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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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Gluten Free Labeling Now Being Enforced by FDA

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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 Approves Botox Cosmetic for New Intended Use

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On September 11, 2013, the U.S. Food and Drug Administration (FDA) approved onabotulinumtoxin A, the drug marketed as Botox and Botox Cosmetic, for the temporary minimizing of the appearance of moderate to severe lateral canthal lines, more commonly known as crow’s feet, in adults. Botox, made from botulinum neurotixn, prevents muscles from tightening when administered via intramuscular injection. You can read the announcement here. The FDA approved Botox Cosmetic for treating crow’s feet after the drug’s safety and effectiveness for that intended use were established by two clinical studies. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA…
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FDA Publishes CPG on Food Facility Registration

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On April 4, 2013, the U.S. Food and Drug Administration (FDA) published its Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration—Human and Animal Food. This compliance policy guide, when finalized, will provide a resource to FDA staff on the requirements of food facility registration under Section 415 of the Federal Food, Drug, and Cosmetic Act (FDCA) and aid the Agency in determining whether parties subject to food facility registration are compliant with all applicable laws and regulations. The draft is available here. Section 415 was added as an amendment to the FDCA by Section 305 of the Public Health,…
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