The GRAS Process Under the Final Rule (Part 2): Increased Emphasis on Exposure

Published on October 1, 2016

The finalized GRAS rule and associated Federal Register Notice1 emphasizes the FDA’s opinion that dietary…

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New Draft Guidance on Allergy Assessment of Genetically Modified Plants from EFSA: More Tests to Ensure Safety for Everyone

Published on September 1, 2016

The European Food Safety Authority (EFSA) has issued a new draft guidance on allergenicity testing…

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Colors from Natural Sources: Are They Safe for New Uses?

Published on March 1, 2016

With today’s focus on “clean” labels, food manufacturers are replacing artificial colors with colors from…

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Regulatory Update: FDA Issues a “Stay” For Parts of the Final Guidance for INDs

Published on March 1, 2016

In September 2013, the FDA issued Guidance for Clinical Investigators, Sponsors and IRBs: Investigational New…

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Five Questions to Consider Before Fortifying Foods

Published on February 1, 2016

In November 2015, the Food and Drug Administration’s (FDA) Center for Food Safety and Applied…

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The Thanksgiving meal is chock full of potential toxins – which ones can be avoided?

Published on November 1, 2015

It’s that time of year again, when cooks turn their attention to foods they will…

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Food Allergen Labeling: New Guidance for Exemption

Published on September 1, 2015

In June 2015, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) issued a…

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Risk Assessments: Which is Best for Food Ingredients?

Published on July 1, 2015

Traditionally, NOAELs from subchronic toxicity studies have been used to determine margins of safety for…

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Emulsifiers, gut microbiota and biological responses: Unjustified conclusions based on flawed research

Published on June 1, 2015

In March, 2015 a study was published by Chassaing et al. in Nature entitled “Dietary…

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EFSA’s Recently Released Opinion on Nickel

Published on April 1, 2015

Nickel is a natural element of the earth’s crust and is found in food, water,…

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Iodine Supplementation: Should it be considered for people consuming vegetable-based diets?

Published on March 1, 2015

In 2009, I wrote an article on evidence supporting iodine supplementation during pregnancy (1). Iodine…

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Draft Guidelines from FDA for Medical Foods: More Attempts by FDA to Limit Development of Functional Foods

Published on March 1, 2014

  FDA has recently issued two different guidance documents for medical foods in an attempt…

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When Bad Study Design Comes Back to Bite You (Part 2): The Critical Importance of the Selection of Dose

Published on June 1, 2013

The importance of proper study design was introduced in Part One of this series, which…

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When Bad Study Design Comes Back to Bite You

Published on March 1, 2013

A recent study published by Séralini et al. (Séralini study) about the long term toxicity…

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Proposition 37: A Deceptive Measure That Could Be Applied to Foods Produced by Conventional Methods

Published on September 1, 2012

A California initiative (Proposition 37) which would require the labeling of genetically engineered foods, has…

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Claims: The US vs. the European Perspective (Part 4). Will the FDA permit the same claim for cocoa flavanols and blood flow as EFSA?

Published on September 1, 2012

This article, which focuses on a health claim approved by the European Food Safety Agency…

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