| Public Health Service Food and Drug Administration |
Kansas City District Telephone: (913) 752-2100 |
Department of Health and Human ServicesMay 25, 2011
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
Ref: KAN 2011-09
Mr. Patrick Higgins
Cellular RX
5405 East Central PMB103
Wichita, KS 67208
Dear Mr. Higgins:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the internet address www.cellpro7.com in April 2011. FDA has determined that your product Cell Pro 7 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 therapeutic claims on your website establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the product with these claims violates the Act. You may find the Act and FDA regulations through links at FDA's home page at www.fda.gov.
Examples of some of the claims observed on your website include:
On the home page, under the heading, "Cell Pro 7 with OM24@ supports":
• "Arthritis, joint and muscle pain relief"
• "Migraine... and Allergy headache relief"
• "Asthma, COPD, bronchial infection relief"
• "Reduction in PSAv counts (prostate)"
On the webpage, "Cell Pro 7 FAQs":
"Q. What is Cell Pro 7 with OM24®?":
• " ... a powerful anti-inflammatory, anti-bacterial, anti -viral, anti -fungal...compound."
"Q. What benefits will I get from taking Cell Pro 7 with OM24? ... If you suffer from any of the following ... , this product is for you:"
• "Arthritis & Bone Loss"
• "Asthma & allergies"
• Cardiovascular issues, High Blood Pressure
• "Depression ... "
• "Auto-Immune System dysfunction"
• "Chronic Inflammation"
Your website also contains disease claims in the form of personal testimonials on the webpage "Cell Pro 7 Testimonials," including:
• "I started taking the Cell Pro 7 with OM24® months prior to my total knee replacement surgery. The surgeon was concerned that I would not be able to heal at the normal rate because I am 76 and a smoker. The doctor and the Physical Therapist were both very surprised how fast the incision healed and the swelling reduced. They said that I was recovering faster than the 20 and 40 year olds that they see!"
• "I have suffered from arthritis, depression and allergies for many years. I was on a lot of prescription medications. Now, all I take is Cell Pro 7 with OM24® tablets and spray."
• "I accidentally severely burned my hand with chemicals. I put your Cell Pro 7 with 024® Lotion on the bums and it stopped the pain very quickly. I was amazed at how fast the injury healed."
• "I have had severe Cluster Headaches for many years .... I would have to miss work occasionally due to the severity of the headaches, until I started using the Cell Pro 7 with OM24®. Now, if a headache starts all I have to do is use the Oral Spray (2 squirts in each nostril) and the pain stops! ... I have continued to take the tablets and now the headaches don't even happen."
• " ...I was overcome with a severe migraine .. , . I tried the Cell Pro 7 with OM24® Oral Spray and was shocked that it relieved the pain within minutes!"
• "My Prostate Specific Antigen (PSAv) has slowly risen over the past several years. I was concerned that I was heading toward Prostate Cancer, so I did some research and found your product. Within a couple of months of starting the tablets, I have seen a substantial change for the better in the reading of all of my blood work results. Now my PSA is lower ... I would recommend Cell Pro 7 with OM24® to anyone!"
In addition, we note that the Facebook account at http://www.facebook.com/pages/Cell-Pro7/351345481336 includes numerous testimonials, including videos, which make disease claims such as:
• "When I started taking OM24®, within days my osteoarthritis was relieved."
• "I totally control my diabetes and blood pressure with the tablets .... "
Your product 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 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 product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. Because the product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layperson can use the product safely for its intended uses. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act.
The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. The unlawful disease treatment and prevention claims made on your website were too numerous to list in this letter. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations, We advise you to review your website, product labels, other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
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.
Please send your reply to Patrick L. Wisor, Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 11630 West 80th Street, Lenexa, KS, 66214-3340.
Sincerely,
/S/
John W. Thorsky
District Director
Kansas City District Office
cc: Ms. Judy Dudley
1755 Tara Falls Ct
Witchita, KS 67207
cc: Patrick J. Higgins
342 N. Quentin
Wichita, KS 67208
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