FDA WARNING_LETTER - Ruyan America, Inc.

The FDA issued a Warning Letter to Ruyan America, Inc. on September 8, 2010, regarding their RUYAN brand electronic smoking products, including e-cigarettes, e-cigars, and e-pipes. The letter also implicated joint venture partner Ruyan Holdings Ltd. and distributor Nathan & James Group LLC.

The FDA determined, based on product labeling and promotional materials from websites like www.ruyanamerica.com, www.getruyanusa.com, and www.ruyan.com.cn, that RUYAN products are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act (sections 505 and 502, respectively). The products are marketed with claims suggesting they affect body structure/function or mitigate/treat/prevent disease, such as aiding in reducing nicotine consumption, satisfying cravings, and providing relief for conditions attributed to tobacco use. The RUYAN RAPP E-Mystick, containing lobelia, was also cited for similar claims.

The FDA considers these products "new drugs" because they are promoted as smoking deterrents or for other drug uses without adequate data establishing their general recognition as safe and effective, as required by 21 CFR § 310.544 and section 201(p) of the Act. No approved applications exist for these products.

Ruyan America, Inc. must take prompt action to correct these violations within fifteen working days