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New Draft Guidance on FDA’s Accredited Third-Party Certification Program

Posted on May 2, 2022

FDA Issues the Accredited Third-Party Certification Program: Questions and Answers: Draft Guidance for Industry

As previously covered on this blog, on November 27, 2015, FDA finalized the rule, “

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FDA Issues Draft Action Levels for Lead in Juice

Posted on April 29, 2022

On April 27, 2022, FDA issued a draft guidance providing draft action levels for lead in single-strength apple juice and other single-strength juices. FDA states that the new levels are

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Baby Food Lawsuit Dismissed as “Simply Speculative”

Posted on April 27, 2022

On April 25, a New Jersey federal judge dismissed a putative class action lawsuit against baby food producer Sprout Foods, Inc. finding that the alleged harm was “simply speculative” (subscription

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FDA Releases Draft Guidance on NAC Enforcement

Posted on April 22, 2022

On April 21, 2022 FDA announced the issuance of draft guidance on FDA’s policy regarding dietary supplements containing N-acetyl cysteine (NAC). The guidance details the agency’s intent to exercise enforcement

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CSPI Criticizes FDA Allergen Guidance

Posted on April 21, 2022

As previously reported, FDA recently released a draft guidance regarding the agency’s approach to evaluating the public health risks of allergens other than the nine major food allergens. On

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FDA Amends Added Fluoride Levels in Bottled Water

Posted on April 20, 2022

On April 20, the FDA published a final rule for added fluoride levels in bottled water. The final rule amends the quality standard, and specifies that domestically packaged and imported

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FDA Issues Final Guidance on Reconditioning Fish

Posted on April 14, 2022

In September 2019, we reported that FDA had issued a draft guidance for industry titled “Reconditioning of Fish and Fishery Products by Segregation.” On April 13, 2022, FDA issued its

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Congress Voices Concern Over FDA’s Food Safety Actions

Posted on April 13, 2022

On April 11, Senator Patty Murray (D-WA), who leads the Senate Committee on Health, Education, Labor, and Pensions, sent a letter to FDA Commissioner Robert Califf about her concerns over

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FDA Completes Review of GE Canola Seeds After Response to Last Year’s Inadvertent Release

Posted on April 11, 2022

Plants produced through genetic engineering (GE) are subject to the same FDA safety standards as other plants. Given the possibility for food from some GE plants to have new allergens,

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FDA Confirms N-acetyl-L-cysteine (NAC) is Excluded From the Dietary Supplement Definition and Leaves Open Potential Rulemaking to Allow the use of NAC in Dietary Supplements

Posted on April 4, 2022

We previously reported on FDA’s November 24, 2021 tentative response denying requests in two citizens petitions (June 1, 2021 Council for Responsible Nutrition (CRN) petition and August 18, 2021 Natural

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