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FDA warning letter 32 articles

Homeopathic drug maker hit with FDA warning

Seoul-based homeopathic smoking cessation gum and lozenge maker Dae Young Foods Co. Ltd., was warned by the Food and Drug Administration (FDA) for not thoroughly screening the ingredients in its products, some of which could be harmful to consumers. The company manufactures Smoker’s Appetite Relief, promoted to curb excessive appetite, food cravings and irritability, a claim that the FDA takes issue with. Products intended to diagnose, cure, mitigate, treat or prevent disease and/or are intended to affect the structure or any function of the body are considered misbranded drugs and are in violation of federal law. But even more of ... Read More

Compounding pharmacy warned about ‘serious deficiencies’

Guardian Pharmacy Services in Dallas, Texas, was slapped with a Food and Drug Administration (FDA) warning letter following an inspection of its compounding center that was spurred by more than 40 report of serious adverse events by patients who had received injections of drugs compounded by Guardian Pharmacy Services following cataract surgery. At least 43 were received by the FDA in April and June, each of whom had been given eye injections of a drug containing the steroid triamcinolone and the anti-infective moxifloxacin. The patients who received the injections developed various symptoms over the course of several months, including blurred ... Read More

FDA warns companies selling products with marijuana derivative claiming to cure disease

Four companies caught illegally selling products online that claimed to prevent, diagnose, treat or cure disease were already in hot water with the Food and Drug Administration (FDA). But when the agency caught wind that the companies’ products promoted to cure serious diseases like cancer also contained cannabidiol (CBD), a component of the marijuana plant that is not FDA approved in any drug production for any indication, the agency took action. “Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. We don’t let companies market products that deliberately ... Read More

Clinical trial safety protocol overlooked, FDA says

The Food and Drug Administration (FDA) issued a warning letter to Dr. Laveeza Bhatti with Beverly Hills’ Cedars-Sinai Medical Group for disregarding safety protocols regarding cardiovascular safety during clinical trials of experimental drugs, Law360 reports. The name of the drugs were redacted in the letter published online, but the letter indicated that the drugs carried potential cardiovascular risks. Thus, the study’s protocol called for participants to have electrocardiograms (ECG) performed during the testing and for the drugs to be discontinued if certain heart problems were diagnosed. However, at least five patients in the study missed some of the ECGs. “Failure ... Read More

FDA: Supplement ads make false claims

Dietary supplement marketer Absonutrix LLC, was hit with a Food and Drug Administration (FDA) warning letter for promoting products to cure, mitigate, treat or prevent diseases, rendering them drugs in the eyes of the federal government. The company was also chastised for posting without permission the FDA logo on its website. “To the public, such use would send a message that FDA favors or endorses a private sector organization or the organization’s activities, products, services, and/or personnel (either overtly or tacitly), which FDA does not and cannot do,” the warning letter states. These violations must be corrected or the company ... Read More

Supplement maker slapped with warning

Significant violations of Current Good Manufacturing Practice (CGMP) regulations were identified during an inspection of dietary supplement maker Black Seed Herb Inc.’s facility in Liberty, New York, resulting in a Food and Drug Administration (FDA) warning letter. “These violations cause your dietary supplement products, including but not limited to Diabalance Herbal Blood Sugar Balance Tablets, Quick Slim with pure Hoodia Gordonii Capsules, BHealthy Black Seed Bitter Melon 90 Veggie Capsules, Black Seed w/ Olive Leaf/Garlic Capsules, Black Seed Honey Booster, Sweet Excitement Her Honey, Revive Honey Herbal Elixir, Flax Seed Oil, Black Seed Oil, and Black Cumin Seed Oil, to ... Read More

Same equipment used to make Car polish, mouthwash

During a rather unappetizing inspection of Wisconsin-based ChemRite CoPac Inc.’s facility, the Food and Drug Administration (FDA) found concerning manufacturing practices such as using the same equipment to make its over-the-counter and other oral products as it used to make industrial car polishes and other nonpharmaceutical products. The car polishes are paraffin-based and have warning labels that state “harmful or fatal if swallowed” and “keep out of reach of children.” “The ingredients in your non-pharmaceutical products are extremely difficult to remove from manufacturing equipment, and could contaminate the drug products that you manufacture on shared equipment, such as the various ... Read More

Egg donation center slapped with FDA warning

The Food and Drug Administration (FDA) has cracked down on a fertility clinic for not properly screening its egg donors for exposure to Zika, HIV, syphilis and other diseases. The agency issued Illinois-based Center for Reproductive Health a warning letter for deeming at least four women eligible to be egg donors before receiving the results of communicable disease tests. The FDA also found other concerning violations such as donor records with multiple or altered assessment dates. Medical history forms also had confusing dates and didn’t include questions related to conditions such as West Nile virus and syphilis or behaviors that ... Read More

Supplement maker slapped with FDA warning letter

The Food and Drug Administration (FDA) came down on a manufacturer of dietary supplements for promoting its products to treat, cure or prevent diseases, which renders them unapproved drugs as defined by federal law. In a warning letter to Dr. Carolyn Dean, who runs the website www.rnareset.com and takes orders for the products ReMyte, ReAline, ReMag, ReStructure, and ReCalcia Pico Meter Calcium, the FDA said it found that some of the website claims and testimonials “provide evidence that your products are intended for use as drugs.” For example, the company’s ReMyte boasts protection against cancer, claims to treat arthritis, to ... Read More

FDA warns workout supplement manufacturer

Xcel Sports Nutrition LLC was warned by the Food and Drug Administration (FDA) for manufacturing and marketing dietary supplements that were in violation of federal law, Law360 reports. The company’s Xcelerator XTC Preworkout Blackberry Limeade contains an ingredient called acacia rigidula, which is also known as vachellia rigidula, chaparro rieto or blackbrush, and is promoted as an energy booster. The FDA says the ingredient has not been present in the nation’s food supply nor is there a history that suggest a reasonable likelihood of safety, rendering the ingredient a “new dietary ingredient,” which requires FDA clearance before it can be ... Read More