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FDA Asks Denture Cream Manufacturers to Replace Dangerous Zinc Ingredient

Approximately 35 million Americans use denture creams and several popular adhesives have been linked to serious and debilitating injuries caused by excess levels of zinc contained in the products that may enter the body.

A June 2008 study published in the journal American Academy of Neurology highlighted the potential dangers of excess exposure to the zinc found in some denture adhesive creams. The researchers concluded that that “chronic, excess zinc intake can result in copper deficiency and profound neurologic disease.”

At least one manufacturer has voluntarily withdrawn its zinc-containing denture cream, and now the Food & Drug Administration finally appears poised to take action of its own. On February 23, 2011, Steven D. Silverman, FDA’s Director of its Office of Compliance Center for Devices and Radiological Health, wrote a letter to all denture adhesive manufacturers that recommends “replacing zinc with an ingredient that presents less health risks.”

The letter, titled “NOTICE and RECOMMENDED ACTION,” says that FDA “ has received numerous reports of adverse events related to the use of denture adhesives” and that “literature and research that suggest that zinc contained in some denture adhesives may be a contributing factor in these adverse events.”

In addition to the recommendation that zinc be removed from denture adhesive products, FDA also urged manufacturers to perform a risk analysis labeling to assess how risks can be mitigated; conduct human factors studies to assess consumer understanding of labeling and the potential for misuse of your product; and to modifying existing labeling to include a statement that the products contain zinc and to define maximum safe usage in easily understood terms.

Previously, the National Institutes of Health has warned consumers that too much zinc can purge the body of copper, and a copper deficiency can cause nerve damage. Nerve damage may cause symptoms such as:

  • Weakness and numbness in arms and legs
  • Difficulty walking and loss of balance
  • Dognitive or memory impairment

Do I Have a Zinc Lawsuit

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in zinc lawsuits. We are currently accepting new cases in all 50 states.

Again, if you or a loved one has been injured or suffered an overdose from a zinc, you should contact our lawyers immediately by clicking the link below or calling toll free 1-800-773-0849. You may be entitled to compensation for your injuries and we can help.

Categories: Product Liability
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