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U.S. Marshals Seize Products from California Firm upon FDA ’s Repeated Finding of Violations

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On May 22, 2012, the U.S. Food and Drug Administration (“FDA”) announced that U.S. Marshals, acting at the requests of the Agency, had seized certain products deemed to be unapproved new drugs. HybriSil (methylprednisolone acetate 1% in silicone gel), the drug at issue was being marketed without FDA approval and therefore in violation of the Federal Food, Drug and Cosmetic Act (“FFDCA”). In particular, the seizure came as a result of two inspections conducted by the Agency, where the firm was found to be selling the product in violation of a number of FDCA provisions. Crescendo Therapeutics, LLC, the firm…
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FDA and FAAN Aim to Educate Public during Food Allergy Awareness Week

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This week (May 13 – May 19, 2012) is recognized as Food Allergy Awareness Week (“FAAW”). FAAW was created by the Food Allergy & Anaphylaxis Network (“FAAN”), a non-profit organization dedicated to promoting awareness food allergies and those who suffer from them. An annual event since 1998, FAAW began at a time when companies were not required to declare major food allergens in labeling. In 2004 Congress passed the Food Allergen Labeling and Consumer Protection Act (“FALCPA”), thereby giving the U.S. Food and Drug Administration (“FDA”) the authority to regulate in this area. Since the passage of FALCPA, the FDA…
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FDA Warns Companies Marketing Supplements Containing DMAA

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On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) issued warning letters to several dietary supplement manufacturers in connection with their alleged improper marketing of supplements containing dimethylamylamine (“DMAA”). DMAA, also referred to as geranium extract, is an ingredient found in many dietary supplements and is frequently marketed as a natural stimulant. As discussed in the FDA’s announcement, the Agency considers the marketing of products containing DMAA improper because the ingredient has not been proven to be safe for consumers. Accordingly, these products are considered adulterated under the Federal Food, Drug and Cosmetic Act (“FFDCA”). Under the FDA’s…
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FDA Enters into Consent Decree with Seafood Processor over Alleged Manufacturing Deficiencies

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On April 11, 2012, the U.S. Food and Drug Administration (“FDA”) announced that, with the aid of the Department of Justice, it has entered into a consent decree with a California seafood processor. The consent decree precludes the company from engaging in any manufacture or distribution of fish and fish products until it has remedied certain hazardous conditions in its facilities. Yamaya USA, Inc., the company at issue, was alleged to have been preparing its fish and fish products in facilities contaminated with the pathogen Listeria monocytogenes. For more information about this bacteria, please see our previous report here. In…
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FDA Enters Into Consent Decree of Permanent Injunction with Cheese Producer Due to Listeria Contamination

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On April 9, 2012, the U.S. Food and Drug Administration (“FDA”) announced it has entered into a consent decree with a Washington State cheese producer. The company, Del Bueno, which processes and distributes cheeses, and its owner Jesus Rodriguez, agreed to the terms of a consent decree recently entered by U.S. District Judge, Lonny Suko, in the Eastern District of Washington. As part of the consent decree, Del Bueno cannot sell or otherwise distribute any food products unless and until it first proves that its goods are safe for human consumption. To this end, Del Bueno must develop a control program…
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