Inspections, Compliance, Enforcement, and Criminal Investigations

Seeds of Light Enterprises 10/15/15

  

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

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
 
Telephone: 407-475-4700
FAX: 407-475-4770 

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-16-02
October 15, 2015
 
Seeds of Light Enterprises, Inc.
Attn: Marcela Vigilante
7180 SW 103 Court Circle
Miami, FL 33173
 
Dear Ms. Vigilante:
 
The United States Food and Drug Administration (FDA) recently reviewed your website at www.slimeast.com.  Based on our review, FDA has determined that you offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, FDA has determined that a product you offer for sale, “Meizi Super Power Fruits” is an unapproved new drug under sections 505(a) and 301(d) of the FD&C Act [21 U.S.C. §§ 355(a) and 331(d)] and is a misbranded drug sold in violation of sections 502 and 301(a) of the FD&C Act [21 U.S.C. §§ 352 and 331(a)], as detailed below.
 
Unapproved New Drugs
 
FDA confirmed through laboratory analysis that your product, “Meizi Super Power Fruits” contains 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in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the United States market on December 21, 2010 after clinical data indicated sibutramine poses an increased risk of heart attack and stroke.
 
You market “Meizi Super Power Fruits” as a dietary supplement. However, under section 201(ff)(3)(B)(ii) of the FD&C 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 it was authorized for investigation 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. Based on the information available to FDA, sibutramine was not marketed as a dietary supplement or as a food before it was authorized for investigation as a new drug. Therefore, “Meizi Super Power Fruits” which contains sibutramine, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the FD&C Act.
 
 Your “Meizi Super Power Fruits” product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and intended to affect the structure or function of the body and, thus, is a drug as defined by section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)].
 
Labeling statements documenting the intended uses of “Meizi Super Power Fruits” include, but are not limited to the following:
 
On your website, www.slimeast.com: 
  • “Shape your body from legs, belly, buttocks, arms and face where it is easy to accumulate more fat.”
  •  “[Y]ou will feel how easy it is to lose weight.”
  • “Start losing weight today!”
  • “Lose weight, eat freely with no diet” 
 
On the product label: 
  • “100% Natural Herbal Slimming Formula”
In addition, your “Meizi Super Power Fruits” is also a new drug under section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in its labeling. Under sections 301(d) and 505(a) of the FD&C Act, a new drug may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the FD&C Act [21 U.S.C. § 355(b) or (j)] is in effect for it.  There is no FDA-approved application on file for “Meizi Super Power Fruits.” The distribution or sale of this product without an approved application violates these provisions of the FD& C Act.
 
Furthermore, “Meizi Super Power Fruits” is a “prescription drug” as defined in section 503(b)(1)(A) of the FD&C Act [21 U.S.C § 353(b)(1)(A)], because, in light of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary for its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer such drugs. “Meizi Super Power Fruits,” which contains undeclared sibutramine, is a prescription drugs because 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. It is also a prescription drug because the FDA approval of Meridia was withdrawn because of serious safety risks. 
 
Misbranded Drugs
 
Additionally, under section 502(a) of the FD&C 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 FD&C 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 product, “Meizi Super Power Fruits” is misbranded under section 502(a) of the FD&C Act because the product’s 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 this product. 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. 
 
“Meizi Super Power Fruits” is also misbranded under section 502(f)(2) of the FD&C Act [21 U.S.C. § 352(f)(2)], because the product’s labeling lacks adequate warnings for the protection of users. As noted, there is potential for adverse events associated with the use of this product, particularly since someone who takes it would be unaware of the presence of the undeclared ingredient.
 
Likewise, “Meizi Super Power Fruits” is misbranded under section 502(j) of the FD&C Act, [21 U.S.C. § 352(j)], because it is dangerous to health when used in the dosage or manner recommended in the labeling. As previously noted, sibutramine poses an increased risk of heart attack and stroke. 
 
The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301(a) of the FD&C Act].
 
We also documented that you offer the products, “Trim-Fast Slimming Soft Gel,” “Fruta Bio,” “Meizitang Strong Version,” “2 Day Diet” and “Super Slim” for sale to consumers in the United States. Previously, FDA lab analysis has revealed that these products have been found to contain the undeclared ingredients sibutramine, phenolphthalein or a combination of both. Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm234592.htm).  While the Agency has not tested and sampled these products from your inventory to date, this letter is to express our serious concern about their safety and emphasize that it is your legal responsibility under federal law to ensure they do not contain any undeclared and potentially harmful ingredients.
 
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.  
 
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 ensure that your firm complies with all requirements of federal law and FDA regulations, and to ensure that all products you manufacture or distribute are in compliance with the FDCA and all of its implementing regulations and all other requirements of federal law. You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action of violations may result in legal action without further notice, including, without limitation, seizure, injunction, and/or prosecution.
 
You should notify this office in writing within fifteen (15) working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, please 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 all corrections before you respond, you should explain the reason for the delay and include a timetable for the implementation of any remaining corrections. 
 
Your response should be sent to Randall Morris, Compliance Officer, US Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions with regard to this letter, Mr. Morris can be reached at 407-475-4741 or Randall.morris@fda.hhs.gov.
 
Sincerely,
/S/
Susan M. Turcovski
Director, Florida District

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