ADMINISTRATION

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 are common food,…

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GNC to Strengthen Supplement Quality Controls – Implications for Suppliers

The New York Times reported that the 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 Approved 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 Authority; Second Suspension Under New FSMA Powers

The U.S. Food and Drug Administration (US FDA) suspended the registration of a food facility at Roos Foods in Kenton, Delaware. Facility registration is required…

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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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