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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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AloeElite 3/30/11

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
FAX: 407-475-4770 
 


 

 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
WARNING LETTER
FLA-11-23
March 30, 2011
 
Mr. Torrey Rozycki
President
Organic Ease, Inc. D.B.A. AloeElite
1844 N. Nob Hill Rd. #192
Plantation, FL 33322
 
Dear Mr. Rozycki:
 
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.aloeelite.com in March 2011 and has determined that the product “AloeElite” 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 found on your website www.aloeelite.com include:
 
On your homepage, under the title “Frequently Asked Questions” about AloeElite, you list the following responses to the following questions:
 
What is AloeElite used for?
 
“Ulcerative Colitis, Crohn's Disease, Diverticulosis, Diverticulitis, Irritable Bowel Syndrome, Ulcers, Peptic Ulcer … Gastroenteritis … Hepatitis … Interstitial Cystitis, Nephritis … Celiac Disease, Fibromyalgia, Dermatosis … Lupus, Arthritis, Rheumatoid Arthritis”
 
How does AloeElite work?
 
“The main ingredient in AloeElite™ – Research has shown that Aloe Mucilaginous Polysaccharides have a remarkable ability to:
  • Work as a potent anti-inflammatory …
  • Provide powerful healing for many auto-immune disorders …
  • The aloe mucilaginous polysaccharides contain antibacterial, antiviral, antifungal, and antiparasitic properties”
 
Your www.aloeelite.com website also contains claims in the form of personal testimonials, located on your homepage under the title “Testimonials,” including:
                      
  • “After a year on Aloe Elite I was able to lower the dosage of my medication. I have now been symptom free of Crohn’s for a year.”
  • “After suffering 17 years with colitis and urgency to get to a public toilet, I found relief with the Aloe Elite Product.”
  • “I followed the instructions, took the suggested dosage, and within a month, my I.B.S. symptoms seemed to lesson [sic] to the point of not being noticeable about 95% of the time. … Now, after about a year of taking A.M.P., my I.B.S. symptoms are gone.” 
  • “For years … I have gone thru bouts of flareups of Ulcerative Colitis. No medication ever worked and the only relief was temporary …. Thanks to you [sic] wonderful product I am now off all of those costly medications. I am symptom free.”
 
In addition, we note that the facebook account at the internet site http://www.facebook.com/pages/AloeElite/102153884510#!/pages/AloeElite/102153884510?sk=info includes the following claim that can be accessed by clicking the “Info” tab on your account:
 
  • “AloeElite is an all-natural supplement used to treat moderate to severe digestive disorders such as Ulcerative Colitis, Crohn’s disease, IBS, diverticulitis, and a host of other conditions.”
 
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, AloeElite, 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, therefore, 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, [21 U.S.C. § 331(a)].
 
The above violations are not meant to be an all-inclusive list of deficiencies in your product and its labeling. The unlawful disease treatment and prevention claims 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 websites, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your product 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 within fifteen days, please state the reason for the delay and the date by which the corrections will be completed.
 
Your written response should be directed to the U.S. Food and Drug Administration, Attn: Andrea H. Norwood, Compliance Officer, Florida District Office, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions regarding any issues in this letter, please contact Andrea Norwood at 407-475-4724.
 
Sincerely,
/S/     
Emma R. Singleton
District Director
Florida District Office