What happened
Original notice title
Jack B Goods Outlet Store MARCS-CMS 566674, November 07, 2018
From the archived source record
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, your Tianaa Red, Tianaa White, and Tianaa Green 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)]. Adulterated Dietary Supplements Even if your Tianaa Red, Tianaa White, and Tianaa Green products did not have claims that make them unapproved new drugs and misbranded drugs, your products would be adulterated dietary supplements under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)] because they contain an unsafe food additive. Any food additive that has not been approved for its intended use in food is deemed to be unsafe and causes the food to be adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)]. Adulterated foods cannot be legally imported or marketed in the United States. Because tianeptine does not qualify as a dietary ingredient and is not GRAS or otherwise exempt from the food additive definition, your Tianaa Red, Tianaa White, and Tianaa Green products are adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)] because they contain an unsafe food additive. The violations cited in this letter are not intended 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..
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
- 966be45e59cb
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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