2014 – Shehadeh Giannamore, PLLC

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Liability of the FL Condominium Association and Board Members

Board Member of a Condo Association When you think about what it means to be a board member of a Condominium Association, it doesn’t take long to realize that there is a lot more to it than winning elections and running meetings. The office of a board member comes with a great deal of responsibility – and potential liability. First and foremost, under Florida law, a condominium association is either going to be a corporation for profit, or a not for profit corporate entity. This means that, like any other corporation, those who make up the board of directors of…

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FDA HACCP Enforcement Sandwiches Food Company between a Rock and a Hard Place

FDA FDA, Food, HACCP, Warning Letters

On November 21, 2014, the U.S. Food & Drug Administration (“FDA”) filed for a permanent injunction in the Eastern District of Michigan against Scotty’s Incorporated, a manufacturer of ready-to-eat sandwiches. The FDA alleges that Scotty’s violated the Hazard Analysis and Critical Control Points (HACCP) food safety management system, which according to FDA must be followed under federal law. Scotty’s had previously received a Warning Letter in 2009 for failing to have adequate processes and controls in place to minimize the risk of contamination and for failing to have a written HACCP plan for the tuna salad sandwiches prepared at the…

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Condo and Home Owners Association meetings

Condominium and Homeowners Association FL HOA attorney, FL HOA statutes

Association Statutes and Voting It has been said before that the operation of a Condominium or Homeowners Association is a lot like that of a small government. That concept rings the most true in the context of association meetings and voting. Holding membership and board meetings is the main process by which association business is conducted, and it is through voting that the will of the unit owners is heard. A poorly run meeting or election can create a mess of things very quickly. Improper ballots, insufficient notice, and even failing to put things on the agenda can all lead…

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USDA Organic Labeling

USDA Labeling, National Organic Program, NOP, organic, USDA

The United States Department of Agriculture (USDA) oversees the National Organic Program and organic labeling in the United States. The National Organic Program is a regulatory program housed within USDA Agricultural Marketing Service, which sets standards for organically produced agricultural products. These standards do not address food safety or nutrition, as these issues are within the regulatory oversight of FDA or other USDA programs. The statutes under which the National Organic Program operates are found here. When a company wants to use organic labeling or label a product in a way that promotes the use of to organic ingredients, they…

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FDA Food Allergen Labeling

FDA Allergens, FDA, Food, Gluten-Free, Labeling, Recalls

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 Imports: Foods and Cosmetics

FDA Cosmetics, FDA, FDA Imports, Food, imports, Labeling, Prior Notice, VCRP

Do you ever wonder how your favorite exotic cheese, foreign cookies, or champagne make it to the United States? As it turns out, importing food and cosmetics into the United States is not as simple as putting it in boxes and shipping it to the supermarket or local drug store. The U.S. Food and Drug Administration (FDA) is guided by a comprehensive statutory scheme that governs food and cosmetics produced in foreign countries and imported into the United States. Understanding the issues surrounding FDA imports, including how the importation of foods and cosmetics are affected by federal regulations, is important…

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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…