ADMINISTRATION

FDA Warning Letters

FDA Warning Letters The Significance of Warning Letters FDA Waring Letters are the most commonly used enforcement tool. Employed across product categories FDA Warning Letters…

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GNC to Strengthen Supplement Quality Controls – Implications for Suppliers

The New York Times reports today that GNC will institute “sweeping new testing procedures” on its herbal supplements following an investigation and accusations from the…

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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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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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New FDA E-Cigarette Rules – What Does It Mean

Yesterday (April 24, 2014) the US Food and Drug Administration (FDA) announced new regulation of e-cigarettes. The rule changes the FDA’s prior position of only…

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Nearly 25% of 2014 Warning Letters Issued to Seafood Industry

A warning letter issued by the US FDA is the most common and widely used enforcement tool. It is also among the most public. Every…

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FDA Uses FSMA Suspension Auhtority; Second Suspension Under New FSMA Powers

The US Food and Drug Administration (US FDA) suspended the food facility registration of Roos Foods of Kenton, Delaware. The facility registration is required by…

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FDA Proposes New Nutrition Label

The US Food and Drug Administration announced today dramatic new changes to the food nutrition label. The proposed label is open for comment over the…

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FY 2013 483 Data Released; Top Ten Observations Unchanged

The US FDA released enforcement data from fiscal year 2013. The data provides the total number of Form 483 Inspectional Observations, the most common pre-enforcement…

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FDA Publishes Draft Approach to Identifying High Risk Foods Under FSMA

The US Food and Drug Administration announced its

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New FSMA Rule; Proposed Rule on Sanitary Transportation of Human and Animal Food

The US Food and Drug Administration announced a new rule to prevent food safety risks during the transport. This is the seventh and final major…

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