FDA Issues Warning and Recommends Denture Cream Manufacturers Stop Using Zinc
On February 23, 2011, the U.S. Food and Drug Administration (“FDA”) sent a Notice and Recommended Action letter to denture adhesive manufacturers requesting that they consider removing zinc from denture cream products. In support of its request, the FDA highlighted the mounting literature and research suggesting that zinc contained in denture creams leads to zinc toxicity, which can result in severe neurological damage. The two primary denture adhesive manufacturers in the United States are Proctor & Gamble, which makes Fixodent, and GlaxoSmithKline, which makes Super Poligrip.
FDA Outlines Specific Recommendations
In the Notice and Recommended Action letter, the FDA specifically outlined a course of action that denture adhesive manufacturers should consider: (1) Perform a risk analysis of their labeling; (2) Conduct a study to assess consumer understanding of labeling and potential misuse of the product; (3) Modify the labeling to indicate that the product contains zinc and clearly define the maximum safe dosage; and (4) Replace zinc with a less harmful ingredient. While the letter did not amount to an FDA recall, it sent a clear message to denture cream manufacturers that immediate action is required and that the agency is taking this matter very seriously. In fact, the letter required that its recipients acknowledge that they received the notice and reminded manufacturers that they are required to report all adverse events to the FDA.
What Prompted the FDA to Issue the Zinc Warning?
Recently, the serious side effects associated with denture creams have received increased media attention. Although the dangers associated with denture cream use have been known for some time as studies published in medical journals continue to establish a link between zinc poisoning and denture adhesives, and lawsuits against denture cream manufacturers continue to mount, an increase in public awareness may have prompted the FDA to take action. With over 35 million Americans using denture creams, zinc poisoning is a public health and safety issue, warranting further regulatory action.
Contact a Denture Cream Lawyer Today
If you or a loved one uses Fixodent, Poligrip, or another brand of denture cream and suffers from symptoms of zinc poisoning, such as pain and numbness in the hands and feet, you should contact one of our denture cream lawyers immediately to discuss your legal rights and options for pursuing a denture cream lawsuit. The lawyers at Bernstein Liebhard LLP have extensive litigation experience, and have recovered billions of dollars for their clients. In addition to being staunch advocates for your claim, our denture cream lawyers also provide personal attention to guide you through the complex litigation process.