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
Premium Flax
Graviola Max
Super Liposomal Plus
On your website, www.thetruthaboutcancerstore.com:
 
Liposomal Vitamin B17 Amygdalin
Liposomal Vitamin C
Palladium Lipoic Complex
Rerum Blue
On your website, www.totalhealinginstitute.com
 
Liposomal Curcumin
Graviola
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

This page was posted on April 30, 2019.

Links to Recommended Companies

  • PharmacyChecker.com: Compare drug prices and save money at verified online pharmacies.
  • ConsumerLab.com: Evaluates the quality of dietary supplement and herbal products.
  • Amazon.com: Discount prices, huge inventory, and superb customer service.
  • OnlyMyEmail: Award-winning anti-spam services.
  • 10 Types: Website design, development, and hosting with superb technical support.