Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm431461.htm
Timestamp: 2019-04-25 08:28:08+00:00

Document:
Attn: Scott Willey & Steven A. Sciarretta, Esq.
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.
“Each capsule of DigestaCure® contains 500mg of pure, concentrated immune modulating components, for the restoration of immunity and elimination of autoimmunity.
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.
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.

References: § 321
 § 321
 § 355
 § 331
 § 352
 § 331