From: SF Gate

Johnson and Johnson  should pay $351 million to Louisiana for defrauding the state’s Medicaid system with false claims about the safety of its antipsychotic drug Risperdal, a lawyer for the state told jurors.

The state’s case centers on drug safety claims that J and J and its Ortho-McNeil-Janssen Pharmaceutical unit made in November 2003 correspondence to 700,000 doctors. The U.S. Food and Drug Administration responded with a warning letter saying J and J made false and misleading claims that minimized the potentially fatal risks of diabetes and overstated the drug’s superiority to competitors.

An FDA warning letter sent in April 2004 said the J and J missive failed to disclose new data on diabetes in the warning label; “minimizes the risk of hyperglycemia-related adverse events” that can lead to coma or death; fails to recommend glucose control monitoring for patients; and “misleadingly claims that Risperdal is safer than other atypical antipsychotics.”

J and J said research “suggests” that Risperdal “is not associated with an increased risk of diabetes” compared with an earlier class of antipsychotics. It also said evidence “suggests” Risperdal is “associated with a lower risk of diabetes than some other studied atypical antipsychotics.”

Click on the link for more information.

Relevant Nexreg Compliance Links: CPSC compliance, OSHA MSDS authoring, MSDS authoring

From: FDA

The FDA today issued warning letters to three companies that manufacture and market mouth rinse products with claims that they remove plaque above the gum line or promote healthy gums. These claims suggest the products are effective in preventing gum disease when no such benefit has been demonstrated.

Warning letters were sent to, Johnson and Johnson (Listerine Total Care Anticavity Mouthwash), CVS Corporation (CVS Complete Care Anticavity Mouthwash), and Walgreen Company (Walgreen Mouth Rinse Full Action).

Under federal law, a company cannot claim its product is effective in treating a disease unless those claims have been reviewed and approved by the FDA in a new drug application or the active ingredient has been generally recognized as safe and effective for these claims in an over-the-counter (OTC) drug monograph.

Click on the link for more information.

Relevant Nexreg Compliance Links: CPSC compliance, OSHA MSDS authoring, MSDS authoring

From: Emirates Week

AsiaInspection, a leading provider of quality control services for the manufacturing industry in Asia, today announces the results of a survey of laboratory tests of toys manufactured in China and ready for shipment to Europe and the United States. The results show 25% of the survey sample contained dangerous levels of phthalates, a group of chemicals found in plastics and which has been placed under stringent regulations in Europe and North America.

Over the last two months, AsiaInspection randomly selected 35 China-made plastic toys destined for Europe and USA and standard phthalates content tests were conducted. Approximately 25% of these toys were found to contain dangerously high levels of phthalates, and consequently they did not conform to EU and USA chemical content regulations. Among the survey sample, a toy first aid kit was found to contain more than 130 times the allowable limit of DEHP, a regulated phthalate.

Click on the links for more information.

Relevant Nexreg Compliance Links: REACH compliance, EU SDS authoring, SDS authoring

From: OSHA

OSHA initiated an inspection after receiving an employee complaint alleging workplace safety and health hazards. As a result of the inspection, Miskeen was cited for one willful violation with a penalty of $28,000, 12 serious violations with a $15,150 penalty, and seven other-than-serious violations, which carry no penalty.

The serious violations include employee overexposure to methylene, failing to provide personal protective equipment, conduct a personal protective equipment assessment, evaluate respiratory hazards, properly monitor for methylene chloride, conduct medical evaluations for respirators, provide eyewash, train employees on how to use fire extinguishers, establish a regulated area for employees exposed to methylene chloride and implement effective engineering controls. An OSHA violation is serious if death or serious physical harm could result from a hazard an employer knew or should have known exists.

Click on the links for more information.

Relevant Nexreg Compliance Links: CPSC compliance, OSHA MSDS authoring, MSDS authoring

Today, a new video has been released in our  ‘Nexreg on Compliance’ video series, which addresses hazard communication (HazCom) issues for jurisdictions such as Canada, the United States and the   European Union.  The videos can be found on Nexreg’s YouTube channel at http://www.youtube.com/user/Nexreg.

• New Canadian VOC ( Volatile Organic Compound) Regulations

A look at the state of Canadian VOC ( Volatile Organic Compound) regulations for architectural coatings, automotive refinishing products and certain consumer products.

Nexreg plans on adding a new video every Friday.  The questions answered in the video series will come from viewer requests, so please   send your questions to info@nexreg.com.

To learn more about Nexreg Compliance please visit www.nexreg.com or call our toll-free line at (866)361-3032.

From: TSCA Consulting

EPA is issuing significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for two chemical substances which were the subject of Premanufacture Notices (PMNs). The two chemical substances are identified generically as multi-walled carbon nanotubes (MWCNT) (PMN P–08–177) and single-walled carbon nanotubes (SWCNT) (PMN P–08–328).

This action requires persons who intend to manufacture, import, or process either of these two chemical
substances for a use that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity.

This final rule is effective October 18, 2010.

Click on the links for more information.

Relevant Nexreg Compliance Links: CPSC compliance, OSHA MSDS authoring, MSDS authoring

Nexreg Canada is rapidly expanding and is looking to add members to our Canadian team in London, Ontario, Canada. Our ideal candidate is an intelligent, personable, highly motivated individual that is looking to continue a lucrative career in the regulatory compliance industry.

Location: London, ON.

Salary: Negotiable, based on experience.   Please send salary expectations along with resume.

Hours: Full time – 37.5 hours a week.

Primary Duties:

• Assist regulatory consultants with authoring Canadian and/or Canadian/U.S.compliant MSDSs using Nexreg’s proprietary MSDS authoring system.
• Assist regulatory consultants with authoring Canadian compliant product labels for the industrial, consumer chemical, and cosmetics markets.

Qualifications:

• Minimum one year of experience with MSDS authoring, regulatory consulting or government registrations.
• Completion of a Bachelor degree is required. A degree in a science related field an asset.
• Experience with Microsoft Office, particularly Word and Excel required.
• Second-language ability an asset, but not required.

Location: London, ON, Canada.

About Us: Nexreg Compliance Inc. is a leader in delivering high quality, chemical regulatory compliance, Material Safety Data Sheets (MSDS) authoring and technical translations. We are committed to providing our clients with first rate services, regardless of the regulatory challenge. Our mission is to deliver exceptional chemical regulatory and translation services around the world.

Nexreg offers a highly competitive salary with the potential for significant career advancement. If interested, please e-mail cover letter, current resume and salary expectations ATTN: Jeff Burns, Canadian Regulatory Manager to info@nexreg.com.

From: Environmental Leader

A new study suggests exposure to bisphenol-A  (BPA) is actually far greater than previously thought, and its authors urge the federal government to act quickly to regulate BPA which is found in baby bottles, food-storage containers, can linings and many household products, Food Safety News reports.

“Our data raise grave concern that regulatory agencies have grossly underestimated current human exposure levels,” the study states. “On this basis of our findings, we propose that the higher than predicted serum levels of unconjugated BPA in men and women reflect significant non-oral BPA exposure in addition to oral exposure.”

The U.S. Environmental Protection Agency, which last year rated the potential effects of low doses of BPA as “of some concern,” has said daily exposure of up to 50 micrograms of BPA per kilogram of body weight is safe.  But the study suggests people are exposed to at least eight times that amount.

Click on the links for more information.

Relevant Nexreg Compliance Links: CPSC compliance, OSHA MSDS authoring, MSDS authoring

Sept 22, 2010 – Elite Foil-Ware 2.5 Hour Methanol Gel by Modern Houseware Imports Inc.

Health Canada’s auditing process has revealed that the recalled product does not meet the bilingual labelling requirements for consumer chemical products under Canadian law.

The product lacks the English and French warnings required for toxic and flammable products. In addition, the current hazard labelling is not positioned or sized properly according to the Regulations. These omissions could present a significant risk that may result in serious and irreversible harm.

Sept 7, 2010 – Aluminum and Chrome Car polish

Health Canada’s auditing process has revealed that these products do not meet the mandatory warning labelling and child-resistant container requirements, as required under Canadian law.

The container is not child-resistant and is missing hazard labelling explaining how to safely use the product. These omissions present a risk that can result in serious and irreversible harm.

If you have any doubts about the compliancy of your chemical products, please do not hesitate to contact us. More information about our label review services can be found here:

• Canadian Consumer Label Review
• Canadian Industrial Label Review
• Canadian Cosmetic Product Label Review

We can be contacted at:
Nexreg Toll Free: 1-866-361-3032
E-mail:info@nexreg.com

From: ECHA

The document is addressed to manufacturers, importers, downstream users and distributors of chemical substances and mixtures.

It goes beyond the relevant chapters on CLP hazard labelling as presented in the Introductory Guidance on the CLP Regulation and the Guidance on the Application of the CLP Criteria as it further specifies and explains the application and arrangement of the CLP label elements on the hazard label for substances and mixtures. Its content will replace Part 5 (Labelling) and Annex V (Selection of precautionary statements) of the Guidance on the Application of the CLP Criteria.

In particular, this guidance will clarify:
•    what aspects to consider when estimating the label size needed,
•    what types of supplemental information are possible, and where to place this
•    information on the label, see section 4.7 below;
•    the conditions for small packaging exemptions;
•    the interaction between CLP and the transport labelling rules;
•    how to select the most appropriate set of precautionary statements for the label.

Click on the link to be directed to the Guidance on Labelling and Packaging in accordance with Regulation (EC) No 1272/2008 (draft)

Relevant Nexreg Compliance Links: REACH compliance, EU SDS authoring, SDS authoring