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Natural American Spirit tobacco is not natural; contains dangerous chemical additives

By Alien Sex Fiend, Oct 10, 2015 | Updated: Oct 10, 2015 | | |
Rating:
5/5,
  1. Alien Sex Fiend
    Natural American Spirit tobacco is not natural; contains dangerous chemical additives
    NASlogo.png

    FDA
    Center for Tobacco Products
    10903 New Hampshire Avenue
    Silver Spring, MD 20993 ​

    AUG 27, 2015​
    VIA UPS and FAX

    Michael Little, President
    Santa Fe Natural Tobacco Company, Inc.
    1 Plaza La Prensa
    Santa Fe, NM 87507


    WARNING LETTER

    Dear Mr. Little:

    The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) reviewed your cigarette product labeling and determined that your cigarette products are manufactured and distributed or offered for sale to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including cigarettes, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).

    FDA has determined that several of your cigarette products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are modified risk tobacco products sold or distributed without an FDA order in effect that permits such sale or distribution.

    Modified Risk Tobacco Product Violations

    You sell or distribute cigarette products the label, labeling, or advertising of which represents explicitly and/or implicitly that the products or their smoke do not contain or are free of a substance and/or that the products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products. Specifically, you sell or distribute Natural American Spirit cigarettes described in product labeling as “Natural” and “Additive Free.”

    A tobacco product is considered a “modified risk tobacco product” under section 911(b)(2)(A)(i) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(i)) if its label, labeling, or advertising explicitly or implicitly represents that: (1) the product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products; (2) the product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or (3) the product or its smoke does not contain or is free of a substance. Under section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A product that is in violation of section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)) is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)). Your product labeling for Natural American Spirit cigarettes, which uses the descriptors “Natural” and “Additive Free,” represents explicitly and/or implicitly that the products or their smoke do not contain or are free of a substance and/or that the products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products. As such, these products are modified risk tobacco products. Because these products are sold or distributed to customers in the United States without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), these products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).

    FDA recognizes that Santa Fe Natural Tobacco Company, Inc. has entered into a consent order with the Federal Trade Commission (FTC) regarding the company’s use of additive free claims in tobacco product advertising (Federal Trade Commission, In the Matter of Santa Fe Natural Tobacco Company, Inc., a corporation, Docket No. C-3952, Decision and Order, Issued June 12, 2000). This order requires, in part, that the company display certain disclosures (e.g., “No additives in our tobacco does NOT mean safer”) in any advertisements using claims that represent tobacco products as having no additives, unless the company possesses and relies upon competent and reliable scientific evidence demonstrating that such products pose materially lower health risks than other tobacco products of the same type. This consent order predates the Tobacco Control Act, which was enacted on June 22, 2009 and gave FDA authority to regulate the manufacture, sale, distribution, and promotion of tobacco products, including authority over modified risk tobacco products under Section 911 of the FD&C Act (21 U.S.C. § 387k). As noted above, under section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). Because you sell or distribute modified risk tobacco products without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), you are in violation of the FD&C Act, notwithstanding your consent order with FTC.

    Conclusion and Requested Actions

    The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to those stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act.

    It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, criminal prosecution, seizure, and/or injunction. Please note that adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.

    Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative promotion, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. You can find the FD&C Act through links on FDA’s homepage at www.fda.gov.

    Please note your reference number, RW1500345, in your response and direct your response to the following address:

    DPAL-WL Response, Office of Compliance and Enforcement
    FDA Center for Tobacco Products
    c/o Document Control Center
    Building 71, Room G335
    10903 New Hampshire Avenue
    Silver Spring, MD 20993-0002

    If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235 or via email at CTPCompliance@fda.hhs.gov.

    Sincerely,
    /S/
    Ann Simoneau, J.D.
    Director
    Office of Compliance and Enforcement
    Center for Tobacco Products


    VIA UPS and FAX

    cc:

    Susan M. Cameron
    President and Chief Executive Officer
    Reynolds American Inc.
    401 North Main Street
    Winston-Salem, NC 27101-3804

    Dr. James Swauger
    Vice President Regulatory Oversight
    401 North Main Street
    Winston-Salem, NC 27102


    Source: FDA
    http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm459778.htm

Comments

  1. sassieone
    Re: Natural American Spirit tobacco is not natural; contains dangerous chemical addit

    If you're a smoker, then you KNOW this is an unhealthy and gross addiction.

    What I will never understand is why parents of babies and kids don't realize their second hand smoke is awful for their little lungs and bodies.

    It infuriates me when I see some woman driving in her car, "Baby on Board" signage in the back window, and she's smoking a cigarette with all the windows rolled up. Not even a small crack in the driver's side window. Where is the logic? Common sense?

    As a grown woman and mother, I was the child of two chain smoking parents. My clothes smelled like an ashtray even if they were spotlessly clean. So did my freshly washed hair.

    Addicts/smokers....keep your addictions in your body and away from those of us who want no part of it. I'm not asking smokers to stop smoking....smoke away....just be considerate of those tiny voices who cannot speak for themselves and even to those of us who can.

    Are smokers really not aware of the harm smoking does to the human body with or without additives? Most of the smokers I know really don't give that issue a second or third thought. They just need their nicotine fix. It IS an addiction.
  2. Alien Sex Fiend
    Re: Natural American Spirit tobacco is not natural; contains dangerous chemical addit

    additives in question included ammonia. FDA says American Spirit is a modified tobacco product unlike organic tobacco it claims to be. American Spirit also falsifies the claim that their products non-addictive, its printed on the carton. In fact their product is as addictive as any other cigarette brand and contains higher tar content. Natural Spirit is seeking a way to sell more of their cigarettes by adding chemicals to their tobacco (like any other tobacco company) and on top of that saying theirs is not addictive. Any tobacco product is very addictive
  3. Alfa
    Re: Natural American Spirit tobacco is not natural; contains dangerous chemical addit

    Also see: 'Crack' nicotine in cigarettes varies widely
    Freebase Nicotine

    The addition of ammonia is to react with nicotine and create freebase nicotine. The same principle that turns cocaine into crack. Freebase nicotine is much more addictive than nicotine which is clearly the objective of adding this additive.

    For those smokers who have a hard time quitting tobacco its a good strategy to first move onto a brand that does not add additives like this. There are only a few such brands that claim this. Santa Fe / American Spirit has been caught to be a fraud.

    It is true that all tobacco is addictive, but would be ignorant to think that its all equal. Just leave it up to such tobacco companies to make addictive tobacco into something almost impossible to quit.

    One consumer has started a class action law suit against Santa Fe Tobacco for their deceit. I would not be surprised if the consumer ends up with a lot of cash.
  4. Alien Sex Fiend
    Re: Natural American Spirit tobacco is not natural; contains dangerous chemical addit

    Wonder if there will ever be a list of cigarette brands that DO NOT have chemically added ammonia and urea? I bet majority common brands are "crack" freebase nicotine
  5. rawbeer
    Re: Natural American Spirit tobacco is not natural; contains dangerous chemical addit

    It's easy to find rolling tobacco that's not ammoniated. In fact it seems most of it isn't...I can't list any brands because when I hand-rolled I bought from a local tobacconist that sold their own blends, but none of them were. I feel like the Nat Shermans I used to smoke weren't ammoniated. Other than that, I think every cigarette I've ever pulled out of a pack was.

    It's pretty easy to tell the difference. If you're addicted to pre made cigarettes hand rolled smokes just won't seem satisfying. The nicotine comes on slowly, you never get that "pop" and head rush. That was always my problem trying to quit with rolling tobacco, it just didn't satisfy me. I'd invariably wind up trading hand rolled smokes for crack smokes.

    The practice of ammoniating cigarettes became widespread, I believe, in the late 60's-early 70's. I've always wondered how this slipped by smokers. The difference in the two types of tobacco is what I would call "profound". If you hopped into your car and lit an ammoniated cigarette when you were addicted to non-ammoniated, I think you'd probably have a strong desire to pull over and lay down. Maybe they stepped the degree up over time? It seems to me everyone would have realized something weird was up.

    Then again after smoking a few, everyone would have fallen in love and stopped bitching...
  6. Alien Sex Fiend
    Re: Natural American Spirit tobacco is not natural; contains dangerous chemical addit

    That means that I never tried real tobacco they smoked in medieval europe.

    However, I tried moist pipe tobacco, I found it soft, very weak and kinda like really mild weed feeling as long as you continue pulling on the pipe. you stop puffing, any effect disappears
  7. rawbeer
    Re: Natural American Spirit tobacco is not natural; contains dangerous chemical addit

    Medieval Europeans didn't have tobacco. It was unknown outside of the Americas until 1492.

    I do believe most pipe tobacco is not ammoniated. Or cigars. I think it's a cigarette thing.
  8. Alien Sex Fiend
    Re: Natural American Spirit tobacco is not natural; contains dangerous chemical addit

    Isn't 1492 Late Medieval? With Shakespeare smoking and all?

    I had a proper wooden sherlock pipe from a reputable company and a tin of tobacco. I never finished it. I wasn't impressed.
  9. Alfa
    Re: Natural American Spirit tobacco is not natural; contains dangerous chemical addit

    Can someone post more information about the class action suit?

    There are two studies done on that exact subject. One in 2003 and one much later. Thats actually what got the ball rolling on this. Maybe someone with medline access can post these?
  10. Calliope
    Re: Natural American Spirit tobacco is not natural; contains dangerous chemical addit

    The two studies are now in the file archive:

    Chem Res Toxicol. 2003 Aug;16(8):1014-8.
    Percent free base nicotine in the tobacco smoke particulate matter of selected commercial and reference cigarettes.
    Pankow JF1, Tavakoli AD, Luo W, Isabelle LM.

    Tob Control. 2006 Jun;15(3):189-98.
    Brand differences of free-base nicotine delivery in cigarette smoke: the view of the tobacco industry documents.
    Ferris Wayne G1, Connolly GN, Henningfield JE.

    As a note of caution on this topic, there seems to be some data contradicting the idea that higher ammonia levels in smoke increase nicotine absorption and thus increase the addictiveness of cigarettes. The abstract from a paper reporting a recent study which comes to this conclusion:
    Description: The nicotine bolus theory states that the dependence-producing potential of cigarettes relates to a rapid increase in nicotine at brain receptor sites. It has been suggested that ammonia, a compound typically found in tobacco products, further increases the amount of nicotine absorbed and its absorption rate. The aim of this study was to determine whether different ammonia yields in cigarettes affected the rate or amount of nicotine absorption from the lungs to arterial circulation. 34 adult smokers received 3 separate puffs from each of 2 test cigarettes with different ammonia yields (ammonia in smoke: 10.1 μg per cigarette vs. 18.9 μg per cigarette), followed by rapid radial arterial blood sampling (maximum one sample per second) with 30 min between puffs. Arterial blood samples were assayed for nicotine by liquid chromatography tandem mass spectrometry. Pharmacokinetic modeling was performed and the two test cigarettes were assessed for bioequivalence. No significant differences were found in area under the curve, C(max), or T((max)) and the 2 test cigarettes were found to be bioequivalent based on 2 one-sided tests at a significance level of 5%. In addition, the zero-order rate constant (k(0)) obtained from the initial slope of the curves and the model-dependent first-order rate constant (k(a)) were not significantly different. This study provides strong evidence that the different ammonia yields of the test cigarettes had no impact on nicotine pharmacokinetics; thus, the ammonia did not increase the rate or amount of nicotine absorption from a puff of cigarette smoke. (Evaluation of the effect of ammonia on nicotine pharmacokinetics using rapid arterial sampling Mckinney, Diana L ; Gogova, Maria ; Davies, Bruce D ; Ramakrishnan, Viswanathan ; Fisher, Kelly ; Carter, W Hans ; Karnes, H Thomas ; Garnett, William R ; Iyer, Sunil S ; Somani, Amit A ; Kobal, Gerd ; Barr, William H. Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, May 2012, Vol.14(5), pp.586-95)​

    It is worth paying attention to the fact this study seems to have looked at only cigarettes that produced smoke containing ammonia levels. I am not in a position to say whether that makes it irrelevant to a product like American Spirits is purported to be, that is, free of additives like ammonia. For all I know this only means that a little bit of ammonia goes a long long way. Is the smoke from untreated tobacco free of ammonia?

    I've started a thread on the American Spirit lawsuit here
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