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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

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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