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Court Issues Injunction after FDA Warning Letter Issues Persist

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On January 16th 2015, a California dietary supplement manufacturer, Health One Pharmaceuticals, Inc., was ordered to stop sales of its products until the company meets certain U.S. Food & Drug Administration ("FDA") regulations and mandated standards (Current Good Manufacturing Practices or “CGMPs”). According to the FDA, the steps taken by the manufacturer in response to an FDA warning letter and FDA inspections did not bring the facility back into compliance with the CGMPs, prompting FDA to move forward with the action for injunction. In the case against the company, the judge signed a consent decree of permanent injunction, which requires…
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FDA Food Allergen Labeling

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When consumers with food allergies are purchasing food products, they normally examine the food labels to make sure a product does not contain any ingredients that would cause them to have an adverse reaction. Milk, eggs, fish, shellfish, nuts, wheat, peanuts, and soybeans are all common ingredients considered “major food allergens” that can potentially cause life-threatening consequences for consumers with allergies. The U.S. Food and Drug Administration notes that each year in the United States, food allergies cause 30,000 visits to the emergency room, 2,000 hospitalizations, and 150 deaths. Because of these health concerns, food allergen labeling has emerged as…
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FDA Releases Proposed Rules under FSMA

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On September 19, 2014, the U.S. Food and Drug Administration (FDA) released revisions to four proposed rules, opening them up for public comment. When these four rules are finalized in 2015, they will implement portions of the FDA Food Safety Modernization Act (FSMA) of 2011. The four new rules open for public comment set guidelines for the following food safety issues: Enhanced produce safety Preventative controls for human food Best practices and guidelines for animal food The foreign supplier verification program The FDA is looking towards shifting its focus under the FSMA from after-the-fact responses, or a reactionary approach, to…
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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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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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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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Listeria-Laden Onions Spur Recalls throughout United States

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On July 28, 2012, the U.S. Food and Drug Administration (“FDA”) published a press release notifying consumers of a voluntary recall initiated by GH Foods CA, LLC. The recall covers a variety of products containing certain onions distributed by Gills Onions and shipped to various packagers and retail supermarkets throughout the United States. According to the California-based manufacturer, the recall was initiated because the onions have the potential to be contaminated with listeria monocytogenes. The recall of Gills Onions initially commenced on July 18, 2012 but has since been expanded and prompted several other recalls of its kind. Because the…
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FDA Notifies Consumers of Supplement Recall after Discovery of Undeclared Drug Ingredients

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On May 18, 2012, the U.S. Food and Drug Administration (“FDA”) published a press release announcing the voluntary recall of certain dietary supplements marketed as male enhancements. West Coast Nutritionals, Ltd., the firm responsible for the supplements, initiated the recall after an FDA laboratory analysis uncovered the presence of undeclared Tadalafil in an assortment of the Company’s products. Tadalafil is the active ingredient in Cialis, the popular drug approved by the FDA to treat Erectile Dysfunction (“ED”). Because of the presence of the undeclared pharmaceutical ingredient, the FDA warns that the Company’s products are considered unapproved new drugs under the…
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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 of Recall Due to Undeclared Milk Derivatives in Several Beverage Products

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On May 10, 2012, the U.S. Food and Drug Administration (“FDA”) posted a press release on its website notifying consumers of a recent recall of various fruit beverages. Jonlly Fruits Inc., the manufacturer of the beverages, opted to initiate the voluntary recall of the affected products after labeling deficiencies were uncovered during the FDA’s inspection of its facilities. According to the Company’s press release, several of its products may contain the milk derivative sodium caseinate. Under the Food Allergen Labeling and Consumer Protection Act and its corresponding FDA regulations, manufacturers and/or labelers of finished food products are required to declare…
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