Inspections, Compliance, Enforcement, and Criminal Investigations

MyNicNaxs, Inc. 2/20/15

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
                Fax: 407-475-4770 

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-15-18
February 20, 2015
 
MyNicNaxs, Inc.
Attn: Chevonne Torres
1012 Alpine Dr
Deltona, FL 32725-7204
 
 
Dear Ms. Torres:
 
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.
 
Related Compliance History
 
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[1] and phenolphthalein[2]. 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.
 

Product
Undeclared pharmaceutical ingredient 
Reduce Weight Fruta Planta
Phenolphthalein
JIANFEIJINDAN
N-di-desmethylsibutramine
FRUTA Bio
Sibutramine and Phenolphthalein
Super Fat Burning Bomb
N-desmethylsibutramine and Phenolphthalein
Japan Hokkaido
Phenolphthalein
SlimEasy Herbs
Sibutramine and N-desmethylsibutramine
Meizi Evolution
Sibutramine, N-desmethylsibutramine, and Benzylsibutramine
Slim Xtreme
Sibutramine, N-desmethylsibutramine, and Benzylsibutramine
Magic Slim
Sibutramine, N-desmethylsibutramine, and Benzylsibutramine
Meizitang Strong Version
Sibutramine, N-desmethylsibutramine, and Benzylsibutramine

 
 
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.
 
Unapproved New Drugs
 
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 drugs as defined by section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. The intended use of a product may be determined by, among other things, its labeling claims, advertising, and circumstances surrounding its distribution. [See 21 C.F.R. §201.128]. For example, labeling statements that document the intended uses of your Reduce Weight Fruta Planta include, but are not limited to, the following:
 
  • “People worldwide are losing up to 15 lbs a month using this supplement”
  • “Effective and Safe Reduce Weight”
  • “[S]uitable for . . . normal obesity, adolescent obesity, post-natal obesity. . .”
  • “Can reduce your food intake by at least 60 to 80%”
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.
 
Misbranded Drugs
 
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.[3] 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.
 
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action by FDA without further notice. The FD&C Act authorizes the seizure of illegal products and injunctions against the manufacturers and/or distributors of those products [21 U.S.C. §§ 332 and 334].
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct all of the violations described above. Include in your response documentation to show that correction has been achieved. Additionally, if another or additional firm manufactures the products identified above, your reply should include the name and address of the manufacturer. If you cannot complete all corrections before you respond, state the reason for the delay and the time within which you will complete the corrections.
 
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 .
 
 
Sincerely,
/S/
Susan M. Turcovski
Director, Florida District
 
 
_______________________________________

[1] Sibutramine is the active pharmaceutical ingredient in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the U.S. market on December 21, 2010, after clinical data indicated sibutramine poses an increased risk of heart attack and stroke. 
 
[2] 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.
 
[3]A full list of all tainted products discovered by FDA can be found at:  http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder

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