What happened
Original notice title
Healing Noni Co., LLC 8/26/16
From the archived source record
Based on our investigation and our review, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs Based on FDA’s review of your website at the Internet address www.healingnoni.com in March 2016 and June 2016, we have determined that you take orders there for the products including, but not limited to: HEALING Noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” and HEALING Noni Brand: “all natural GOJI JUICE made with 100% PURE goji juice” .The claims on your website establish that these products are drugs under section 201(g)(1)(B) of 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. 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). Accordingly HEALING Noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” products 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)]. During our inspection of your facility, our investigator observed the following significant violations: 1. Misbranded Dietary Supplements Further, even if the labeling for your HEALING Noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” and HEALING Noni Brand: “all natural GOJI JUICE made with 100% PURE goji juice” products did not make therapeutic claims, which make the products unapproved new drugs, and to the extent that you intend to market these products as dietary supplements, these products would be misbranded within the meaning of section 403 [21 U.S.C. § 343] of the Act, and the regulations implementing the food labeling requirements of the Act, which are found in 21 CFR Part 101.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 969a6d518252
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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