New FDA E-Cigarette Rules – What Does It Mean

FDA new rule e cigarette

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 regulating e-cigarettes if the aim of the product was to aide in smoking cessation. Effectively the prior regulations intended to regulate e-cigarettes only if they were intended to be marketed…

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Nearly 25% of 2014 Warning Letters Issued to Seafood Industry

warning letters seafood

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 couple of weeks or so the US FDA updates its public warning letter database with “recently posted” actions. Reading those letters over the past couple of months a striking trend…

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FDA Proposes New Nutrition Label

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 next 90-days. Following the comment period the final rule would be issued likely a year later.

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FY 2013 483 Data Released; Top Ten Observations Unchanged

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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 tool used by the agency, for the prior year. Comparing the new data to fiscal year 2012 provides insight into the Agency’s enforcement priorities. The informal review below again shows…

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Marijuana, THC, and the US FDA – What Does Increasing Legalization Mean for Food, Drugs, and Dietary Supplements?

Cannabis THC Marijuana FDA

Colorado made headlines this past week when its decriminalization of marijuana went into effect. Since that time an increasing number of calls and e-mails rushed in to ask what the FDA position was and if foods, dietary supplements or drugs could contain cannabis. The short answer is no. For federal purposes marijuana remains a schedule…

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SNAP Trafficking Charge Letter

SNAP Trafficking Charge Letter Overview of USDA/FNS Charge Letter Response and Appeal SNAP Trafficking charge letter act as the official notification from the USDA FNS (United States Department of Agriculture Food and Nutrition Service) to a SNAP retailer. It will indicate the nature of the trafficking violations, the time-frame to respond, which is incredibly short,…

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