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 :
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”:
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::
On the product label of Sour Sop Leaves & Sour Sop Tea Bags:
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:
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:
Under the subheading, “Is soursop really a cure for cancer?”
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:
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:
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:
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

This page was posted on April 30, 2019.

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