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  5. DoctorVicks.com - 512642 - 04/17/2017
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WARNING LETTER

DoctorVicks.com MARCS-CMS 512642 —

Recipient:
Recipient Name
Sholom Levitin
DoctorVicks.com

2112 59th St.
Brooklyn, NY 11204
United States

Issuing Office:
New York District Office

United States

 

   

Black HHS-Blue FDA Logo

 

 
 
New York District
158-15 Liberty Ave
Jamaica, NY 11433

 

WARNING LETTER NYK-2017-8
                                                                       
April 17, 2017
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
DoctorVicks.com
Attn: Sholom Levitin
2112 59th St.
Brooklyn, NY 11204
 
28500 Nutwood Lane
Wickliffe, OH 44092
 
Dear Mr. Levitin,       
                                   
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.doctorvicks.com in March 2017 and has determined that you take orders there for the products Freeda Vitamins – Garlic 400 mg, Freeda Vitamins – Niacin (B3) 500 mg, Freeda Vitamins – Quercetin 50 mg, Freeda Vitamins – Vitamin B2 (Riboflavin) 50 mg, Maxi Health – Livamax with Milk Thistle, Maxi Health – Maxi Omega-3 2000, Maxi Health – Triple Maxi Omega-3 Concentrate with D3 2000IU, Maxi Health – Maxi Resveratrol – Kosher Heart & Memory Formula, Freeda Vitamins – Chewable Lecithin Gram-O-Leci 1000 mg, Freeda Vitamins – Magnesium Citrate 400 mg, and Zahler’s – ParaGuard (Former BugFree) – Kosher Parasite Formula. The claims on your website establish that the products are 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)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce violates the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov. 
 
Examples of some website claims that provide evidence that your products are intended for use as drugs include:
 
On the Freeda Vitamins – Garlic 400 mg product webpage, www.doctorvicks.com/freeda-vitamins-garlic-400-mg-100-500-tablets/ 
  • “reduce the likeliness of getting a cold”
  • “prevent certain cancers”
On the Freeda Vitamins – Niacin (B3) 500 mg product webpage, www.doctorvicks.com/freeda-vitamins-niacin-b3-500-mg-100-tablets/:
  • “suppress inflammation”
  • “lower cholesterol, help improve diabetes, or lower the chance of a second heart attack or stroke” 
On the Freeda Vitamins – Quercetin 50 mg product webpage, www.doctorvicks.com/freeda-vitamins-quercetin-50-mg-100-tablets/ 
  • “protect against heart disease and cancer”
  • “anti-histamine and anti-inflammatory effect … can help with allergic reactions and swelling”
On the Freeda Vitamins – Vitamin B2 (Riboflavin) 50 mg product webpage, www.doctorvicks.com/freeda-vitamins-vitamin-b2-riboflavin-50-mg-100-tablets/ 
  • “prevent … the development of heart disease and cancer” 
On the Maxi Health – Livamax with Milk Thistle product webpage, www.doctorvicks.com/maxi-health-livamax-with-milk-thistle-kosher-liver-formula-60-120-maxicaps/:
  • “fix the damage done to the liver by alcohol”
  • “Silymarin also seems to have anti-cancer properties. It can stop cancer cells from multiplying, kill cancer cells, and block their blood supply.” 
On the Maxi Health – Maxi Omega-3 2000 and the Maxi Health – Triple Maxi Omega-3 Concentrate with D3 2000IU product webpages, www.doctorvicks.com/maxi-health-maxi-omega-3-2000-100-200-maxigels/ and www.doctorvicks.com/maxi-health-triple-maxi-omega-3-concentrate-with-d3-2000-iu-100-200-maxigels/:
  • “preventing heart disease and strokes”
  • “lower cholesterol and blood pressure”
  • “reduce the risk of cancer, macular degeneration, osteoporosis”
  • “improve diabetes…lessen symptoms of asthma arthritis SLE [sic]”
On the Maxi Health – Maxi Resveratrol – Kosher Heart & Memory Formula product webpage, www.doctorvicks.com/max-health-maxi-resveratrol-kosher-heart-memory-formula-60-maxicaps/:
  • “prevent cancer” 
Furthermore, your website has a tab titled, “Symptoms & Conditions” in which you list various diseases and link to products for each disease. Diseases you list include the following:
  • ADHD
  • Antifungal/Antiviral
  • Arthritis/Bone/Joint
  • Diabetes/Blood Pressure 
Finally, claims made on the shop section of your Facebook page, www.facebook.com/pg/DoctorVicks/shop/?rid=514915762050801&rt=9, from which you take orders for the products Freeda Vitamins – Chewable Lecithin Gram-O-Leci 1000 mg, Freeda Vitamins – Magnesium Citrate 400 mg, and Zahler’s – ParaGuard (Former BugFree) – Kosher Parasite Formula, provide further evidence that your products are intended for use as drugs:
 
On the Freeda Vitamins – Chewable Lecithin Gram-O-Leci 1000 mg product page, www.facebook.com/commerce/products/1123707364384842/
  • “useful for liver disease … and Manic-depressive disorder” 
On the Freeda Vitamins – Magnesium Citrate 400 mg product page, www.facebook.com/commerce/products/1267850796581707/
  • “help with or help prevent Asthma, depression, heart conditions, diabetes … osteoporosis” 
On the Zahler’s – ParaGuard (Former BugFree) – Kosher Parasite Formula product page, www.facebook.com/commerce/products/1380987761928636/
  • “fights worms and bug parasites”
  • “rid the body of worms and other parasites”
Your Freeda Vitamins – Garlic 400 mg, Freeda Vitamins – Niacin (B3) 500 mg, Freeda Vitamins – Quercetin 50 mg, Freeda Vitamins – Vitamin B2 (Riboflavin) 50 mg, Maxi Health – Livamax with Milk Thistle, Maxi Health – Maxi Omega-3 2000, Maxi Health – Triple Maxi Omega-3 Concentrate with D3 2000IU, Maxi Health – Maxi Resveratrol – Kosher Heart & Memory Formula, Freeda Vitamins – Chewable Lecithin Gram-O-Leci 1000 mg, Freeda Vitamins – Magnesium Citrate 400 mg, and Zahler’s – ParaGuard (Former BugFree) – Kosher Parasite Formula products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products 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 sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 335(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating 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 Freeda Vitamins – Garlic 400 mg, Freeda Vitamins – Niacin (B3) 500 mg, Freeda Vitamins – Quercetin 50 mg, Freeda Vitamins – Vitamin B2 (Riboflavin) 50 mg, Maxi Health – Livamax with Milk Thistle, Maxi Health – Maxi Omega-3 2000, Maxi Health – Triple Maxi Omega-3 Concentrate with D3 2000IU, Maxi Health – Maxi Resveratrol – Kosher Heart & Memory Formula, Freeda Vitamins – Chewable Lecithin Gram-O-Leci 1000 mg, and Freeda Vitamins – Magnesium Citrate 400 mg products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Furthermore, your products are intended for prevention of one or more diseases that are not amenable to prevention by consumers themselves without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your products are 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 these misbranded drugs violates 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 violations in connection with your products or their labeling. It is your responsibility to ensure that your products and labeling comply with the Act and its implementing regulations. 
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement 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 you will complete the corrections.
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. Your written response should be sent to Compliance Officer W. Martin Rennells, Compliance Officer, U.S. Food and Drug Administration, One Winner’s Circle, Suite 110, Albany, New York 12205. Compliance Officer W. Martin Rennells at (518) 453-2314 x 1038 or by e-mail at william.rennells@fda.hhs.gov.
 
 
 
Sincerely,
/S/ 
Ronald Pace
District Director
New York District

 

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