Inspections, Compliance, Enforcement, and Criminal Investigations

Northern Health Products 12/22/16

 

  

Black HHS-Blue FDA Logo

 

 

 
Atlanta District
60 8th St NE
Atlanta, GA 30309 

 

December 22, 2016
 
VIA UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
Kevin J. Jessup
Northern Health Products, Inc.
4095 Winchester Way
Loganville, GA 30052
WARNING LETTER
(17-ATL-03)
Dear Mr. Jessup:
 
 
This letter concerns your firm's marketing of several drugs intended for use in humans or animals, including DCA Cancer Treatment Kit (Sodium Dichloroacetate and Thiamine Vitamin 81), ALA Alpha Lipoic Acid, N-A-C N-Acetyl L-Cysteine, DMSA Synergy, and DCA (sodium dichloroacetateL also referred to as "Pet DCA". The U.S. Food and Drug Administration (FDA) reviewed your websites at the internet addresses www.northernhealthproducts.com, www.petdca.com and numerous other related websites1 where you promote and sell these products. As discussed further below, we have determined that your marketing of these products violates the Federal Food, Drug, and Cosmetic Act (the Act). You may find the Act through links on FDA's website at www.fda.gov.
 
I.    Unapproved New Drugs
 
FDA reviewed your website at the Internet address www.northernhealthproducts.com in September 2016 and determined that you take orders there for the products DCA Cancer Treatment Kit (Sodium Dichloroacetate and Thiamine Vitamin BlL ALA (Alpha Lipoic Acid), and N-A-C (N-Acetyl L- Cysteine). The claims on your website establish that the products are drugs under section 201(g)(1)(B) of 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.
 
Examples of some of the claims that provide evidence that your products are intended for use as drugs include:
 
DCA Cancer Treatment Kit
 
• "DCA Cancer Treatment Kit"
 
• "Pure DCA Cancer Treatment Supplement"
 
• "Medical studies ... confirmed that scientists now believe the understand the true cause of cancer! For more information, read the full information at the DCA Cancer website here.  In 2011 there were an estimated 1,596,670 new cases of cancer (not including non-melanoma skin cancers). DCA can be an effective tool in shrinking tumor size and mass, reversing illness, and increasing health and vitality of patients."
 
• "Thiamine B1 Supplements are an important part of your DCA cancer treatment. Thiamine is the food that DA uses so it's important to supplement your treatment with Thiamine to avoid Thiamine Deficiency and possible neuropathy (which is a result of Thiamine Deficiency, not a side-effect of DCA)."
 
This product page directly links to this website:
 
http://dcacancer.org/dca-information/
 
• "DCA Cancer Information"
 
• "Representatives from the University of Alberta (UA) claim that it is possible to use DCA as a cure for various forms of cancer. One of the professors from the above mentioned University proved that DCA helps with regression of lung and breast cancers, as well as brain tumors (among others)."
 
• " It was successfully used in treatment of inborn defects connected with metabolism. These diseases were reported to have a connection with mitochondria. It should be noted that for nearly 80 years researchers have known that cancer has a negative influence on mitochondria, causing them to function abnormally. For most of this time, however, the most popular claim was that it was not possible for the mitochondria to function normally after they have been affected by cancer."
 
• "The results of the tests surpassed his expectations. Dichloroacetate (DCA) not only prevented the mitochondria from being devastated, but also decreased the tumor growth in test tubes and animal models. Unlike a great number of chemotherapies used nowadays, DCA did not affect healthy tissues."
 
• "According to Michelakis, this may happen because DCA targets a process, which may only be observed in cancer cells. He stressed the fact that Dichloroacetate may be used as a treatment for several forms of cancer."
 
• " Because DCA is a small molecule, it is easier for the body to absorb it. Therefore, it may be used to treat forms of cancer such as brain cancers, which are unreachable by commonly used drugs. DCA was marked as relatively non-toxic and therefore action may be taken to test it on people with cancer."
 
ALA Alpha Lipoic Acid
 
• "Chelation treatment is the removal of toxic heavy metals such as lead and mercury using a product called DMSA."
 
• "DMSA alone can NOT enter the brain to remove toxic heavy metals. To enter the brain and remove heavy metals ALA must be taken at the same time as DMSA is taken."
 
N-A-C N-Acetyl L-Cysteine
 
"Clinical Applications"
 
1. "Heart disease. Research has pinpointed a specific lipoprotein called Lp(a) as one of the two most reliable indicators of heart disease. Lp(a) is a much more reliable indicator than blood cholesterol levels, low density lipoprotein (HDL) levels, or the ratio of LDL to HDL."
 
"Diets and drugs designed to lower blood cholesterol levels do not lower Lp(a) levels. Recently, it was reported that NAC is the most effective nutrient known to lower Lp(a) levels."
 
"NAC also inhibits heart damage by preventing LDL from being oxidized, by reducing plasma homocysteine levels, and by free-radical quenching effects. NAC also protects against ischaemic and reperfusion damage. NAC also potentiates the coronary dilating and anti-platelet effects of nitroglycerine as well as limiting the development of tolerance to nitroglycerine. Finally, ST-depression, a clinical sign of myocardial ischaemia, was not seen following pretreatment with NAC, suggesting attenuation of impaired tissue oxygenation and preservation of myocardial performance by NAC."
 
2. "Immunity and AIDS. NAC effects immunity via its role in intracellular GSH production. This role becomes clinical when normal GSH production pathways are impaired, as for example, by HIV. Eck has shown that reduced intracellular GSH is the "direct and early consequence of retroviral infection". Intracellular GSH has a powerful influence on how well T- and B-lymphocyte cells function and the production of phagocytes (macrophages, monocytes and neutrophils). NAC has been shown to block the AIDS virus production in-vitro."
 
3. "Detoxification & Chelator. Sulphydryl groups protect against toxins. SH groups react directly with many poisons, including herbicides, drugs (acetaminophen), environmental pollutants such as carbon tetrachloride, microorganisms including E. coli and aflatoxin, and against heavy metals. Indirectly, NAC helps with detoxification by producing optimal amounts of GSH for conjugation reactions, making harmful compounds less toxic."
 
"NAC is approved as a drug for use to prevent liver damage from acetaminophen overdose."
 
4. "NAC has been used for over 30 years as a mucolytic in persons having bronchopulmonary diseases including chronic bronchitis, cystic fibrosis, asthma, sinusitis, and pneumonia. Recently, a number of studies have appeared studying the role of NAC in preventing influenza. In 1991, in an Italian multi- centric double-blind, placebo-controlled study of 262 patients (75% were over 65 years of age), NAC dose of 600mg twice a day resulted in only 29% developing flu-like clinical syndrome, compared to 51% of placebo-treated subjects (p=0.0006)."
 
Your above products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are "new drugs" under section 20l(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 FDA, as described in section SOS(a) of the Act [21 U.S.C. § 3SS(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)].  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.
 
Further, your products, DCA Cancer Treatment Kit (Sodium Dichloroacetate and Thiamine Vitamin B1), and N-A-C (N-Acetyl L-Cysteine) 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 these drugs safely for their intended purposes.
 
Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)). The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
II.    "DMSA Synergy" Product
 
Based on our review of your websites, www.northernhealthproducts.com and www.dmsachelation.com, we have determined that your product DMSA Synergy is an unapproved and misbranded drug in violation of sections 505(a) and 502(f)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 355(a) and 352(f)(1)].
 
DMSA, which is listed as an ingredient in your DMSA Synergy product, is the active pharmaceutical ingredient (API) in the FDA-approved drug DMSA Kit for the Preparation of Technetium TC-99M Succimer for Injection (hereinafter "DMSA Kit" ), approved on May 18, 1982, for the use as an aid in the scintigraphic evaluation of renal parenchymal disorders and CHEMET®, approved on January 30, 1991, to treat lead poisoning in pediatric patients. You market DMSA Synergy as a dietary supplement. However, under section 201(ff)(3)(B) of the Act [21 U.S.C. § 321(ff)(3)(B)], dietary supplements cannot contain an article that is approved as a new drug under section 505 of the Act unless that article was marketed as a dietary supplement or food prior to FDA approval of such drug. To the best of our knowledge, DMSA was not marketed as a dietary supplement or food prior to FDA's approval of DMSA Kit or CHEMET®. Therefore, your product DMSA Synergy is excluded from the definition of a dietary supplement under section 201(ff)(3)(B) of the Act.
 
Based on the claims, your product DMSA Synergy is a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevent ion of disease. Examples of labeling claims that establish the intended use of DMSA Synergy include, but are not limited to, the following:
 
www.northernhealthproducts.com
• Product tags: "Chelation Therapy, DMSA, Heavy Metal Poisoning, Lead Poisoning, Mercury Poisoning"
 
www.dmsachelation.com
• "DMSA Chelating Agent Removes 20 Toxic Metals Quickly"
 
• "DMSA is used to remove toxic heavy metals. It is particularly effective at removing lead and mercury. If you have lead poisoning symptoms or arsenic poisoning symptoms DMSA can help you. It is safe and works very quickly. No Prescription Needed."
 
Your product DMSA Synergy is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a "new drug" 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 FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 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 uses. "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 product DMSA Synergy is offered for conditions not amenable to self-diagnosis and treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, DMSA Synergy fails to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug violates section 301(a) of the Act [21 U.S. C.§ 331(a)].
 
III.    Unapproved New Animal Drugs
 
FDA has determined that your product DCA (sodium dichloroacetate), also referred to on your websites at the internet addresses www.northernhealthproducts.com and www.petdca.com as "Pet DCA," is intended for use in the mitigation, treatment, or prevention of disease in animals, which makes it a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g){1){B)] . Further, as discussed below, this product is an unapproved new animal drug and introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.
 
Examples of some of the claims that provide evidence that your product DCA (sodium dichloroacetate)/ "Pet DCA" is intended for use as a drug include:
 
• "A new product called DCA (sodium dichloroacetate) has had many amazing results in clinical trials by dramatically reducing tumors by 70% in just three weeks!"
 
• "This cat cancer treatment is a massive leap forward unlike conventional cat cancer treatment options such as radiation, chemotherapy, and other prescription drugs because DCA is easily absorbed by the body and only affects cancerous cells. Treatments such as radiation and chemotherapy wreak havoc on the body, killing good and bad cells, and has to be administered by specialists so the patient doesn't die before the cancer does."
 
• "DCA works as an effective cat cancer treatment because it assists in correcting the damaged cells (cancer cells) and leaves healthy cells intact."
 
• "Unlike other dog cancer treatment options, DCA only affects cancerous cells and leaves healthy cells intact. Other treatments such as chemotherapy and radiation kill both healthy cells and bad cells, wreaking havoc and leaving patients sick, weak, and suffering."
 
• "As a dog cancer treatment, DCA can be a humane and effective tool in riding your beloved pet from cancer."
 
Because this product is intended to prevent, mitigate or treat disease in animals, it is a drug within the meaning of section 201(g)(1)(B) of the Act, [21 U.S.C. § 321 (g)(1)(B)]. Moreover, this product is a new animal drug, as defined by 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. It is not the subject of 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-1]. Therefore, is is unsafe within the meaning of 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 an adulterated drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
This letter is not intended to be an all-inclusive review of your products. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
 
We note that you also market over-the-counter (OTC) drugs, Gravol, on your website. It is your responsibility to ensure that your OTC drug products comply with, in part, an applicable OTC drug monograph or have an approved application in effect to be legally marketed in the United States.
 
You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include any documentation necessary to show that correction has been achieved. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.
 
Please direct your response to Janice L. King, Compliance Officer, U.S. Food and Drug Administration, 60 Eighth Street, NE, Atlanta, GA 30309.
 
 
Sincerely,
/S/
Ingrid A ZambranaDistrict Director
Atlanta District Office
Southeast Region, Office of Regulatory Affairs
U.S. Food and Drug Administration
 
______________________________________
1 FDA reviewed your other related websites, including but not limited to: www.petdca.com, www.northerhealthproducts.com, www.Iivercancerindogs.com, www.lymphomaincats.com, www. wheretobuydca.com, www .osteosarcomaindogs.net, www.lumpsondogs.net, www.skincancerindogs.net, www.petdca.org, www.caninelymphoma.org, www.catcancer.org, www.dcacancer.org, www.puredca.com, www.thedcastore.com, www.dcatestimonials.com, and www.dmsachelation.com.

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