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FDA Guides on General Wellness and Low Risk Devices

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On January 20, 2015, the U.S. Food and Drug Administration (FDA) published a proposed guidance document regarding the FDA’s current position on low risk devices and general wellness products. This guidance document directs the Center for Devices and Radiological Health (CDRH) to deal with inquires from manufacturers asking whether or not their products qualify as “devices” under the Federal Food, Drug, and Cosmetic Act (FDCA). Devices are defined in section 201(h) of the FDCA as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is ...intended…
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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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Responsibilities of a FL HOA

Responsibilities of a FL HOA

Condominium and Homeowners Association
Responsibilities of the Association Over the last few decades, condominium and homeowner associations have become quite numerous in Florida, particularly in South Florida. One need only look around at the many gated communities and condo communities that seem to have popped up all around South Florida. And while many people live in communities of this type, it is likely a small fraction who have any idea what sort of responsibilities go along with running a condo or homeowners association. Just about anyone who is familiar with the operation of a condominium or homeowners association will likely tell you that running…
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Overview of FDA’s Final Menu and Vending Labeling Rules

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Menu and Vending Labeling Rules On November 25, 2014, the U.S. Food and Drug Administration (FDA) finalized two rules requiring that calorie counts be listed on menus and menu boards in certain restaurants and vending machines (menu and vending labeling rules). The full text of the menu and vending labeling rules can be found here. The menu labeling rule applies to restaurants if they are part of a chain of 20 or more locations, doing business under the same name, and offering more or less the same menu items. The 1990 Nutrition Labeling and Education Act established nutrition labeling on…
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Liability of the FL Condominium Association and Board Members

Liability of the FL Condominium Association and Board Members

Condominium and Homeowners Association
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

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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

Condo and Home Owners Association meetings

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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

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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

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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 Imports: Foods and Cosmetics

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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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