Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products - Small Entity Compliance Guide
Small Entity Compliance Guide: Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products
This guidance is intended to help small businesses understand and comply with FDA’s amendments to certain of its regulations to include tobacco products, where appropriate, in light of FDA’s authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products are subject to the same general requirements that apply to other FDA-regulated products. Parties must be in compliance with that final rule beginning on April 2, 2012.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.