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, California 92612-2506
Telephone (949) 608-2900
Fax            (949) 608-4415 

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED                                                           
 
December 11, 2012
                                                                                                                                                     WL  11-13
AMARC Enterprises, Inc.
Attn: Albert Sanchez, CEO
1339 Broadway
El Cajon, CA 92021
 
Dear Mr. Sanchez:
                                                                             
This letter concerns your firm’s marketing of the products, Poly-MVA and Poly-MVA for Pets. The U.S. Food and Drug Administration (FDA) reviewed your websites, www.polymva.com and www.polymva.net, as well as literature included in the information packet which accompanied the sale and shipment of your product, “Poly MVA” on November 15 and has determined that “Poly MVA” 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 claims in the literature and on your websites establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your product with these claims violates the Act. 
 
In addition, we reviewed your websites at www.polymva4pets.com and www.polymvaforpets.com where you promote and sell your “Poly-MVA for Pets” veterinary product. We have determined that Poly-MVA for Pets is intended for use in the cure, mitigation, treatment, or prevention of disease in animals, or to affect the structure or function of the body of animals, which makes it a drug under section 201(g)(1) of the Act. [21 U.S.C. § 321(g)(1)]. Further, as discussed below, this product is an unapproved new animal drug as defined by the Act and your marketing of it therefore violates the law.  
 
Examples of claims in the form of testimonials, on your websites, www.polymva.com and www.polymva.net, on the webpage titled, “Customer Experiences” include:
 

 

 
Examples of claims also appear in the information packet, which was purchased from your website, www.polymva.com, and accompanied the shipment of your product, “Poly MVA.” Included in the packet is a book titled, “Poly-MVA A New Supplement in the Fight Against Cancer” with the following claims:
 
In Chapter 6 which is titled, “Palladium Lipoic Complex: Research Evidence”
 
On page 23:
 
 
In Chapter 7 titled, “True Stories of Cancer Survival with Palladium Lipoic Complex” are numerous testimonials, including the following:
 
On pages 32-33:
 
 
On page 41:
 
 
On Page 44 under the heading, “Case Study 4: Multiple Myeloma”:
 
 
On Pages 45-46, under the heading, “MANY MORE SUCCESS STORIES”:
 
 
In Chapter 8 which is titled, “Using Palladium Lipoic Complex for Nutritional Support and Protection”
 
On pages 47-48:
 
 
 
On page 48, under the heading, “PDLA FOR PROTECTION AGAINST STROKE-INDUCED BRAIN DAMAGE”:
 
 
On page 49 under the heading, “PALLADIUM LIPOIC COMPLEX AND AUTOMIMMUNE DISEASES”:
 
 
On page 49 under the heading, “PALLADIUM LIPOIC COMPLEX AND ENDOMETRIOSIS”:
 
 
On page 53 titled, “Conclusion”:
 
 
The information packet also included a document titled, “Testimonials” which contains the following claims:
 
 
 
 
We also noted the following claims on your firm’s website, www.polymvaforpets.com that show the intended uses of Poly-MVA for Pets:
 
On the webpages titled, “Tumors in Cats”, “Leukemia in Cats”, “Lymphoma in Cats”, “Symptoms of Cancer in Dogs”, “Osteosarcoma in Dogs”, “Sarcomas in Dogs”, and “Cancer in Dogs”:
 
 
On the webpage titled, “About Poly-MVA for Pets”:
 

 

 

 

 
On the webpage titled, “Pet Nutrition”:
 
 
On the webpage titled, “Find a Vet”:
 
 
On the webpage titled, “Customer Experiences” you include claims in the form of testimonials which establish the intended use of your product, “Poly-MVA for Pets” as a drug. Several examples of these claims include, but are not limited to, the following:
 
 
 
We also note claims made on your Facebook account accessible at: https://www.facebook.com/poly.mva, which includes a link to your website at www.polymva.com. The following are examples of the claims:
 
            In a March 10, 2011 post which was “liked” by “Poly Mva”:
 
 
In a May 5, 2010 post you provide a link to the blog post titled, “Children with Cancer Often Use Alternative Approaches” which can be found on your website at www.polymva.com/blog-news/218/children-with-cancer-often-use-alternative-approaches. At the end of the post is the following statement and a link to the website, www.facr.org:
 
 
Your products are not generally recognized as safe and effective for the above referenced conditions and therefore, these products are also “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 this drug safely for its intended uses. 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 the labeling fails to bear adequate directions for use. The introduction of misbranded drugs into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Further, Poly-MVA for Pets is considered a “new animal drug” under section 201(v) of the Act [21 U.S.C. § 321(v)] because it is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.
 
To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-l]. Poly-MVA for Pets is not approved or index-listed by the FDA, and therefore the product is considered unsafe under section 512(a) of the Act [21 U.S.C. § 360b(a)] and adulterated under section 501(a)(5) of the Act. [21 U.S.C. § 351(a)(5)].   The introduction of adulterated drugs into interstate commerce is prohibited under 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 your products and their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory 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. 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 state the date by which the corrections will be completed.
          
Your response should be sent to:
 
Mr. Blake Bevill
Director, Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506
 
If you have questions regarding any issues in this letter, please contact Marco Esteves, Compliance Officer at 949-608-4439.
 
Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District
 
 
Cc:     
Ms. Ingeborg Small, Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS 7602
P.O. Box 997435
Sacramento, California 95899-7435
 

This page was posted on November 24, 2018.

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