When the FDA discovers that a company has significantly violated federal regulations, the agency issues a warning letter. These letters enumerate some of the key violations and instruct the offender to devise and execute a plan to correct them within a designated timeline. All of these letters deal with serious food safety violations – filth, … Read more
The FDA is warning five companies that are illegally selling foods containing CBD, a compound in marijuana. The FDA has not determined the safe dosage, especially for children and pregnant women. The warning letters were sent to these companies: 11-11-11 Brands Naturally Infused LLC Newhere Inc dba CBDFX Infusionz LLC CBD American Shaman, LLC The … Read more
The FDA is warning seven companies for allegedly illegally selling dietary supplements for heart disease. The FDA says that these corporations claim that their products cure, treat, mitigate, or prevent cardiovascular disease or related conditions, such as stroke, atherosclerosis, or heart failure. These products are considered unapproved new drugs and have not been evaluated by … Read more
The FDA has warned four companies allegedly selling tainted honey products that may be contaminated with hidden active drug ingredients. The four companies are Thirstyrun LLC, also known as US Royal Honey LLC; MKS Enterprise LLC; Shopaxx.com; and 1am USA Incorporated doing business as Pleasure Products USA. The FDA says these products can “post a … Read more
The FDA has sent warning letters to companies that are allegedly selling adulterated dietary supplements. The supplements contain new dietary ingredients for which the FDA has not received the required premarket NDI notifications. Others contain unsafe food additives. And others are drugs that have not been approved, because they are intended for use in the … Read more
The FDA has warned 10 companies for selling dietary supplements with false claims, sending them warning letters. These supplements “claim to cure, treat, mitigate, or prevent depression and other mental health disorders, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).” The warning letters were issued to: Enlifta LLC; Lifted Naturals; Mountain … Read more
The Lansing, Michigan Quality Dairy has Listeria monocytogenes and roach problems, according to a warning letter posted by the FDA on May 13, 2020. That facility produces ready-to-eat sandwiches, salads and bakery products. There is zero tolerance for Listeria monocytogenes contamination in RTE products. FDA has issued Form 483, which details food safety issues and … Read more
The FDA has sent the company Gourmet Catering to Go a warning letter detailing the violations of Good Manufacturing Practice after an inspection in September and October 2019. That facility is located at 801 Hanger Lane in Nashville, Tennessee. Inspectors found mold, rodent excreta pellets, and dead cockroaches at the facility. The company makes ready … Read more
The FDA has sent a warning letter to Country Fresh of Spring, Texas, about Listeria monocytogenes that was found in their facility that produces fresh, ready-to-eat produce. Inspections of the facility “found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP and PC Rule), Title … Read more
U.S. Marshals seized more than 300,000 containers of dietary supplements from Life Rising Corporation in June 2019 at the request of the FDA. The seized goods included tablets, capsules, and teas. The brand names for some of the 500 products are Life Rising, Holicare, or HopeStream. The U.S. District Court for the Northern District of … Read more