• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Deseo Rebajar 3/7/14

  

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

Public Health Service
Food and Drug Administration
 San Juan District
Compliance Branch
466 Fernandez Juncos Ave.
San Juan, PA 00901
Telephone: 787-474-9500
Fax: 787-729-6658 

 

WARNING LETTER
14-SJN-WL-02

March 7, 2014
 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Deseo Rebajar Inc.
Ave. Principal Baralt, G12 Suite 3
Fajardo, PR 00738

Mr. Jose Polanco-Ortiz, President
Deseo Rebajar inc.
P.O. Box 7218
Humacao, PR 00792
 

Dear Mr. Polanco-Ortiz:

This is to advise you that the United States Food and Drug Administration (FDA) reviewed the information on your websites www.deseorebajar.com, www.adipotrim.com, www.facebook.com/Adipotrim.BajardePeso/info, and www.facebook.com/DeseoRebajarhtc in November 2013. FDA's review has concluded that your products, "Adipotrim XT," "Burn 7," "Reductrol Fat Burner Formula," ''Adipocleanse," "Adipocleanse XT," "Lipozene," and "Slim Patch" are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§355(a) and 331(d)] and are misbranded drugs sold in violation of sections 502 and 301(a) of the FDCA [21 U.S.C. §§ 352 and 331(a)] as described below. 

Products Marketed as Dietary Supplements with Undeclared Active Pharmaceutical Ingredients

FDA laboratory analyses of your products, Adipotrim XT, Bum 7, and Reductrol Fat Burner Formula, revealed the presence of undeclared active pharmaceutical ingredients as delineated in the table below.
 

 Your ProductUndeclared Pharmaceutical Ingredient(s)
 Adipotrim XTfluoxetine
 Burn 7sibutramine ad phenolphthalein
 Reductrol Fat Burner Formulaacetaminophen and phenolphthalein 

 

Due to the presence of these aforementioned ingredients, Adipotrim XT and Reductrol Fat Burner Formula cannot be dietary supplements under section 201(ff)(3)(B) [21 U.S.C. § 321 (ff)(3)(B)] of the FDCA. Under section 201(ff)(3)(B)(i) [21 U.S.C. § 321(ff)(3)(B)(i)], a dietary supplement cannot contain an article that is approved as a new drug under section 505 of the FDCA unless that article was marketed as a dietary supplement or food prior to FDA approval of the article in a new drug. Fluoxetine is the active pharmaceutical ingredient in the FDA approved drug, Prozac, a drug for the treatment of depression and other mood disorders. Acetaminophen is an active ingredient in several FDA-drugs approved drugs for pain. FDA approved Prozac in December 1987 and approved the first acetaminophen containing product in April 1950. Therefore, Adipotrim XT and Reductrol Fat Burner Formula are excluded from the definition of a dietary supplement.

In addition, Burn 7 cannot be a dietary supplement because, under section 201(ff)(3)(B)(ii) of the FDCA [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 the article's authorization as a new drug. Sibutramine is the active pharmaceutical ingredient in Meridia, a prescription drug previously approved for 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. 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, your product Burn 7 is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the FDCA.

Your products, Adipotrim XT, Burn 7, and Reductrol Fat Burner Formula, are drugs as defined by section 201(g)(1) of the FDCA [21 U.S.C. § 321(g)(1)], because they are intended to cure, mitigate, treat, or prevent disease conditions and/or 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]. Labeling statements documenting the intended use of your above listed products inclUde, but are not limited to, the following:  

Adipotrim XT

• "El major product para la perdida de peso. Saca la tetencion de liquid, calma la ansiedad y el apetito y transforma grasa en energia sin necesidad de crear ansiedad."

(English translation: The best product to lose weight. Eliminates liquid retention, calms anxiety and appetite, transforms fat in energy without creating anxiety.)

Burn 7

• "Function: Lose weight ... "

Reductrol Fat Burner Formula

• ''Fat Burner Formula"

Your products are also "new drugs'' as defined by section 201(p) of the FDCA [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for the above referenced uses nor are your products marketed in conformity with any over-the-counter (OTC) Drug Monograph. Under section 505 of the FDCA [21 U.S.C. § 355], a new drug may not be legally marketed in the United States without an FDA approved application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. There are no FDA approved applications in effect for your "new drugs." Thus, the marketing and distribution of these products for their intended uses violate this provision of the FDCA. The introduction of an unapproved new drug into interstate commerce is a violation of section 301(d) of the FDCA [21 U.S.C. § 331(d)].

Your products, Adipotrim XT, Burn 7, and Reductrol Fat Burner Formula, are also misbranded drugs under section 502 of the FDCA [21 U.S.C. § 352] and in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. Adipotrim XT, Burn 7, and Reductrol Fat Burner Formula are misbranded under section 502(a) of the FDCA [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 FDCA [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 ...." The failure to disclose the presence of fluoxetine in Adipotrim XT, sibutramine and phenolphthalein in Burn 7, and acetaminophen and phenolphthalein in Reductrol Fat Burner Formula renders these products misbranded under section 502(a) of the FDCA [21 U.S.C. § 352(a)].

The undeclared drug ingredients in your Adipotrim XT, Burn 7, and Reductrol Fat Burner Formula also cause these products to be misbranded under section 502(f)(2) of the FDCA [21 U.S.C. § 352(f)(2)] because their labeling lack adequate warnings for the protection of users. Consumers who use Adipotrim XT, Burn 7, or Reductrol Fat Burner Formula would be unaware of the presence of the undeclared drug ingredients and placed at risk for their associated adverse events.

As discussed above, Burn 7 contains the undeclared ingredient, sibutramine. Sibutramine may pose serious health risks to consumers, including increased risk of heart attack and stroke, and these risks are compounded by the fact that sibutramine is not declared on the label. Therefore, Burn 7 is misbranded under section 502(j) of the FDCA [21 U.S.C. § 352(j)] because it is dangerous to health when used in the dosage or manner recommended in their labeling.

The introduction of your misbranded drugs, Adipotrim XT, Bum 7, and Reductrol Fat Burner Formula, into interstate commerce violates section 301(a) of the FDCA [21 U.S.C. § 331(a)].

Other Unapproved New Drugs and Misbranded Drugs

In addition, Adipocleanse, Adipocleanse XT, Lipozene 1500 mg, and Slim Patch are drugs as defined by section 201(g)(1) of the FDCA [21 U.S.C. § 321(g)(1)] because they are intended to cure, mitigate, treat, or prevent disease conditions. As previously stated, 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]. Labeling statements documenting the intended use of your above listed products include, but are not limited to, the following:

Adipocleanse

• "Algunos de los beneficios para la salud asociados son los siguiente ... baja el colesterol ... fortalece el sistema inmunol6gico ... "

(English translation: Some of the associated health benefits are the following ... lowers cholesterol ... strengthens the immune system ... )

Adipocleanse XT

• "[D]isminuir los niveles de trigliceridos."

(English translation: Reduce/decrease triglyceride levels.)

Lipozene 1500 mg

• "[E]s natural y contiene la super fibra glucornanano ... Esta fibra solouble se ha utilizado para tartar el estrefiimiento, la obesidad, el cholesterol alto y la diabetes tipo 2 durante siglos."

(English translation: Is natural and it contains the super fiber glucomanano. This soluble fiber has been used to treat constipation, obesity, high cholesterol, and type 2 diabetes for centuries.)

Slim Patch 1

• "[P]enetran en el area provista para contraer y expulsar todo la grasa retenida en sitios especiticos del cuerpo . . . [b]loquear los carbohidratos y elimina la ansiedad de estar comiendo golosinas durante el dia."

(English translation: Penetrates the area provided to contract and expel all the retained fat in the specific body sites ... Block carbohydrates and eliminates the anxiety of eating sweets during the day.)

These products are also "new drugs'' as defined by section 201(p) of the FDCA [21 U.S.C. § 321(p)] because they ate not generally recognized as safe and effective for the above referenced uses nor are your products marketed in conformity with any over-the-counter (OTC) Drug Monograph. Under section 505 of the FDCA [21 U.S.C. § 355], a new drug may not be. legally marketed in tbe United States without an FDA approved application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonsttate that the drug is safe and effective. There are no FDA approved applications in effect for your "new drugs." Thus, the marketing and distribution of these products for their intended uses violate this provision of the FDCA. The introduction of an unapproved new drug into interstate commerce is a violation of section 301(d) of the FDCA (21 U.S.C. § 331(d)].

Because Adipocleanse, Adipocleanse XT, Lipozene 1500 mg, and Slim Patch are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the products safely for their intended uses. Thus, your products' labeling fail to bear adequate directions for their intended uses, causing them to be misbranded under section 504(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)]. The introduction of your misbranded drugs, Adipocleanse, Adipocleanse XT, Lipozene 1500mg, and Slim Patch into interstate commerce violates section 301(a) of the FDCA [21 U.S.C. § 331(a)].

Under tbe FDCA, as amended by the Dietary Supplement Health and Education Act, dietary supplements may be legally marketed with truthful and non-misleading claims to affect the structure or function of the body (i.e., structure/function claims) if certain requirements are met. However, with the exception of certain health claims specifically and expressly authorized by FDA, any claims that dietary supplement products are intended to prevent, diagnose, mitigate, treat, or cure disease (disease claims) cause such products to be drugs rather than dietary supplements. 2

This letter is not intended to be an all-inclusive review of your website nor is it an all-inclusive list of the violations caused by the products your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the FDCA and its implementing regulations.

We acknowledge that your firm is cooperating with FDA by conducting a voluntary recall of your Adipotrim XT product. 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 FDCA 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. 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 Ms. Maridalia Torres, District Director, at 466 Fetnartdez Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Ms. Margarita Santiago, Compliance Officer, at (787) 474-9538 or via email at margarita.santiago@fda.hhs.gov.
 

Sincerely,

/S/
Maridalia Torres
District Director
San Juan District

__________________________________________________________

1 Only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements under section 201(ff) of the FDCA [21 U.S.C. § 321(ff)].

2 For more information regarding the difference between structure/function claims and disease claims, see FDA's final rule at http://www.gpo.gov/fdsys/pkg/FR-2000-01-06/html/00-53.htm (codified at Title; 21 of the Code of Federal Regulations (21 C.F.R.) § 101.93(g)). Also see 21 C.F.R., Parts 310 and 330-358, which contain FDA's regulations on over-the-counter drugs, for information regarding certain over-the-counter drugs that are not new drugs and may be legally marketed without prior approval from FDA.