FDA WARNING_LETTER - Flu & Cold Defense LLC

On January 24, 2013, the FDA and FTC issued a Warning Letter to Flu and Cold Defense LLC, specifically addressing the marketing of their product, GermBullet, on www.germbullet.com and www.nsaroma.com.

The agencies determined that GermBullet is an unapproved new drug under sections 201(g)(1) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1) and § 321(p). This classification is based on website claims indicating the product's intent to prevent, treat, or cure disease conditions or affect body structure/function, such as "reduce illness-causing bacteria, cold and flu viruses and fungi" and "effectively combating germs, so that you remain healthy." The product is not generally recognized as safe and effective for its labeled uses.

Consequently, the sale of GermBullet without an FDA-approved application violates sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a). Furthermore, the product is misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1