Sometimes a hand sanitizer will reach too far in its claims. Four companies that say their products, including hand sanitizers, can prevent infection from the superbug MRSA, or methicillin-resistant Staphylococcus aureus, have been issued warning letters by the U.S. Food and Drug Administration, the federal agency announced April 20.
Since the products, which are all nonprescription, claim to prevent disease, they are classified as drugs, which are within the purview of the FDA. The agency said it does not have sufficient evidence that these particular products are safe and effective for these purposes.
Some of the products also advertise that they preventinfection from E.coli and the H1N1 flu virus. But there is not sufficient proof the combination of ingredients in the products, which include plant oils, the chemical benzethonium chloride, and the antimicrobial agent triclosan can actually impede infection from these diseases. The FDA is still evaluating whether triclosan can be used as an antimicrobial.
Alcohol-based sanitizers, on the other hand, are effective in preventing the spread of the seasonal flu, H1N1, colds and other viral- and bacterial-based diseases.
The warning letters explain the companies are marketing these products in violation of federal law.
"MRSA is a serious public health threat. The FDA cannot allow companies to mislead consumers by making unproven prevention claims," said Deborah Autor, director of the office of compliance in the FDA's Center for Drug Evaluation and Research.
The four companies have 15 days to correct the violations cited in the warning letters. Failure to do so may result in legal action, including seizure and injunction, the FDA said.
The warning letters were sent to these companies:* Tec Laboratories, for Staphaseptic First Aid Antiseptic/Pain Relieving Gel
* JD Nelson and Associates, for Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant
* Dr. G.H. Tichenor Antiseptic Co., for Dr. Tichenor's Antiseptic Gel
* Oh So Clean Inc., doing business as CleanWell Co., for CleanWell All-Natural Foaming Hand Sanitizer, CleanWell All-Natural Hand Sanitizer, CleanWell All-Natural Hand Sanitizing Wipes, and CleanWell All-Natural Antibacterial Foaming Handsoap
The FDA encouraged health care professionals and patients to report any adverse events or side effects from these products to the agency's MedWatch Safety Information and Adverse Event Reporting Program.
Pass it on: Companies that claim their products prevent MRSA have insufficient evidence for their advertisements, the FDA says.
This story was provided by MyHealthNewsDaily, a sister site to LiveScience
The Healthy Homes and Building blog is a professional blog dedicated to discussing healthy homes and building issues. Topics include but are not limited to indoor air quality, asbestos, lead, dust mites, rodents, IPM, radon, second hand smoke, safety and PBCs in building materials(e.g. caulking, paint etc.) .
Friday, April 22, 2011
Tuesday, April 19, 2011
Formaldehyde in Hair Products
Beauty Salons May Expose Workers and Customers to Carcinogens
OSHA issues formaldehyde warning and Sussex Environmental Health Consultants provide comprehensive formaldehyde testing services.
PRLog (Press Release) – Apr 18, 2011 – Few people who visit a beauty salon realize they may be putting their health at risk. The Brazilian Blowout, the name given to a controversial hair straightening procedure, has come under the scrutiny of the Occupational Safety and Health Administration (OSHA). The reason for the concern is the presence of formaldehyde in many of the products used in the procedure. According to an article last week in the Los Angeles Times, “State OSHA offices in California and Oregon began investigating the Brazilian Blowout and other hair smoothing products several months ago after a host of complaints from salon workers and clients reporting headaches, nosebleeds, blisters, burning eyes, vomiting, asthma attacks and other respiratory problems. Several state-level agencies -- including those in California, Oregon and Connecticut -- issued warnings about the products. Health Canada issued an outright ban.” Formaldehyde is widely used in many consumer products and common building materials. The World Health Organization’s (WHO) International Agency for Research on Cancer (IARC) has classified formaldehyde as a known human carcinogen. According to OSHA, some of the chemicals being used, including some labeled as ‘formaldehyde free’ actually contain the chemical at levels above federal limits. Sussex Environmental Health Consultants, LLC (SEHC) is an environmental, health and safety consulting firm located in Delaware that has an extensive history of investigating indoor air quality (IAQ) issues involving formaldehyde across the Mid-Atlantic region. “Both workers and the general public need to be aware of the health risks associated with prolonged or elevated exposure to formaldehyde,” stated Susan White, Ph.D., CMC, President of SEHC. “In the case of the Brazilian Blowout products, beauty salons using these chemicals should have the products evaluated, increase ventilation for the salons, provide personal protective equipment for employees and conduct routine exposure monitoring. Failure to do this could result in temporary or even permanent health problems,” she continued.
OSHA issues formaldehyde warning and Sussex Environmental Health Consultants provide comprehensive formaldehyde testing services.
PRLog (Press Release) – Apr 18, 2011 – Few people who visit a beauty salon realize they may be putting their health at risk. The Brazilian Blowout, the name given to a controversial hair straightening procedure, has come under the scrutiny of the Occupational Safety and Health Administration (OSHA). The reason for the concern is the presence of formaldehyde in many of the products used in the procedure. According to an article last week in the Los Angeles Times, “State OSHA offices in California and Oregon began investigating the Brazilian Blowout and other hair smoothing products several months ago after a host of complaints from salon workers and clients reporting headaches, nosebleeds, blisters, burning eyes, vomiting, asthma attacks and other respiratory problems. Several state-level agencies -- including those in California, Oregon and Connecticut -- issued warnings about the products. Health Canada issued an outright ban.” Formaldehyde is widely used in many consumer products and common building materials. The World Health Organization’s (WHO) International Agency for Research on Cancer (IARC) has classified formaldehyde as a known human carcinogen. According to OSHA, some of the chemicals being used, including some labeled as ‘formaldehyde free’ actually contain the chemical at levels above federal limits. Sussex Environmental Health Consultants, LLC (SEHC) is an environmental, health and safety consulting firm located in Delaware that has an extensive history of investigating indoor air quality (IAQ) issues involving formaldehyde across the Mid-Atlantic region. “Both workers and the general public need to be aware of the health risks associated with prolonged or elevated exposure to formaldehyde,” stated Susan White, Ph.D., CMC, President of SEHC. “In the case of the Brazilian Blowout products, beauty salons using these chemicals should have the products evaluated, increase ventilation for the salons, provide personal protective equipment for employees and conduct routine exposure monitoring. Failure to do this could result in temporary or even permanent health problems,” she continued.
Wednesday, April 13, 2011
Girls Clothing Recall due to Lead
Connecticut Department of Public Health 410 Capitol Avenue, MS#51 LED Hartford, CT 06134-0308 Message Cover Sheet DATE: April 13, 2011 TO: Directors of Health Chief Sanitarians Regional Lead Treatment Centers Lead Contacts FROM: Rhonda Wisniewski, Health Program Assistant PHONE: (860) 509-7299 FAX: (860) 509-7295 RE: Girl’s Clothing Recalled by My Michelle Due to Risk of Lead Exposure cc: LPPCP Staff, Suzanne Blancaflor, Francesca Provenzano and Joan Jordan (CT DCP) Number of pages including cover sheet: 3 Please see the attached product recall issued by CPSC. The products (Girl's Tops) are distributed by My Michelle, of New York, NY. The jewelry and decorative trim attached to the girl's garments contain high levels of lead. Lead is toxic if ingested by young children and can cause adverse health effects. This recall involves girl's tops and dresses sold in sizes small to extra-large and 7 to 16. The garments were sold in various styles including: tops with beaded necklaces attached to the collar and tops with metallic beads attached to the collar. All styles of the tops and dresses have a black tag on the collar with pink print that reads "mymichelle." The recalled items were sold at Burlington Coat Factory, Dillard's, J.C. Penney, Kohl's, Army and Air Force Exchange (AAFES), K & G Fashion Superstore and other retail stores nationwide from January 2011 through March 2011 for about $38. They were manufactured in Vietnam. Please see the recall notice for specific information for consumers and contact information for the company. You may also contact the CT Department of Public Health Lead Poisoning Prevention & Control Program at 860-509-7299.
Monday, April 11, 2011
National Gypsum Announces Dismissal of Lawsuit
National Gypsum Announces Dismissal of Attempted Class Action Lawsuit Company’s Product Continues to Withstand Baseless Claims CHARLOTTE, N.C.--(BUSINESS WIRE)--National Gypsum Company, one of the nation’s largest manufacturers of gypsum wallboard, today announced that the plaintiff in Yee v. National Gypsum, et al. (pending in the U.S. District Court for the District of Arizona) voluntarily dismissed his putative nationwide class action lawsuit filed against the company in October 2009. “Our wallboard has passed the industry’s most rigorous testing and certification processes for indoor air quality and has been used by the U.S. Environmental Protection Agency (EPA) and the U.S. Green Building Council in their buildings.” “While we are pleased with the outcome of this case, we are hardly surprised. Throughout this litigation, we have never doubted the quality and safety of our gypsum wallboard and were confident we would be fully exonerated,” said Craig Weisbruch, Sr. vice president of Sales & Marketing. “Our wallboard has passed the industry’s most rigorous testing and certification processes for indoor air quality and has been used by the U.S. Environmental Protection Agency (EPA) and the U.S. Green Building Council in their buildings.” The putative class action, Yee v. National Gypsum, et al, alleged that the company manufactured defective drywall which emitted high levels of sulfur, damaged property inside homes and caused health symptoms. These problems have typically been associated with defective Chinese drywall, not domestic drywall. National Gypsum vigorously defended itself against the claims and denied all allegations. The plaintiff did not produce any credible scientific evidence that could substantiate his allegations. “We have not seen any reliable evidence that our gypsum wallboard poses any of the issues associated with defective Chinese drywall,” said Weisbruch. All of the wallboard that National Gypsum manufactures is made in the United States and has attained the highest level of GREENGUARD certification for helping achieve healthy air in homes, schools, hospitals and other public buildings. National Gypsum’s wallboard has earned numerous awards for safety and product quality and has been recognized for its environmental benefits by the EPA and contributes credits to numerous projects certified by the U.S. Green Building Council’s Leadership in Energy and Environmental Design (LEED) Green Building Rating System. For more information on National Gypsum and its products, visit www.NationalGypsum.com or www.DrywallFacts.com. About National Gypsum National Gypsum, based in Charlotte, NC, is a leading supplier of gypsum board, interior finishing products and cement board to the construction industry. It has a network of over 40 facilities in North America. Contacts National Gypsum CompanyCraig Weisbruch, 704-365-7556Director, Corporate Communications
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