What happened
Original notice title
Nature's Vision, Inc 5/1/17
From the archived source record
Based on the inspection, a review of the product labeling you provided during the inspection, and our subsequent review of your website www.naturesvisioninc.com, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs In March, 2017, we reviewed your product labeling, including product labels and your website at the internet address [see original source] where you take orders for several of your dietary supplement products, including Cinnamon Extract tablets and Alpha Lipoic Acid tablets. 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 Cinnamon Extract product fails to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)]. Dietary Supplement CGMP Violations Even if your Cinnamon Extract tablets, Alpha Lipoic Acid tablets, Elderberry Ultimate Immune Response and Party Recovery products did not have therapeutic claims, which make them unapproved new drugs, they would still be adulterated under section 402(g)(1) of the Act, 21 U.S.C. § 342(g)(1), as are other dietary supplement products that you distribute, and that have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, 21 CFR Part III. The inspection revealed the following significant violations of the CGMP requirements for dietary supplements: 1. Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements. 1 In particular, the Act prohibits a person from introducing or delivering for introduction,
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
- bca7a8c8a819
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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