The FDA’s failure to regulate a multibillion-dollar market is a detriment to consumers and businesses alike.
In August of last year, the Food and Drug Administration held a teleconference with Sarah Brown, the proprietor of Maison Terre, a natural products repackager that Brown ran out of her home in Arkansas. An FDA lab analysis had found that one of her products, a goldenseal root powder, was “contaminated with high counts of various bacteria, including multiple pathogens” and that the agency was “aware of one infant death associated with use of this product on the umbilical cord stump.” When FDA officials visited Brown’s manufacturing facility, they discovered it wasn’t a manufacturing facility so much as a house, where she was using her living room ottoman as a packaging table. In the agency’s assessment, Brown’s product was mislabeled, potentially contaminated, and, well, produced on an unsterilized piece of living room furniture.
The FDA issued a public warning to consumers against using the product, and a few days later, Maison Terre voluntarily recalled its organic goldenseal root powder. But overall, it was a light touch from the government, with enforcement coming in the form of a warning letter issued eight months later stating, “You are responsible for investigating and determining the causes of any deviations and violations and for preventing their recurrence or the occurrence of other deviations and violations.”
This is a far cry from the protection most Americans assume they’re getting from the FDA. The FDA’s original mission, in the words of acting FDA Commissioner Janet Woodcock, centered on “frustrating the sale of products peddled by frauds, charlatans, and careless companies.” But it isn’t doing that, and it hasn’t for a while now. [Read More @ Politico]
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