FDA

FDA Regulation of Personal Lubricants

FDA Regulation of Personal Lubricants –

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Cuban Cigars and the FDA

With the announcement today by US President Barack Obama that the United States will begin to normalize relations with Cuba a number of questions come-up….

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Review: FY 2014 Inspectional Observation Summaries

At the end of each fiscal year the US FDA posts a summary of the Inspectional Observations from Form 483. The fiscal year for the…

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FDA, FSMA, and the USDA Budget Increases- Update from Latest Spending Bill

The latest reporting on the spending bill passed by the United States House of Representatives contains budget increases for the U.S. Food and Drug Administration…

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FTC Sues Gerber Over Unapproved Health Claim

The US Federal Trade Commission announced today its intent to sue Gerber for unapproved and unsubstantiated health claims made on its

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FDA Textbook by Springer International; Release Date Annouced

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Gluten Free Label Rule Now In Effect

Last year the US Food and Drug Administration (FDA) annouced a new rule for gluten free labeling. The rule gave manufacturers until yesterday (August 5,…

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Three Steps to Selling FDA Regulated Products on Amazon

“Is it FDA approved?” This is the most frequent question received by phone and e-mail. It’s also the most commonly asked question by Amazon. The…

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Press Release: Springer Taps Marc Sanchez for Food Law Textbook

  For Immediate Release: June 23, 2014 Marc C. Sanchez, Esq.             Senior Counsel, Contract In-House Counsel and Consulting, LLC Adjunct Professor of Law, Northeastern…

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FDA Finalizes Rule Prohibiting Certain Nutrient Content Claims for DHA, EPA, and ALA Omega-3 Fatty Acids

The FDA annouced a new rule in late April limiting the claims that can be made about food and dietary supplement products containing Omega 3…

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Tips for Appeals and FDA Meetings: Reflections from Recent Visit to FDA HQ

An enforcement meeting with the US FDA, whether in person or over the phone, can become an intimidating task. There are number of variables to…

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Watermelon Water – New Fad, but FDA Approved?

ABC news and other media outlets are reporting on a new beverage fad – watermelon water. Before jumping on the bandwagon, it is important to…

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