Belcorp of America 6/27/11
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Center for Tobacco Products|
9200 Corporate Boulevard
Rockville, MD 20850-3229
JUN 27, 2011
Roberto R. Ribeiro
Belcorp of America
1759 NW 79th Avenue
Doral, FL 33126
Dear Mr. Ribeiro:
The Food and Drug Administration (FDA) recently reviewed your website http://www.belcorpfactorydirect.com
and determined that the cigarette products listed there are manufactured, promoted, and offered for sale 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, 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 your Galaxy Pro, Derby, Rich, and First One cigarettes are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because you promote them as modified risk tobacco products without an FDA order in effect that permits such promotion. Additionally, FDA has determined that these products are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) because your labeling for these products is false and misleading. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
You describe products that you offer for sale on your website as being light or ultra light by referring to them as such in product advertising and adding the qualifiers “Light” or “Ultra Light” to the product names. Specifically, our review of your website revealed that you offer for sale Galaxy Pro, Derby, Rich, and First One cigarettes with the following qualifiers: “Gold (Formerly Lights),” “Silver (Formerly Ultra Lights),” and “Green (Formerly Menthol Lights).”
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 website uses the descriptor “Light” or similar descriptors for the above-listed products, the products are modified risk tobacco products. Because these products are offered for sale to U.S. customers 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 revealed that your above-listed tobacco products are offered for sale as “FDA approved.” A tobacco product with labeling that is false or misleading in any particular is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)). Offering your tobacco products for sale as “FDA approved” is false and misleading because FDA has not, in fact, approved these products in any regard. Because their labeling is false and misleading, these products are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)).
You should immediately correct the violations stated above and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. We have noticed that your website is inaccessible at this time. If this change is permanent, then it would correct the violations discussed above. The violations discussed in this letter, however, do not necessarily constitute an exhaustive list, and it is your responsibility to ensure that your tobacco products on this website, or any other websites you own, operate, and/or control, comply with the applicable provisions of the FD&C Act. 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 importation 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.
Please direct your response to the following address:
PAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850.
If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products