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Public Health Service Food and Drug Administration |
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Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax
(949) 608-4415 |
Department of Health and Human Services
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:
- “I want everyone to know that I am now 3 years clear of lung cancer!! When I was told I had a mass in my lung, the first thing I did when I returned home was to call AMARC Enterprises – the PolyMVA people. PolyMVA helped save my life. I began a regimen of PolyMVA…After 3 months, the Stage 2 cancer was down to Stage 1. And here I am, 3 years later…the PET Scan is as clear as a bell. Thank you again and again for the support that PolyMVA gave my body in my fight against cancer!”
- “…I said “No” Chemotherapy!…I became quite ill and was diagnosed with stage 3 ovarian cancer…I had surgery to remove a very large tumor and was scheduled to begin an aggressive chemotherapy regimen as the cancer had spread. Even with chemotherapy I was aware that the prognosis was not encouraging…One of the supplements that my naturopath highly recommended was Poly MVA…In my opinion anyone in my situation involving cancer could be greatly improved by using Poly MVA…”
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:
- “[An] [o]ncological surgeon…administered Palladium Lipoic Complex intravenously to ninety-five patients. The cancers from which these patients suffered included cancers of the breast, lung, colon rectum, prostate, pancreas, ovary, skin (malignant melanoma), and brain. Ninety percent of the patients had failed to improve after undergoing virtually all available therapy. During their experimental treatment with Palladium Lipoic Complex, they received moderate doses of chemotherapy. Under normal circumstances, 20 to 60 percent of patients would only survive an average of another six months. However, nine months after initiation of intravenous Palladium Lipoic Complex, 90 percent of them were still alive.”
In Chapter 7 titled, “True Stories of Cancer Survival with Palladium Lipoic Complex” are numerous testimonials, including the following:
On pages 32-33:
- “[A] forty-two-year-old breast cancer survivor discovered Palladium Lipoic Complex very shortly after her breast cancer diagnosis…At the time of her surgery, she had been taking Palladium Lipoic Complex for fifteen days, and a preoperative ultrasound showed that her tumor had shrunk.”
On page 41:
- “Today, Daniel’s tumor is inactive due to necrosis. There has been “no growth” since he began taking PdLA. The post-radiation side effects are more manageable because of this supplement.”
On Page 44 under the heading, “Case Study 4: Multiple Myeloma”:
- “An Alaskan woman diagnosed with multiple myeloma sent a letter to the makers of Palladium Lipoic Complex. She had received her diagnosis…and after taking Palladium Lipoic Complex for a little over two years, she was told that her blood tests and exams showed “no measurable signs of multiple myeloma carcinoma” and that she was “in total remission.””
On Pages 45-46, under the heading, “MANY MORE SUCCESS STORIES”:
- “A thirty-month outcome-based investigation by Dr. James W. Forsythe, lends further support for Palladium Lipoic Complex in the treatment of late-stage cancer…In this study, the greatest impact of Palladium Lipoic Complex was seen in cancers of the breast, lung, and prostate…As you have read, Palladium Lipoic Complex has powerful, remarkable results for many types of cancer patients.”
In Chapter 8 which is titled, “Using Palladium Lipoic Complex for Nutritional Support and Protection”
On pages 47-48:
- “In a time when one out of three people can expect to have cancer at some point, it make sense to improve your odds every way you can and Palladium Lipoic Complex…would be an excellent way to do so.”
- “Free-radical accumulation with inadequate antioxidant protection is implied in the causes and effects of many other diseases, including diabetes, Alzheimer’s dementia, heart disease, stroke and arthritis. Palladium Lipoic Complex is a superior antioxidant that could help to prevent these diseases as well.”
On page 48, under the heading, “PDLA FOR PROTECTION AGAINST STROKE-INDUCED BRAIN DAMAGE”:
- “When Palladium Lipoic Complex is administered immediately following a global ischemic insult, apoptic death is reduced by 70 percent.”
On page 49 under the heading, “PALLADIUM LIPOIC COMPLEX AND AUTOMIMMUNE DISEASES”:
- “Practitioners who use Palladium Lipoic Complex have found that both oral and topical versions are effective for the treatment of psoriasis – even the most severe cases.”
On page 49 under the heading, “PALLADIUM LIPOIC COMPLEX AND ENDOMETRIOSIS”:
- “Palladium Lipoic Complex offers a remarkably effective alternative treatment for endometriosis.”
On page 53 titled, “Conclusion”:
- “PdLA compounds were specifically designed to support healthy cells with the goal of selectively destroying abnormal cells without harming noncancerous cells. The manner in which Palladium Lipoic Complex does so has yet to be completely explained, but the research and the success stories from cancer patients are compelling enough – and the substances nontoxic enough – to merit its use by anyone who wishes to reverse or prevent cancer.”
The information packet also included a document titled, “Testimonials” which contains the following claims:
- “I would recommend Poly-MVA for anyone wanting to be more healthy…especially if your systems are compromised…due to cancer.”
- “I received the news of my recurrent brain tumor with dread and shock. My father…sent me my first bottle of Poly-MVA. I took it immediately along with the conventional treatments. Since then, I have had clean MRI scans and I consider Poly-MVA…to be the cornerstones of my recovery.”
- “I was diagnosed with uterine cancer (carcino sarcoma)…I had radical surgery and there was the possibility that it may have metasticized [sic] into the upper abdomen. I was introduced to this product…before I was scheduled for chemotherapy…I never had nausea or vomiting. I had increased energy and a hearty appetite. My…Gyn Oncologist…was so amazed at my rapid recovery…During cold and flu season I was not affected. My blood cells were normal…I did receive a miracle and I know that God has given you the formula for helping people with life threatening diseases…I had recovered so well and so fast that I did not need to complete the radiation and chemotherapy treatments that were supposed to last for six more months…”
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”:
- “Poly-MVA for Pets is a unique and patented nutriceutical form of nutritional support for animals, clinically shown to be effective by numerous veterinarians and pet owners alike for animals undergoing cancer therapy. The unique nature of Poly-MVA for Pets makes it safe, effective and well-suited for your pet, so your beloved companion will feel better and experience a greater quality of life.”
On the webpage titled, “About Poly-MVA for Pets”:
- “Poly MVA for Pets is perfect for animals facing all types of health, nutrition or energy challenges. Furthermore, if your pet is dealing with a difficult illness, or an associated treatment such as chemotherapy or radiation therapy, Poly-MVA for Pets may be just what you’re looking for.”
- “Notable with the cancer research is the fact that a majority of the most common canine cancers have seen positive results when PdLA is a part of an integrative protocol:”
- “The largest clinical integrative cancer investigation of PdLA was a veterinary oncology program with over 900 dogs enrolled. Patients received the PdLA supplement as part of their chemotherapy radiation and/or surgical protocol. The PdLA seemed most effective in the cases of solid tumors (i.e. soft tissue sarcoma, hemangiosarcoma, mast cell, transition cell carcinoma, lung, anal sac carcinoma, renal carcinoma, squamous cell carcinoma, fibrosarcoma, melanoma, menigioma [sic],neuroblastoma, mammary adenocarcinoma). Some of the most effective findings were apparent in the osteosarcoma patients. (Notable is that the cause/origin of osteosarcoma in large dogs is considered identical to the disease progression in human children.) In this study, integrative PdLA support (PdLA + amputation) improved the animals’ median survival time 62% (103 days more) compared to surgery alone. When the PdLA supplement was added to the chemotherapeutic regimen, the dogs exhibited a 27% longer median survival (79 days more).”
- “A leading veterinary oncologist used PdLA in his practice and concluded that following PdLA complementary support, chemotherapeutic animals demonstrated improvements in various objective parameters (i.e. weight, anemia, liver and kidney function).”
On the webpage titled, “Pet Nutrition”:
- “Whether your pet is an older pet, is facing a serious illness and/or harsh treatment. . . Poly-MVA for Pets offers nutritional support that can ensure that your animal companion maintains a full, active and enjoyable life.”
On the webpage titled, “Find a Vet”:
- “Many veterinarians across the country are utilizing Poly-MVA for Pets in their protocols for overall pet health and well-being, and when dealing with degenerative disease.”
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:
- “I started my chow on Poly-MVA for Pets right away, along with other nutrients, to help her immune system keep her melanoma at bay. That was years ago, and she is still full of life and still bringing joy to our lives!”
- “My 10-year-old chocolate lab. . . was diagnosed with liver cancer. . . I was told she had a month to live. . . . the vet. . . did say “you might want to try Poly-MVA for Pets for support”. . . . now. . . [my dog] is eating again and still taking her 2.1 mile walks a day!”
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”:
- “PolyMVA has done wonders for me. I take it intravenously 2x a week and it has helped me tremendously. It enabled me to keep cancer at bay without the use of chemo and radiation…Thank you AMARC”
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:
- “For information on how palladium lipoic complexes can nutritionally support the body during cancer and cancer therapy, visit the Foundation for Advancement in Cancer Research’s website.”
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 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 i
nclude 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.
nclude 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.
