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 In this section:

                Rules, Regulations and Guidance

Rules, Regulations and Guidance

                        Rules and Regulations
          Guidance
          Center for Tobacco Products’ Regulation and Guidance Policy Agenda
          Family Smoking Prevention and Tobacco Control Act - An Overview Home
          Tobacco Products
          Products, Guidance & Regulations
          Rules, Regulations and Guidance
          Section 903 of the Federal Food, Drug, and Cosmetic Act - Misbranded Tobacco ProductsRules, Regulations and Guidance Section 903 of the Federal Food, Drug, and Cosmetic Act - Misbranded Tobacco Products
  
  	
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**On this page:**

In General
	Prior Approval of Label StatementsRelated Resources for Section 903

**Final Guidance**

Further Amendments to General Regulations of the FDA to Incorporate Tobacco Products – Small Entity Compliance Guide**In General.** A tobacco product shall be deemed to be **misbranded**

	if its labeling is false or misleading in any particular;
		if in package form unless it bears a label containing
		the name and place of business of the tobacco product manufacturer, packer, or distributor;
			an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;
			an accurate statement of the percentage of the tobacco used in the product that is domestically grown tobacco and the percentage that is foreign grown tobacco; and
			the statement required under section 920(a),
		except that under subparagraph (B) reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary;
		if any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, or designs in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
		if it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name prominently printed in type as required by the Secretary by regulation;
		if the Secretary has issued regulations requiring that its labeling bear adequate directions for use, or adequate warnings against use by children, that are necessary for the protection of users unless its labeling conforms in all respects to such regulations;
		if it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 905(b), 905(c), 905(d), or 905(h), if it was not included in a list required by section 905(i), if a notice or other information respecting it was not provided as required by such section or section 905(j), or if it does not bear such symbols from the uniform system for identification of tobacco products prescribed under section 905(e) as the Secretary by regulation requires;
		if, in the case of any tobacco product distributed or offered for sale in any State
		its advertising is false or misleading in any particular; or
			it is sold or distributed in violation of regulations prescribed under section 906(d);
		unless, in the case of any tobacco product distributed or offered for sale in any State, the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that tobacco product
		a true statement of the tobacco product's established name as described in paragraph (4), printed prominently; and
			a brief statement of
			the uses of the tobacco product and relevant warnings, precautions, side effects, and contraindications; and
				in the case of specific tobacco products made subject to a finding by the Secretary after notice and opportunity for comment that such action is appropriate to protect the public health, a full description of the components of such tobacco product or the formula showing quantitatively each ingredient of such tobacco product to the extent required in regulations which shall be issued by the Secretary after an opportunity for a hearing;
		if it is a tobacco product subject to a tobacco product standard established under section 907, unless it bears such labeling as may be prescribed in such tobacco product standard; or
		if there was a failure or refusal
		to comply with any requirement prescribed under section 904 or 908; or
			to furnish any material or information required under section 909.
	**Prior Approval of Label Statements.** The Secretary may, by regulation, require prior approval of statements made on the label of a tobacco product to ensure that such statements do not violate the misbranding provisions of subsection (a) and that such statements comply with other provisions of the Family Smoking Prevention and Tobacco Control Act (including the amendments made by such Act). No regulation issued under this subsection may require prior approval by the Secretary of the content of any advertisement, except for modified risk tobacco products as provided in section 911. No advertisement of a tobacco product published after the date of enactment of the Family Smoking Prevention and Tobacco Control Act shall, with respect to the language of label statements as prescribed under section 4 of the Federal Cigarette Labeling and Advertising Act and section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 or the regulations issued under such sections, be subject to the provisions of sections 12 through 15 of the Federal Trade Commission Act.

                                                                                  Content current as of:
      05/15/2019
              
              
Regulated Product(s)
		 TobaccoRules, Regulations and Guidance

          
                        Rules and Regulations
          Guidance
          Center for Tobacco Products’ Regulation and Guidance Policy Agenda
          Family Smoking Prevention and Tobacco Control Act - An Overview
 
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