Inspections, Compliance, Enforcement, and Criminal Investigations
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PruTect Rx 8/27/12
| Public Health Service Food and Drug Administration |
| Denver District Office Bldg. 20-Denver Federal Center P.O. Box 25087 6th Avenue & Kipling Street Denver, Colorado 80225-0087 Telephone: 303-236-3000 |
Department of Health and Human Services
August 27, 2012
WARNING LETTER
UPS OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
PruTect Rx
Attn: Chad Prusmack, M.D.
9457 South University Blvd.
#165
Highlands Ranch, CO 80126
Ref #: DEN-12-18-WL
Dear Dr. Prusmack:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website, www.prutectrx.com, in August 2012 and has determined that your NeuroPruTect, Omega3PruTect, VitaminD3PruTect, and OsteoPruTect products are promoted for conditions that cause the products to be 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)]. The claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act. You can find the Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.
Examples of the claims observed on your website include the following:
On the webpage titled, “Introducing the PruTect Series”:
- “Omega3PruTect… lowering cholesterol”
- “NeuroPruTect … reducing … cognitive decline, including Alzheimer's. NeuroPruTect also helps prevent nerve damage and post-concussion syndrome in all athletes…”
On the webpages titled, “Harnessing the Spice of Life with NeuroPruTect” and “NeuroPruTect”:
- “Reduces … cognitive decline (including Alzheimer’s)”
- “Prevents nerve damage (numbness/weakness) … like carpal tunnel syndrome”
- “Prevents post-concussion syndrome in both amateur and professional athletes”
- Pterostilbenes (ingredient of NeuroPruTect): “Pterostilbenes…helps prevent cancer and other diseases.”
- “NeuroPruTect … reduc[es] the effects of … nerve damage, and post-concussion syndrome caused by head trauma.”
On the website titled, “Preventing Post-Concussion Syndrome”:
- “NeuroPruTect contains 200mg of turmeric (95% curcuminoids), which prevent the effects of a condition that is gaining awareness among professional and youth athletes: post-concussion syndrome…. Turmeric plays a role in reducing the effects of repeated head trauma …. Turmeric limits damage, reducing side effects and shortening recovery time.”
- “As part of the PruTect Series, NeuroPruTect … reduc[es] the effects of … nerve damage, and post-concussion syndrome caused by head trauma.”
On the website titled, “Omega3PruTect: Improve Mental Health”:
- “Like its sister product NeuroPruTect, Omega3PruTect can help reduce mood disorders, depression, … and even memory loss by reducing inflammation with docosahexaenoic acid (DHA) found in Omega-3.”
- “Low DHA levels lead to brain cells becoming less fluid and pliant …. This puts the brain at risk of maximum damage during a concussion or other traumatic brain injury. Omega3PruTect increases the body's DHA level, which helps keep the brain resilient…. Low DHA levels also leads to a limiting of how many red blood cells can reach the brain, increasing the likelihood of death during cardiac arrest, known as ‘sudden cardiac death.’”
- “In his article, "Omega-3 fatty acid supplementation and reduction of traumatic axonal injury in a rodent head injury model," Dr. Bailes shows that Omega-3 supplementation prevented significant neuron damage in traumatic head injury. This suggests Omega-3 may also help prevent post concussive syndrome and/or cognitive decline.”
- “Because the body cannot produce Omega-3 that is commonly found in fish oil, it is important to take supplements like Omega3PruTect to … limit inflammation that affects the brain.”
On the webpage titled, “SurgiPack: Optimize Your Surgical Recovery”:
- The PruTect Series supplements in SurgiPak: “These supplements ... help ensure a fast recovery with minimal pain, inflammation and risk of infection when taken on a perioperative basis–30 days before and after surgery”
- “SurgiPack … is especially useful for the following surgeries:”
o “Spinal fusion”
o “Joint, hip and knee replacements”
o “Procedures affecting the shoulder, back, and soft tissue (e.g. ACL)”
On the webpage titled, “Omega3PruTect Fish Oil Supplement”:
- “Omega3PruTect … reduces back pain, joint pain, arthritis, and allergies.”
On the webpage titled, “VitaminD3PruTect: Liquid Sunshine”:
“The active form of Vitamin D3 … lowers the risk of colon, breast and prostate cancer–even multiple sclerosis (MS).”
On the webpage titled, “OsteoPruTect: Supports Total Bone Strength and Joint Health”:
- “OsteoPruTect pharmaceutical-grade supplements feature 550mg of highly absorbable calcium that binds with one of the leading collagen-generating catalysts on the market . . . . This combo enhances . . . strength . . . and flexibility to prevent fractures at all ages. The addition of Vitamin D3 . . . helps prevent cancer, Parkinson’s and MS.”
- “OsteoPruTect is ideal for:
o Osteoporosis Prevention: particularly for menopausal women and smokers at high risk . . .
o Reduced Joint Pain: when combined with OmegaPruTect, the collagen created by ch-OSA promotes connective tissue generation that eases suffering
o Surgical Recovery: including those who’ve recently had shoulder, spine or anything bone-related”
These claims on your website that promote your products for use in the cure, mitigation, treatment, or prevention of disease establish that your products are drugs. Your products are not generally recognized as safe and effective for the above referenced uses 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 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 NeuroPruTect, Omega3PruTect, VitaminD3PruTect, and OsteoPruTect 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 these drugs safely for their intended purposes. 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 their labeling fails to bear adequate directions for use. 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)].
The violations cited in this letter are not meant to be an all-inclusive list of violations that exist in connection with your products and their labeling. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, such as seizure and/or injunction.
Please notify this office in writing within fifteen (15) business days from your receipt of this letter as to the specific steps you have taken to correct the violations cited above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections within fifteen days, explain the reason for the delay and state the date by which the corrections will be completed.
Please send your reply to the attention of Nancy G. Schmidt, Compliance Officer, Food and Drug Administration, 6th Ave. and Kipling St., Building 20 DFC; P.O. Box 25087; Denver, CO 80225-0087. If you have any questions regarding this letter, please contact Ms. Schmidt at 303-236-3046.
Sincerely,
/S/
LaTonya M. Mitchell
Denver District Director
cc:
Sky Ridge Medical Center
Attn: Chad Prusmack, M.D.
10103 Ridgegate Parkway
#306
Lone Tree, CO 80124
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