- Delivery Method:
- VIA UPS and Electronic Mail
- Issuing Office:
- Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
JAN 14, 2020
Dear Timothy J. Dutmers:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.targard.com and determined that the cigarette filters listed there are offered for sale or distribution to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act, these products are tobacco products because they are components or parts of products made or derived from tobacco and intended for human consumption. Certain tobacco products, including cigarette filters, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
FDA has determined that your TarGard Cigarette Filter products including the TarGard Permanent Cigarette Filter System, TarGard Original Disposable Cigarette Filters, and TarGard Mini Disposable Cigarette Filters 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
Our review of the website https://www.targard.com revealed that you sell or distribute cigarette filter products (to be used with combustible tobacco products) that are described as presenting a lower risk of tobacco related disease, being less harmful than one or more other commercially marketed tobacco products, or having a reduced level of/exposure to a substance. Specifically, the website https://www.targard.com and/or product labels include the following claims:
TarGard Cigarette Filters including TarGard Permanent Cigarette Filter System, TarGard Disposable Cigarette Filters, and TarGard Mini Disposable Cigarette Filters
• "Cut the Tar ... Keep the Taste"
• "TarGard Cigarette Filters trap sticky tars BEFORE they enter your body. [emphasis in original)"
• "How TarGard Works: All TarGard filters employ the scientific Venturi principle to modify the flow of smoke, spinning off heavy tars and particles and trapping them within the filter to provide vastly improved and effective filtration. [emphasis in original]"
• "That just means that the filter is removing more tar from your smoke, which I think we can all agree is a good thing."
• "After only smoking a few cigarettes through any of our tar trapping cigarette filters, you'll see just how much tar the filters save your lungs from [sic]."
• "Tar is removed from the cigarette smoke and it doesn't change the taste."
• "The amber filter does not change the full flavored taste of my cigarettes whatsoever but very effectively captures all those evil little tar balls that otherwise would have claimed my life way before now ... says Doc [sic]. [emphasis in original]"
• "I thought that using a filter might help. And it did. Not only do the filters keep that collected tar out of my lungs, it got rid of the smoker's cough and the smell of cigarettes on my hands ... says Denise."
• "My fingers are not stained any more and my teeth are also whiter ... Being able to breath deeper is also an added benefit that I wasn't expecting. I use the permanent filter so I see all the bad stuff my lungs and teeth missed when cleaning it ... says Deborah [sic]. [emphasis in original]"
• "Smoking is known to cause gum disease, which TarGard cigarette filters help prevent ... TarGard helps prevent bad breath caused by smoking because our cigarette filters actually remove tar from the cigarette smoke before it comes in to contact with your gums, teeth and tongue. Without using TarGard, a portion of the tar sticks to your tongue and teeth and contributes to the production of bad breath. [emphasis in original]"
• "REGAIN LOST LUNG CAPACITY ... Over time, smoking causes tar build up in the lungs ... This is the problem that TarGard is designed to address."
• "'Cut the Tar, Keep the Taste' has been the TarGard motto for years because it's the perfect summary of what it does. We know why smokers enjoy smoking and we also understand the hazards of it, which is why we're focused on allowing you to continue to enjoy smoking while at the same time reducing the harmful effects it has on you."
• "How the Venturi Principle Works .. .Tar is removed from the cigarette smoke and it doesn't change the taste. TarGard's Venturi principle is the key. It's also why TarGard's filters are more effective than the competitors' products."
• "Aide Smoker's Cough ... The reduction of smokers' cough is by far the most common comment we hear from our customers. We hear it from those who have used TarGard filters for a few weeks, as well as those who have used them for years."
• "SMOKER'S COUGH RELIEF ... How? ... The strongest evidence about the health benefits of TarGard Cigarette Filters come straight from our customers. Nowhere are our customers more passionate than in their descriptions of how TarGard filters help them kick their nagging smoker's cough."
• "RELIEVE SORE & SWOLLEN GUMS ... The use of a TarGard cigarette filter can help minimize the negative health effects that cigarette smoke has on your gums. [emphasis in original]"
• "How Does TarGard Relieve Gum Soreness? ... A simple way of understanding it is to think about how holding the filter in your teeth will cause the inhaled smoke to miss your gums entirely. It's simple and very effective."
• "A Relieved Customer ... My dentist actually got me on them due to gum problems and reseeding gum lines which can make you lose your teeth. My dentist said it helps but still wants me to quit.. .Trying .. . and this product does help ... says Randy [sic]. [emphasis in original]"
• "What TarGard Customers Say About Their Teeth ... Within the first month my gums were no longer sore by the end of each day from smoking. By the end of the second month I noticed I wasn't as winded while walking my dog on our half a mile walk each day ... says Ginny."
• "We consider TarGard to be a healthier alternative ... lf you're looking for a way to smoke healthier, please give a TarGard cigarette filter a try today! [emphasis in original]"
• "The disposable filters are inexpensive and easy to use and are a healthier way to smoke, thanks to Tar Gard ... says Doris."
• "My coughing has stopped over time and looking at the tar buildup in the filter keeps reminding me to keep using them .. . says Louise [emphasis in original]."
• "My lungs feel clearer, my smokers cough went away three weeks after I began using them .. . says Eddie. [emphasis in original]"
• "All my doctors say my lungs sound perfectly clear. They are amazed when I tell them I have been smoking for 45 years and have no smoker symptoms ... says Bill. [emphasis in original]"
• "Not only did it help to cool down the smoke from my hand rolled cigarettes, but it did something else too! For the first couple of weeks of using it I coughed up all kinds of gunk from my lungs and then ... my cough went away, forever! Since then I have not had any serious respiratory infections, no cough, and none of the respiratory problems that so many of my smoking friends have. My doctor is always so amazed at how clear my lungs are, being that I am a life long smoker. I know that biggest reason is that I have been using the Tar Guard filter. I still enjoy lighting up, and I buy all my Tag Guards on line. I am always telling my smoking friends, that cough and wheeze, to get themselves a Tar Guard filter or quit smoking. It really works! Thank you Tar Guard! ... says Kerry [sic]. [emphasis in original]"
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)).
The above listed products are modified risk tobacco products because the website and/or product labels describe them as presenting a lower risk of tobacco-related disease or being less harmful than one or more other commercially marketed tobacco products and containing a reduced level of a substance or presenting a reduced exposure to a substance. 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)).
Conclusion and Requested Actions
The violation discussed in this letter does not necessarily constitute an exhaustive list. You should immediately correct the violation that is referenced above, as well as violations that are the same as or similar to the one 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 on this website, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments 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, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Please note that adulterated and/or 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 labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you believe that your products are not 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 http://www.fda.gov.
Please note your reference number, RW1901218, 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.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products
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