Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm436724.htm
Timestamp: 2019-04-23 10:45:48+00:00

Document:
You are receiving this letter because you continue to distribute unapproved new drugs and misbranded drugs in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The products that you sell containing undeclared active pharmaceutical ingredients are unapproved new drugs distributed in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 355(a) and 331(d)] and are misbranded drugs sold in violation of sections 502 and 301(a) of the FD&C Act [21 U.S.C. §§ 352 and 331(a)] as detailed below.
In July 2013 you were notified that the United States Customs and Border Patrol detained a package addressed to you containing the unapproved new drug, Reduce Weight Fruta Planta. Sample of your Reduce Weight Fruta Planta were, subsequently, confirmed through laboratory analyses to contain sibutramine.
In November 2013, FDA sampled your products Fruta Planta and Fat Loss Slimming Beauty and confirmed the presence undeclared sibutramine and phenolphthalein. Likewise, laboratory analyses of the ten products collected during an FDA inspection your distribution facility in November 2013 also confirmed the presence of undeclared sibutramine, analogues of sibutramine, and/or phenolphthalein (see Table 1 below).
Table 1. Results of laboratory analyses of product samples collected during FDA’s November 2013 establishment inspection of MyNicNaxs, LLC.
In February 2014, you agreed to voluntarily recall the above-listed unapproved new drugs. However, in July 2014 and again in August 2014, U.S. Customs and Border Patrol refused import entry of packages addressed to you containing unapproved new drugs including the product Reduce Weight Fruta Planta, which was analyzed and confirmed once again to contain sibutramine. Moreover, as of the date of this letter, you continue to distribute Reduce Weight Fruta Planta through your website as well as numerous other products that FDA has publicly announced were confirmed by laboratory analysis to contain undeclared active pharmaceutical ingredients.
You market Reduce Weight Fruta Planta and numerous other products as dietary supplements. However, under section 201(ff)(3)(B)(ii) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)(ii)], a dietary supplement may not include an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public unless the article was marketed as a dietary supplement or food before it was authorized for investigation as a new drug.
The investigational new drug (IND) application for Meridia (sibutramine) was received by FDA on December 24, 1985, and sibutramine became authorized for investigation as a new drug under an IND on January 23, 1986. When Meridia was approved for marketing as a new drug in the United States, the existence of substantial completed clinical investigations of sibutramine were public. Based on the information available to FDA, sibutramine was not marketed as a dietary supplement or as a food until after it was authorized for investigation as a new drug. Therefore, Reduce Weight Fruta Planta, as well as any other product you sell that contains sibutramine, is excluded from the definition of a dietary supplement 201(ff)(3)(B)(ii) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)(ii)].
Your sibutramine-containing weight loss products are also “new drugs” under section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because these products are not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301(d) and 505(a) of the FD&C 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. There are no FDA- approved applications in effect for your before-mentioned new drugs. The distribution or sale of Reduce Weight Fruta Planta or your other sibutramine-containing weight loss products violate theses provision of the FD&C Act.
Reduce Weight Fruta Planta and your other sibutramine-containing weight loss products are misbranded drugs under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] because their labeling fail to bear adequate directions for their intended uses. "Adequate directions for use" means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 C.F.R. § 201.5]. It is impossible to write adequate directions for use for your products for at least two reasons: 1) prior to withdrawal of Meridia's approval, FDA approval of sibutramine was limited to use under the professional supervision of a practitioner licensed by law to administer such drugs and 2) FDA approval of Meridia was withdrawn because of serious safety risks. As such, the labeling of your before-listed unapproved new drugs fail to bear adequate directions for their intended uses. Your products are not exempt from the requirement that their labeling bear adequate directions for use under 21 C.F.R. § 201.100(c)(2) and 201.115 because no FDA-approved applications are in effect for your before-listed products.
Reduce Weight Fruta Planta and your other sibutramine-containing weight loss products are also misbranded drugs under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], which states that a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act [21 U.S.C. § 321(n)], provides that, “[I]n determining whether an article's labeling or advertising is misleading, there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations . . . " The labeling of your unapproved new drugs include false and misleading statements regarding safety and fail to disclose the presence of sibutramine and other material facts such as health-related consequences that may result from the use of these products. Sibutramine may pose serious health risks to consumers which are only compounded by the fact that sibutramine is not declared on the label.
Although this letter specifically addresses examples of unapproved new and misbranded drugs that contain undeclared sibutramine, FDA notes that you also sell numerous other products that have previously been confirmed to contain other undeclared active pharmaceutical ingredients. It is your responsibility under the FD&C Act to ensure that products marketed by your firm do not contain undeclared ingredients and comply with all requirements of the FD&C Act and its implementing regulations.
The violations cited in this letter are not meant to be an all-inclusive list of violations in your products and their labeling. Again, it is your responsibility to ensure that products marketed by your firm comply with the FD&C Act and its implementing regulations. We advise you to review your website, product inventory, product labels and other labeling as well as promotional materials for your products to ensure that the claims you make for your products or the presence of undeclared active pharmaceutical ingredients do not cause your products to violate the FD&C Act.
Your response should be sent to U.S. Food and Drug Administration, Erica M. Katherine, Compliance Officer at the address noted above. If you have any questions with regard to this letter, the compliance officer can be reached at (407) 475-4731 or email Erica.Katherine@fda.hhs.gov .
 Phenolphthalein is a known carcinogen that was once an ingredient used in over-the-counter laxatives but is no longer approved for marketing in the United States.

References: § 321
 § 321
 § 321
 § 352
 § 201
 § 201
 § 352
 § 321