DRUG

US Supreme Court Hears Flavored Vape Case: Key Takeaways for Industry Stakeholders

The U.S. Supreme Court heard oral arguments on Monday in Wages and White Lion Investments. The Court heard arguments regarding the FDA’s defense of refusing…

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Nicotine Pouches and FDA Regulations

Nicotine pouches have gained popularity as an alternative to smoking. Here, we will guide you through the FDA regulations surrounding nicotine pouches.

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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). The rule is titled, “Administrative…

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FDA Label Review – Overview and Tips

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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

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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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 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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