DRUG

New FDA Automatic Destruction Rule

New FDA Automatic Destruction Rule Under New Authority Re-Export Option May be Removed An ominous sounding new rule goes into effect tomorrow (October 15, 2015)….

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FDA Label Review – Overview and Tips

FDA Label

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FDA Regulation of Homeopathic Drugs – Meeting Foreshadows Changes

FDA Regulation of Homeopathic Drugs Current Regulation of Homeopathy The FDA currently regulates homeopathic drugs under a 1988 Policy Guide. The Policy Guide is detailed…

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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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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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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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