I'm pretty sure if this bill doesn't pass, the FDA will continue to label the e-cig as a medical delivery device which would call for testing to be carried out.
If this bill passes and the e-cig is found to be a reduced harm tobacco product, then we would be fine. We want it to be a tobacco product it seems to me.
I'll post portions of the bill so others can verify what I'm saying.
SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.
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(a) Definition of Tobacco Products- Section 201 of the Federal Food, Drug, and Cosmetic Act (
21 U.S.C. 321) is amended by adding at the end the following:
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‘(rr)(1) The term ‘tobacco product’ means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).
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‘(2) The term ‘tobacco product’ does not mean an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 503(g).
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‘(3) The products described in paragraph (2) shall be subject to chapter V of this Act.
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‘(
4) A tobacco product shall not be marketed in combination with any other article or product regulated under this Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement).’.
Skip down to the modified risk tobacco product and it appears to me that the e-cig would fit this definition if found to be a tobacco product.
‘SEC. 911. MODIFIED RISK TOBACCO PRODUCTS.
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‘(a) In General- No person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product unless an order issued pursuant to subsection (g) is effective with respect to such product.
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‘(b) Definitions- In this section:
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‘(1) MODIFIED RISK TOBACCO PRODUCT- The term ‘modified risk tobacco product’ means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.
‘(2) SOLD OR DISTRIBUTED-
‘(A) IN GENERAL- With respect to a tobacco product, the term ‘sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products’ means a tobacco product--
[bold] ‘(i) the label, labeling, or advertising of which represents explicitly or implicitly that--
‘(I) the tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products;
‘(II) the tobacco product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or
‘(III) the tobacco product or its smoke does not contain or is free of a substance;[/bold]
‘(ii) the label, labeling, or advertising of which uses the descriptors ‘light’, ‘mild’, or ‘low’ or similar descriptors; or
‘(iii) the tobacco product manufacturer of which has taken any action directed to consumers through the media or otherwise, other than by means of the tobacco product’s label, labeling, or advertising, after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, respecting the product that would be reasonably expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful than one or more commercially marketed tobacco products, or presents a reduced exposure to, or does not contain or is free of, a substance or substances.
‘(B) LIMITATION- No tobacco product shall be considered to be ‘sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products’, except as described in subparagraph (A).
‘(C) SMOKELESS TOBACCO PRODUCT- No smokeless tobacco product shall be considered to be ‘sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products’ solely because its label, labeling, or advertising uses the following phrases to describe such product and its use: ‘smokeless tobacco’, ‘smokeless tobacco product’, ‘not consumed by smoking’, ‘does not produce smoke’, ‘smokefree’, ‘smoke-free’, ‘without smoke’, ‘no smoke’, or ‘not smoke’.
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‘(3) EFFECTIVE DATE- The provisions of paragraph (2)(A)(ii) shall take effect 12 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act for those products whose label, labeling, or advertising contains the terms described in such paragraph on such date of enactment. The effective date shall be with respect to the date of manufacture, provided that, in any case, beginning 30 days after such effective date, a manufacturer shall not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with paragraph (2)(A)(ii).
‘(c) Tobacco Dependence Products- A product that is intended to be used for the treatment of tobacco dependence, including smoking cessation, is not a modified risk tobacco product under this section if it has been approved as a drug or device by the Food and Drug Administration and is subject to the requirements of chapter V.
‘(d) Filing- Any person may file with the Secretary an application for a modified risk tobacco product. Such application shall include--
‘(1) a description of the proposed product and any proposed advertising and labeling;
‘(2) the conditions for using the product;
‘(3) the formulation of the product;
‘(4) sample product labels and labeling;
‘(5) all documents (including underlying scientific information) relating to research findings conducted, supported, or possessed by the tobacco product manufacturer relating to the effect of the product on tobacco-related diseases and health-related conditions, including information both favorable and unfavorable to the ability of the product to reduce risk or exposure and relating to human health;
‘(6) data and information on how consumers actually use the tobacco product; and
‘(7) such other information as the Secretary may require.
‘(e) Public Availability- The Secretary shall make the application described in subsection (d) publicly available (except matters in the application which are trade secrets or otherwise confidential, commercial information) and shall request comments by interested persons on the information contained in the application and on the label, labeling, and advertising accompanying such application.
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‘(f) Advisory Committee-
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‘(1) IN GENERAL- The Secretary shall refer to the Tobacco Products Scientific Advisory Committee any application submitted under this section.
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‘(2) RECOMMENDATIONS- Not later than 60 days after the date an application is referred to the Tobacco Products Scientific Advisory Committee under paragraph (1), the Advisory Committee shall report its recommendations on the application to the Secretary.
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‘(g) Marketing-
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‘(1) MODIFIED RISK PRODUCTS- Except as provided in paragraph (2), the Secretary shall, with respect to an application submitted under this section, issue an order that a modified risk product may be commercially marketed only if the Secretary determines that the applicant has demonstrated that such product, as it is actually used by consumers, will--
‘(A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and
‘(B) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.
‘(2) SPECIAL RULE FOR CERTAIN PRODUCTS-
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‘(A) IN GENERAL- The Secretary may issue an order that a tobacco product may be introduced or delivered for introduction into interstate commerce, pursuant to an application under this section, with respect to a tobacco product that may not be commercially marketed under paragraph (1) if the Secretary makes the findings required under this paragraph and determines that the applicant has demonstrated that--
‘(i) such order would be appropriate to promote the public health;
'(ii) any aspect of the label, labeling, and advertising for such product that would cause the tobacco product to be a modified risk tobacco product under subsection (b) is limited to an explicit or implicit representation that such tobacco product or its smoke does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke;
‘(iii) scientific evidence is not available and, using the best available scientific methods, cannot be made available without conducting long-term epidemiological studies for an application to meet the standards set forth in paragraph (1); and
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‘(iv) the scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely in subsequent studies.
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‘(B) ADDITIONAL FINDINGS REQUIRED- To issue an order under subparagraph (A) the Secretary must also find that the applicant has demonstrated that--
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‘(i) the magnitude of the overall reductions in exposure to the substance or substances which are the subject of the application is substantial, such substance or substances are harmful, and the product as actually used exposes consumers to the specified reduced level of the substance or substances;
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‘(ii) the product as actually used by consumers will not expose them to higher levels of other harmful substances compared to the similar types of tobacco products then on the market unless such increases are minimal and the reasonably likely overall impact of use of the product remains a substantial and measurable reduction in overall morbidity and mortality among individual tobacco users;
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‘(iii) testing of actual consumer perception shows that, as the applicant proposes to label and market the product, consumers will not be misled into believing that the product--
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‘(I) is or has been demonstrated to be less harmful; or
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‘(II) presents or has been demonstrated to present less of a risk of disease than 1 or more other commercially marketed tobacco products; and
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‘(iv) issuance of an order with respect to the application is expected to benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.
The rest is here:
http://www.govtrack.us/congress/billtext.xpd?bill=s111-982