FDA bans India manufactured Ranbaxy drugs from US market

In a setback to Indian pharmaceutical giant Ranbaxy, the US has prohibited the company from producing and distributing drugs for the American market from its Toansa facility in Punjab.

In an order, the Food and Drug Administration yesterday prohibited Ranbaxy from distributing in the US the drugs manufactured using Active Pharmaceutical Ingredients (API) in Toansa, including drugs made by Ranbaxy's Ohm Laboratories facility in New Jersey. Ranbaxy has also been prohibited from manufacturing API at its Toansa facility for FDA-regulated drug products; exporting API from Toansa to the US for any purpose; and providing API from Toansa to other companies, including other Ranbaxy facilities, making products for American consumers. 

"We are taking swift action to prevent substandard quality products from reaching US consumers," said Carol Bennett, acting director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. 

"The FDA is committed to ensuring that the drugs American consumers receive, no matter where they are produced, meet quality standards and are safe and effective," he added.

In a statement, FDA said it exercised its authority under a provision in the consent decree which permits the agency to extend the decree's terms to any Ranbaxy-owned or operated facility if an FDA inspection finds the facility in violation of the Federal Food, Drug and Cosmetics Act or FDA regulations, including CGMP requirements. CGMP requirements serve as the primary regulatory safeguard over drug manufacturing and must be followed by companies to ensure manufacturing quality.

The FDA also acted under a separate provision in the decree which permits the agency to order additional corrective actions that FDA determines are necessary to achieve compliance with the law or the decree, it said. 

The caramel color in your cola may kill you, Consumer Reports warns

If you love drinking cola, beware. A potentially carcinogenic chemical called 4-methylimidazole (4-MeI) is found in some types of the artificial coloring used in sodas, Consumer Reports has warned. The FDA is also probing how dangerous it can be.

The chemical that gives sodas their distinct golden-brown color can possibly cause cancer, the Consumer Reports warned, adding that a potentially carcinogenic chemical called 4-methylimidazole (4-MeI) is found in some types of the artificial coloring.

"Caramel color, added to many soft drinks and some foods to turn them brown, may sound harmless, even appetizing. But in no way does it resemble real caramel," the group said. "Some types of this artificial coloring contain a potentially carcinogenic chemical called 4-methylimidazole (4-MeI)."

Consumer Reports isn't the only one saying the chemical, which appears as "caramel coloring" in food products,is dangerous to health. The World Health Organization's International Agency for Research on Cancer and the state of California also said that the chemical can potentially cause cancer. A 2007 federal government study has likewise found that the chemical caused cancer in mice.

California even has a law that says any food or beverage product sold in the state that gives consumers 29 micrograms of 4-MeI exposure a day must carry a health warning label: "WARNING: This product contains a chemical known to the State of California to cause cancer."

Experts at the Consumer Reports though think 29 micrograms is still too high. "Even if your choice of soft drink contains half that amount, many people have more than one can per day," said Urvashi Rangan, toxicologist and executive director of Consumer Reports' Food Safety & Sustainability Center. "Given that coloring is deliberately added to foods, the amount of 4-MeI in them should pose a negligible risk, which is defined as no more than one excess cancer case in 1 million people."

In its report Thursday, Consumer Reports also said that lab analyses showed Pepsi One and Malta Goya exceeded what California considered as safe level of 4-MeI. "While our study was not large enough to recommend one brand over another, both rounds of testing found that the level of 4-MeI in the samples of Pepsi One and Malta Goya purchased in both locations exceeded 29 micrograms per can or bottle. The products we purchased in California did not have a cancer-risk warning label," it said.

In response to the report, the Food and Drug Administration (FDA) said it will review the safety of the artificial coloring. "These efforts will inform the FDA's safety analysis and will help the agency determine what, if any, regulatory action needs to be taken," FDA spokeswoman Juli Putnam to The Associated Press.

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