From: Public Radio International

The U.S. Food and Drug Administration is in the middle of a lengthy review of the chemical triclosan — a product that’s in countless consumer products like toothpaste and soap. There’s a movement to try and get the product more stringently regulated in the United States — or banned outright. And they might have just gotten a boost from Canada.

Triclosan has been around for 40 years. For nearly all that time U.S. officials have been investigating the chemical’s safety and effectiveness. Now the Canadian government has just declared the antibacterial agent an environmental toxin, and has proposed regulations to curtail its use in Canada.

The FDA review is supposed to be completed by winter 2012.

For more information see the above link.

From National Council of Churches News:

The National Council of Churches expressed disappointment in the Food and Drug Administration’s conclusion that there is insufficient evidence to ban bisphenol-a (BPA), a chemical found in many aluminum cans and some infant formula containers.

The chemical is linked to health concerns in numerous studies that identify such problems as early puberty in girls, prostate and breast cancer, obesity and type II diabetes, heart disease, infertility and neurological issues.

“The faith community is clear on the need to care for the health of our neighbors and to prevent suffering,” said Chloe Schwabe,Environmental Health Program Manager for the NCC’s EcoJustice programs.

“With a scientific body of evidence that continues to produce studies showing harm, we believe the F.D.A. made the wrong decision to allow BPA, a chemical linked to prevalent health conditions, to remain in aluminum cans and infant formula.” Schwabe said.

The full statement is below:

The Food and Drug Administration’s (FDA) decision to allow bisphenol-a (BPA) to continue to be used in baby bottles, sippy cups, infant formula cans, and food cans in the face of numerous studies that link BPA exposures at low-doses to prevalent health concerns such as cancer, early puberty in girls, and type II diabetes is a violation of our call as Christians to protect the health of God’s children, low-income communities, and all life on Earth.

In the hard economic times, more families prepare meals with canned food and a recent study from Boston University School of Public Health used data from the National Institute of Health and found that low-income communities who receive emergency food assistance have higher levels of BPA in their bodies. People living in poverty should not be unduly exposed to BPA or any chemical with mounting evidence of harm to people and God’s Creation.

As 11 states, Canada, France, Denmark, China, Taiwan, Malaysia, the United Arab Emirates, and the EU Commission pass stringent restrictions on this chemical, and the chemical industry and product manufacturers move forward to replace BPA in baby bottles, sippy cups, and aluminum cans, the FDA falls short of guaranteeing a healthy future for all God’s children in the United States.”

We will keep you updated regarding ongoing changes to BPA regulations.

From care2.com:

In recent years, many research and news organizations have published reports about the toxicity of Bisphenol A (commonly called BPA). If you’ve kept up on this topic, you know BPA is in many food and beverage containers (including in the lining of metal cans that hold vegetables, soups and beans) and that it’s a potent endocrine disruptor that acts as a hormone in the human body.

In a recent interview published by Yale Environment 360, BPA researcher Frederick vom Saal of the University of Missouri’s Endocrine Disruptor Group provides some no-nonsense information about BPA and harshly criticizes government oversight of this powerful chemical. Here are some quick facts from the interview.

BPA is derived from petroleum. It was approved by the Environmental Protection Agency for use as a food contact material in 1963. There are more than 100,000 chemicals in commerce, but the U.S. government only has regulatory authority over a percentage of those. In the 1970s, it “grandfathered” in 62,000 chemicals—including BPA—through the Toxic Substances Control Act. That means there is basically no regulatory oversight of this chemical. The Food and Drug Administration came out in 2010 and said it agreed with many researchers that BPA is a concern, but that it doesn’t have the authority to ban or regulate it.

BPA has been linked to early puberty, many types of cancer, obesity, diabetes, heart disease, impaired memory, asthma, allergies and low sperm counts. It damages every part of the human reproductive system.

The common rationalization you hear about BPA being in contact with our foods and beverages is that it’s at such a low level, we don’t need to worry. However, vom Saal explained that his team used human breast cancer cells to study estrogen chemicals for their potency, and BPA lit up like a Christmas tree. He says even at extremely low levels, BPA is anything but weak. The chemical industry threatened vom Saal and his research team, asking them not to publish their findings on BPA.

Of studies funded by the chemical industry, 100 percent say that BPA is safe. However, when you look at the entire body of research studies on BPA, 90 percent of non-industry-funded studies find that BPA is harmful to humans.

The clear message I took away from this interview is that we have to protect and educate ourselves and each other. No government agency is going to make sure the products on grocery store shelves are safe. Please pass this information on.

To learn more about BPA, check out the following resources (the first link is the complete interview with vom Saal):

• Is There Poison in Our Food? Concerns About BPA
• Eating Fresh Food Drastically Reduces BPA Levels, Study Finds
• Plastics: What’s Dangerous, What’s Not
• China Leaps Ahead of U.S. With BPA Ban

We will keep you informed of any developments.

From the FDA:

The U.S. Food and Drug Administration says users of epinephrine inhalers containing chlorofluorocarbons (CFCs) should plan now to get a prescription for a replacement product because these inhalers will not be made or sold after Dec. 31, 2011.

Epinephrine inhalers, marketed by Armstrong Pharmaceutical Inc. as Primatene Mist, are the only FDA-approved inhalers for the temporary relief of occasional symptoms of mild asthma that are sold over-the-counter in retail stores without a prescription. The product uses CFCs to propel the medicine out of the inhaler so that consumers can breathe it into their lungs.

However, Primatene Mist will no longer be available by year’s end because no CFC-containing epinephrine inhalers can be made or sold after Dec. 31, 2011, to comply with obligations made under the Montreal Protocol on Substances that Deplete the Ozone Layer. This is an international agreement signed by the United States, in which countries agreed to phase-out substances that deplete the ozone layer, including CFCs, after certain dates.

For more information or the full article please see the above link.

From The Center For Consumer Freedom:

Since Prop 65’s passage in 1986, lawyers have exploited this safe-drinking-water law to shakedown food manufacturers for producing foods that have chemicals in them that might—emphasize might—be carcinogenic, depending on the exposure. In their sights now is a chemical called acrylamide. In 1990, California listed acrylamide as potentially hazardous due to concerns about workplace exposure. But more recently, scientists discovered that acrylamide can form in foods (in very, very low levels) during frying, roasting, and baking.

In May, a California law firm filed a lawsuit over acrylamide being in coffee and demanded warning labels on every cup of joe. Sound a little overzealous? Washington D.C.-based WTOP reports that even the Food and Drug Administration says acrylamide isn’t a major health issue:

“The FDA is continuing its research on acrylamide, but there is nothing that has been shown that this is a public health concern,” says FDA spokesman Doug Karas.

Karas says recent tests on animals showed that when exposed to very high levels of acrylamide, it can lead to cancer. But he says those are “much higher levels than we would ever be exposed to when eating.”

How much higher? The average person is exposed to levels of acrylamide thousands of times lower than the amount that causes cancer in lab rats. In order to be in any real danger from acrylamide, a person of average weight would have to consume 62 pounds of potato chips or 182 pounds of french fries every day for a lifetime.

For the full story, click on the link above.

From: Bureau Veritas Group

All sunscreen products are considered over-the-counter (OTC) products and are required to be in the “Drug Facts” format.

The FDA states that a sunscreen must protect equally against both types of sun radiation (UVB and UVA) to be considered “broad spectrum.” Broad Spectrum sunscreens with an SPF value 15 or higher can claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Non-Broad Spectrum sunscreens, and Broad Spectrum sunscreens with an SPF value lower than 15, can only claim to “help prevent sunburn.”

Any sunscreen product that is not Broad Spectrum, or that is Broad Spectrum with an SPF value less than 15, requires a warning statement. The wording of this warning has been revised to state, ‘‘Skin Cancer/Skin Aging Alert: [in bold font] Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not [in bold font] skin cancer or early skin aging.”

Click on the links for more information.

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: The Daily Targum

The first case in a mass litigation against Novartis Pharmaceutical Corporation for allegedly failing to inform customers of the risks associated with two of the firm’s cancer drugs will begin next Monday in Middlesex County Superior Court….The question before the court will concern the safety of Aredia and Zometa, medications Novartis developed to treat cancers of the bone, according to court documents.

Plaintiffs in the case allege that the drugs in dispute caused cells in the bone of the jaw to die unnecessarily.

The U.S. Food and Drug Administration approved Aredia for sale in 1996 and Zometa in August 2001, according to centerwatch.com, an online pharmaceutical journal.

After doctors and medical researchers warned the company of the risk of osteonecrosis of the jaw associated with Aredia and Zometa, Novartis decided to add a warning label to the drugs’ packaging in 2004, according to the complaint.

Also at issue in the suit is Novartis’ redeployment of Zometa in treating diseases other than cancer.

Click on the links for more information.

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

From: Real Estate Law

Individuals who have suffered serious injuries and side effects from the medication Levaquin could soon have access to what could potentially be the most important litigation against the drug’s manufacturers and distributors. In an announcement that may set the precedent for future legal action regarding Levaquin, the law firm of Carey and Danis made public their fillings of four lawsuits naming Johnson and Johnson and Ortho-McNeil Pharmaceutical Inc., as well as Walgreen Co., one of the largest distributors of the drug, as defendants. The civil suits, filed to represent twenty plantiffs, allege that Johnson and Johnson and Ortho-McNeil knew about the severe risk of tendonitis and possible tendon rupture, especially in patients over 60, and yet continued marketing the drug as a safe and efficacious treatment option for several different types of infections; these included lung, sinus, skin and urinary tract infections.

Through 2007 and 2008, the FDA instituted a requirement for the packing of Levaquin, requiring an extended side effect list to be present with the medication as well as giving the drug the FDA’s strongest warning label, the Black Box label. The FDA has been quoted recently saying that Levaquin, , “poses a serious and significant public health concern.”

The lawsuit asserts that Johnson and Johnson and Ortho-McNeil had knowledge of these side effects years before cases began surfacing, yet they continued to market the drug as a safe and viable alternative. Additionally, the lawsuits allege that the two companies manipulated study data in order to circumvent potentially damning evidence against the drug and that the companies minimized the risks to patients when marketing the drug to physicians. The suit charges Johnson and Johnson and Ortho-McNeil with negligence, breach of warranties, and violations of the Illinois Consumer Fraud Act, just to name a few.

Click on the links for more information.

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