Shehadeh Giannamore – Page 4 – Shehadeh Giannamore, PLLC

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FDA Approval Required for Company Enjoined from Marketing Products

FDA Disease Claims, Drug, Drugs, Enforcement, FDA, FDA Approval, Injunction, Labeling, Marshalls, NDA, Seizure

On October 10, 2014, a federal judge from the U.S. District Court for the Southern District of Ohio sided with the U.S. Food & Drug Administration (“FDA”) and entered a consent decree for permanent injunction against Ascend Laboratories, LLC. As we previously reported, Ascend had been targeted in connection with the marketing and sale of certain products, deemed drugs by the FDA, without first obtaining formal FDA approval. As explained in FDA’s announcement of the injunction, the Company is now enjoined from marketing these products until they first secure FDA approval and post bond to recover the seized products. As…

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Court Finds FDA Exceeded Authority in Device Reclassification

FDA 510(k), FDA, Medical Devices, Rulemaking

On September 26, 2014, The United States Court of Appeals for the District of Columbia Circuit ruled that the FDA had “short circuited” its procedural requirements, pertaining to device reclassification and formal rulemaking, when it reevaluated a medical device being sold on the market in an effort to require the device to obtain further approval. The medical device that was the subject of the controversy was an absorbable surgical mesh, designed for use in knee replacement surgeries, called the Collagen Scaffold. In 2008, the device manufacturer obtained clearance from the FDA, through the 510(k) process, to market the Collagen Scaffold.…

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FTC-FDA Warning Letter Issued to Company Marketing Ebola Cure

FDA, FTC Dietary Supplements, Disease Claims, Drugs, FDA, FTC, Labeling, Substantiation, Warning Letters

On September 23, 2014, the U.S. Food & Drug Administration ("FDA"), in conjunction with the Federal Trade Commission ("FTC"), issued a Warning Letter to Natural Solutions Foundation in Newton, New Jersey. FDA representatives allege the FDA warning letter was prompted by the certain marketing. In particular, the Company violated the Federal Food, Drug, and Cosmetic Act by promoting the use of several products to cure, treat, mitigate, or prevent disease. According to the letter, Dr. Rima Laibow promoted Nano Silver as a "natural therapy" or "cure" for the Ebola virus. Additionally, Laibow's website contained claims referring to the product as…

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FDA Releases Proposed Rules under FSMA

FDA Food, Food Facility Registration, Food Safety Modernization Act, Recalls, Rulemaking

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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FDA Inches Closer to New Nutrition Facts Panel Rules

FDA Beverages, FDA, Food, Labeling, Nutrition Facts, Rulemaking

On August 1, 2014, the U.S. Food and Drug Administration (FDA) closed its comment period for a proposed rule that would make significant changes to food labeling requirements, particularly nutrition facts panels. Per the Administrative Procedure Act, the FDA is currently reviewing the 264,723 comments that it received regarding the proposed rule and changes to nutrition facts panels that appear on all FDA-regulated food products. The proposed rule can be found here. As soon as the rule is finalized, it will be implemented in sixty (60) days’ time. For existing products, manufacturers will have two (2) years to comply with…

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Dietary Supplement Company Prohibited from Operations After Ignoring FDA Warning Letter

FDA CGMP, dietary supplement marketing, Dietary Supplements, Disease Claims, Drugs, Enforcement, FDA, Labeling, manufacturing practices, permanent injunction, Structure-Function Claims, Warning Letters

On August 8, 2014, the U.S. Food and Drug Administration ("FDA") obtained a court order from the United States District Court for the Middle District of Georgia against a dietary supplement manufacturer. The Order prohibits the manufacturer from selling dietary supplements until they comply with FDA good manufacturing regulations and other applicable, federal requirements. In addition to purported manufacturing deficiencies, the Company, BioAnue, sold dietary supplements that were marketed as treatments for common diseases, causing the FDA to deem these products to be unapproved new drugs. The FDA’s announcement can be found here. BioAnue received a warning letter from the…

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Permanent Injunction Sought after Cheese Manufacturer Fails to Respond to FDA Warning Letter

FDA CGMP, Enforcement, FDA, Food, Warning Letters

On August 8, 2014, the U.S. Food and Drug Administration ("FDA") filed a Complaint for Permanent Injunction against a Michigan Cheese Manufacturer and its owners under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 332. The FDA seeks to prevent S. Serra Cheese Company, based in Clinton Township, Michigan from receiving, preparing, processing, packing, holding, or distributing food until they meet FDA requirements. The Complaint for Permanent Injunction comes as a result of inspectional observations and the Company’s failure to take prompt action when notified of these observations. In particular, FDA inspected the manufacturing facility in 2013 and…

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Gluten Free Labeling Now Being Enforced by FDA

Uncategorized

On August 5, 2014, the U.S. Food and Drug Administration ("FDA") regulations regarding “gluten free” labeling came into effect. Last year, on August 5, 2013, the FDA issued a final rule that effectively determined what characteristics a food must have in order to be considered gluten free and bear “gluten free” labeling. We reported about the final rule on gluten free labeling when it was issued exactly one year ago. Our previous report on the gluten free labeling rules may be accessed here. FDA has authority to issue the rule defining gluten free and restricting gluten free labeling under Section…

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FDA Seeks Injunction against Company for Misbranding Drug Products

FDA Disease Claims, Drug, Drugs, Enforcement, FDA, Labeling, Warning Letters

On June 25, 2014, the U.S. Department of Justice ("DOJ"), in response to a request made by the U.S. Food and Drug Administration ("FDA"), filed a complaint seeking a permanent injunction against Laclede, Inc. of Rancho Domingo California and the Company's president, Michael A. Pellico. The injunctive relief, which was sought in the U.S. District Court for the Central District of California, related to Laclede's illegal distribution of over-the-counter (OTC) vaginal drug products that did not have the required FDA approval. News pertaining to this action can be found here. The unapproved products that were subject to the complaint against…

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FDA Warning Issued Regarding Weight Loss Products

FDA Dietary Supplements, Drugs, Enforcement, FDA, imports, Labeling, Warning Letters

On April 7, 2014, the U.S. Food and Drug Administration ("FDA") released an advisory, warning consumers not to use bee pollen capsule marketed under the name Zi Xiu Tang Bee Pollen. The purpose for the advisory, previously reported here, was to alert the public that the product contained potentially harmful active pharmaceutical ingredients, which had not been listed on the label for the product and was the subject of a FDA warning letter. The undeclared substances, Sibutramine Hydrochloride (sibutramine), an active ingredient in the obesity drug Meridia (pulled from the United States market in December 2010 based on increased risk…