|Company:||Healthy Body Forero|
|Subject:||New Drug/Labeling/False & Misleading Claims/Misbranded|
|Issuer:||San Juan District Office|
|Issued:||March 15, 2010||Closed:||Feb. 11, 2011|
Department of Health and Human Services
Public Health Service
Food and Drug Administration
466 Fernandez Juncos Avenue
San Juan, Puerto Rico, 00901-3223
March 15, 2010
Return Receipt Requested
Mr. Juan Carlos Torres Ruiz
Healthy Body Forero Inc.
Drive In Plaza, Road #2
2135 Suite I
Bayamon, PR 00959-5222
Dear Mr. Torres:
This letter concerns your firm's repackaging, relabeling, distribution and marketing of the products, "YI SHOU Ultimate Fat Burner 400mg capsules" and "YI SHOU Ultimate Fat Burner Extra Strength 650mg capsules." These products were marketed and distributed in violation of provisions of the Federal Food, Drug and Cosmetic Act (the Act) as described below.
The United States Food and Drug Administration (FDA) inspected your facility located at Drive In Plaza, Road # 2, 2135 Suite 1, Bayamon, Puerto Rico 00959 in September and October of 2009. Over the course of the inspection, the investigator collected samples, promotional information and labeling associated with "YI SHOU Ultimate Fat Burner 400mg capsules" and "YI SHOU Ultimate Fat Burner Extra Strength 650mg capsules." Laboratory analysis found that both products contain sibutramine, the active pharmaceutical ingredient in the FDA-approved prescription 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, "YI SHOU Ultimate Fat Burner 400mg capsules" and "YI SHOU Ultimate Fat Burner Extra Strength 650mg capsules" are not dietary supplements.
Statements on your products' labels and promotional information displayed in your facility describe the intended use of the aforementioned products. These statements have included, but are not limited to, the following:
• The name of your products, "YI SHOU Ultimate Fat Burner" and "YI SHOU Ultimate Fat Burner Extra Strength," suggests that the products are intended to affect the structure or function of the body by reducing fat.
• "The fat burner of this moment and the future"
• "Be ready to lose weight"
• "Transform fat to a source of energy"
• "Control your appetite"
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, your "YI SHOU Ultimate Fat Burner 400 mg capsules" and "YI SHOU Ultimate Fat Burner Extra Strength 650mg capsules" 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)(1)(A) of the Act (21 U.S.C. § 353(b)(1)(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. are not safe for use except 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, it is impossible to write "adequate directions for use" for prescription drugs. However, 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)(1); 21 U.S.C. § 353(b)(2). 21 C.F.R. § 201.115.
In light of the fact that they are unapproved prescription drugs, the labeling of your products "YI SHOU Ultimate Fat Burner 400mg capsules" and "YI SHOU Ultimate Fat Burner Extra Strength 650mg capsules" fail 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(o)(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 before you offer them for sale.
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, without limitation, seizure, injunction, and/or prosecution.
For your information. on November 9, 2009, you informed FDA of your intention to recall the YI SHOU products. On November 20 and 21, 2009, FDA conducted a recall-audit effectiveness-check on your three stores and 13 other retailers at which your firm has distributed the YI SHOU products. The recall-audit-effectiveness-check revealed that your firm retrieved all YI SHOU products from retail distribution points and informed your distributors that the products had some "labeling deficiencies." Your firm did not, however, indicate to its distributors that the YI SHOU products contained sibutramine, or warn its distributer of the potential harm presented by undeclared sibutramine in a product. Furthermore, FDA has been informed that your firm moved your inventory of these two products from retail stores to your residence. and that the products have been embargoed by the Puerto Rico Administration of Mental Health and Drug Prevention Services (ASSMCA).
Within fifteen working days of receipt of 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, as well as copies of related documentation. In addition, please provide evidence of the current status of the embargoed products and any necessary supporting documentary evidence. 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.
Your reply should be sent to the Food & Drug Administration, San Juan District Office, 466 Fernandez Juncos Ave., San Juan, PR 00901-3223. to the attention of Margarita Santiago, Compliance Officer.
San Juan District Office
Enclosures: FDA 483