Office of Regulatory Affairs
Office of Human and Animal Food Operations
East Division IV
Compliance Branch
466 Avenida Fernández Juncos
San Juan, Puerto Rico 00901-3223
Tel: (787) 729-8500

 

June 29, 2017
 
WARNING LETTER
 
17-OHAFOED4-WL-06/CMS No.522709
 
 
VIA-UNITED PARCEL SERVICE
NEXT DAY - SIGNATURE REQUIRED
 
God Quest, Inc. d/b/a Creation Today
Mr. Eric M. Hovind, President
29 Cummings Road
Pensacola, Florida  32503-7627
 
Dear Mr. Hovind:     
 
This is to advise you that during April 2017, the Food and Drug Administration (FDA) reviewed your web site at www.creationtoday.org and has determined that you take orders there for your products B17 Amygdalin and Bitter Raw Apricot Seeds by Apricot Power. FDA has also reviewed the book, World Without Cancer: The Story of Vitamin B17, which you sell as part of your Wellness & B17 Package along with your products B17 Amygdalin and Bitter Raw Apricot Seeds by Apricot Power. The claims on your website and in the book establish that the 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 can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include, on the page http://creationtoday.org/product/wellness-b17-package:
 
Under Wellness & B17 Package
Under World Without Cancer
In addition, along with offering your B17 Amygdalin and Bitter Raw Apricot Seeds by Apricot Power for sale through your website at www.creationtoday.org, your website offers for sale the book, World Without Cancer: The Story of Vitamin B17,which includes claims relating to Vitamin B17, an ingredient in your products B17 Amygdalin and Bitter Raw Apricot Seeds by Apricot Power. World Without Cancer: The Story of Vitamin B17 further establishes the intended use of your B17 Amygdalin and Bitter Raw Apricot Seeds by Apricot Power products as drugs. Under Title 21, Code of Federal Regulations, Part 201.128, "intended use" is defined in part as "the objective intent of the persons legally responsible for the labeling of drugs,” which intent “may be shown by the circumstances surrounding the distribution of the article." World Without Cancer: The Story of Vitamin B17 is sold alongside, as well as in part of your Wellness & B17 Package with, your B17 Amygdalin and Bitter Raw Apricot Seeds by Apricot Power. 
 
Based on the circumstances surrounding the distribution of your products, the following claims provide further evidence that your B17 Amygdalin and Bitter Raw Apricot Seeds by Apricot Power are intended for use as drugs: 
o    “Is it possible that the rheumatic diseases, certain aspects of hypertension (high-blood pressure), tooth decay, many of our gastrointestinal disorders, sickle-cell anemia—and cancer—all are related directly or indirectly to a simple vitamin B17 deficiency?”
o    “It is no longer a speculation but a fact supported by a mountain of evidence that vitamin B17 is a vital part of an amazing biochemical process that destroys cancer cells . . .”
 
Your products B17 Amygdalin and Bitter Raw Apricot Seeds by Apricot Power 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), 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. 
 
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 products B17 Amygdalin and Bitter Raw Apricot Seeds by Apricot Power 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 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, B17 Amygdalin and Bitter Raw Apricot Seeds by Apricot Power fail to bear adequate directions for their intended use and, therefore, the 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 violations cited in this letter are not meant 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 ensure that your firm complies with all requirements of federal law, including 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 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 action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction.
 
If you need additional information or have questions concerning any products distributed through your website, you may contact Compliance Officer, Ms. Beira Montalvo at (561) 416-1065, Ext. 1108, or by e-mail at: Beira.Montalvo@fda.hhs.gov.
 
Your written response to this letter should be sent to the Food and Drug Administration, Office of Human and Animal Food, East Division IV, 466 Fernandez Juncos Avenue, San Juan, P.R. 00901-3223, to the attention of Ms. Maridalia Torres, District Director.
 
Sincerely yours,
/S/ 
Maridalia Torres-Irizarry 
District Director
OHAFO East Div IV

This page was posted on April 30, 2019.

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