Fear, Loathing & Hand Sanitizer
A wave of news outlets are reporting an FDA finding that some skin sanitizers and skin protectants were found to contain high levels of disease-causing bacteria. The contaminated samples were discovered during a recent inspection of the Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah.
According to the FDA, “Some of these bacteria can cause opportunistic infections of the skin and underlying tissues. Such infections may need medical or surgical attention, and may result in permanent damage.
There is no doubt that such a finding is deeply troubling to American consumers, particularly coming off the media induced pandemic of H1N1 Flu (Swine Flu). However, logic suggests that it be noteworthy for the common consumer to know exactly what the FDA’s warning necessitates? What makes these particular bacteria any more dangerous than those living on bathroom door knobs or shopping cart push-handles?
Poop, anyone?
The FDA emphasizes that these findings are, “…particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds, damaged skin, and protect against various infectious diseases.”
Capt. Obvious statement aside, I can never recall putting hand sanitizer on an open wound. However, yes, I get the irony.
Bill Markham, President/co-owner of Clarcon Labs, is confident that the contamination occurred after manufacturing, and explained in an interview with Fox 13 that the contamination had only been found randomly in one batch (in decreasing levels), and all other testing was clean.
In addition, the contaminated samples were discovered by the FDA only after the company requested FDA approval.
Apparently, Clarcon, was ramping up their business and taking the necessary steps to market their products to hospitals. Ahh, expansion.
Clearly, any company concerned with the quality of its manufacturing process does not voluntarily request an FDA inspection of its product. Still, Clarcon agreed with the FDA to destroy all of its output, and the Ogden, Utah lab is now closed. According to Fox 13, “Markham said he was unsure if Clarcon would survive the hit.”
In an interview with WebMD, Markham indicates that the company's products aren't in stores and aren't sold directly to the public, and that "we have never, ever, ever had a side effect, health issue" from the products.
In contrast, the FDA emphatically warns consumers not to use skin products made by Clarcon due to bacterial contamination risk. They further explain that consumers should, “…throw these products away in household refuse.”
If it’s true that said products are not in stores, or sold directly to the public, then why so nervous? Doesn't due diligence indicate a thorough testing of the local Utah supply where the company was only beginning to distribute?
Instead, the FDA decided to provoke a pandemic of idiocy, resulting in: concerned calls from around the world; panicked consumers; fear induced national headlines; and the systematic crushing of a company diligently testing for the treatment of burn victims. All in a days work.
My guess is that someone down at the FDA gets a gold star sticky on their desk. Wow.
According to the FDA, “Some of these bacteria can cause opportunistic infections of the skin and underlying tissues. Such infections may need medical or surgical attention, and may result in permanent damage.
There is no doubt that such a finding is deeply troubling to American consumers, particularly coming off the media induced pandemic of H1N1 Flu (Swine Flu). However, logic suggests that it be noteworthy for the common consumer to know exactly what the FDA’s warning necessitates? What makes these particular bacteria any more dangerous than those living on bathroom door knobs or shopping cart push-handles?
Poop, anyone?
The FDA emphasizes that these findings are, “…particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds, damaged skin, and protect against various infectious diseases.”
Capt. Obvious statement aside, I can never recall putting hand sanitizer on an open wound. However, yes, I get the irony.
Bill Markham, President/co-owner of Clarcon Labs, is confident that the contamination occurred after manufacturing, and explained in an interview with Fox 13 that the contamination had only been found randomly in one batch (in decreasing levels), and all other testing was clean.
In addition, the contaminated samples were discovered by the FDA only after the company requested FDA approval.
Apparently, Clarcon, was ramping up their business and taking the necessary steps to market their products to hospitals. Ahh, expansion.
Clearly, any company concerned with the quality of its manufacturing process does not voluntarily request an FDA inspection of its product. Still, Clarcon agreed with the FDA to destroy all of its output, and the Ogden, Utah lab is now closed. According to Fox 13, “Markham said he was unsure if Clarcon would survive the hit.”
In an interview with WebMD, Markham indicates that the company's products aren't in stores and aren't sold directly to the public, and that "we have never, ever, ever had a side effect, health issue" from the products.
In contrast, the FDA emphatically warns consumers not to use skin products made by Clarcon due to bacterial contamination risk. They further explain that consumers should, “…throw these products away in household refuse.”
If it’s true that said products are not in stores, or sold directly to the public, then why so nervous? Doesn't due diligence indicate a thorough testing of the local Utah supply where the company was only beginning to distribute?
Instead, the FDA decided to provoke a pandemic of idiocy, resulting in: concerned calls from around the world; panicked consumers; fear induced national headlines; and the systematic crushing of a company diligently testing for the treatment of burn victims. All in a days work.
My guess is that someone down at the FDA gets a gold star sticky on their desk. Wow.
posted by F. Willard Morris Jr at
10:54 PM
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