What happened
Original notice title
Eden’s Answers, Inc. MARCS-CMS 648182, June 28, 2023
From the archived source record
Based on inspectional findings and subsequent review of product labels collected during the inspection, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. We address the responses below, in relation to each of the noted violations. Violations of the CGMPs for the Manufacturing of Dietary Supplements The inspection of your facility from August 22 through November 9, 2022, revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). Based on these violations, your Dental Health, Honey Herbal Syrup, and Lil’ Ones Sleepy Time are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Your significant violations of CGMP requirements are as follows: 1. You failed to establish identity specifications for each component you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1), and you failed to establish specifications for the identity, purity, strength, and composition of the finished batch of dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). a. Misbranded Dietary Supplements In addition, we reviewed product labels collected during the inspection and have determined the dietary supplement products Honey Herbal Syrup and Sleepy Time that you manufacture are misbranded under section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements.
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
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 6d8b3dacda31
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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