What happened
Original notice title
Bee Products J L 11/14/16
From the archived source record
Even if these products were dietary supplements and not unapproved new drugs or misbranded drugs, they would be misbranded dietary supplements under 403 of the Act [21 U.S.C. § 343] and adulterated dietary supplements under 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the products have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements in 21 Code of Federal Regulations Part 111 (21 CFR Part 111). 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 Bee Pollen and Bee Propolis with Rose Hips products fail to bear adequate directions for their intended uses 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)]. Dietary Supplement CGMPs If your Bee Pollen, Bee Propolis with Rose Hips, and Royal Jelly with Rose Hips products were not unapproved new drugs or misbranded drugs, and if these products were properly labeled as dietary supplements, they would be adulterated dietary supplements under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the products were prepared, packed, or held under conditions that do not meet the CGMP regulation for dietary supplements in 21 CFR Part 111. During the inspection our FDA investigators observed the following significant violations of the CGMP regulations for dietary supplements: 1. Misbranded Dietary Supplements If you intend to market your Bee Pollen, Bee Propolis with Rose Hips, and Royal Jelly with Rose Hips products as dietary supplements, our label review shows that these products are not properly labeled as 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
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- fd823efa23ca
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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