federal_register: 2016-20913

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2016-20913 Submission of Warning Plans for Cigars; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Submission of Warning Plans for Cigars." The draft guidance, when finalized, will help those involved in the manufacture, distribution, and sale of cigars in the United States understand the new cigar warning plan requirements under FDA's final rule deeming these products to be subject to the tobacco product authorities in the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The draft guidance reiterates the required health warning statements and the requirements for random display and distribution that should be provided in cigar warning plans, and, when finalized, will help persons determine who should submit a warning plan, when a plan must be submitted, and what information should be included when submitting a plan. 2016-08-31 2016 8 https://www.federalregister.gov/documents/2016/08/31/2016-20913/submission-of-warning-plans-for-cigars-draft-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2016-08-31/pdf/2016-20913.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Submission of Warning Plans for Cigars." The draft guidance, when finalized, will help those involved in the manufacture, distribution, and...  

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