Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm398466.htm
Timestamp: 2019-04-19 12:25:27+00:00

Document:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.mundonatural.tv in March of 2014 and has determined that you take orders there for the products “Neuro AD,” “Stop Diabetes,” “Stop High Blood Pressure,” “Moringa 7” and “Purpurea Echinacea,” which the website promotes for conditions that cause the products to be 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)]. The therapeutic claims on your website establish that the products are drugs 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.
In addition, the names of these products (i.e., “Stop Diabetes” and “Stop High Blood Pressure ”) are disease claims.
“Echinacea Purpurea... fomentan la actividad del sistema inmunológico...anti-inflamatorio, antiviral y ayuda a combatir los resfriados, la influenza y las infecciones del sistema respiratorio.
Your ““Neuro AD,” “Stop Diabetes,” “Stop High Blood Pressure,” “Moringa 7” and “Echinacea Purpura” products are not generally recognized as safe and effective for the above referenced uses and, therefore, the 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 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 products are 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 their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of misbranded drugs into interstate commerce is a violation of § 301(a) of the Act [21 U.S.C. § 331(a)].
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. It is your responsibility to ensure that all products marketed by your firm 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 legal action without further notice, including seizure and/or injunction.
Please notify this office in writing within 15 working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above. Your response should include any documentation that would assist in evaluating your corrections. If you cannot complete all corrections within 15 working days, please explain the reason for the delay and the date by which each such item will be corrected.
Please send your written response to the attention of Ms. Marilyn Santiago, Compliance Officer, Food and Drug Administration, San Juan District Office. If you have any questions regarding this letter, please contact Marilyn Santiago at (787) 729-8707 or via email at Marilyn.Santiago@fda.hhs.gov.

References: § 321
 § 321
 § 355
 § 331
 § 352
 § 301
 § 331