November 17, 2020

FDA Issues the First Injunction Under the Produce Safety Rule

The FDA has issued itsĀ first injunction under the Produce Safety Rule against a company that makes sprouts and soy products. That Rule, which was part of the Food Safety Modernization Act of 2011 and was finalized on January 26, 2016, gives the FDA power to issue consent decrees of permanent injunction against corporations for violating safety standards. The Produce Safety Rules mandates that sprout operations take measures "to prevent the introduction of dangerous microbes into seeds or beans used for sprouting; test spent sprout irrigation water (or, in some cases, in-process sprouts) for the presence of certain pathogens; test the growing, harvesting, packing and holding environment for the presence of the Listeria species or Listeria monocytogenes; and take corrective actions … [Read more...]

Temporary Injunction Issued Against Genesis II Church of Health and Healing

The FDA has asked a judge to enter a temporary injunction against Genesis II Church of Health and Healing, preventing the sale of Chlorine Dioxide products that are the equivalent to industrial bleach to treat coronavirus. The FDA issued a warning letter against the company on April 8, 2020 about this issue, but "The court also found that there is a danger that the defendants will continue violating the law without the temporary restraining order." The company makes "Miracle Mineral Solution" (MMS) which is an "unproven and potentially harmful treatment offered for sale to treat Coronavirus." The courtt found that the FDA has demonstrated that Genesis is violating the Federal Food, Drug, and Cosmetic Act by unlawful distributing MMS, which is an unapproved new drug and misbranded … [Read more...]

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