Reasonable Rules and Records Inspection

Reasonable Rules and Records Inspection

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As discussed in a previous blog post, found here, Florida Condominium and Homeowners’ Associations are required under Florida law to maintain their official records and allow members of the association to conduct records inspection upon request and proper notice. Associations receiving such a request need to move quickly to respond and provide the requested documents if they wish to avoid the possibility of liability. The right to inspect records is an important right of all association members and it is not something that is easily curtailed by any association. The right of an association member to conduct a records inspection is not…
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Florida Condominium Record Inspection

Florida Condominium Record Inspection

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Florida Condominium and Homeowners’ Associations, like any other corporation, are required by law to maintain certain records, which may be subject to record inspection. These records include copies of the declaration and bylaws, the current rules of the association, minutes of all meetings, and current insurance policies, just to name a few examples, and all of the official records of the association must be maintained for at least 7 years. This requirement may seem burdensome, particularly to smaller associations that are self-managed, but the reason behind this requirement is that Florida law requires that Florida Condominium and Homeowners’ Associations make…
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FDA Untitled Letters: FDA Warnings with a Twist

FDA Untitled Letters: FDA Warnings with a Twist

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The U.S. Food and Drug Administration (“FDA”) has recently been issuing letters to companies that are distinct from traditional FDA Warning Letters. Referred to as FDA Untitled Letters, these letters must be taken seriously, as the terms of FDA Untitled Letters require the recipients to take immediate action once a letter has been issued. FDA Untitled Letters: Why It Matters? Many businesses may be well versed when it comes to handling FDA Warning Letters, but when it comes to FDA Untitled Letters recipients of Untitled Letters may not fully understand how to respond. Accordingly, there are a few things to…
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Florida Condominium and Homeowners Associations Law: Priority of Liens

Florida Condominium and Homeowners Associations Law: Priority of Liens

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One issue that comes up often for Florida Condominium and Homeowners Associations is lien priority. It is safe to say that nearly everyone who has lived in a Florida Condominium or Homeowners Association knows that unit owners have to pay certain monthly maintenance assessments and often special assessments on top of that. This is an obligation that comes with living in an Association, and each unit owner is bound by the governing documents of the Association to pay these assessments. What is seemingly not as well-known is that the Association has the power to place a lien on the property…
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FDA Regulation of Aromatherapy and Essential Oil Products

FDA Regulation of Aromatherapy and Essential Oil Products

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Aromatherapy and essential oil products are becoming more popular by the day, and marketing these products in compliance with federal regulations must be a key consideration for marketers and distributors of these products. On September 22, 2014 the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Young Living for alleged violations of the Federal Food, Drug & Cosmetic Act (FDCA) in connection with the marketing of their aromatherapy essential oils. According to the FDA, these violations stemmed from the Company’s claims of curing and treating diseases with the usage of Young Living Essential Oil aromatherapy products, causing…
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Foreclosures for Associations: The Florida Condominium Act and Safe Harbor Rule

Foreclosures for Associations: The Florida Condominium Act and Safe Harbor Rule

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Foreclosure is an unfortunate reality that many Florida Condominium and Homeowners’ Associations must face in their communities. Accordingly, it is important for Condominium and Homeowners’ Associations to be aware of the rules governing foreclosures, what happens following foreclosures, and what the rights and responsibilities of the Association are in the case of foreclosure. The Florida Condominium Act The foreclosure of a property by a lienholder will typically extinguish liens that came after it, known as junior liens. This would be a potential nightmare scenario for Associations who are owed unpaid assessments, as unit owners who fail to pay assessments usually…
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Cosmetic Products and the FDA

Cosmetic Products and the FDA

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FDA Regulation of Cosmetics Products Importers introducing cosmetic products into the United States must be mindful of FDA regulations, which can present a barrier to market entry if the appropriate steps are not taken to ensure compliance. The U.S. Food & Drug Administration (“FDA”) works in conjunction with the U.S. Customs and Border Protection (CBP) to monitor cosmetic products at the time of entry. Noncompliance with FDA regulations can result in a shipment being refused entry into the United States or a product being recalled from the market after entry. However, one may mistakenly assume that cosmetic products are subjected to the…
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FDA Imports: Tradeoff — Less Vigilance for More Diligence

FDA Imports: Tradeoff — Less Vigilance for More Diligence

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The U.S. Food and Drug Administration (FDA) has found its ability to inspect and re-inspect all of the entities involved in food importing in a slow decline, resulting in delays for those dealing in FDA imports.  Troubled by its inability to get Congressional funding to pay all of its bills, the FDA came up with an idea: have the importer and the food manufacturer pay for the inspections and re-inspections.  With congressional approval, the Food Safety Modernization Act (2011) provides the FDA with the authority to charge such fees based on past costs (currently 2013) of inspections and re-inspections, and…
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District Court sides with Industry on Dietary Supplement Substantiation

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A U.S. District judge New Jersey has ruled in United States v. Bayer Corporation that Bayer will not be held in contempt for alleged violations of a 2007 consent decree regarding the marketing of its Phillip’s Colon Health (PCH) product. The 2007 Consent Decree prohibited Bayer from “making any claim about the performance or efficacy of any dietary supplement, multivitamin or weight-control product unless, at the time Bayer makes the claim, the company possesses competent and reliable scientific evidence to support the claim.”  The current decision originates from a motion for an order to show cause filed by the Department…
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FDA Clears Device via De Novo Process

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On December 8, 2015, the U.S. Food & Drug Administration (“FDA”) cleared for marketing in the United States a cooling cap to reduce hair loss in breast cancer patients undergoing chemotherapy.  Marketed under the name the DigniCap® Cooling System, the cooling cap is manufactured by Dignitana, a Swedish company making its first foray into the United States medical device market. After multiple clinical studies and extensive use in overseas markets, the DigniCap® scalp cooling system is the only such device to have completed an FDA-cleared multi-center clinical trial and is cleared for use with treatment regimens associated with breast cancer.…
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