AG/FDA Blog

Prior Notice of “Grey Market” Food Imports

Yesterday, FDA published a final rule making some technical amendments to its prior notice of imported food regulations.  The prior notice regulations implement section 801(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(m)), which req… Read More
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CFSAN Soon Will Issue Certificates of Free Sale for Exports Online

U.S. purveyors of foods, food additives, dietary supplements, and cosmetics for export are often asked by foreign customers or foreign governments to supply a “certificate” for products regulated by FDA.  Review of a certificate may be r… Read More
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Adverse Event Information Now Available Online for CFSAN-Regulated Products

FDA has begun posting online (and intends to update quarterly) information derived from adverse event reports the agency has received about conventional foods (including food/color additives), dietary supplements, and cosmetics.  This information is… Read More
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Uniform Compliance Date for Upcoming Food Labeling Regulations

FDA has set January 1, 2020, as the uniform compliance date for new or amended food labeling regulations that are issued between January 1, 2017, and December 31, 2018. Use of a uniform compliance date provides for an orderly and economical industry… Read More
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What Is “Dietary Fiber”(for Purposes of Nutrition Labeling)?

FDA has issued two notices for publication in the Federal Register: A Request for Scientific Data, Information, and Comments (comments due within 45-days of publication); and A notice of availability about a draft guidance (comments due within 60-da… Read More
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FDA Issues Final Guidance on VQIP

FDA today announced the availability of its finalized “FDA’s Voluntary Qualified Importer Program: Guidance for Industry.”  It also published a Fact Sheet on the Final Guidance, as well as Instructions for Submission of Voluntary Qualified Imp… Read More
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Aspartame Potentially Subject to California Prop 65 Listing – Update

As previously reported, at an upcoming, November 15, 2016, public meeting of the Proposition 65 Carcinogen Identification Committee (CIC), aspartame will be discussed prior to the CIC sending advice to the Office of Environmental Health Hazard Assess… Read More
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Small Entity Compliance Guides on CGMP and Preventive Controls Final Rules for Human Food and Food for Animals

FDA has issued two Small Entity Compliance Guides (SECG) to enable domestic and foreign food facilities to better understand and comply with the requirements of two final rules implementing the FDA Food Safety Modernization Act.   See generally Foo… Read More
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Draft FSMA Guidance for Industry: Describing a Hazard that Needs Control because Permissibly Not Controlled Upstream

FDA has made available for comment a draft guidance for industry that sets forth its current thinking about compliance with provisions of four FSMA final rules that require an entity (e.g., supplier) to include a disclosure statement, in documents ac… Read More
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Aspartame Potentially Subject to Prop 65 Listing

The Carcinogen Identification Committee (CIC) – California’s qualified experts on carcinogenicity for purposes of Proposition 65 (Prop 65)) – pursuant to a meeting scheduled for November 15, 2016, will be providing the state’s Office of Envir… Read More
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