Inspections, Compliance, Enforcement, and Criminal Investigations

Menscience Androceuticals 7/18/16

  

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-16-17
July 18, 2016
 
 
Federico Sanchez, Owner
Menscience Androceuticals
319 NW 25th St
Miami, FL 33127
 
Dear Mr. Sanchez:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.menscience.com/ in May 2016 and has determined that you take orders there for the product Anti-Aging Formula. The claims on your website establish that the product is a drug under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and/or 21 U.S.C. § 321(g)(1)(C)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or is intended to affect the structure or any function of the human body. As explained further below, introducing or delivering this product 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 includes:
 
Anti-Aging Formula
  • “Retinol is widely prescribed by doctors and dermatologists for the treatment of acne, darkened cells and hyperpigmentation, and signs of aging. Retinol is also incorporated into procedures for the vision and immune systems, and assistance in bone growth. Because it is fat-soluble, it is able to absorb into fatty layers of skin to promote greater cell renewal and increases in collagen and elastin production.”
  • “Peptides utilized in the Anti-Aging Formula are Acetyl Hexapeptide-3 and Palmitoyl Oligopeptides…that block the release of a neurotransmitter which causes facial muscles to tense and wrinkles to appear. Palmitoyl Oligopeptides…encourages collagen production…”
  • “GABA Relaxes muscles and bodily tissues by inhibiting and controlling nerve impulses. Because of its unique ability to release muscle tension, it is being used in a variety of ways, from treating nerve disorders and epilepsy to promoting hormone growth and as a dermatological-grade ingredient.”
  • “Hydrocotyle Widely used in Indian herbal remedies to reduce skin inflammation, irritation, itching and burning, and facilitate quicker healing of wounds. Also assists in increasing blood circulation and in the creation of new skin cells. Historically, has been used to treat skin conditions, fever, diarrhea, ulcers and anxiety disorders.”
Your product 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. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 
 
This letter is not an all-inclusive statement of violations associated with your product or its labeling, and we have not attempted to list here all of the products that are promoted on your website for intended uses that cause them to be drugs.  It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.  We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.
 
We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products.
 
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If you do not believe that your product is in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
 
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 Randall L. Morris, Compliance Officer. If you have any questions about the contents of this letter, please contact Randall L. Morris at 407-475-4741 (phone) or 407-475-4768(fax).
 
 
Sincerely,
/S/
Susan M. Turcovski
Director, Florida District
 

Page Last Updated: 09/01/2016
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