Inspections, Compliance, Enforcement, and Criminal Investigations

Amazing Sour Sop, Inc. 4/17/17

 

  

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Florida District Office
555 Winderley Place, Suite 200
Maitland, Florida 32751 

 

VIA UPS NEXT DAY AIR
w/ RETURN RECEIPT
 
 
 WARNING LETTER
FLA-17-08
April 17, 2017
 
Amazing Sour Sop, Inc.
Attention: Dr. Dennis Grant
7624 Margate Blvd.
Margate, FL 33063
 
 
Dear Dr. Grant:                                                                                  
                                   
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.amazingsoursop.com in March 2017 and has determined that you take orders therefor the products Sour Sop Capsules, Sour Sop Tea Bags, and Sour Sop Leaves. In addition, FDA reviewed your product label and promotional literature for your Sour Sop Tea Bags and labeling for your products on your social media accounts in January 2017.   The claims on your product labeling, including your firm’s website, establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
 
Examples of some of the claims on your website, product label, and other product labeling that provide evidence your products are intended for use as drugs include:
 
On the webpage titled “FREE SAMPLE” accessed at http://amazingsoursop.com/product/freesamplegrantamazingteabags3ct :
  • “[S]our Sop Tea … Cancer Killing Properties.” 
On your promotional literature, titled “Miracle Unleashed,” which accompanies the sale of your products Sour Sop Capsules, Sour Sop Tea Bags, and Sour Sop Leaves:
 
Under the heading, “Miracle Unleashed”:
  • “[C]ancer-fighting product…”
  • “[C]ancer-killing tree.”
  • “Graviola leaves and stems were found effective in attacking and destroying malignant cells.”
  • “Graviola has proven to be an immensely potent cancer killer in 20 independent laboratory tests…”
  • “[O]ne chemical in Graviola was found to selectively kill colon cancer cells at 10,000 times the potency of (the commonly used chemotherapy drug) Adriamycin.”
  • “Graviola was shown to selectively target the cancer cells, leaving the healthy cells untouched, unlike chemotherapy…”
  • “[L]eaves from the Graviola tree killed cancer cells among six human cell lines and were especially effective against prostate, pancreatic and lung cancers.”
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include::
  • “Prostate and Bladder Cancer…I was diagnosed with prostate and bladder cancer…I chose to bypass surgery and started my own research to find alternate treatment. In my search I found an article that explained the effects of sour sop on cancer cells. I started a daily regiment [sic] of sour sop about two years and low and behold the mass has been steadily shrinking.”
  • “Arthritis…I used to have arthritic pain in my legs, and since I started using the Sour Sop Leaf, “I am now pain free.””
  • “High Cholesterol and High Blood Pressure…My high cholesterol and high blood pressure ailments are now normal after drinking the Sour Sop Leaf.”
On the product label of Sour Sop Leaves & Sour Sop Tea Bags:
  • “Sour Sop known to many as graviola or (Spanish guanabana) has been known for ages for its medicinal uses and properties. Research has proven it to be 10,000 times stronger than the chemotherapy drug Adriamycin. Recently there has been an increase in the demand for Sour Sop (Graviola) leaves…which studies suggest to be effective in helping with prostate, lung, breast, colon and pancreatic cancers. It is also said to be used in the treatment for tumor, arthritis…bladder infections, high blood pressure, high cholesterol…and protection of your immune system to avoid deadly infections.”
  • “Testimonials has suggested it helps with infertility, impotence…etc.”
We also noted claims on your Facebook account, accessible at http://www.facebook.com/AmazingSourSop, which links to your website www.amazingsoursop.com where your products can be purchased directly, provide further evidence that your products are intended for use as drugs:
 
In a November 21, 2016 Facebook post:
  • “Do You Know Someone Suffering from: Cancer? Diabetes?...Infertility? A study published in the Journal of Medicinal Chemistry in 1997 suggests that soursop compounds tested on breast cancer cells in culture were more effective than chemotherapy in destroying the cells!” 
In an August 26, 2016 Facebook post which links to the blog authored by Dennis Grant and accessible at http://amazingsoursop.blogspot.com/ titled, “Health Benefits Of Sour Sop amazingsoursop.com” that includes a link to your website, www.amazingsoursop.com:
  • “Soursop Leaves Benefits:…[B]lood & organ disorders, cancer…insomnia, arthritis and more”
  • “Guyabano, or the soursop fruit, came into limelight when researchers found its ability to cure cancer.”
Under the subheading, “Is soursop really a cure for cancer?”
  • “Many would be surprised to know that soursop has miraculous cancer cell killing properties, almost 10000 times stronger than Chemo.” 
On your firm’s LinkedIn page, accessible at https://www.linkedin.com/company/grant-amazing-inc which includes your firm’s website and physical address:
  • “According to Science, a cup of sour sop leaves tea a day help ward off cancer.” 
On your firm’s Twitter account, accessible at https://twitter.com/amazingsoursop, which includes your firm’s website, in the Amazing Sour Sop (@AmazingSourSop) account description:
  • “HELPS IN THE PREVENTION AND TREATMENT OF CANCER AND OTHER AILMENTS.”
On your firm’s Instagram account, accessed via the Instagram mobile application, in a photo posted to the @amazingsoursop account, which includes your firm’s website:
  • “May help with Cancer prevention and cure, Arthritis, High Blood Pressure…Diabetes and more.” 
Your Sour Sop Capsules, Sour Sop Tea Bags, and Sour Sop Leaves products are not generally recognized as safe and effective for the above referenced uses and, therefore, these 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 the FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 335(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your Sour Sop Capsules, Sour Sop Tea Bags, and Sour Sop Leaves products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Furthermore, your Sour Sop Capsules, Sour Sop Tea Bags and Sour Sop Leaves products are intended for prevention of one or more diseases that are not amenable to prevention by consumers themselves without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your Sour Sop Capsules, Sour Sop Tea Bags and Sour Sop Leaves products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates 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 in connection with your products or their labeling. It is your responsibility to ensure that your products and labeling comply with the Act and its implementing regulations. 
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure and/or injunction. 
 
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 in the future. 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 the date by 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. Your written response should be sent to Compliance Officer Pearl Gonzalez. If you have any questions about this letter, please contact Pearl Gonzalez at (407) 475-4730, or by email at Pearl.Gonzalez@fda,hhs.gov.
 
 
Sincerely,
/S/ 
Susan Turcovski
District Director
Florida District

 

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