Sunday, October 6, 2013

The Tylenol Recall and the Safety of Wooden Pallets


The recent voluntary recall of the over the counter (OTC) arthritis pain reliever Tylenol by its manufacturer (McNeil Consumer Healthcare, a division of Johnson and Johnson) has lead to a series of heated exchanges between industry executives. Tylenol caplets were recalled en masse amidst reports that customers had detected an unpleasant odor resembling mildew issuing from the pills. Some consumers reported to the U.S. Food and Drugs Administration that they had suffered unpleasant symptoms such as nausea, stomach pains, vomiting and diarrhea upon taking the tablets. After consulting with the FDA, McNeil decided to withdraw the product from sale immediately while their scientists investigated possible causes.

The controversy appears to have been sparked by McNeil's press release explaining the recall, in which it appeared to be downplaying reports that consumers had become unwell upon taking the product. The company stated that all observed events which had come to its attention were 'temporary and non-serious'. The culprit was identified in subsequent analysis as the trace of a breakdown product from a chemical used to treat wooden storage pallets - 2,4,6-tribromoanisole. However, the company's wording was somewhat ambiguous - the responsible substance is 'believed' to have been a breakdown product, a choice of words which might be taken to imply that McNeil was not entirely sure that this really was the case when they issued the statement.

The Chief Executive Officer of a company manufacturing hard plastic pallets (Bob Moore of Intelligent Global Pooling Systems, or iGPS) condemned the use of wooden pallets in the transportation and storage of food and drug products. Wooden pallets have to be treated to preserve the wood; a treatment which Moore claimed involved the use of harmful pesticides and other chemicals such as urea formaldehyde. The latter is known to have carcinogenic properties and releases traces into the air as it 'off-gases'. The use of treated wooden pallets increases the risk of contamination not only to the products stored on them, but to workers who have to move them about.

In addition, according to Mr. Moore, wooden pallets are often fumigated with methyl bromide (an exceptionally poisonous compound which also depletes the ozone layer) and are often exceptionally dirty - his company detected high levels of pathogenic organisms such as Listeria and even rodent nests when wooden pallets commissioned by the firm were randomly tested.

The Centers for Disease Control and Prevention estimate that up to 40,000 Americans are killed each year by prescription drugs, with several thousand more fatalities being caused by OTC preparations. In the light of such statistics, Mr. Moore's call for the FDA and Congress to take action over the use of wooden pallets in connection with food and drug products seems eminently reasonable. While there is a limited amount that can be done to prevent accidental adverse reactions that some individuals have to OTC and prescription drugs, it would seem only reasonable to make certain that these products are transported in the safest, cleanest way possible.

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