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After 18 months of complaints, drug recalls and a warning letter from the Food and Drug Administration for its "Failure to thoroughly investigate," McNeil Consumer Healthcare has proposed remediation measures that will do nothing to avert future contamination.
"Early on McNeil's stated theory for the contamination was taint from chemically-treated wood," said Bruce Scholnick, president and CEO of the National Wooden Pallet and Container Association. "We believe that purported theory was an attempt to identify a scapegoat that would cause McNeil the least amount of inconvenience. The chemical causing the contamination has a stronger affinity for plastic that it does for wood, but if the problem is in the plastic bottles that house the pills, McNeil has a much more difficult problem on its hands."
The first complaints of a musty odor in the Tylenol caplets were made to McNeil in September 2008. Similar complaints were made in April 2009. In November, the company announced a limited, voluntary recall of five lots of Tylenol Arthritis Red EZ-Open Cap. This was followed in December 2009 by an expanded recall to all lot numbers of the Tylenol Arthritis Pain caplets. In January 2010, McNeil, in consultation with the FDA expanded its recall to Motrin, Benadryl Allergy Ultratab, Rolaids Antacid Tablets, Simply Sleep and St. Joseph products.
The taint was determined to be 2,4,6 tribromoanisole (TBA), produced by the conversion of its precursor 2,4,6 tribromophenol (TBP) which is used in some countries in products ranging from packaging materials to textiles to paints as a fire retardant and a fungicide. The conversion is caused when certain specific fungi come into contact with TBA which, once it is airborne, can attach itself to any surface; it has a particular affinity for plastic.
"McNeil asks consumers to believe that a chemical (TBP) on a tertiary transport platform broke down into TBA then spread through various layers of shrink wrap, cardboard, plastic packaging, and aluminum composite seals to the primary product."
But a case involving an Australia beer company provides evidence that the taint could as easily spread from the shipping container to the pallet. In the Australian case, after TBA was identified as the taint, the company tested and detected both TBA and TBP in the beer, empty cans, paper, fibreboard dividers and flooring of the shipping container. By contrast, only TBP, not TBA, was detected in the wood pallet; that chemical was determined to have been caused by environmental contamination since TBP was confirmed not used as a wood treatment. It was proposed that high concentrations of both chemicals on the shipping container floor clearly indicated the flooring as the root source of contamination which then spread to the secondary and primary products.
"Our industry has reason to be skeptical as to the wood pallet as a root cause in the Tylenol case as well," said Scholnick. "We find it curious that McNeil provided to the public only a redacted copy of its testing - the name of the laboratory that conducted the testing was blacked out."
"Also McNeil says in that report that the unidentified laboratory is 'limited to only 8 samples per day.' But NWPCA has identified new technology such as ultrahigh-speed short column GC that enables real-time analysis."
The McNeil report to FDA included a Remediation Plan related to Pallets. While heat treating pallets is consistent with international shipping regulations, the purpose behind that measure has nothing to do with TBA or TBP.
"As evidenced in the Australian beer incident, this remediation plan will not prevent a future contamination," warned Scholnick. "If a shipping container is tainted with TBA it can spread to the pallets – whether they are wood, plastic, corrugated or steel – and on to the secondary and primary product."
NWPCA has asked McNeil to share its laboratory test data with the wood packaging industry, but to date it has refused to do so.
"Is McNeil sincere about finding a long-term solution or a quick fix that will temporarily placate the FDA and make reporters turn to other issues?" asked Scholnick.
The Tylenol contamination involved a shipment into the U.S. from McNeil's plant in Puerto Rico. NWPCA has members in 28 countries and cooperative partnerships with pallet associations in others.
"Every industry in the supply chain from packaging to transportation has a stake in safety and efficiency from the warehouse to the medicine cabinet," said Scholnick. "We encourage McNeil's president, Peter Luther, to reach out and work collaboratively with representatives across the global supply chain to make genuine remediation efforts."