Inspections, Compliance, Enforcement, and Criminal Investigations

Moringa Nativa 12/18/15

  

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

Public Health Service
Food and Drug Administration
 
San Juan District
Compliance Branch 
466 Fernández Juncos
 San Juan, Puerto Rico 00901-3223
 
Telephone: 787-729-8764
FAX: 787-729-8765

 

December 18, 2015
 
WARNING LETTER
16-SJN-WL-04
 
VIA UNITED PARCEL SERVICE
NEXT DAY – SIGNATURE REQUIRED
 
 
Mrs. Ivette Veiga
Moringa Nativa
PO Box 7891 PMB 495
Guaynabo, Puerto Rico 00970
 
Dear Mrs. Veiga:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://yvette67.wix.com/moringa-new?deeplink_referrer=ess#!body-care/ccov in November 2015, and has determined that you take orders there for products “Moringa Nativa Powder” and “Pure Moringa Capsules”. The claims on your website establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.   
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
“Benefits of Moringa:
  • Promotes natural Serum cholesterol
  • It is an anti-inflammatory
  • Fights many types of Cancers” 
In addition, your website at http://yvette67.wix.com/moringa-new?deeplink_referrer=ess#!body-care/ccov, where your “Moringa Nativa Powder” and “Pure Moringa Capsules” products can be purchased directly, links to your Facebook page where there are claims about your products. The claims on this social media page provides further evidence that your “Moringa Nativa Powder” and “Pure Moringa Capsules” products are intended for use as a drug:
 
Posts by your company on your Facebook page include the following:
 
 
English Translation:
 
“Algunos de los beneficios de Moringa:”
 
  • “Reduce el azúcar en la sangre”
  •  “Combate la Colitis…”
  •  “Elimina los calambres”
  •  “Alivia dolores de cabeza”
  •  “Baja la presión arterial”
  • “Reduce el colesterol”
  • “Combate la artritis”
  • “Combate enfermedades del corazón”
  • “Combate muchas formas de cáncer”
  • “Mejora la…hepatitis, depresión”
 
Some of the Benefits of Moringa:
 
  • Reduces sugar in the blood
  • Combats Colitis…
  • Eliminates cramps
  • Relieves headaches
  • Lowers blood pressure
  • Reduces cholesterol
  • Combats Arthritis
  • Combats heart diseases
  • Combats many types of cancer
  • Improves…hepatitis, depression
 
 
Your products “Moringa Nativa Powder” and “Pure Moringa Capsules” are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. § 301(d), 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your products “Moringa Nativa Powder” and “Pure Moringa Capsules” intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your “Moringa Nativa Powder” and “Pure Moringa Capsules” products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
This letter is not intended to be an all-inclusive review of your website and labeling and the products your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above.  Your response should include any documentation that would assist in evaluating your corrections. If you cannot complete all corrections within fifteen (15) working days, please explain the reason for the delay and the date by which each such item will be corrected.
 
You may respond in writing to Ms. Maridalia Torres, District Director, at 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223.  If you have any questions regarding any issue in this letter, please contact Ms. Dayna I. Martínez, Compliance Officer, at (787) 729-8608 or via email at dayna.martinez@fda.hhs.gov.
 
 
Sincerely,
/S/ 
Maridalia Torres
District Director
San Juan District

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