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WARNING LETTER

Woodland Sedgwick LLC 30/12/2015

Woodland Sedgwick LLC - 12/30/2015


Delivery Method:
UPS and Electronic Mail

Recipient:
Woodland Sedgwick LLC

46 West Germantown Pike

East Norristown, PA 19401
United States

Issuing Office:
Center for Tobacco Products

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Food and Drug Administration
 
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

DEC 30, 2015

VIA UPS and Electronic Mail
 
 
Black Cat Cigar Company
Attn: Michael Driban
46 West Germantown Pike
East Norristown, Pennsylvania 19401
 
 
WARNING LETTER
 
Dear Mr. Driban:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.blackcatcigars.com and determined that the cigarette tobacco and/or roll-your-own tobacco 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 (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 cigarette tobacco and roll-your-own tobacco, are subject to Chapter IX of the FD&C Act under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
 
FDA has determined that the website, http://www.blackcatcigars.com, offers for sale or distributes cigarette tobacco and/or roll-your-own tobacco products. 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 the website, you present a loose tobacco product that is offered for sale or distributed as cigarette tobacco and/or roll-your-own tobacco, specifically Black Cat Premium – Danish Blend, with a product description stating that “THIS TOBACCO IS PRIMARILY MEANT TO BE USED FOR RYO.” The overall presentation of this product on the website strongly suggests that it is intended for use in a cigarette and/or likely to be purchased by consumers for making cigarettes. Therefore, the product meets the definition of “cigarette tobacco” and/or “roll-your-own tobacco” in the FD&C Act.
 
FDA has determined that Black Cat Premium - Danish Blend cigarette tobacco and/or roll-your-own tobacco is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because it is amodified risk tobacco product 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, http://www.blackcatcigars.com, revealed that you sell or distribute the following cigarette tobacco and/or roll-your-own tobacco product, which is listed or described as being mild or using similar descriptors: Black Cat Premium – Danish Blend (described as “mild”).
 
A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” “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)). 
 
The above listed product is a modified risk tobacco product because the website uses the descriptor “mild” or similar descriptors to describe this product. Because this product is 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)), this product is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
 
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 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 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. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
 
Please note your reference number, RW1500436, 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 Electronic Mail
 
cc:
 
Woodland Sedgwick LLC / Capricorn Tobacco Inc.
114 Woodland Road
Wyncote, PA 19095
 
Corporation Guarantee & Trust Co
3331 Street Road, Ste. 110
Two Greenwood Square
Bensalem, PA 19020
 
Bobby Holstein
Black Cat Cigar Company
bobby@fujipub.com
hostmaster@fujipub.com

 
 
Shopify, Inc.
abuse@shopify.com

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