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U.S. Department of Health and Human Services

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Enforcement Actions

Platinum Strategies, Inc. - 9/23/09

  

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

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139

WARNING LETTER
2009-DET-19


September 23, 2009


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Jamie Miralles
Platinum Strategies Inc,
1500 N, Curry Pike
Bloomington, IN 47404

Dear Mr. Miralles:

This letter concerns your firm's marketing and distribution of the products, "Pineapple Fat Reducing Slimming Capsule," "Tomato Slimming (Lose Weight)," "Slim Up," "Fresh Lemon Slimming (Xian Ning Meng Shou Shen)," "Slim Quick Result 3 in 1," "Perfect Combination Balishou Capsule," "Apple Slim," and "Shoufsy Activity Girl" on your website, www.911healthshoP.com. These products were marketed and distributed in violation of provisions of the Federal Food Drug and Cosmetic Act (the Act) as described below.

Your products "Pineapple Fat Reducing Slimming Capsule," "Tomato Slimming (Lose Weight)," "Slim Up," "Fresh Lemon Slimming (Xian Ning Meng Shou Shen)," "Slim Quick Result 3 in 1," "Perfect Combination Balishou Capsule," "Apple Slim," and "Shoufsy Activity Girl" contain sibutramine, the active pharmaceutical ingredient in FDA-approved obesity drug Meridia, Under section 201 (ff)(3)(B) of the Act, (21 U.S.C. §321(ff)(3)(B)), dietary supplements may not include articles approved as a new drug under section 505 of the Act, unless the article was marketed as a dietary supplement or food before its approval as a drug, FDA approved Meridia as a new drug on November 24, 1997, and sibutramine was not marketed as a dietary supplement or as a food before this date, Therefore, "Pineapple Fat Reducing Slimming Capsule," "Tomato Slimming (Lose Weigh!)," "Slim Up," "Fresh Lemon Slimming (Xian Ning Meng Shou Shen)," "Slim Quick Result 3 in 1," "Perfect Combination Balishou Capsule," "Apple Slim," and "Shoufsy Activity Girl" are not dietary supplements,

Statements on your product label and website describe the intended uses of the aforementioned products, These statements have included, but are not limited to, the following:

Pineapple Fat Reducing Slimming Capsule

• The name of this product suggests that the product is intended to affect the structure or function of the body by reducing fat and slimming.
"This all natural supplement uses the healthy benefits of pineapple to help reduce fat and may help you gain and maintain a healthy weight."

Tomato Slimming (Lose Weight)

• The name of this product suggests that the product is intended to affect the structure or function of the body by slimming.
"The product may help reduce weight through its specially chosen ingredients that work in the intestines to reduce fat absorption."

Slim Up

• The name of this product suggests that the product is intended to affect the structure or function of the body by slimming.
"Constipation"
"Defat [sic]"
"[C]an adjust metabolism of human body, reduce accumulation of subcutaneous fat, eliminates toxic substances from body, and reduces the fatness [sic]."

Fresh Lemon Slimming (Xian Ning Meng Shou Shen)

• The name of this product suggests that the product is intended to affect the structure or function of the body by slimming.
"This all natural supplement may help cleanse your system aiding in weight loss and overall beauty!"

Slim Quick Result 3 in 1

• The name of this product suggests that the product is intended to affect the structure or function of the body by slimming.
"[S]lim 3-in-1 slim formula works in two ways to tackle the problem of fat accumulation effectively: First, it decomposes and blocks the absorption of excess sugar and fat."

Perfect Combination Balishou Capsule

"Enhances the speed of breaking up the fat to offer to the cells to utilize, it will make the assimilated heat turn into energy to consume."

Apple Slim by Apple Slim

• The name of this product suggests that the product is intended to affect the structure or function of the body by slimming.
"It extracts apple cider vinegar from natural green apple which helps slim and beauty [sic] effectively."

Shoufsy Activity Girl

"This product is aimed at the progressiveness water pail waist to reduce the meat and to burn the surplus fat."

Under section 201(g)(1)(C) of the Act, (21 U.S.C. § 321 (g)(1)(C)), products (other than foods) that are intended to affect the structure or function of the body are defined as drugs. The intended use of a product may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution. 21 C.F.R. § 201.128. Your products are intended to affect the structure or function of the body. Accordingly, "Pineapple Fat Reducing Slimming Capsule," "Tomato Slimming (Lose Weight)," "Slim Up," "Fresh Lemon Slimming (Xian Ning Meng Shou Shen)," "Slim Quick Result 3 in 1," "Perfect Combination Balishou Capsule," "Apple Slim," and "Shoufsy Activity Girl" are drugs.

Moreover, these products are new drugs, as defined by section 201(p) of the Act, (21 U.S.C. § 321(P)), because they are not generally recognized as safe and effective for their labeled uses. 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. Your sale of these products without an approved application violates these provisions of the Act.

The product labeling for the aforementioned products does not declare that these products contain sibutramine. The failure to declare in the products' labeling the presence of sibutramine, an active pharmaceutical ingredient with the potential to cause side effects, renders your products' labeling false and misleading and the products are therefore misbranded under section 502(a) and 201 (n) of the Act, (21 U.S.C. §§ 352(a), 321(n)).

Furthermore, your products are "prescription drugs" as defined at section 503(b)(I)(A) of the Act (21 U.S.C. § 353(b)(I)(A», in that their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer them. Indeed, all anabolic steroid drugs which have been approved for marketing by the FDA are limited by an approved new drug application to use under the professional supervision of a practitioner licensed by law to administer such drug.

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, it is impossible to write "adequate directions for use" for prescription drugs. FDA-approved drugs which bear their FDA-approved labeling are exempt from the requirement that they bear adequate directions for use by a layperson, otherwise all prescription drugs by definition lack adequate directions for use by a layperson,(21 U.S.C. § 352(f)(I); 21 U.S.C. § 353(b)(2).

In light of the fact that they are unapproved prescription drugs, the labeling of "Pineapple Fat Reducing Slimming Capsule," "Tomato Slimming (Lose Weight)," "Slim Up," "Fresh Lemon Slimming (Xian Ning Meng Shou Shen)," "Slim Quick Result 3 in 1," "Perfect Combination Balishou Capsule," "Apple Slim," and "Shoufsy Activity Girl" fail to bear adequate directions for their intended uses, causing them to be misbranded under section 502(£)(1) of the Act, 21 U.S.C. § 352(f)(1). Because they lack required approved applications, these drugs are not exempt from this requirement under 21 C.F.R. § 201.115.

Therefore, the introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301(a) of the Act, (21 U.S.C. § 331 (a)).

The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. 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. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations. We advise you to ensure that you have knowledge of the ingredients in your products.

Please make certain that you have corrected all violations cited in this letter, and that you have knowledge of where your products are manufactured and what ingredients they contain. Future violations may result in legal action without further notice, including, without limitation, seizure and injunction.

For your information, although not specifically sampled from your firm's inventory, your website has offered other products found to contain sibutramine. For example, your website offered "SuperSlim," "Slim 3 in 1," "Miaozi Slim Capsules," Reduce Wehigt [sic]," "Super Slimming," "Extrim Plus," "3 Day Fit," "7 Day Herbal Slim," "Body Shaping," "Fasting Diet," "Herbal Xenical," "Imelda Perfect Slim," "Meizitang," "Perfect Slim 5x," "ProSlim Plus," "Royal Slimming Formula," and "Starcaps." These products are listed in an FDA consumer alert on March 20, 2009, at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149547.htm.

We understand that you report to have stopped receipt and distribution of all weight loss products from Chinese sources. You have also reported the destruction of all Chinese weight loss products in stock except "Pai You Guo," "2 day diet," and "Super Slim." Please submit documentation of this action and the disposition of "Pai You Guo," "2 day diet" and "Super Slim." Within fifteen working days of receipt of this letter, please notify this office in writing of the specific additional steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
If you no longer distribute or market the aforementioned products, your response should so indicate, including the reasons that, and the date on which, you ceased distribution. Additionally, if another firm manufactures these products, identified above, your reply should include the name and address of the manufacturer.


If the firm from which you receive these products is not the manufacturer, please include the name of your supplier in addition to the manufacturer.

Please address your reply to the U.S. Food and Drug Administration, Judith A. Putz, Compliance
Officer, 300 River Place, Suite 5900, Detroit, MI 48207.


SincereIy,
/S/
Joann M. Givens
District Director 
Detroit District Office