Inspections, Compliance, Enforcement, and Criminal Investigations

Pristine Nutraceuticals, LLC. 1/21/15

  

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


 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-15-10
January 21, 2015
 
Pristine Nutraceuticals, LLC
Attn: Scott Willey & Steven A. Sciarretta, Esq.
2799 NW Boca Raton Blvd., Suite 203
Boca Raton, FL 33431
 
Dear Mr. Willey and Mr. Sciaretta:
                                   
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.digestaqure.com in October 2014 and has determined that you take orders there for your product, “DigestaCure [or DigestaQure],” which the website promotes 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 and in promotional literature establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introduction or delivering this products for introduction into interstate commerce for such uses violates the Act.
 
Examples of some of the claims observed on your website include the following:
 
On the homepage:
  • “If you suffer from an Autoimmune Condition, we have your Solution.”
 
On the webpage titled, “Ingredients”:
  • “Each capsule of DigestaCure® contains 500mg of pure, concentrated immune modulating components, for the restoration of immunity and elimination of autoimmunity.
 
On the webpage titled, “FAQs”:
  • “You would take the healing dosage of DigestaCure® until all symptoms, abnormalities, and imbalances have dissipated…”
 
Further, your homepage includes a “submit your symptoms for analysis” link. This takes users to a “Symptoms and Conditions Submission Form” where users are invited to check “My conditions” boxes for “conditions you have been diagnosed with” for “analysis” and “receive a written response from our Specialist Support Team.” Examples of the listed “My conditions” include:
 
  • “Asthma”
  • “Balo Disease”
  • “Cardiomyopathy”
  • “Diabetes Type I & II”
  • “Lou Gehrig’s Disease”
  • “Mutliple Sclerosis”
  • “Osteoporosis”
  • “Rheumatic Fever”
  • “Sarcoidosis”
  • “Vision Loss”
  • “Wilson’s Syndrome”
 
The website, thecodeoflife.info also contains evidence of intended use in the form of personal testimonials recommending or describing the use of DigestaCure for the cure, mitigation, treatment, or prevention of disease. Your website links directly to the testimonials on the thecodeoflife.info website . Examples of the testimonials include:
 
  • “I was diagnosed with Celiac Disease …I had osteoporosis, anemia…a friend introduced me to a man who used Digestaqure…I decided it was worth a try…I quit the prescriptive medicines…
 
  • “I have been using your product (DigestaCure)…and I don't know what I would do without it and the continued relief it brings me from the Gout, leg and foot pain.”
 
  • “I have used your product and no longer have celiac disease.”
 
  • “I was diagnosed with ulcerative colitis, gerd, and lupus. I suffered terribly with all of the common symptoms of them, including sever [sic] joint pain to where I could barely walk at times…my life has a new beginning with Digestaqure…My colitis was gone, my gerd was gone and my joint pain was completely gone…Digestaqure…”
 
  • “I have had epilepsy…and have experienced violent seizures and convulsions…I have been on Digestacure…the frequency of my seizures…and the severity of the seizures has diminished...”
 
  • “I started Digestacure…Within a few weeks I was symptom-free of UC.”
 
  • “After 2 bottles of your product, I believe that my Ulcerative Colitis has disappeared!”
 
  • “The product has healed me of Crohn’s disease…”
 
  • “[I] am so happy with the Digestacure formula. I have been struggling with a severe case of Hashimoto's Disease…my tendons have relaxed, and are no longer in pain…after one bottle of Digestacure.”
 
In addition, The Code of Lifebook, which you take orders for on your website, also contains evidence of intended use. . Examples of such claims for DigestaCure are in both the online and the print version of the book. The examples include:
 
On page 59 of the online version, page 60 of the print version:
 
  • “[M]y experience with the reduction of symptoms and eradication of digestive diseases with the formula “Digestacure,” was made quickly visible by the body…”
 
On page 68 of both the online and print versions, under the heading, “How to effectively combat aging (and disease)…”:
 
  • “[D]isease prevention, and recovery. (see DigestaCure…)…”
 
On page 109 of the online version and pages 106-107 of the print version, under the heading, “Nutritional Protocol for Prevention, Anti-Aging, and Disease Recovery”:
 
  • “[D]isease prevention, and recovery. (see DigestaCure, pages 59-61)”
 
Finally, the claims quoted above are supplemented by the meta tags used to bring consumers to your website through Internet searches. The meta tags include:
 
  • “colitis,” “ulcerative colitis,” “Crohn's disease,” “crohns, disease,” “diverticulitis,” “IBS,” “GERD,” “irritable bowel syndrome,” “chronic fatigue syndrome,” “arthritis,” “diabetes”
 
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a “new drug” 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 the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. 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 DigestaCure product is 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 its intended purposes. Thus, this drug is misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. 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 violations that exist. 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 your firm complies 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/or injunction. 
 
Within fifteen working days from of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above. Include any explanation of each step being taken to prevent the recurrence of the violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the corrections.
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. You may respond in writing to Carla Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions regarding this letter, please contact Ms. Norris at (407) 475-4730.
 
Sincerely,
/S/ 
Susan M. Turcovski
Director, Florida District
 
 
cc:       
Steven A. Sciarretta, Esq.
2799 NW Boca Raton Blvd. Suite 203
Boca Raton, FL 33431
 
2805 E. Oakland Park Blvd., #419
Fort Lauderdale, FL 33306
 

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