Investigations into Lead Content and the Recall Process

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Howard Aughinbaugh
04-07-2011

By Howard Aughinbaugh

Regulatory agencies are not the only groups concerned about safety. Consumer advocacy organizations and institutions of higher education are also keenly interested in protecting consumers. As we have discussed here before, research and product testing by any of these groups can have an influence on the recall process. In a recent study, Jefferson Medical College found that ceramics sold in Philadelphia’s Chinatown contain levels of lead that exceeded the Food and Drug Administration (FDA)’s safety standards. While we cannot be sure whether the release of this report will trigger a recall, it should serve as a reminder that companies should frequently test their own products for safety and continuously review their recall preparedness plans.

While lead content usually falls under the purview of the Consumer Product Safety Administration, the FDA is also concerned with lead whenever there is a possibility that it might contaminate a food product The Jefferson study, released in late March, found that 25 percent of more than 80 products tested contained lead, including three plates and two spoons that vastly exceeded FDA limit of two parts per million. One plate tested for the study was found to contain more than 145 parts per million.

The researchers are concerned that the level of lead found in products sold in Philadelphia’s Chinatown is high enough that it could leach from the utensils and kitchen supplies into the food being prepared. In fact, Dr. Gerald F. O’Malley, the lead researcher, told The New York Times that he is already planning a follow-up study to determine whether lead in utensils can, in fact, turn up in the bloodstream. So far, there is no research data that confirm whether this is a reasonable concern, but companies should understand that the regulators are taking the matter very seriously.

The results of this study, along with Dr. O’Malley’s plans for additional research, could be enough to trigger changes in federal standards or regulatory action against the manufacturers of the products. Smart companies will take this as a warning sign. Do not wait to take action until after tougher standards are set or new regulations are put into effect. Whenever a regulatory agency believes health and safety are at risk, a recall can result. Prepare now so that your company can take action quickly if the situation demands it.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

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