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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Synticare Corp 3/15/13

  

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

Public Health Service
Food and Drug Administration
 Los Angeles District
19701 Fairchild
Irvine, CA 92612-2506
Telephone:  949-608-2900
FAX:  949-608-4417 

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED                                                
 
 
March 15, 2013
                                                                                                                                    W/L# 29-13
Dr. Farshid Paydar
Synticare Corp.
www.macularvitamin.com
2530 W. Hwy 89A Ste. B-3
Sedona, AZ 86336
 
Dear Dr. Paydar:
                                                                             
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.macularvitamin.com in February 2013 and has determined that your macular degeneration products, Maximum Lutein, AREDS 1, AREDS 1 Smokers, AREDS 2, Combo AREDS 1 and 2, and Combo Smokers AREDS 1 and 2, are promoted 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 these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act. You can find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.
 
Examples of some of the claims for your macular degeneration products and their ingredients on your website include:
 
o   “The proven supplement (AREDS) for age related macular degeneration”
o   “These macular degeneration formulas contain specific antioxidant vitamins for the treatment of macular degeneration”
o   “These are the best known, medically accepted antioxidants used regularly by eye doctors for medical (non-surgical) macular degeneration treatment. These formulas help to slow macular degeneration damage and vision loss in your eyes.”
o   “Also the same institutions [United Nations, World Health Organization, Food and Agriculture Organization] have given Lutein and Zeaxanthin the safest rating of 100. This means that the recommended dose is extremely safe and better if used at higher doses for macular degeneration treatment.”
o   “The AREDS one study is the only medical treatment proven to slow macular degeneration.”
o   “Omega three oils (not Omega six oils) have antioxidant and anti-inflammatory benefits for the Macular area to slow damage caused by macular degeneration. The Omega three oils in the AREDS2 formula are Docosahexaenoic acid (DHA) 350mg and Eicosapentaenoic acid (EPA) 650 mg ….”
o    “All of these formulas are useful for treatment of Both Dry and Wet Macular Degeneration. MDS [Macular Degeneration Supplements] is considered for macular degeneration treatment only if taken everyday on a continuous basis.”
o   “These macular degeneration supplement formulas are the treatment of choice by eye doctors. The ingredients in these formulas are the only known medical treatment for macular degeneration…”
o   “If you have dry or wet macular degeneration, symptoms of early macular degeneration, or family history of AMD, then you should be taking these supplements regularly.”
 
In addition, when scientific references are used commercially by the seller of a product to promote the product to consumers, such references may become evidence of the product’s intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a dietary supplement is considered to be a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The home page of your website provides links to online summaries of two studies that pertain to prevention and treatment of macular degeneration: 
 
  • Age-Related Eye Disease Study (AREDS), National Eye Institute, National Institutes of Health [http://www.nei.nih.gov/neitrials/static/study44.asp]
  • Age-Related Eye Disease Study 2, The Lutein/Zeaxanthin and Omega-3 Supplementation Trial [http://www.areds2.org/]
 
Your website promotes your products AREDS 1, AREDS 1 Smokers, and AREDS 2 for prevention and treatment of macular degeneration by claiming that they contain the same ingredients used in these studies. 
 
Your products 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 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.
 
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 products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for use. 
 
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 violations cited in this letter are not meant to be an all-inclusive list of violations that exist in connection with your products and their labeling. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations.  It is your responsibility to ensure that your firm complies with all requirements of federal law and regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, such as seizure and/or injunction. 
 
Within fifteen (15) working days from your receipt of this letter, please notify this office in writing as to the specific steps you have taken to correct the violations cited above. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete all corrections within fifteen working days, state the reason for the delay and the date by which the corrections will be completed.
 
Your written response to this letter should be sent to:
 
Mr. Blake Bevill
Director, Compliance Branch
United States Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506
 
If you have questions regarding this letter, please contact Marco Esteves, Compliance Officer, at 949-608-4439.
 
Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District
 
 
Cc:     
Patrick Kennelly, Acting Branch Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
Sacramento, CA   95899-7413