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News Archives

Credit: FDA

May 15, 2020: Summitt Labs Issues Nationwide Recall of KORE ORGANIC Watermelon CBD Oil Due to High Lead Results

KORE ORGANIC Watermelon CBD Oil Recall News – Summit Labs has issued a recall for its KORE ORGANIC Watermelon CBD Oil Tincture due to test results showing high lead levels. KORE ORGANIC Watermelon CBD Oil Recall Informaton On May 12, 2020, Summit Labs issued a recall for its KORE ORGANIC Watermelon CBD Oil Tincture due to high lead levels. The products affected include the following information: Batch#730 Lot#K018, 30 ml bottle, 15mg 450x. The Florida Department of Agriculture and Consumer Services tested a random sample from Summit Labs’ KORE ORGANIC Watermelon CBD Oil and found lead levels at 4.7 parts per million (ppm). Summit Labs launched an investigation into the elevated lead levels in its KORE ORGANIC Watermelon CBD Oil by sending a sample of the affected batch to an ISO/IEC accredited lab. The lab yielded lead results at 0.5 Read More

May 14, 2020: Federal Judge Issues Injunction Against Xephyr LLC d/b/a N-Ergetics for continued sale of unapproved COVID-19 Products

N-Ergetics Federal Injunction News – A Federal Judge entered a temporary restraining order against Xephyr, LLC doing business as N-Ergetics, and three individuals associated with the business, requiring them to immediately stop sale and distribution of colloidal silver products. N-Ergetics Federal Injunction Information On May 14, 2020, a Federal Court issued an injunction against N-Ergetics and associated individuals for the immediate stoppage of distribution and sale of colloidal silver products marketed for the treatment or cure of COVID-19 (coronavirus) and other diseases. N-Ergetics defied the U.S. Food and Drug Administration (FDA) and Federal Trade Commission’s (FTC) March 6, 2020 warning letter regarding their colloidal silver products. The Court found that the United States demonstrated that N-Ergetics and those associated named in the injunction are in violation of the Federal Food, Drug, and Cosmetic Act (FD&C) by unlawfully selling and distributing Read More

May 7, 2020: FDA Continues its Fight Against Fake COVID-19 Medical Products

On May 7, 2020, the U.S. Food and Drug Administration (FDA) issued an update as to its continued efforts to combat fraudulent information and products marketed by individuals and companies to cure or treat COVID-19 (coronavirus). To date, the FDA has issued 42 warning letters to companies claiming their products can aid against coronavirus, including Genesis II Church and its “Miracle Mineral Solution“. On April 17, 2020, a Federal Judge entered a temporary injunction against Genesis II Church for not complying with the FDA’s warning letter. Information on the FDA’s Operation The FDA has dubbed their work towards identifying fake medical products geared towards COVID-19 as “Operation Quack Hack”. Over the past few weeks, the FDA has uncovered hundreds of fraudulent products including drugs, testing kits, and personal protective equipment (PPE) sold online with accompanying unproven claims. Online marketplaces, domain Read More

May 1, 2020: FDA Issues Emergency Use Authorization for Possible COVID-19 Treatment

On May 1, 2020, The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the antiviral drug remdesivir to be used as a potential treatment for coronavirus (COVID-19). This allows for hospitals and healthcare facilities to use remdesivir on patients, both children and adults, with suspected or confirmed coronavirus and severe disease. Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator. Remdesivir Information The FDA advises that while there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, a clinical trial has shown that it seems to shorten recovery time in some patients. Based on evaluation of the emergency use authorization criteria and the scientific evidence available, the FDA Read More

April 24, 2020: FDA Cautions Against Use of Chloroquine or Hydroxychloroquine for COVID-19 Treatment outside of Hospital Setting or Clinical Trial

On April 24, 2020, the U.S. Food and Drug Administration (FDA) issued an announcement cautioning use of hydroxychlroquine or chloroquine outside of a hospital setting or clinical trial due to potential hazardous and fatal outcomes. The FDA had issued an Emergency Use Authorization (EUA) for temporary use of hydroxychlorquine and chloroquine in COVID-19 patients only when clinical trials were not available. These medicines have numerous side effects, including but not limited to serious heart rhythm problems that can be life-threatening. Issues With Unsupervised Use of Chloroquine and Hydroxychlroquine Officials at the FDA have reviewed data from the FDA Adverse Event Reporting System database, published medical literature, and the American Association of Poison Control Centers National Poison Data System concerning serious heart-related adverse events and death in patients with COVID-19 receiving hydroxychloroquine and chloroquine, either alone or combined with azithromycin or other Read More

April 17, 2020: Federal Judge Enters Temporary Injunction Against Genesis II Church For Continuing to Market “Miracle Mineral Solution”

Genesis II Church Injunction News – The U.S. Food and Drug Administration (FDA) announced that a Federal Judge issued a temporary injunction against Genesis II Church for failure to comply with the FDA’s April 8, 2020 warning letter ordering Genesis II Church to stop claiming its “Miracle Mineral Solution” (“MMS”) could treat or prevent COVID-19 (coronavirus). Genesis II Church Injunction Information On April 17, 2020, a Federal Judge issued a temporary injunction against Genesis II Church for failing to comply with the FDA’s warning letter. Genesis II Church has been marketing its MMS as a prevention and treatment towards coronavirus. The Court found that the United States demonstrated that Genesis II Church and the affiliated individuals named in the injunction are violating the Federal Food, Drug, and Cosmetic Act (FD&C) by unlawfully distributing MMS. The FDA has cautioned that MMS is Read More

April 8, 2020: FDA Issues Warning Letter to Genesis II Church for Selling Fraudulent Products related to Coronavirus (COVID-19)

Genesis II Church Warning Letter News – The U.S. Food and Drug Administration (FDA) has issued a warning letter to Genesis II Church of Health and Healing regarding its marketing of fraudulent and dangerous chlorine dioxide products known as “Miracle Mineral Solution” as a means of prevention and treatment of the “Novel Coronavirus Disease 2019” (COVID-19). Genesis II Church Warning Letter Information On April 8, 2020, the FDA issued a warning letter to Genesis II Church for its marketing of “Miracle Mineral Solution” as a treatment and cure for COVID-19. The FDA is not aware of any scientific evidence supporting the safety or effectiveness of chlorine dioxide products sold online as medical treatments and, further, they pose significant risks to patient health. Per the FDA: “Despite previous warnings, the FDA is concerned that we are still seeing chlorine dioxide products Read More

April 3, 2020: FDA Issues Update on COVID-19 (Coronavirus) Response

FDA COVID-19 Update News – On April 3, 2020, the U.S. Food and Drug Administration (FDA) issued an announcement with their continuing COVID-19 response. FDA COVID-19 Update Information The FDA has announced the following updates: They are working in collaboration with government, industry, and academic partners to develop and implement a protocol to provide convalescent plasma to patients in need throughout the U.S. Convalescent plasma, or plasma from people who have had the virus, has the potential to lessen the severity or shorten the length of illness from COVID-19. An FAQ as to whether respirators approved under standards used in other countries, such as KN95s, can be used in the US during the COVID-19 pandemic has been posted. A new Emergency Use Authorization (EUA) for non-NIOSH-approved respirators made in China has been issued allowing use of respirators approved in other countries, under Read More

April 1, 2020: FDA Requests Removal of All Ranitidine Products (Zantac) from Market

FDA Ranitidine (Zantac) Removal News – The U.S. Food and Drug Administration (FDA) has requested that all products containing Ranitidine (commonly known by the brand name: Zantac) be removed from the market due to an impurity having potential to cause cancer. Ranitidine (Zantac) Removal Information On April 1, 2020, the FDA issued a statement requesting that manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is due to the fact that a contaminant known as N-Nitrosodimethylamine (NDMA) was found in Zantac and in other ranitidine medications, per an ongoing investigation. As a result of the FDA’s immediate market withdrawal request, Zantac and other ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S. The FDA is sending letters to all manufacturers of Zantac and ranitidine products requesting they Read More

March 6, 2020: FDA and FTC Issue Warning Letter to Xephyr, LLC d/b/a N-Ergetics for Unapproved and Misbranded Products Related to COVID-19

N-Ergetics Warning Letter News – The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have issued a joint warning letter to Xephyr, LLC d/b/a N-Ergetics (N-Ergetics)for listing and promoting colloidal silver products on its website for sale in the United States, intended to mitigate, prevent, treat, cure or diagnose COVID-19 (coronavirus) in people. N-Ergetics Warning Letter Information On March 6, 2020, the FDA and FTC jointly issued a warning letter to N-Ergetics for selling misbranded and unapproved products on its website intended to treat or prevent COVID-19. Per the FDA and FTC’s warning letter: FDA has determined that these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, Read More

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