Inspections, Compliance, Enforcement, and Criminal Investigations

Mc-Cor, LLC 6/30/16

  

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) 729-8652
FAX: (787) 729-8826 

 

June 30, 2016
 
WARNING LETTER
16-SJN-WL-07
CMS # 494483
 
SENT VIA – UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
 
Mr. Jorge Miranda Massari
MC-COR, LLC
207 Calle Uruguay
San Juan, Puerto Rico  00917
 
Dear Mr. Miranda Massari:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.metacorllc.com/en on June 2016 and determined that you take orders there for the product “GlucoCoR” capsules. Based on our review of your product labeling, including your Firm’s website, we established that the product is a drug 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 it is intended for use in the cure, mitigation, treatment, or prevention of disease.[1]  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 product is intended for use as a drug include:
  • “Promote healthy glucose levels”
  • “Promote… tissue repair”
  • “GlucoCor is a Metabolic Corrector”
  • “Helps maintain adequate levels of blood sugar”
  • “Attends the biochemical origin of the disease” 
Furthermore, the title of your webpages, which appear on the tab of the internet page, state the following:
  • “Treatment for Diabetes 1 and 2 diabetes GlucoCor”
  • “Metabolic Correction for Diabetes Type 2 and Diabetes Type 1”
In addition, your website at https://www.metacorllc.com/en, where your “GlucoCoR” product can be purchased directly, links to your Facebook page where there are claims about your product. The claims on this social media page provides further evidence that your “GlucoCoR” product is intended for use as a drug:
 
Posts by your company on your Facebook page include the following:
 

Spanish: 
English Translation:
 
“Corrector Metabólico:”
 
  • “Promueve niveles saludables de glucosa”
 
“ Metabolic Corrector: ”
 
  • Promote healthy glucose levels
 

“Los ingredientes activos de GlucoCor pueden ayudar a disminuir los niveles de glucosa en la sangre y mejorar síntomas neuropaticos tales como dolor, quemazón y entumecimiento de las extremidades.”
 
English Translation:
 
GlucoCor active ingredients could help to lower glucose levels in blood and improve neuropathic symptoms such as pain, burning and numbness of extremities.
 
“Correctores Metabólicos para la Diabetes Tipo 2 y Diabetes Tipo 1”.
 
“Correctores Metabólicos para la Diabetes Mellitus, los Correctores Metabólicos son un producto natural realizado por MetaCoR, para la Diabetes Mellitus.”
 
English Translation:
 
Metabolic Correctors for Type 2 Diabetes and Type 1 Diabetes.
 
Metabolic Correctors for Diabetes Mellitus, a natural product made by MetaCoR, for Diabetes Mellitus.
 
Your product “GlucoCor” is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” 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 product “GlucoCor” is 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 product safely for its intended purposes. Accordingly, your “GlucoCor” product fails to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug 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 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. Margarita Santiago, Compliance Officer, at (787) 729-8702 or via email at margarita.santiago@fda.hhs.gov
 
Sincerely,
/S/ 
Maridalia Torres
District Director
San Juan District
 
Copy to:
 
Mrs. Rita M. Rodriguez Valentin
Chief Executive Manager
MC-COR, LLC
344 Villa Nevarez
Ave. Americo Miranda, Local A
San Juan, Puerto Rico 00927


[1] As defined in 21 CFR 101.93(g)(1), a “disease” is “damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.” 

Page Last Updated: 11/23/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English