Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435680.htm
Timestamp: 2019-04-23 14:41:17+00:00

Document:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://nutregloproducts.com in December 2014 and has determined that you take orders there for the products Sour Sop (Guanabana) Graviola, Moringa (Oleifera), and Guinea Hen weed (Anamu) petiveria, 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, introduction 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.
Your products, Sour Sop (Guanabana) Graviola, Moringa (Oleifera), and Guinea Hen weed (Anamu) petiveria, are not generally recognized as safe and effective for the above referenced uses and, therefore, the product 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 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, your Sour Sop (Guanabana) Graviola, Moringa (Oleifera), and Guinea Hen weed (Anamu) etiveria products 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 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 deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
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 Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740, Attention: Mabel Lee (HFS-608). If you have any questions concerning this letter, please contact Ms. Lee at 240-402-0972.

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