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Company’s Operations Halted for Violating FDA Food Labeling Rules

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On March 13, 2013, the U.S. Food and Drug Administration (“FDA”) announced that a federal judge has signed a consent decree of permanent injunction, enjoining a New Jersey-based food company’s operations. In particular, Butterfly Bakery Inc. (“the Company”) is prohibited from processing and distributing food until it brings its operations into compliance with the Federal Food, Drug and Cosmetic Act (“FFDCA”). According to the consent decree, the Company’s products were deemed misbranded due to various labeling deficiencies, whereby the Company allegedly failed to comply with federal law and accompanying FDA food labeling rules. As noted by the FDA, the present action demonstrates…
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Supreme Court to Review Design Defect Case against Generic Drug Company

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On March 19, 2013, the U.S. Supreme Court will hear arguments in Mutual Pharmaceutical Company, Inc. v. Karen L. Bartlett. The defendant-appellant in the case, Mutual Pharmaceutical Company (“Mutual”) appealed from a decision of the U.S. Court of Appeals for the First Circuit, in Karen L. Bartlett v. Mutual Pharmaceutical Company, Inc., 678 F.3d 30 (1st Cir. 2012), where the Court found that the Federal, Food, Drug, and Cosmetic Act (“FDCA”) does not preclude a state law design defect claim against a generic drug manufacturer. You can find the documents in the case here. Mutual is a Pennsylvania company that…
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FDA Approves Orphan Drug to Treat Aplastic Anemia

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On February 21, 2013, the U.S. Food and Drug Administration (“FDA”) granted orphan drug status to an aplastic anemia treatment. Aplastic anemia is a rare condition where bone marrow does not produce sufficient blood cells or platelets. The treatment, placental expanded (PLX) cells, is sponsored by Pluristem Therapeutics, Inc. You can read more about the requirements for obtaining orphan drug status here. Pursuant to the Orphan Drug Designation program, the FDA provides incentives for the development of products that will diagnose or treat rare diseases. Orphan drug status qualifies a drug sponsor to receive tax credits for clinical testing of…
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Food Seasonings Recalled Due to Undeclared Allergens

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On February 15, 2013, the DeCoty Coffee Company of San Angelo, Texas announced that it was recalling its 1.25 pound and 5.75 pound DeCoty Taco Seasoning products. Prompting this recall are labeling concerns, specifically that the products contain an undeclared ingredient, soy, and people who have allergies or sensitivity to soy may run the risk of a serious allergic or life threatening reaction if they consume this product. As of this date, no illnesses have been reported due to ingesting this product. More information about the recall may be accessed here. In 2004, Congress passed the Food Allergen Labeling and…
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Marshals Seize Supplements with Undeclared Drug Ingredients

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On February 14, 2013, U.S. Marshals, acting on behalf of the U.S. Food and Drug Administration (FDA), raided the headquarters of Globe All Wellness, LLC, a dietary supplement manufacturer based in Hollywood, Florida. Marshals seized what are alleged to be tainted dietary supplements, believing the products to be unsafe, as they may contain an undisclosed active pharmaceutical ingredient. Marshals noted that several of the products that were seized contain sibutramine hydrochloride (sibutramine), which is the active ingredient in Meridia, an obesity drug. Meridia was pulled from the market in the United States in December of 2010, after clinical trials determined…
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FDA/FTC Issue Joint Warning Letter to Company Marketing Flu Remedy

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On January 24, 2013, the U.S. Food and Drug Administration (“FDA”) and the U.S. Federal Trade Commission (“FTC”) issued a joint warning letter to Flu & Cold Defense, LLC (“the Company”), a Florida company, for unlawfully marketing its “GermBullet” inhaler as a cold and flu remedy. The “GermBullet” is sold online as well as in small pharmacies and health food stores. You can read the warning letter here. According to the text of the Warning Letter, the FDA targeted the Company, Flu & Cold Defense, along with its managing member Todd Whidden, for marketing the “Germ Bullet” as an unapproved…
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FDA Approves Bladder Control Drug for OTC Use, Highlighting Rx to OTC Switch

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On January 25, 2013, the U.S. Food and Drug Administration (“FDA”) announced the approval of the first women's bladder control product available without a doctor's prescription. In the past, all bladder control drugs were only available by prescription. This product, called Oxytol for Women, will be made available without a prescription for women aged 18 years and up only. Oxytol will remain available through a prescription only for men. The full story may be accessed here. Overactive bladder, a condition where the bladder squeezes too often or without warning, affects up to 33 million Americans annually, and the majority of…
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FDA Enjoins Beverage Maker’s Operations until it Complies with the FDCA

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On January 25, 2013, the U.S. Food and Drug Administration (“FDA”) announced that it has entered into a consent decree of permanent injunction with Jonlly Fruits, Inc. (“Company”) and its President, Bartolo Pérez Román. Jonlly Fruits is a frozen fruit, juice, and vegetable manufacturing company located in Puerto Rico.  Under the consent decree, signed by Judge Gustavo A. Gelpi of the U.S. District Court for the District of Puerto Rico, the Company agrees to cease all operations until it complies with the Federal Food, Drug, and Cosmetic Act (“FDCA”). This will include complying with Current Good Manufacturing Practice (“cGMP”) and Hazard…
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FDA Warns Online Cigarette Retailers for Marketing Violations

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In January 2013, the U.S. Food and Drug Administration (”FDA”) sent out several warning letters to online retailers of cigarettes, detailing certain marketing or product statements made that are in violation of federal laws that govern the practice. Several companies were targeted, including those with websites located at: www.smoke-cash.com and www.cheap-cig.com. A complete list of companies that were sent warning letters can be seen by clicking here. In the warning letters, these firms were strongly advised to correct marketing practices on specific products immediately and to submit a response to the warning letters with a specific plan to get their…
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FDA Permits Marketing of Device Capable of Testing for 11 Causes of Infectious Gastroentiritis

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On January 14, 2013, the U.S. Food and Drug Administration (FDA) announced that for the first time it will permit marketing for a new diagnostic test that has the ability to simultaneously detect up to eleven (11) prevalent bacterial, viral, and parasitic causes for infectious gastroenteritis from a single sample from a patient. The FDA’s announcement may be accessed here. An inflammation of the stomach and intestines, infectious gastroenteritis is caused by certain parasites, bacteria, or viruses and can be detected by common symptoms such as diarrhea, vomiting. The condition can be a serious affliction for infants, the elderly, and…
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