Inspections, Compliance, Enforcement, and Criminal Investigations
Slim Beauty USA 1/31/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Kansas City District|
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214-1524
Telephone: (913) 495-5100
January 31, 2014
RETURN RECEIPT REQUESTED
Ref. KAN 2014-07
Paul D. Martin, Owner
Slim Beauty USA
503 E. 23rd St.
Kearney, NE 68847
Dear Mr. Martin:
The U.S. Food and Drug Administration (FDA) conducted an inspection at your firm located at 503 E. 23rd St., Kearney, NE 68847 on December 9, 2013. FDA also reviewed your website, www.slimbeautyusa.com, and note that you sell your products on eBay. Based on information and evidence collected during the inspection of your firm and investigation of your website, FDA has concluded that Dr. Ming's Chinese Capsule, Magic Slim, and Dream Body Slimming Capsule are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 355(a)] and are misbranded drugs under section 502 and 503 of the FDCA [21 U.S.C. §§ 352 and/or 353] as detailed below. The introduction of these products into interstate commerce violates section 301 (d) and (a) of the FDCA [21 U.S.C. §§ 331 (a) and (d)].
FDA confirmed through laboratory analyses that Dr. Ming's Chinese Capsule, Magic Slim, and Dream Body Slimming Capsule 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in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the market in the United States on December 21, 2010 after clinical data indicated sibutramine poses an increased risk of heart attack and stroke.
FDA also confirmed through laboratory analyses that Dr. Ming's Chinese Capsule and Magic Slim contain undeclared phenolphthalein. Phenolphthalein was used as an active pharmaceutical ingredient in some over-the-counter laxative products until 1999 when FDA reclassified the ingredient as "not generally recognized as safe and effective."
You market Dr. Ming's Chinese Capsule, Magic Slim, and Dream Body Slimming Capsule as dietary supplements. However, under section 201 (ff)(3)(B)(ii) of the FOCA [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 was authorized as a new drug. The investigational new drug (!NO) 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 were 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, Dr. Ming's Chinese Capsule, Magic Slim, and Dream Body Slimming Capsule, which contain sibutramine, are excluded from the definition of a dietary supplement under section 201 (ff)(3)(B)(ii) of the FDCA [21 U.S.C. § 321 (ff)(3)(B)(ii)].
Dr. Ming's Chinese Capsule, Magic Slim, and Dream Body Slimming Capsule are drugs as defined by section 201 (g)(1) of the FDCA [21 U.S.C. § 321 (g)(1 )] because they are articles (other than food) intended to affect the structure or function of the human body. Labeling statements documenting their intended uses include, but are not limited to, the following:
Dr. Ming's Chinese Capsule
• "Lose weight naturally without diet or exercise, increase metabolism & energy"
• "Prevents the digestion of dietary fat, hence reducing its absorption by the body. After sometime [sic] of consumption, body parts prone to fat accumulation (belly, arms, thighs and buttocks) could see dramatic benefits."
Dream Body Slimming Capsule
• Bossting [sic] fat metabolism and blocking the non-fat material converting into fat."
In addition, Dr. Ming's Chinese Capsule, Magic Slim, and Dream Body Slimming Capsule are new drugs under section 201 (p) of the FDCA [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 FDCA [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. No approved applications are in effect for these products. Therefore, the market and sale of Dr. Ming's Chinese Capsule, Magic Slim, and Dream Body Slimming Capsule violate these provisions of the FDCA.
Your Dr. Ming's Chinese Capsule, Magic Slim, and Dream Body Slimming Capsule are also misbranded under section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] in that the labeling for these drugs fail 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 Dr. Ming's Chinese Capsule, Magic Slim, and Dream Body Slimming Capsule because: 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. Dr. Ming's Chinese Capsule, Magic Slim, and Dream Body Slimming Capsule 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. As such, their labeling fail to bear adequate directions for their intended uses causing these products to be misbranded under section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)].
Additionally, your Dr. Ming's Chinese Capsule, Magic Slim, and Dream Body Slimming Capsule are misbranded under section 502(a) of the FDCA [21 U.S.C. § 352(a)], which states 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 labeling of your Dr. Ming's Chinese Capsule, Magic Slim, and Dream Body Slimming Capsule make false and misleading statements regarding safety and fail to reveal their sibutramine and phenolphthalein content, which are 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.
The undeclared drug ingredients in your Dr. Ming's Chinese Capsule, Magic Slim, and Dream Body Slimming Capsule 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 Dr. Ming's Chinese Capsule, Magic Slim, and Dream Body Slimming Capsule would be unaware of the presence of the undeclared drug ingredients and placed at risk for their associated adverse events.
Likewise, Dr. Ming's Chinese Capsule, Magic Slim, and Dream Body Slimming Capsule are misbranded under section 502(j) of the FDCA, [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 FDCA [21 U.S.C. § 331 (a)].
We also documented that you are selling other products on your website that have previously been found to contain undeclared ingredients, including, but not limited to Dr. Ming's Slimming Capsule, Beautiful Slim Body, Best Slim Diet Pills, Fruta Planta Diet Pills, Jadera Slimming Diet Pills, Japan Rapid Weight Loss Green Diet Pills, Lishou Slimming Diet Pills, Lose Weight Coffee Slim Delicious, Zi Xiu Tang Bee Pollen Floyd Nutrition, Japan Rapid Weight Loss Blue Diet Pills, 2 Day Diet, Acai Berry Soft Gel ABC, Japan Rapid Weight Loss Yellow, Meizitang, P57 Hoodia, and Lida DaiDaihua.1
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 FDCA and its implementing regulations.
In particular, it is your responsibility under the FDCA to ensure that products marketed by your firm do not contain undeclared ingredients and comply with all requirements of federal law and regulations. We also advise you to review your website, your products, 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 FDCA.
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 under Section 304 and 302 of the FDCA [21 U.S.C. §§ 334 and 332].
We acknowledge that you claim to no longer sell Dr. Ming's Chinese Capsule, Magic Slim, and Dream Body Slimming Capsule. However, we note that you have declined to voluntarily issue public notification to warn consumers about the potential for injury.
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 within this letter, 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 and address of your supplier in addition to the manufacturer information. 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, Jessica E. Hensley, Compliance Officer at the address noted above. If you have any questions with regard to this letter, CO Hensley can be reached at (913) 495-5183 or email firstname.lastname@example.org
Ann M. Adams Ph.D
Acting District Director
Food Safety and Consumer Protection Administrator
Nebraska Department of Agriculture
P.O. Box 95604
Lincoln, NE 68509
U.S. Drug Enforcement Administration
Attn: Graziano Iezzi, Task Force Officer
William. J. Green Federal Building
600 Arch Street, Room 10224
Philadelphia, PA 19106
1 A full list of all tainted products discovered by FDA can be found at: http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder.