An order of permanent injunction has been entered against Confidence USA Inc. of Long Island, New York, and the company's president Helen Chian and general manager and founder Jim Chao by Judge Edward R. Korman of the U.S. District Court for the Eastern District of New York. The order was entered until the company "comes into compliance with federal supplement current good manufacturing practice regulations and other Federal Food, Drug, and Cosmetic Act (FD&C Act) requirements." The defendants must cease manufacturing, holding, or distributing dietary supplements until the FDA tells them they can resume operations. The company has made and distributed more than 50 dietary supplements under brand names that include Confidence USA, American Best, USA Natural, and The Herbal Store. … [Read more...]
FDA Issues the First Injunction Under the Produce Safety Rule
The FDA has issued its 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...]
