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  1. Warning Letters

WARNING LETTER

Domestic Tobacco Co. MARCS-CMS 510911 —

Recipient:
Domestic Tobacco Co.

United States

Issuing Office:
Center for Tobacco Products

United States

 

  

Black HHS-Blue FDA Logo

 

 

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

 

WARNING LETTER
 
January 19, 2017
 
Lois B. Ranck
President
Domestic Tobacco Company, Inc.
830 N Prince St.
Lancaster, PA 17603
 
Dear Ms. Ranck:
 
The Center for Tobacco Products (CTP) of the U.S. Food and Drug Administration (FDA) has reviewed your submissions to the FDA and our inspection records, and determined that Domestic Tobacco Company, Inc. manufactures and distributes smokeless tobacco products for commercial distribution 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), your smokeless tobacco products are tobacco products because they are made or derived from tobacco and intended for human consumption. Smokeless tobacco is subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
 
Misbranded Products
 
FDA has determined that all smokeless tobacco products manufactured by Domestic Tobacco Company, Inc. are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because they have been manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 905(b). Specifically, you are required to register your establishment engaged in these activities on or before December 31 of each year pursuant to section 905(b) of the FD&C Act (21 U.S.C. § 387e(b)). You registered your sole manufacturing establishment located at 830 N Prince St. Lancaster, PA 17603-2732 with the FDA on February 4, 2010, but have failed to submit your annual establishment registration since that date.  The introduction into interstate commerce of any tobacco product that is misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)). The failure to register your establishment in accordance with section 905 is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. § 331(p)). You were informed of your obligation to register your manufacturing establishment with the FDA, as well as your failure to do so, by FDA investigators during inspections conducted at your firm in December 2015 and in February 2014. 
 
Additionally, section 905(i) of the FD&C Act (21 U.S.C. § 387e(i)) requires every person who registers under section 905(b) to provide a list of all tobacco products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution and which have not been included in any list of tobacco products filed by that person before such time of registration. Our records indicate that you filed a product list on March 26, 2014. FDA has not received an updated product listing since that date. Section 905(i)(3) of the FD&C Act requires every registrant to provide a biannual report of any change in product list, during the month of June of each year and during the month of December of each year. The biannual report must report any product that was not previously included in a prior list, any product which the manufacturer has discontinued manufacturing, any product previously reported as discontinued that is has now resumed manufacturing, and any material changes to a previously submitted product listing.
 
FDA has determined that all smokeless tobacco products manufactured by Domestic Tobacco are also misbranded under section 903(a)(10)(A) of the FD&C Act (21 U.S.C. § 387c(a)(10)(A)) because you have not provided the Center for Tobacco Products with Harmful and Potentially Harmful Components (HPHC) reports as required under section 904(a)(3) of the FD&C Act (21 U.S.C. § 387d (a)(3)). Under section 904(a)(3) of the FD&C Act, “each tobacco product manufacturer or importer, or agents thereof ” must report quantities of harmful and potentially harmful constituents (HPHCs) for tobacco products by brand and sub-brand. The introduction into interstate commerce of any tobacco product that is misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)). In addition, the failure to provide any information required by section 904 is a prohibited act under section 301(q)(1)(B) of the FD&C Act (21 U.S.C. § 331(q)(1)(B)).  Further, under section 903(a)(10)(A) of the FD&C Act, a tobacco product is deemed misbranded if there was any failure or refusal to comply with any requirement prescribed under section 904.  FDA investigators informed you of your obligation to submit your required HPHC reports to the FDA, as well as your failure to do so, during consecutive inspections of your firm conducted in December 2015 and February 2014. As of the date of this letter, you have not submitted your required HPHC reports to FDA.
 
FDA has also determined that all smokeless tobacco products manufactured by Domestic Tobacco are misbranded under section 903(a)(10)(A) of the FD&C Act (21 U.S.C. § 387d(a)(1) because you failed to comply with requirements prescribed under section 904 of the FD&C Act. Under section 904(a)(1) “each tobacco product manufacturer or importer, or agents thereof ” must provide “a listing of ingredients, including tobacco, substances, compounds, and additives that are, as of such date, added by the manufacturer to the tobacco, paper filter, or other part of each tobacco product by brand and by quantity in each brand and sub-brand.”   The failure to provide any information required by section 904 is a prohibited act under section 301(q)(1)(B) of the FD&C Act (21 U.S.C. § 331(q)(1)(B)).  In addition, under section 903(a)(10)(A) of the FD&C Act, a tobacco product is deemed misbranded if there is any failure or refusal to comply with any requirement prescribed under section 904.  The introduction into interstate commerce of any tobacco product that is misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)). During the June 2012 and February 2014 inspections of your firm, you provided a partial listing of ingredients in hard copy to the investigators. However, the lists provided by your firm did not contain required information, as described in section 904(a)(1). The FDA investigators informed you of your obligation to submit the required ingredient listings to the FDA, as well as your failure to do so, during consecutive inspections of your firm conducted in December 2015 and February 2014. As of the date of this letter, you have not submitted your required ingredient listings to FDA.
 
Additional Observations
 
In addition, we note that you are also required to comply with section 920(a) of the FD&C Act (21 U.S.C. § 387t(a)). Section 920(a) requires that the label, packaging, and shipping containers for tobacco products other than cigarettes for introduction or delivery for introduction into interstate commerce in the United States bear the statement, “Sale only allowed in the United States.” Failure to comply with section 920(a) of the FD&C Act (21 U.S.C. §387t(a)) renders a product misbranded under section 903(a)(2)(D) of the FD&C Act (21 U.S.C. §387c(a)(2)(D)). The introduction into interstate commerce of any tobacco product that is misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)). Moreover, failure to furnish any notification or other information required by section 920 is a prohibited act under section 301(q)(1)(B) of the FD&C Act (21 U.S.C. 331(q)(1)(B)). FDA investigators informed you of your obligation to correct the information on your shipping containers to include this statement, as well as your failure to do so, during consecutive inspections of your firm conducted in December 2015, February 2014, and June 2012. During the December 2015 inspection, a representative of your firm told an FDA inspector that the firm would comply with the labeling requirements of the FD&C Act.
 
Conclusion and Requested Actions
 
The violations and noted observation discussed in this letter do not necessarily constitute an exhaustive list, and it is your responsibility to ensure that all of your tobacco products comply with the applicable provisions of the FD&C Act and implementing regulations. Failure to ensure full compliance with the FD&C Act and implementing regulations may result in FDA initiating further action without notice, including but not limited to, seizure or injunction.
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. Please identify your response with FEI #3000451788.
 
You should submit your written response and supporting documentation to:
 
DEM-WL Response, Office of Compliance and Enforcement
Food and Drug Administration
Center for Tobacco Products
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 David Keith at (301) 796-2722 or David.Keith@fda.hhs.gov .
 
Sincerely,
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
                                                                                                                       
 
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