Source: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm191067.htm
Timestamp: 2016-08-26 08:36:47
Document Index: 446811527

Matched Legal Cases: ['§ 321', '§ 321', '§ 331', '§ 353', '§ 331', '§ 352', '§ 352']

BUZZ, LLC, 11/16/09 Quick Links: Skip to main page content
BUZZ, LLC, 11/16/09
TO: Buzz net
Net - BUZZ LLC
Fresno, Texas 7754
TO: Buzz LLC
The United States Food and Drug Administration (FDA) has reviewed your website at cheap-phentermine-online.net and has determined that you are offering products for sale in violation of the Federal Food, Drug, and Cosmetic Act (the Act). These products include, but are not limited to, "Acomplia (Brand)," "Acomplia (Generic)," "Rimonabant," "Herbal Ambien," "Herbal Xanax," "Viagra (Brand)," "Phentermine," "Xanax (Brand)," "Valium (Brand)," and "Ambien (Brand)." We request that you immediately cease marketing violative products.
Your firm offers many unapproved new drugs including, but not limited to "Acomplia (Brand)," "Acomplia (Generic)," "Rimonabant," "Herbal Ambien," and "Herbal Xanax." FDA is taking this action against your firm because of the inherent risk in buying unapproved prescription drugs. Unapproved drugs from unregulated sources do not have the same assurance of safety and effectiveness as drugs subject to FDA oversight and have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. For drugs that are regulated by FDA, FDA protections include rigorous scientific standards for prescription drug approval and label review for accuracy and completeness, manufacturing procedures and testing performed under closely controlled conditions at FDA registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states. Unapproved new drugs delivered to the American public from unregulated sources may not be safe and effective.
Rimonabant (also marketed under the name Acomplia) was specifically rejected for FDA approval because it did not meet the statutory requirements for safety and effectiveness. In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts among patients. Accordingly, the "Acomplia (Brand)," Acomplia (Generic)," and "Rimonabant" dispensed through your websites are "new drugs," as defined by section 201(p) of the Act, 21 U.S.C. § 321(p).
You also offer "Herbal Ambien" and "Herbal Xanax" on your website. "Ambien" and "Xanax" are approved drugs well known for their intended use(s) to treat disease. Therefore, including these drug names causes "Herbal Ambien" and "Herbal Xanax" to be subject to regulation as drugs under Section 201(g) of the Act because they are intended for use in the diagnosis, cure, mitigation treatment, or prevention of disease. Moreover, "Herbal Ambien" and "Herbal Xanax" are new drugs as defined by section 201(p) of the Act, 21 U.S.C. § 321(p). Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of several products, including "Acomplia (Brand)," "Acomplia (Generic)," "Rimonabant," "Herbal Ambien," and "Herbal Xanax" without approved applications violates these provisions of the Act.
Your website sell products, including but not limited to, "Viagra (Brand)," "Phentermine," "Xanax (Brand)," "Valium (Brand)," and "Ambien (Brand)" without requiring that the products be dispensed under a prescription from a duly licensed practitioner. Some of the products available on your website are also controlled substances; the sale of these products is particularly concerning because of the potential for abuse and dependency. Therefore, the drugs are misbranded under section 503(b)(1) of the Act, 21 U.S.C. § 353(b)(1), and are marketed in violation of sections 301(a), 301(b), and 301(k) of such Act, 21 U.S.C. §§ 331(a), 331 (b), and 331(k).
Further, your website offers products for sale and states that the products are FDA-approved. As noted above, your products are not FDA-approved and are offered for sale in violation of the Act. Therefore, these products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs is false and misleading.
In addition, you offer "Herbal Ambien" and "Herbal Xanax" for sale. These drugs are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs are false and misleading. The labeling is false and misleading because it erroneously suggests that the products contain Ambien and Xanax, which are the proprietary names for FDA-approved products containing the active pharmaceutical ingredient zolpidem and alprazolam. Regardless of whether your products contain Ambien or Xanax, the products you are offering for sale are not manufactured by the sponsors of the approved applications for products, and it is false and misleading to suggest that your products are manufactured by those sponsors.