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Entries in FDA (3)

Wednesday
Aug152012

Feds Seek To Force Kabco Pharmaceuticals To Stop Selling Possibly Contaminated Supplements

With failure to clean up its manufacturing practices after years of federal warnings, Kabco Pharmaceuticals is now facing an injunction to stop producing and selling its dietary supplements.

Manufacturing photo from Kabco Pharmaceuticals.

The U.S. Justice Department filed the injunction accusing the company of implementing inferior product safety and manufacturing practices, and producing dietary supplements that are potentially dangerous to people’s health.

The products produced by the company include: Brewers Yeast Tablets, Dandelion Root Capsules, Night-Time Herb Capsules, Inositol Calcium & Magnesium Capsules, Vitamin C-500 with Rose Hip Time-Released Tablets, and Joint All Capsules.

An investigation by the U.S. Federal Food and Drug Administration found that, “The company did not review and investigate product complaints, and Kabco also failed to hold dietary supplements under conditions designed to prevent product mix-ups.”

In November 2010, the FDA sent a warming letter to Kabco citing a number of violations. The allegations included that the company “did not perform identity testing on any of the dietary ingredients” received from distributors, such as valerian root (a sedative for sleep problems and anxiety) and ginkgo biloba (an aide for memory and concentration improvement).

The FDA also accused the company of failing to indicate what steps it would take “regarding already distributed dietary supplements” made from untested ingredients.

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Sunday
May102009

Outraged Senator Introduces Federal Act to Protect Young Children From Widespread Contaminants in Personal Care Products

Sen. Kristen Gillibrand (D-N.Y.) . Stock photo.

NEW YORK- In response to a children’s health study done by the Campaign for Safe Cosmetics, Sen. Krsiten Gillibrand (D-N.Y.) has introduced the Safe Baby Products Act into the federal legislature.

In conjunction with the bill, now awaiting a reference number, Gillibrand wrote a letter to Frank M. Torti, acting commissioner of the U.S. Food and Drug Administration, stating that “due to complete and total lack of oversight, the products that we use to care for our children could be putting their health and lives at risk. I find it to be unacceptable that the FDA does not regulate personal care products, as it does food and drugs.”

Gillibrand went on to say in her letter that, “The Campaign for Safe Cosmetics commissioned laboratory tests that revealed that personal care products are commonly contaminated with formaldehyde or 1,4-dioxane, which have been linked to cancer and skin allergies.

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Monday
Feb092009

Peanut Products From Over 100 Companies Are Now Affected by the Nationwide Recall

Photo courtesy of Fiery-Foods.com

WASHINGTON, D.C. - The Peanut Corporation of America has distributed potentially contaminated products to more than 100 consignee firms for use as ingredients in hundreds of different products, such as cookies, crackers, cereal, candy, ice cream, and pet food, according to the latest information released in the investigation by the U.S. Food and Drug Administration.

All of the PCA’s affected peanut products were made at the company’s Blakely, Ga. facility, which is no longer in operation. The FDA has been working with the company and purchasers to identify affected products and facilitate their removal from the market. Affected products are those that were produced between January 1, 2007 to the present.

“More than 400 products at this time” have been recalled, said FDA Dr. Stephen Sundlof. Concerned consumers can check the FDA’s new peanut products recall webpage to check and see if they have purchased any contaminated products.

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