Inspections, Compliance, Enforcement, and Criminal Investigations

Nutreglo Products, Inc. 2/26/15

  

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

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

 

WARNING LETTER
FEB 26, 2015 
 
VIA EXPRESS MAIL
 
Erma Melvin
NUTREGLO Products Inc.
4128 SW 195 Terrace
Miramar, FL 33029
 
Re: 446318
 
Dear Ms. Erma Melvin:                                                                                 
                                   
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://nutregloproducts.com in December 2014 and has determined that you take orders there for the products Sour Sop (Guanabana) Graviola, Moringa (Oleifera), and Guinea Hen weed (Anamu) petiveria, which the website promotes for conditions that cause the products to be 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)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introduction or delivering these products for introduction into interstate commerce for such uses violates the Act. You may 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 provided evidence that your products are intended for use as drugs include:
 
On the webpage titled, “the NUTREGLO Store”:
  • Sour Sop (Guanabana) Graviola
o   “Contains: Anti cancer…properties”
o   “The powerful extract has been shown to kill certain types of Liver, Colon cancer, Ovarian cancer, breast cancer cells. High blood pressure, cure various kinds of diseases, Heart problems,…Leprosy, Dysentery…”
o   Also known to aide with Type 2 Diabetes, High Blood pressure, Arthritis, Asthma, Heart diseases, Breast Cancer,..Lowers Cholesterol,…reduce risk of Atherosclerosis…”
  • Moringa (Oleifera)
o   “Benefits…aide with Type 2 Diabetes, High Blood Pressure, Arthritis, Asthma, Heart Diseases, Breast Cancer,…Lowers Cholesterol,…reduce risk of Atherosclerosis…”
  • Guinea Hen weed (ANAMU) petiveria
o   “Aids with Sexual [sic] transmitted diseases,...Cancer, Leukemia,… Urinary tract infections,…Anti-Viral agent,...”
o   “Also known to aide with Type 2 Diabetes, High Blood Pressure, Arthritis, Asthma, Heart Diseases, Breast Cancer,…Lowers Cholesterol…reduce risk of Atherosclerosis…”
 
On the webpage titled, “THE HEALTH BENEFITS OF USING NUTREGLO PRODUCTS” which is accessed from the “About us” tab on your homepage:
  • “[H]ere are the benefits you can reap from Nutreglo…”
o   “Reduces hypertension and heart disease”
o   “Diabetes”
o   “Reduces certain types of cancer”
 
Your products, Sour Sop (Guanabana) Graviola, Moringa (Oleifera), and Guinea Hen weed (Anamu) petiveria, are not generally recognized as safe and effective for the above referenced uses and, therefore, the product 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 the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. 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. 
 
Furthermore, your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your Sour Sop (Guanabana) Graviola, Moringa (Oleifera), and Guinea Hen weed (Anamu) etiveria products are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction. 
 
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 and to assure that similar violations do not occur in the future. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and the date by which each such item will be corrected.
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. You may respond in writing to Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740, Attention: Mabel Lee (HFS-608). If you have any questions concerning this letter, please contact Ms. Lee at 240-402-0972.
 
 
Sincerely,
/S/ 
William A. Correll
Director
Office of Compliance
Center for Food Safety
   and Applied Nutrition

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