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  5. Aie Pharmaceuticals Inc - 512100 - 04/17/2017
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WARNING LETTER

Aie Pharmaceuticals Inc MARCS-CMS 512100 —

Recipient:
Aie Pharmaceuticals Inc

United States

Issuing Office:
Los Angeles District Office

United States

 

  

Black HHS-Blue FDA Logo

 

 

 
Los Angeles District
19701 Fairchild Road
Los Angeles, CA 92612 

 

WARNING LETTER
 
 
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
April 17, 2017                                                                                                                                    
                                                                                                                           WL # 25-17
Dr. Magdi Youssef
AIE Pharmaceuticals, Inc.
1845 South Vineyard Ave.
Unit #5
Ontario, CA 91761
 
Dear Dr. Youssef:                                                                                         
                                   
This is to advise you that the Food and Drug Administration (FDA) has reviewed your websites at the Internet addresses www.atihealthnet.com and www.naturalvigor.com, in December 2016. You take orders on these websites for several of your products, including your Cevrogin, Cholestrien, ImmunPro, Livral Complex, and Prozidan. The claims on your websites establish that these 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 for such uses violates the Act. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
 
Examples of some of the claims observed on your websites that provide evidence your products are intended for use as drugs include the following:
 
On the Cevrogin product webpages, www.atihealthnet.com/pages/diabetes.html and www.naturalvigor.com/diabetes.html:
  • “Blood Sugar Lowering Effect … reduce their insulin doses to a bare minimum after using Cevrogin”
  • “Reduces Cholesterol … anti-diabetic”
  • “Takes care of Diabetic Neuropathy … relieves you of the symptoms of diabetic Neuropathy”
  • “Dandelion root has also been shown to have potential for fighting cancer”
  • “Ginseng … lower blood pressure & glucose levels when they are high, and raise them … when they are low”
  • “Kelp … treatment of obesity, heart disease, high blood pressure, thyroid deficiency … infectious disease”
  • “L-Carnitine … beneficial effects for treating diabetes”
  • “Guggul (Commiphora Mukul) … reduces the risk associated with … complications of diabetes including atherosclerosis, blindness and nerve degeneration”
  • “Gurmar (Gymnema sylvestris) … lowers blood sugar … helps repair liver, kidney and muscle tissue. In one trial, all 22 patients using gurmar were able to reduce their diabetes medication and five were able to completely stop using pharmaceutical drugs.” 
On the Cholestrien product webpages, www.atihealthnet.com/pages/cholestrien.html, www.naturalvigor.com/cholestrien.html:
  • “Cholestrien is a revolutionary formula that helps to reduce LDL (bad) cholesterol … reduce high blood pressure, anxiety and heart attacks.”
  • “Policosanol has been shown to be equally effective as Zocor® or Pravachol® at lowering low-density lipoprotein (LDL) and total cholesterol levels.”
  • “Lower total cholesterol levels by 21% … Lower LDL levels, or bad cholesterol, by 29% … Increase high-density lipoprotein (HDL) levels, or good cholesterol, by 15%”
  • “prevention of atherosclerosis … shown to reduce blood pressure levels”
  • “potent cholesterol lowering components”
  • “Guggul exhibits a cholesterol lowering ability unlike any other natural substance. In human trials, using gugulipid, the cholesterol levels dropped 14 to 27 percent in a 4 to 12 week period while the tryiglyceride levels dropped from 22 to 30 percent. This guggul has great effect in preventing heart atherosclerosis”
On the ImmunPro product webpages, www.atihealthnet.com/pages/issf.html, www.naturalvigor.com/issf.html and www.naturalvigor.com/chemo1.html:
  • “anti-viral, anti-bacterial and anti virus activity”
  • “kill germs that cause fevers and infections”
  • “Fevers of all kinds, including the rare typhoid, malaria, and meningitis, have been successfully treated and/or prevented by these herbal ingredients.”
  • “effective against … bacterial infections, Bronchitis … chronic infections … Diabetes, Emphysema, fungal infections, parasitic infections, periodontal disease, Pneumonia, radiation exposure … all viral infections”
  • “proven to still be effective against cancer"
  • “proven its effectiveness against all infectious diseases caused by viruses and bacteria”
  • “proven effective against: AIDS … Cancer (all types) … Herpes Simplex” 
On the Livral Complex product webpages, www.atihealthnet.com/pages/livralcomplex.html and www.naturalvigor.com/livralcomplex.html:
  • “The Alternative Hope For Hepatitis, Cirrhosis, Cancer and AIDS Victims”
  • “Also protects the liver from damage associated with … infections such as hepatitis viruses.”
  • “Stop the advancement of liver cirrhosis”
  • “Inactivate HIV as well as Bilharziasis”
  • “Prolong survival rates in alcoholic cirrhosis”
On the Prozidan product webpages, www.atihealthnet.com/pages/prozidan.html and www.naturalvigor.com/livralcomplex.html:
  • “improvements in … depression, anxiety … insomnia, anorexia”
  • “Reduce anxiety and depression”
  • “Saint John’s Wort … treatment of infectious diseases such as … syphilis, tuberculosis, dysentery, whooping cough and worms … treatment of depression, anxiety … insomnia.”
  • “Niacinamide … reduces the cholesterol level … reduces high blood pressure”
  • “Rhodiola Rosea … decrease depression” 
On the “Nutrition and Cancer” webpage, www.atihealthnet.com/pages/research2.html:
  • “beta carotene decreases the risk of a variety of cancers”
  • “cancer-inhibiting benefits, particularly for cancers of the stomach and esophagus.”
  • “Vitamin E has been shown to protect against cancer”
  • “Green Tea and Vitamin D May Lower Prostate Cancer: Epidemiologic studies suggest that vitamin D and green tea may help prevent prostate cancer”
  • “Benefits of Beta Carotene for Prostate Cancer: Beta carotene may sharply reduce the risk of prostate cancer”
  • “Wine My Delay Cancer … group of mice fed wine solids were free of tumors 40 percent longer than mice without wine in their diets.”
  • “Vitamin A Fights Melanoma”
  • “D-3 vitamin compound hindered cancerous lesions”
  • “Black Tea May Fight Skin Cancer”
  • “Selenium Reduces Mortality Rates for Cancer … a 50-percent reduced risk of death from cancer and a 17-percent decrease in overall mortality.”
  • “Grape Seed Extract May Inhibit Tumors”
  • “Grape Substance Inhibits Tumor Formulation … can inhibit tumor formulation at three stages of cancer.”
  • “Soy May Reduce Risk of Uterine Cancer … 54-percent reduction in endometrial cancer risk”
  • “Maitake Mushroom Exhibits Anticancer Effects … improvement in tumor regression in 11 out of 15 breast cancer patients, 12 out of 18 lung cancer patients and seven out of 15 liver cancer patients.”
Moreover, the claims quoted above are supplemented by the meta tags used to bring consumers to your website through Internet searches. The meta tags include:
 
On the Cevrogin product webpages:
  • “Cevrogin helps to lower blood glucose levels in type II diabetics … diabetes, diabetic, herbs for diabetes”
On the Cholestrien product webpages:
  • “helps to reduce LDL while increasing HDL … lower cholesterol, lowering cholesterol”
  • “Liver Hepatitis, Liver Cirrhosis, Alcoholic Liver Disease, Liver Cancer Alternative…Congestive, Heart Failure, cystitis, PMS, Osteoporosis, Bone Loss … Breast Cancer Alternative… Prostate Cancer … High Blood Cholesterol, High Cholesterol … Depression … Arthritis, Rheumatoid, High Blood Pressure, Diabetes, Type II … Lung Cancer, Breast Cancer, Liver Cancer, Leukemia, Pancreatic Cancer, Non‐Hodgkin's, Hodgkin's Disease, Lymphoma, Thyroid cancer, Stomach Cancer, AIDS, HIV, Ovarian Cancer, Colon Cancer”
On the Immunpro product webpage:
  • “arthritis … osteoarthritis, rheumatoid … diabetes … hepatitis … cancer … depression, anxiety, antidepressant … migraine, insomnia, anorexia … impotence … flu … ImmunPro is a anti-viral, H1 Influenza Virus protection, and anti-bacterial activity”
On the Livral Complex product webpages:
  • “hepatitis C, hcv, chronic hepatitis c, hepatitis b, viral hepatitis, cirrhosis" 
On the Prozidan product webpages:
  • “depression … antidepressant … postpartum depression, treatment of depression … anxiety depression, anxiety attack, natural herbal antidepressants alternative health”
Finally, claims made on your Facebook page, www.facebook.com/Aiepharma, which links to your website www.naturalvigor.com where your products can be purchased directly, provide further evidence that your products are intended for use as drugs:
 
On your February 20, 2013 post:
  • “Livral Complex may … stop the advancement of liver cirrhosis … stop Hepatitis virus … Inactivate HIV as well as Bilharziasis”
Your Cevrogin, Cholestrien, ImmunPro, Livral Complex, and Prozidan products are not generally recognized as safe and effective for the conditions, prescribed, recommended, or suggested in the labeling thereof 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), 355(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 Cevrogin, Cholestrien, ImmunPro, Livral Complex, and Prozidan 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. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your Cevrogin, Cholestrien, ImmunPro, Livral Complex, and Prozidan do not bear adequate directions for their intended use and, therefore, 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.
 
Please send your reply to:
 
Kelly D. Sheppard
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. If you have any questions about the contents of this letter, please contact Daniel Cline at 949-608-4433 or via e-mail to Daniel.Cline@fda.hhs.gov.
 
 
Sincerely,
/S/
CDR Steven E. Porter, Jr.
Los Angeles District Director
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