Inspections, Compliance, Enforcement, and Criminal Investigations
Limpia Arteria 2/4/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
FEB 4, 2011
Via UPS Delivery Service
2932 East 194th Street
Bronx, NY 10461
Dear Mr. Merlino:
This is to advise you that the Food and Drug Administration (FDA) reviewed your web site at the Internet address www.limpiarteri.com in February 2011 and has determined that the product LimpiaArteria is promoted for conditions that cause the product to be 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)]. The therapeutic claims on your web site establish that the product is a drug because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act.
Examples of some of the claims observed on your web site include:
Under the heading, “The Benefits of LimpiaArteria and what it may do for you”:
“Reduce, Prevent or Improve in Both Men and Women:
Fibromyositis Arthritis Symptions
High Blood Pressure
Improve Heart Function
Improve Impaired Vision ….”
Under the heading, “What is Limpia Arteria?”:
• “LimpiaArteria is a [sic] Oral Liquid EDTA (Ethylene Diamine Tetra-acetic Acid) Supplement that may help to gradually reduce calcium, atherosclerotic plaque and other clogging materials such as minierals and heavy metals throughout your cardiovascular system by dissolving them way [sic]”
Your web site also contains disease claims in the form of personal testimonials, including:
• “I had an unexpected heart attack . . . . In a months time of me taking LimpiaArteria, I have not experienced any of these [heart attack] symptoms and I have lowered my cholesterol as well, thank you LimpiaArteria.”
• “As I got older, I started to develop a very bad case of Arthritis in my hands . . . . I received a phone call from my daughter, she had told me about this new product that was called LimpiaArteria. She explained what LimipiaArteria was and what it could improve and that one of the symptoms that LimpiaArteria specified as being able to improve was arthritis . . . . I began taking LimpiaArteria as suggested. After my 4th day of taking LimpiaArteria, the pain I was experiencing in my hands was gone . . . . LimpiaArteria is a true miracle.”
• “Before taking LimpiaArteria, I had severe pain in my thighs, knees and feet . . . . My blood pressure was high . . . After the first week, the pain I was experiencing in my thighs, knees and feet was starting to lessen …. After the third week, I had no more pain in my thighs, knees and feet, my blood pressure was normal again …. I would recommend LimpiaArteria to everyone no matter how or what you’re feeling.”
Furthermore, 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 marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C § 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.
Your product, LimpiaArteria, is also misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling for this drug fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].
Because LimpiaArteria is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the product safely for its intended uses. Thus, its labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of § 301(a) of the Act [21 U.S.C. § 331(a)].
The above violations are not meant to be an all-inclusive list of violations that exist in connection with your product and its labeling. It is your responsibility to ensure that the products you market are in compliance with the Act and its implementing regulations.
You should take prompt action to correct the violations described above. Failure to do so may result in enforcement action without further notice, including, but not limited to seizure and injunction [21 U.S.C. §§ 332 and 334].
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 violations noted above and to ensure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be directed to Felicia B. Williams, Compliance Officer, U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement, 5100 Paint Branch Parkway (HFS-608), College Park, Maryland 20740. If you have any questions regarding any issues in this letter, please contact Ms. Williams at (301) 436-2566.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition
cc: New York District Office