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:
On the Cholestrien product webpages, www.atihealthnet.com/pages/cholestrien.html, www.naturalvigor.com/cholestrien.html:
On the ImmunPro product webpages, www.atihealthnet.com/pages/issf.html, www.naturalvigor.com/issf.html and www.naturalvigor.com/chemo1.html:
On the Livral Complex product webpages, www.atihealthnet.com/pages/livralcomplex.html and www.naturalvigor.com/livralcomplex.html:
On the Prozidan product webpages, www.atihealthnet.com/pages/prozidan.html and www.naturalvigor.com/livralcomplex.html:
On the “Nutrition and Cancer” webpage, www.atihealthnet.com/pages/research2.html:
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:
On the Cholestrien product webpages:
On the Immunpro product webpage:
On the Livral Complex product webpages:
On the Prozidan product webpages:
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:
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

This page was posted on April 30, 2019.

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