The FDA has held a container full of product of mine hostage since February 14th. Ostensibly, this unreasonable delay was imposed so that they would have the time necessary to test the hell out of some pet products that I import.
It is a study in bureaucratic inefficiency and disregard for the small businessperson.
I understand completely, the need to keep our pet population safe and with the rash of problems associated with product from Asia, I can rationalize the reason behind the comprehensive testing. What I don't understand is why it takes more 69 days and counting, to render some sort of decision. It's absurd. The testing will have been completed two weeks ago this Wednesday but the "paperwork" has not yet made it to FDA headquarters for review. Really? How are the documents getting there? Even by horse and buggy, they should have arrived a week ago.
My company tests the heck out of all of our raw materials and finished products before they ever get on a container using a unbiased, accredited, third party organization. We make that documentation readily available for government review. I'm keenly aware of my responsibilities as a manufacturer and as a human being, the welfare of the animals will always come before profit. Always.
So, it galls me to have recently read an article where the FDA finally admits to knowing that poultry in America is tainted with arsenic and that they will continue to allow the meat to be sold to consumers because the carcinogen is considered present at "safe" levels. Hysterical.
I have scads of independent laboratory results which testify to the safety of my product. Our ingredients list is deliberately short and clean. With nearly a million units sold, not a single animal has ever been sickened by a product I've manufactured. The chicken industry is rampant with violations of standards. Ethically, it is a train wreck. Many, many, people have been hurt by meat contaminated with salmonella, eColi, antibiotics, growth hormones and a whole host of other things, directly attributable to the way the birds are handled and fed.
And the FDA thinks that arsenic-laced product is safe, while my item, with its clean ingredients statement, rigid adherence to exemplary manufacturing practices and certified lab results, sits in a warehouse collecting dust, waiting for some bureaucrat to give the green light.
When speaking to my compliance officers about what, as a manufacturer, I needed to do to mitigate the possibility of this ever happening again, I got the telephonic equivalent of a shrug and an "I dunno".
Great. Helpful.
It's frustrating being a small company with no influence.
Sunday, April 22, 2012
FDA Woes, Again
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