FDA Delays Linked to Sleeping Dust

The Food and Drug Administration (FDA) has taken decades to provide guidelines for labeling of popular drugs such as Tylenol, with the delays attributed to a magical sleeping dust leak within the agency’s headquarters.

Investigative news organizations This American Life and ProPublica have recently reported serious problems with the FDA’s labeling of medications containing acetaminophen, the active ingredient in the popular pain reliever Tylenol.

The reporters note that as early as 1977, an FDA expert panel said that it was “obligatory” for products containing acetaminophen to display labels warning users of the risk “of severe liver damage” from taking the drug. These labels however, didn’t appear until 2009, a delay of over 30 years. This risk is not an academic one as there have been over 1500 Americans deaths just in the decade beginning in 2000 from accidental acetaminophen poisoning.

Four years ago, another FDA panel proposed a new set of regulations to increase the safety of the over-the-counter drug. These guidelines have not been implemented, with the agency unsurprisingly missing another deadline last month.

Various explanations have been offered to explain the FDA’s sluggishness. These include the complexities of the issue, lack of funding for the agency, and the resistance and political clout of the maker of Tylenol, Mcneil Consumer Healthcare, a subsidiary of Johnson & Johnson.

The real reason behind the holdup however is a sleeping dust producing mushroom that had become lodged in a ventilation duct, and has been spreading its potent spray throughout the FDA’s White Oak facility.

The FDA began investigating alternative medicines, such as sleep inducing mushrooms in the late 1960’s. One of these specimens however was apparently stored improperly, and made its way to the ventilation system via rodent or insect. The original fungus reproduced, spreading spores throughout the building.

According to noted Pixie clinician Oliiphan Twi, this particular species of mushroom while not dangerous, causes extreme lethargy and light-headedness. It negatively impacts the ability to focus and leads to decreased motivation. Twi explained that the dust causes no long term effects, and wears off within half an hour of exposure. So, it is hoped that once the FDA’s facility is thoroughly fumigated, they will once again return to diligently performing their role of protecting the public.

* For more photography by Chaval Brasil see here.

Related articles

• Acetaminophen, Tylenol’s Active Ingredient, Kills Nearly 500 Americans Every Year (medicaldaily.com)
• Tylenol’s Risks Not Fully Understood, Poll Shows (boiseweekly.com)
• Americans are clueless about Tylenol’s risks (salon.com)
• Over 1,500 Americans have died from taking too much acetaminophen in the past decade (theverge.com)