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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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Court Finds FDA’s Prohibition of Off-Label Promotion Unconstitutional

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On December 3, 2012, the U.S. Court of Appeals for the Second Circuit reversed the conviction of a pharmaceutical sales representative, finding that promotion of FDA-approved drugs for unapproved uses, in and of itself, does not constitute a violation of the Federal Food, Drug and Cosmetic Act (“FDCA”). The Defendant-Appellant in the case, Alfred Caronia, appealed from his conviction in which he was found guilty of conspiracy to introduce a misbranded drug into interstate commerce, a violation of the FDCA. In particular, Caronia was charged and thereafter convicted for promoting the drug Xyrem for uses not approved by the U.S.…
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FDA Actions Highlight New Authority under FSMA

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On November 26, 2012, the U.S. Food and Drug Administration (“FDA”) suspended the food facility registration of Sunland, Inc., a New Mexico-based peanut butter plant. Sunland, Inc. has been in the headlines throughout much of 2012 due to a number of recalls spurred after Salmonella was discovered in the Company’s peanut processing facility. More information about the affected products and the ongoing action against Sunland, Inc. may be accessed here. After several successive recalls and months of investigation into the adequacy of Sunland’s facilities, the FDA ultimately suspended the Company’s Food Facility Registration, thereby prohibiting Sunland from producing and distributing…
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FDA Investigates Illnesses Linked to Energy Drinks and Supplements

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On November 16, 2012, the U.S. Food and Drug Administration (“FDA”) issued a statement concerning the Agency’s ongoing investigation of reported illnesses and deaths linked to energy drinks and energy shot supplements. Found here, the Statement details the FDA’s efforts in this area, including its evaluation of adverse event reports. According to the FDA, it is currently in the process of determining whether there is an actual cause-and-effect relationship between the consumption of energy drinks and energy supplements and these medical problems. Under the Federal Food, Drug and Cosmetic Act (“FFDCA”), manufacturers, packers and distributors of all dietary supplement products…
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Jimmy Dean Initiates Recall for Failure to Declare Allergens

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On November 10, 2012, Jimmy Dean issued a Press Release, explaining how the Company is initiating a voluntary recall of certain of its products due to a labeling error that resulted in undeclared allergens. In particular, the Company is recalling certain lots of its French Toast & Sausage Sandwich breakfast products because the labels of such products fail to declare the presence of soy and egg. According to the Company, no other Jimmy Dean brand products are affected. Under the Food Allergen Labeling and Consumer Protection Act (“FALCPA”), all food labels must declare the presence of major food allergens. Pursuant…
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FDA Warns Company for Marketing Medical Device

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On November 5, 2012, the U.S. Food and Drug Administration (“FDA”) announced recent action the Agency has taken against a Tennessee-based company in connection with the Company’s alleged violations of the Federal Food, Drug and Cosmetic Act (“FFDCA”). According to the FDA’s Press Release, found here, The Avalon Effect, Inc. (“the Company”) is in violation of the FFDCA because of several claims made on the Company’s website and other linked websites which contain claims that its light therapy device may be used to cure or treat fungal meningitis, concussions, Lyme disease and other illnesses. In addition, the FDA notes that…
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FDA Targets Online Pharmacies in International Efforts

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On October 4, 2012, the U.S. Food and Drug Administration (“FDA”) announced that it has taken action as part of an international campaign to protect consumers from illegal online pharmacies. Found here, the FDA’s announcement explains its involvement in the international regulatory efforts referred to as “Operation Pangea V.” The week long efforts mark the fifth annual International Internet Week of Action (“IIWA”), whereby international regulatory and law enforcement authorities engage in cooperative efforts aimed at tracking down and stopping distributors and producers of unapproved and illegal pharmaceutical products and medical devices. In addition to Operation Pangea V, the FDA recently announced…
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FDA Approves MS Drug, Noting Boxed Warnings

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On September 12, 2012, the U.S. Food and Drug Administration (“FDA”) announced the approval of the drug Aubagio (teriflunomide). Manufactured by Sanofi Aventis, Aubagio is a once-a-day tablet for the treatment of relapsing forms of multiple sclerosis (“MS”) in adults. The full announcement of the approval may be accessed here. As noted in the FDA’s announcement, Aubagio contains a Boxed Warning intended to alert prescribers and patients of certain risks, including liver problems and birth defects. Accordingly, prescribers are warned to refrain from prescribing Aubagio to patients who have existing liver problems. In addition, prescribers are required to verify that…
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