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          Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products - Small Entity Compliance GuideSearch for FDA Guidance Documents SMALL ENTITY COMPLIANCE GUIDE
	Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products - Small Entity Compliance Guide
					Guidance for Industry
		
		March 2023


	Download the  Final Small Entity Compliance Guide
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-2011-N-0121
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for 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.


 
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						All written comments should be identified with this document's docket number: FDA-2011-N-0121.



  
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Food and Drug Administration
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10903 New Hampshire Avenue
Building 71, Room G335
Silver Spring, MD 20993-0002
		AskCTP@fda.hhs.gov
		    
		    		    	(9 a.m. - 4 p.m. Eastern) 1-877-CTP-1373 (1-877-287-1373)
		    
		    		    
		    
		    		    			    	

    Twitter: https://twitter.com/FDATobacco
    FDA Tobacco Education Resource Library: https://digitalmedia.hhs.gov/tobacco

                                                                                  Content current as of:
      03/17/2023
         
                  
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