May 24, 2024

The FDA’s “Best” Worst Warning Letters of 2022

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, pests, bacteria, but some really stand out. Here are some of the notable warning letters the U.S. Food and Drug Administration (FDA) sent in 2022. "A History of Infestation" Dollar Tree Inc. This letter, sent November 8, 2022, pertains to an FDA inspection that took place January 11 - February 11, 2022, at Family Dollar Distribution Inc., located at 1800 Family Dollar Parkway, West Memphis, AR. At that time, the facility stored and distributed … [Read more...]

FDA Warns Companies Illegally Selling Foods Containing CBD

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 FDA says that these companies are selling CBD-containing products that consumers may think are traditional, which may result in unintentional consumption of overconsumption. Some of these products are appealing to children, including hard candies, cookies, and gummies. One drug containing CBD has been approved by the FDA; it is used to treat certain severe seizures disorders. The drug, Epidiolex, has benefits that … [Read more...]

FDA Warns Companies Selling Supplements For Heart Disease

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 the FDA for safety and efficacy. The warning letters were sent to these companies: Essential Elements (Scale Media Inc.) Calroy Health Sciences, LLC Iwi BergaMet North America, LLC Healthy Trends Worldwide, LLC (Golden After 50) Chambers' Apothecary Anabolic Laboratories, LLC The CDC states that cardiovascular disease is the leading cause of death in this country. In 2020, almost … [Read more...]

FDA Warns Four Companies Selling Tainted Honey Products

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;; and 1am USA Incorporated doing business as Pleasure Products USA. The FDA says these products can "post a significant health risk to consumers." Laboratory testing conducted by the FDA found that the product samples contained active drug ingredients that were not listed on the product labels. They were the active drug ingredients found in Cialis (tadalafil) and Viagra (sildenafil), which are FDA approved drugs that are restricted to use under the supervision of a licensed health care professional. Those ingredients can interact with nitrates … [Read more...]

FDA Warns Companies Allegedly Selling Adulterated Dietary Supplements

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 care, mitigation treatment, or prevention of disease. Edit: The FDA has removed Glanbia from this list "On May 9, 2022, the FDA issued a Constituent Update (below) stating that Glanbia Performance Nutrition (Manufacturing), Inc. (Glanbia), along with 10 other companies, was illegally selling adulterated dietary supplements. However, the FDA has since determined that Glanbia was incorrectly identified and does not sell the … [Read more...]

FDA Warns Companies For Selling Dietary Supplements With False Claims

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 Peak Nutritionals; SANA Group LLC.; Wholesome Wellness; Dr. Garber’s Natural Solutions; ProHealth Inc.; Blossom Nature LLC; FDC Nutrition Inc.; and Silver Star Brands, Inc. Steven Tave, Director of the Office of Dietary Supplement Programs in the FDA's Center for Food Safety and Applied Nutrition, said in a statement, "Dietary supplements that claim to cure, treat, mitigate or prevent depression and other mental health … [Read more...]

Lansing, Michigan Quality Dairy Has Listeria and Roach Problem

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 problems found during inspections. The products made by the manufacturer are considered adulterated "in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health." The company responded to inspection reports on February 19, 2020, describing corrective actions, but the FDA issued the letter to … [Read more...]

Gourmet Catering to Go Warning Letter Details Roaches, Rodents, and Mold

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 to eat meals and food for the airline industry. Based on the FDA's findings, the ready to eat products made in that facility are adulterated "because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health." The FDA issued a Form-483 listing all of the deviations that were uncovered during the inspection. Gourmet … [Read more...]

FDA Warning Letter Sent to TX Country Fresh Over Listeria Findings

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 21, Code of Federal Regulations (CFR), Part 117 (21 CFR Part 117)," according to the letter. Inspectors took swabs of the environment, including areas near food processing operations, and found Listeria monocytogenes. That means that the ready-to-eat products are adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act. No illnesses have been reported in connection with any Country Fresh … [Read more...]

Life Rising Dietary Supplements Seized by U.S. Marshals

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 Illinois found that there was probable cause that "the company prepared, packed, and/or held dietary supplements under conditions that do not conform to the dietary supplement current good manufacturing practice (CGMP) requirements," according to the FDA news release. The FDA issued an Administrative Detention Order in May 2019 to prevent these products from reaching consumers until they could be seized based on these violations. Melinda K. … [Read more...]

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