On December 23, 2019, the U.S. District Court for the Eastern District of New York permanently barred New York-based ABH Nature`s Products, Inc., ABH Pharma, Inc. and StockNutra.com, Inc., as well as the company`s owner, Mohammed Jahirul Islam, of Flushing, New York, from distributing adulterated and mislabeled dietary supplements in violation of Federal Food. Medicines and Cosmetics Act. The injunction requires defendants to destroy food supplements in their possession and to take several consumer safety measures before resuming the production or distribution of food supplements. The defendants agreed to be bound by a permanent injunction consent order, which was filed with a complaint in November 2019. The complaint alleged that ABH and Islam manufactured and distributed food supplements under conditions that did not comply with applicable good manufacturing practice regulations. The complaint also alleged that the defendants had distributed new, unapproved drugs that they believe could be used to treat conditions such as cancer, heart disease, HIV and AIDS. The Supreme Court of the United States is the highest court in the United States. Courts below the federal level include the U.S. Courts of Appeals, the U.S.
District Courts, the U.S. Court of Damages, the U.S. Court of International Trade, and the U.S. Bankruptcy Courts. Federal courts hear cases related to the U.S. Constitution, other federal laws and regulations, as well as certain cases involving parties from various states or states and large sums of money. In February 2007, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) announced that an ongoing outbreak of salmonellosis cases in the United States was directly due to peanut butter produced at the sylvester facility in Georgia. The company voluntarily ceased production at the plant on February 14, 2007 and recalled all peanut butter that had been produced there since January 2004.
The CDC eventually identified more than 700 cases of salmonellosis associated with the outbreak of the disease as of August 2006. The CDC has estimated that thousands of other related cases have gone unreported. The CDC has not identified any deaths related to the outbreak. On March 28, 2018, the District Court issued a consent order for a permanent injunction against Riddhi USA, Inc. and its owner and president, Mohd M. Alam, that permanently prohibits defendants from manufacturing and distributing falsified and mislabeled dietary supplements under the Food, Drugs and Cosmetics Act. The United States claimed in a complaint filed in October 2017 that inspections at Riddhi revealed numerous violations of applicable good manufacturing practice regulations, including failure to establish product specifications for the purity and strength of finished supplements, failure to verify the identity of food ingredients, and failure to follow written quality control procedures. On October 23, 2018, the District Court of Keystone Laboratories, Inc., its owner Melinda Menke and its operator Elizabeth Jumet violated the Food, Drugs and Cosmetics Act by distributing hair care and skin care products that have not been manufactured, processed, packaged or stored and that are subject to good manufacturing practices for pharmaceutical products.
The complaint alleged that FDA inspections of Keystone`s facilities and products had revealed numerous problems, including a case in which the company launched a batch of hair products despite test results suggesting contamination with the potentially harmful bacterium Staphylococcus aureus. According to the court order, defendants may not manufacture or distribute their over-the-counter medications in a facility owned or operated by the defendant unless they comply with the specific remedies set out in the injunction. The decision also provides guarantees in the event that the defendants conclude contracts with third parties for the manufacture of similar products. On July 27, 2018, the District Court issued a permanent decision on three Chicago companies – Global Marketing Enterprises, Inc.; Lifeline Nutrients Corp. and Pronto Foods Company – along with company owner Eduardo Chua and COO Haidee Dawis, are violating federal food, drug and cosmetics law. According to the lawsuit in the case, the defendants manufactured and distributed falsified food supplements that were not prepared in accordance with current good manufacturing practices. The complaint also alleged that the defendants illegally distributed new unapproved drugs based on labeling claims that certain products treated diseases such as HIV and Alzheimer`s disease. The defendants agreed to be bound by a consent order requiring them to take corrective action and obtain FDA approval before resuming the manufacture or distribution of dietary supplements. The 5.
In July 2016, the District Court issued a consent order for a permanent injunction against BEK Catering, LLC d/b/a Floppers Foods, LLC and its co-owners Billy D. Stembridge, Jr. and Kyle Huxen to prevent them from violating the Food, Drugs and Cosmetics Act (FDCA). BEK prepared, processed, packaged and distributed ready-to-eat seafood, namely seafood soups, which were sold under the names Shrimp Locksley and Mama`s Gumbo. The company sold its soups to various vendors after receiving seafood from other states, including Florida. Several FDA inspections since 2011 have revealed violations of seafood hazard analysis and critical control point (HACCP) regulations and applicable Good Manufacturing Practices regulations. During a 2015 inspection, the FDA found that the company did not have adequate HACCP plans to control the dangers of several pathogenic bacteria, including Clostridum botulinum, Clostridum perfringens, and Listeria moncytogenes. It was also found that the company`s products were mislabeled because the labels of the ready-to-eat soups did not list all the ingredients of the soups and did not declare significant food allergens. On February 22, 2019, Judge David Carter dismissed the defendants` request to dismiss the U.S. lawsuit, noting that statements on websites may constitute drug labeling under the Food, Drug, and Cosmetic Act (FDCA).
The government`s complaint alleges that the defendants are illegally marketing their “Zylast” hand sanitizers as new, unapproved drugs to combat various specific pathogens such as Ebola. The complaint alleges that such drug claims appear on the defendant`s main website and on the website of one of the company`s major distributors. Among other things, the court agreed with the government that statements about recommended uses posted on company websites can be “labelled” in a cord against the United States under the FDCA under the 1948 Supreme Court decision. On March 3, 2021, U.S. District Judge Edward R. Korman filed new violations of the Food, Drug, and Cosmetics Act against dietary supplement company Confidence USA and its operators. The court issued a summary decision in favour of the government in January. The defendants manufactured supplements that they sold on their websites and in stores and that they marketed primarily to Chinese-speaking communities. The government presented evidence gathered over nearly a decade that the defendants violated current good manufacturing practices regulations, including failing to ensure that finished batches met specifications or conducting appropriate testing to verify the identity of ingredients.
The court order prohibits defendants from continuing to manufacture or distribute their products unless they comply with the law. The 4. In November 2016, Sheikh Waseem Ul Haq was sentenced to serve a prison sentence and three years of probation for his role in a long-standing plot to ship medicines from Pakistan and the United Kingdom to customers in the United States. The court also issued a consent order for the forfeiture of $388,265.12, Ul Haq`s share of the proceeds from the sale of drugs to customers in the United States. From 2005 to 2012, websites operated by Ul Haq and his co-defendant Tahir Saeed illegally sold $2 million worth of prescription drugs, including anabolic steroids and other controlled substances, to customers around the world, including nearly $780,000 to buyers in the United States. Many of the drugs sold by the defendants were generics that were not approved for sale in the United States; others were Schedule III steroids or drugs used by steroid users, such as Clenbuterol. Clenbuterol is only approved for sale in the United States as a horse bronchodilator, but is sold on the black market for use by bodybuilders. Ul Haq and Saeed were arrested in England in October 2012 and held unrelated until they were extradited to the United States in the spring of 2013.
In January 2014, Ul Haq pleaded guilty to all 48 counts in the indictment, accusing him of conspiracy to import and distribute controlled substances listed in Schedules II, III and IV, conspiracy to defraud the United States and its authorities and introduce drugs into interstate commerce, conspiracy to commit international money laundering, and numerous material crimes under the controlled substances and federal food. Became. Medicines and Cosmetics Act. In January 2014, Tahir Saeed also pleaded guilty to several charges and was sentenced in October 2016. At the time of their conviction, the two defendants had been detained for about 4 years, including the time they spent in an English prison. The 4. In August 2017, the District Court issued a declaration order for a permanent injunction against Isomeric Pharmacy Solutions, LLC and company directors William O. Richardson, Rachael S. Cruz and Jeffery D. Brown.
Isomeric produces, labels and distributes sterile medicines, including injectable hormones, injectable corticosteroids and eye drops.
