Inspections, Compliance, Enforcement, and Criminal Investigations

Oxygen Health Systems, LLC 4/17/17

 

  

Black HHS-Blue FDA Logo

 

 

 
Chicago District Office
550 W. Jackson Blvd., 15th Floor
Chicago, IL 60661
Telephone: (312) 353-5863
Fax: (312) 596-4187 

 

April 17, 2017
 
WARNING LETTER
 
CHI-6-17
 
 
 
UPS NEXT DAY
SIGNATURE REQUIRED
 
Michael Carroll
Oxygen Health Systems, LLC
(b)(6)  
 
Dear Mr. Carroll,        
                                   
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at www.oxygenhealthsystems.com, www.thetruthaboutcancerstore.com, and www.totalhealinginstitute.com, from where you promote and sell several drug products intended for use in humans. As explained further below, introducing or delivering these products for introduction into interstate commerce violates the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.  
 
Based on the labeling claims on your websites, your products are drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Examples of such disease claims found in the labeling of these products include, but may not be limited to, the following:
 
On your website, www.oxygenhealthsystems.com:
 
Liposomal Complete Complex Plus
  • “This has the highest Absorption Rate of 98% directly to the cancer cell . . .” 
Premium Flax
  • “Flax Seed Oil contains lignans, which are naturally antibacterial and are currently being studied for their ability to bind to estrogen receptors and interfere with potentially cancer causing affects [sic] on tissue, especially breast tissue.” 
Graviola Max
  • “Graviola is traditionally used for auto-immune disorders.”
  • “Herbs like these can also be used in conjunction with modern medicine when treating diseases like cancer . . .”
Super Liposomal Plus
  • “Liposomes can be filled with drugs, and used to deliver drugs for cancer and other diseases.”
On your website, www.thetruthaboutcancerstore.com:
 
Liposomal Vitamin B17 Amygdalin
  • “Laetrile (i.e. Vitamin B17) therapy is one of the most popular and best known alternative cancer treatments.” 
Liposomal Vitamin C
  • “Helpful for: colds, flu, cancer . . . and diabetes.”
Palladium Lipoic Complex
  • “It reduces tumor size . . . and helps to repair any damage invasive cancers may have left behind.”
Rerum Blue
  • “Rerum® is Macrophage Activing Factor (MAF) . . .”
  • “studies around the world by many researchers have demonstrated . . . that the activation of macrophages produces pro-immunogenic . . . and even anti-cancer/anti-angiogenetic effects.”
On your website, www.totalhealinginstitute.com
 
Liposomal Curcumin
  • “It fights depression with an effect that’s similar to Prozac.”
  • “Researchers have found that a 9-month curcumin intervention ‘significantly lowered the number of rediabetic individuals who eventually developed’ type 2 diabetes, and with minor side effects.”
  • “It fights inflammation . . . with effects ‘comparable’ to statins but without the recognized dangers.
  • “It fights cancer cells in multiple ways, and makes certain chemotherapy drugs more effective while protecting healthy cells . . .” 
Graviola
  • “Graviola is traditionally used in many types of auto-immune disorders, nervous disorders . . . depression, high blood pressure and bacteria and fungal infections.”
  • “Graviola is still used extensively by native Indians in South America . . . who use Graviola as a natural herbal remedy for health problems such as high blood pressure, digestive issues and infections.”
  • “Herbs like these can also be used in conjunction with modern medicine when treating disease like cancer . . .”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” 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), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating 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 these drugs safely for their intended purposes. Thus, your products 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)]. It is prohibited to introduce or deliver for introduction into interstate commerce a misbranded drug under section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. 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 assure that you comply with all requirements of federal law and FDA regulations.
 
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, including, without limitation, seizure and injunction.
 
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
 
Your response should be sent to U.S. Food and Drug Administration, Attention: Russell Riley, Compliance Officer, Food and Drug Administration, Chicago District Office, 550 W. Jackson Blvd., Suite 1500, Chicago, IL 60661. Refer to the Unique Identification Number (CMS# 513217) when replying. If you have any questions with regard to this letter, please contact Mr. Riley via email at russell.riley@fda.hhs.gov or by phone at 312-596-4219.
 
 
Sincerely,
/S/
William R. Weissinger
District Director

 

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