Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/yellowstone-tobacco-co-llc-07152014
Timestamp: 2020-08-09 23:19:41
Document Index: 336116406

Matched Legal Cases: ['§ 321', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387']

Yellowstone Tobacco Co, LLC. - 07/15/2014 | FDA
Yellowstone Tobacco Co, LLC. - 07/15/2014
Yellowstone Tobacco Co, LLC. July 15, 2014
507 N Ash St.
paperspro@gmail.com
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your websites, http://www.loosetobacco.com and http://www.rollingpapers.com, and determined that your cigarette tobacco and/or roll-your-own tobacco products listed there are offered for sale to customers in the United States. FDA believes these websites are affiliated with one another because both websites display the same physical address, which is directly linked to Yellowstone Tobacco Co., LLC. 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, includingcigarette tobacco and roll-your-own tobacco, 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 websites, http://www.loosetobacco.com and http://www.rollingpapers.com, offer for sale cigarette tobacco and/or roll-your-own tobacco. Section 900(4) of the FD&C Act (21 U.S.C. § 387(4)) defines “cigarette tobacco” as “any product that consists of loose tobacco that is intended for use by consumers in a cigarette.” Section 900(15) of the FD&C Act (21 U.S.C. § 387(15)) defines “roll-your-own tobacco” as “any tobacco product which, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes.”
We note that on your websites, http://www.loosetobacco.com and http://www.rollingpapers.com, you present loose tobacco products containing the package description “pipe tobacco” but that are promoted and offered for sale as cigarette tobacco and/or roll-your-own tobacco, including: Buoy, Criss Cross, and Golden Harvest brand products. The overall presentation of these products on your websites strongly suggests that they are intended for use in a cigarette, likely to be offered to consumers for making cigarettes, and/or likely to be purchased by consumers for making cigarettes. Specifically, you describe these products as “dual purpose,” “Roll Your Own,” “Make Your Own,” or “can be rolled up, injected into a filtered tube.” Therefore, your products meet the definition of “cigarette tobacco” and/or “roll-your-own tobacco” in the FD&C Act.
FDA has determined that several of your 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. Additionally, FDA has determined that several of your cigarette tobacco and/or roll-your-own tobacco products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) or misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because they purport to contain a natural or artificial characterizing flavor. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
You sell or distribute cigarette tobacco and/or roll-your-own tobacco products that you describe on your websites, http://www.loosetobacco.com and http://www.rollingpapers.com, as being “mild” or “light” by referring to them as such in product labeling or advertising and adding the qualifiers “mild,” “ultra light,” or “lightest” to the product names or descriptions. Specifically, our review of your websites revealed that you sell or distribute product Buoy Silver (described as “the lightest of the 3 buoys”, “the most mild”, and “an ultra light”).
A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” or “low,” or a similar descriptor, is a “modified risk tobacco product” under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(ii)). 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)). Because your websites use the descriptors “mild,” “ultra light,” “lightest,” or similar descriptors for the above listed products, 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)).
Additionally,our review of your website, http://www.loosetobacco.com, revealed that you offer for sale the following cigarette tobacco and/or roll-your-own tobacco products: Criss Cross Black Cherry, Criss Cross Mint, and Golden Harvest Mint Blend, which are purported to contain an artificial or natural flavor that is a characterizing flavor of the products. Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) provides:
If, however, these cigarette tobacco and/or RYO tobacco products do not contain a characterizing flavor, they are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) as their labeling or advertising is false or misleading because it makes the representation that the products contain, for example, black cherry or mintas a characterizing flavor of the tobacco products.
It is your responsibility to ensure that your tobacco products and all related promotional materials on these websites, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in retail establishment(s) 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 misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.
Please note your reference number, RW1400171, in your response and direct your response to the following address:
Silver Spring, MD 20993-000
1908 E Seltice Way
panphrack@aol.com
rollingpapers.com@domainsbyproxy.com
Yellowstone Tobacco Co, LLC. - Close Out Letter 10/23/15