer, nasal septum ulcerations and perforations, skin ulcerations, and allergic and irritant contact dermatitis.

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A recent article in the Oroville Mercury Register discusses possible changes to California’s Prop 65:

“Non-stick pans, wind-proof coats, even that 40-pound sack of dogfood hauled home from Costco the other day all need a state Proposition 65 warning because they conceal a potential human carcinogen, a coalition of labor and environmental groups said Wednesday.

The culprit is PFOA, a long-living chemical necessary for modern wonders such as Gore-Tex and Teflon but suspected of contaminating the blood of everyone on the globe. Earlier this month, a federal scientific advisory panel concluded that PFOA, or perfluorooctanoic acid, likely causes cancer in humans.

On Wednesday, seven groups – including United Steelworkers, the Sierra Club, and the Environmental Working Group – asked state Attorney General Bill Lockyer to force manufacturers to warn customers under the 1986 consumer protection law known as Proposition 65.”

See the full article: Oroville Mercury Register.

The Food and Drug Administration (FDA) today approved Fluticasone Propionate Nasal Spray, the first generic version of the brand name drug Flonase, giving American consumers an additional, lower cost alternative when choosing prescription drug products.

“Except for their price, which is much lower, generic drugs are in every way equivalent to their brand name counterparts,” said Dr. Steven Galson, Director of FDA’s Center for Drug Evaluation and Research. “Offering consumers a choice of safe, effective, and reasonably priced generic drug products is an extremely important priority for FDA. Today’s approval is part of our ongoing commitment to provide generic forms of products to the public.”

Generic drug products are used to fill over 50 percent of all prescriptions, and since they cost a fraction of the price of trade name drugs, the economic impact of FDA’s generic drug program is profound. Through hard work, prioritization, and optimizing efficiencies, FDA’s Office of Generic Drugs continues to make record numbers of generic products available. In 2005 alone, FDA approved 452 generic drug applications, the second highest total on record.

Fluticasone Propionate Nasal Spray treats the nasal symptoms of seasonal and chronic (long-lasting) allergic and nonallergic rhinitis, an inflammation of the lining of the nose that can make it stuffy and runny. This product is approved for use in both adults and children 4 years and older.

Fluticasone Propionate Nasal Spray contains a synthetic, trifluorinated corticosteroid with anti-inflammatory activity. Corticosteroids are natural substances found in the body that help fight inflammation. Fluticasone propionate, like other corticosteroids, does not have an immediate effect on allergic symptoms. A decrease in nasal symptoms (stuffiness, runniness, itching, and sneezing) has been noted in some patients 12 hours after initial treatment. Common side effects of fluticasone propionate nasal spray are headache, sore throat and nose bleed.

The brand name product or innovator drug for fluticasone propionate is Flonase, manufactured by GlaxoSmithKline and approved in October, 1994. The drug’s patent, including the pediatric exclusivity, expired in May 2004 and the new dosing schedule exclusivity with its associated pediatric exclusivity expired on November 23, 2005.

FDA received several citizen petitions questioning the approval criteria for the drug’s bioequivalence and for other aspects of nasal sprays related to today’s action. The FDA submits generic drug applications to the same thorough and rigorously scientific review for safety, effectiveness and quality as the applications for new drugs. Consumers and health professionals can be assured that an approved generic drug is bioequivalent to a brand name drug and is its equal in dosage form, strength, route of administration, quality, performance characteristics, and intended use.

After reviewing the issues raised in the petitions, FDA determined that its current standards for approval are appropriate.

Fluticasone propionate nasal spray is manufactured by Roxane Laboratories of Columbus, OH.

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Might there be new food labels regulations coming out of Canada?  The Toronto Star thinks so:

Canadians have little in common with the Olympic athletes competing in our name, says Mary Bush, director of the office of nutrition policy and promotion at Health Canada, and a mover in the new food labelling regulations. “The average Canadian is not a well-oiled machine.”

Bush was one of 46 speakers last week at a Montreal conference trying to untangle the mess and find solutions. Some 280 experts from all levels of the food chain, from field to fork, attended. Run by the McGill Institute for the Study of Canada, the conference was called What Are We Eating? Towards a Canadian Food Policy. It left us with a lot to think about.

The Food and Drug Administration approved Eraxis™ (anidulafungin) to treat certain infections caused by Candida, a yeast-like fungus that can cause serious infections in hospitalized patients or patients with compromised immune systems.

“This product offers a new alternative therapy for several types of infections associated with Candida”, said Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research. “It is a helpful addition to the available antifungal medications that can be used in the treatment of these potentially serious fungal conditions.”

Eraxis, a new molecular entity that has never been marketed in the United States, is an antifungal drug that is administered intravenously, and is used to treat Candida infections in the esophagus (candidiasis), blood stream (candidemia), and other forms of Candida infections, including abdominal abscesses and peritonitis (inflammation of the lining of the abdominal cavity).

The safety and efficacy of Eraxis was evaluated in clinical studies and Eraxis was shown to be safe and effective in the treatment of esophageal candidiasis, candidemia, and other Candida infections including abdominal abscesses and peritonitis.

Eraxis was generally well tolerated in clinical studies. The most commonly reported adverse events were mild diarrhea, mild elevations in laboratory tests of liver enzymes, and headache. Some patients experienced infusion-related reactions, most of which were mild. In a few patients with significant underlying medical conditions who were on multiple concomitant medications, there were reports of serious hepatic abnormalities.

Eraxis is manufactured by Pfizer Inc., New York, NY.

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Today, Bristol-Myers Squibb Co. announced labeling changes for Tequin (gatifloxacin), an antibiotic indicated for the treatment of patients with pneumonia, bronchitis, uncomplicated gonorrhea, and various infections including infections of urinary tract, kidneys, and skin.

Information about the risks of low blood sugar and high blood sugar was added to the WARNINGS section of the U.S. labeling in 2002. Today’s changes strengthen the existing WARNING on hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), add a CONTRAINDICATION for use in diabetic patients, and include information identifying other risk factors for developing low blood sugar and high blood sugar, including advanced age, renal insufficiency, and concomitant glucose altering medications while taking Tequin.

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The Monterey County Weekly discusses the possible approval of methyl iodide for use on farms:

“Methyl iodide causes cancer. Some scientists say this pesticide fumigant is more dangerous than methyl bromide, another chemical which was supposed to be phased out years ago. But now, as it scrambles to find a replacement for methyl bromide, the US Environmental Protection Agency appears determined to approve the more toxic methyl iodide for use on local strawberry fields, and elsewhere.”

See the full article: Monterey County News.

The Food and Drug Administration has issued draft guidance on what the term “whole grain” may include. The guidance will assist manufacturers with what the FDA considers appropriate for food label statements related to “whole grain” content. Consumers will now be able to make dietary choices based on a term that is consistent and reliable.

“One of the most important decisions people can make about their health is the choice of foods they eat,” said Dr. Scott Gottlieb, FDA’s Deputy Commissioner for Medical and Scientific Affairs. “A top priority at FDA is finding additional ways to clearly communicate the health benefits found in food.”

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The U.S. Consumer Product Safety Commission (CPSC) announced today the signing of a Memorandum of Understanding (MOU) with the Republic of Korea’s government to improve the safety of consumer products exported to the U.S from South Korea.

The agreement calls for an exchange of information between the two countries on consumer product safety issues, the development of training programs dealing with consumer product safety, and an exchange of safety professionals to carry out consumer safety programs.

CPSC also has signed agreements with Canada, Chile, China, Costa Rica, the European Commission, India, Israel, Mexico and Taiwan to improve the safety of consumer products.

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