from the depends-on-what-you-are-cooking-up dept.
The U.S. Food and Drug Administration on Tuesday released a warning letter to Nashoba Brook Bakery, reprimanding the West Concord, Massachusetts-based baker and wholesaler about the ingredients it lists in its granola.
One, in particular.
"Your Nashoba Granola label lists ingredient 'Love,'" the agency wrote in the Sept. 22 letter. "'Love' is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient."
Nashoba Chief Executive Officer John Gates said the FDA's take on love as an ingredient "just felt so George Orwell."
Ars Technica additionally reports that was not all that the FDA found:
During a recent bakery inspection, FDA agents discovered: dirt and filth caked onto ceiling vents and sprinklers directly above ready-to-eat foods; parts of the floor and ceiling that were missing for some reason; equipment, including bowls and cooling racks, that wasn't cleaned or maintained; and counters, shelves, and food production surfaces that were coated with an unknown residue.
Insects also proved worrisome. At one point, an FDA inspector noticed a one-inch-long, unidentified crawling insect directly underneath a batch of pastries. Last, the FDA reported that employees weren't following proper hygiene practices. One baker repeatedly dipped a blue bracelet into raw dough while mixing it.
For your reading pleasure, here is the warning letter.
The FDA is proposing a new, risk-based enforcement approach to homeopathic drug products (alternative medicine):
To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA's existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.
Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency's enforcement policies since 1988.
"In recent years, we've seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren't adequately tested or disclosed to patients," said FDA Commissioner Scott Gottlieb, M.D. "Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm."
FDA draft guidance (8 pages).
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