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U.S. Department of Health and Human Services

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Enforcement Actions

Globe All Wellness, LLC 2/6/12

  

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

Public Health Service
Food and Drug Administration
 

555 Winderley Place, Ste. 200
Maitland, Florida 32751
Telephone: (407) 475-4700
FAX: (407) 475-4769

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
WARNING LETTER
 
FLA-12-22
 
February 6, 2012
Eran Hamami, President/Owner
Globe All Wellness, LLC
2854 Stirling Road, Suite G
Hollywood, FL 33020
 
Dear Mr. Hamami:
 
The United States Food and Drug Administration (FDA) conducted an inspection at your own label distribution firm located at 2854 Stirling Road, Suite G, Hollywood, FL, from May 18 through July 8, 2011. We have also reviewed your websites at www.viaxtreme.com and www.diet66.com. The products that are the subject of this letter refer to those sampled at or around the time of the inspection.
 
FDA has determined that SlimXtreme™ Herbal Slimming Capsule (SlimXtreme) and ViaXtreme™ Ultimate Sexual Enhancer Dietary Supplement for Men (ViaXtreme) are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 355(a)] and misbranded drugs in violation of section 502 and 503 of the Act [21 U.S.C. §§ 352 and 353] as detailed below.
 
Products Marketed as Dietary Supplements with Undeclared Pharmaceutical Ingredients
 
FDA confirmed through laboratory analysis that SlimXtreme (Lot SX 30 MFD 10.25.2010 EXP: 10.24.2012) contained undeclared sibutramine hydrochloride (sibutramine). 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in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the United States market on December 21, 2010, after clinical data indicated sibutramine poses an increased risk of heart attack and stroke. 
 
You market SlimXtreme as a dietary supplement. However, under section 201(ff)(3)(B)(ii) of the 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 its authorization 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 became public. Given that sibutramine was not marketed as a dietary supplement or as a food before Meridia was authorized for investigation as a new drug, SlimXtreme, which contains sibutramine, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)].
 
In addition, FDA laboratory analysis confirmed that your ViaXtreme product (Lot A032111 3/13 and Lot 809013 09/12) contained undeclared sildenafil, the active pharmaceutical ingredient in Viagra, an FDA-approved drug used to treat erectile dysfunction (ED). According to section 201(ff)(3)(B) [21 U.S.C. § 321(ff)(3)(B)], dietary supplements cannot contain an article that is approved as a new drug under section 505 of the Act unless that article was marketed as a dietary supplement or food prior to FDA approval of such drug. FDA approved Viagra as a new drug on March 27, 1998, and sildenafil was not marketed as a dietary supplement or as a food before this date.  As such, ViaXtreme is not considered a dietary supplement. These lots of your ViaXtreme product also contained sulfoaildenafil, aildenafil, and thiosildenafil, all of which are phosphodiesterase type-5 (PDE-5) inhibitors and analogues of sildenafil, and none of which were declared on the product label for ViaXtreme.
 
Unapproved and Misbranded Prescription Drugs
 
Both SlimXtreme and ViaXtreme are intended to affect the structure or function of the body and, thus, are drugs as defined by section 201(g)(1)(B) of the Act, [21 U.S.C. § 321(g)(1)(B)].[1] 
 
Labeling statements for SlimXtreme and ViaXtreme documenting these intended uses include, but are not limited to, the following:
 
SlimXtreme
 
  • “What is SlimXtreme? SlimXtreme is a proprietary blend of all-natural herbs specially formulated to help you lose up to 20 pounds in one month! Scientifically proven to help you lose weight fast, burn calories, improve metabolism, significantly restrain appetite, and strongly increase your energy.”
  • “What does SlimXtreme actually contain? SlimXtreme is a proprietary blend of herbs formulated to not only make you lose weight, but also to suppress your appetite. Prepared exclusively from all-natural herbs, SlimXtreme’s formula has been used for centuries effectively for the purpose of slimming and beauty.”
 
Under the Testimonials section of your website, www.Diet66.com, statements include:
 
  • “I just wanted to say thank you for the great product SlimXtreme, which made me lose 22 pounds in just one month.”
  • “And I was more surprised after two weeks taking SlimXtreme I lost 9 pounds.”
 
ViaXtreme
 
  • “What is ViaXtremeTM? ViaXtreme is a proprietary blend of all-natural ingredients designed to deliver peak sexual experience. ViaXtreme will improve your sexual performance through increased penis size, longer, powerful erections and increased libido.”
  • “ViaXtreme increases blood flow to the male genital areas that promote arousal and desire.”
 
Moreover, SlimXtreme and ViaXtreme are new drugs under section 201(p) of the 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 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. The distribution or sale of SlimXtreme or ViaXtreme without approved applications violates these provisions of the Act.
 
SlimXtreme and ViaXtreme are prescription drugs as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], because, in light of their toxicity or potentiality for harmful effect, the method of their use, or the collateral measures necessary for their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer it. SlimXtreme, which contains undeclared sibutramine, is a prescription drug because 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. It is also a prescription drug because the FDA approval of Meridia was withdrawn because of serious safety risks. ViaXtreme is a prescription drug because it contains several PDE-5 inhibitors; all PDE-5 inhibitors which have been approved for marketing by FDA are limited by an approved new drug application to use under the supervision of a practitioner licensed by law to administer them. 
 
According to section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s). “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]. Prescription drugs can only be used safely at the direction, and under the supervision, of a licensed practitioner. Therefore, it is impossible to write “adequate directions for use” for prescription drugs. FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson [21 C.F.R. §§ 201.100(c)(2) and 201.115]. Because there is no FDA-approved application for your firm’s SlimXtreme and ViaXtreme, their labeling fails to bear adequate directions for their intended use, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. 
 
Under section 502(a) of the Act [21 U.S.C. § 352(a)], a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the Act [21 U.S.C. § 321(n)], provides that, in 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 . . . .” Your products, SlimXtreme and ViaXtreme are misbranded under section 502(a) of the Act because their labeling makes false and misleading statements regarding safety and fails to reveal material facts with respect to consequences that may result from the use of these products.  Sibutramine, contained in your SlimXtreme product; and sildenafil, sulfoaildenafil, aildenafil, or thiosildenafil, contained in your ViaXtreme product may pose serious health risks to consumers, which are only compounded by the fact that these ingredients are not declared on the respective product labels.
 
ViaXtreme and SlimXtreme are also misbranded under section 502(f)(2) of the Act [21 U.S.C. § 352(f)(2)] in that the products’ labeling lacks adequate warnings for the protection of users.  As noted, there is potential for adverse events associated with these products, particularly since someone who takes them would be unaware of the presence of sibutramine in your SlimXtreme product; or sildenafil, sulfoaildenafil, aildenafil, or thiosildenafil in your ViaXtreme product.  
 
Additionally, your SlimXtreme product is misbranded under section 502(j) of the Act [21 U.S.C. § 352(j)] because it is dangerous to health when used in the dosage or manner recommended in its labeling. As previously noted, sibutramine may pose serious health risks to consumers, including adverse health consequences such as heart attack, stroke, increased blood pressure, hallucinations, coma, and tachycardia for individuals with existing medical conditions.
 
Accordingly, the introduction or delivery for introduction into interstate commerce of the misbranded products SlimXtreme and ViaXtreme violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist FDA may reinspect your facility to verify that corrective actions have been completed. at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. Furthermore, it is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including seizure, injunction, and/or prosecution. Furthermore,
 
FDA acknowledges that you initiated a voluntary nationwide recall of all lots of SlimXtreme (30-count bottles) on May 24, 2011. We also recognize that, on June 6, 2011, you initiated a voluntary recall of ViaXtreme (6-count bottles), Lots #806030 and 809013, which you later expanded to include Lot #A032111 on or about July 5, 2011. 
 
Within fifteen (15) working days of receiving this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, the current status of the SlimXtreme and ViaXtreme recalls, and the current disposition of these violative products, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you no longer market these products, please indicate this in your response, including the reasons and the date on which you ceased to market them.
 
Please send your response to the attention of Matthew B. Thomaston, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issue in this letter, you may contact Mr. Thomaston via telephone at (407) 475-4728 or via email at Matthew.Thomaston@FDA.HHS.GOV.
 
Sincerely,
/S/
Emma R. Singleton
Director, Florida District
 


[1]As noted, in addition to sildenafil, ViaXtreme also contains sulfoaildenafil, thiosildenafil, and/or aildenafil, all of which are phosphodiesterase type-5 (PDE-5) inhibitors and analogues of sildenafil. Under section 201(g)(1) of the Act (last sentence), the structure/function claims made for a dietary supplement must be made in accordance with section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)] or the product is subject to regulation as a drug.  Section 403(r)(6) authorizes claims that describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body, or that characterize the way in which a nutrient or dietary ingredient maintains the structure or function of the body. However, the structure/function claims quoted above for ViaXtreme do not describe the effects of nutrients or dietary ingredients in the products.  Rather, the claims are made for each of the products as a whole and relate to their sildenafil, sulfoaildenafil, thiosildenafil, and/or aildenafil content.  Since sildenafil, sulfoaildenafil, thiosildenafil, or aildenafil, are not nutrients or dietary ingredients as defined in section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)], but instead are active pharmaceutical ingredients or analogues of active pharmaceutical ingredients, the claims about improvement of sexual function do not conform to section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)]. Therefore, ViaXtreme is also a drug within the meaning of section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)].