Dolphin Intertrade Corporation 8/21/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
w/ DELIVERY CONFIRMATION
August 21, 2013
Dolphin Intertrade Corporation
11314 SW 135th Ct.
Miami, FL 33186-4425
Dear Mr. Delfino:
The U.S. Food and Drug Administration (FDA) conducted an inspection at your firm located at 11314 SW 15th Ct, Miami, FL 33186-4425 on 05/10/2013-05/17/2013. We have also reviewed your websites at www.jadera.net.
FDA has determined that Jadera and Xiyouji Qingzhi samples purchased from your website www.jadera.net 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/or 503 of the Act [21 U.S.C. §§ 352 and/or 353] as detailed below.
FDA confirmed through laboratory analyses that Jadera and Xiyouji Qingzhi contain undeclared 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in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the U.S. market on December 21, 2010, after clinical data indicated sibutramine poses an increased risk of heart attack and stroke.
You market Jadera and Xiyouji Qingzhi as dietary supplements. 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, Jadera and Xiyouji Qingzhi, which contain sibutramine, are excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the Act.
Jadera and Xiyouji Qingzhi 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 and, thus, are drugs as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. Labeling statements documenting these intended uses include, but are not limited to, the following:
- “Lose Weight Effectively”
- “Keep the Weight off”
- “Curb Your Appetite”
- “Burn the Fat Stored on Your Body”
In addition, Jadera and Xiyouji Qingzhi 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 Jadera and Xiyouji Qingzhi without approved applications violates these provisions of the Act.
Jadera and Xiyouji Qingzhi are also misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that the labeling for these drugs fails to bear adequate directions for use. “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 Jadera and Xiyouji Qingzhi 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 Jadera and Xiyouji Qingzhi fail to bear adequate directions for their intended uses. Jadera and Xiyouji Qingzhi 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 these products.
Additionally, 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, Jadera and Xiyouji Qingzhi 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. As described above, sibutramine may pose serious health risks to consumers which are only compounded by the fact that sibutramine is not declared on the label.
Likewise, Jadera and Xiyouji Qingzhi are misbranded under section 502(j) of the Act, [21 U.S.C. § 352(j)] because they are dangerous to health when used in the dosage or manner recommended in their labeling. As previously noted, sibutramine poses an increased risk of heart attack and stroke. The introduction or delivery for introduction into interstate commerce of this misbranded product violates section 301(a) of the Act [21 U.S.C. § 331(a)].
We also documented that you are selling other products on your websites that have previously been found to contain undeclared ingredients, including, but not limited to Lishou, Magic Slim, Fruta Planta, Slim Forte, Pai You Guo, Lida DaiDaiHua, Meizitang, 2 Day Diet and Super Slim.
Your websites, include, but are not limited to the following:www.kmdali.info/; www.lishoucapsule.com/; www.pastillaschinas.info/; www.yadera.com/; www.botanicslimmingsoftgel.com/; www.frutabio.info/; www.lidadaidaihua.mobi/index.htm; www.queesbotanicalslimming.com/; www.slimmingbotanical.org/; www.meizitang.mobi/index.htm; www.paiyouguoslimcapsule.com/; www.easiestandfastestwaytoloseweight.com/; and www.capsulaschinasdeldoctorming.com/.
It is your responsibility under the Federal Food Drug and Cosmetic Act (“Act”) to ensure that products marketed by your firm do not contain undeclared ingredients and comply with all requirements of federal law and regulations. In general, products marketed as dietary supplements that contain the ingredients sibutramine or their analogs are illegal because they are unapproved new drugs under 21 U.S.C. §§ 321(p) and 355(a) and/or adulterated dietary supplements under 21 U.S.C. § 342. When such products contain undeclared ingredients or bear misleading claims (e.g., “100% natural” or misrepresentations about the safety of the product), they are also misbranded drugs under 21 U.S.C. § 352 and/or misbranded dietary supplements under 21 U.S.C. § 343.
The violations cited in this letter are not meant to be an all-inclusive list of violations in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the 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 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 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. 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, Randall L. Morris, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Mr. Morris can be reached at (407) 475-4741 or email Randall.Morris@fda.hhs.gov
Emma R. Singleton
Director, Florida District
Dr. J. Fruin
Florida Department of Agriculture & Consumer Services
3125 Conner Blvd
Tallahassee, FL 32399-1650
U.S. Drug Enforcement Administration
Attn: Graziano Iezzi, Task Force Officer
William. J. Green Federal Building
600 Arch Street, Room 10224
Philadelphia, PA 19106