What happened
Original notice title
Cape Fear Naturals 3/2/17
From the archived source record
The inspection found that your facility has significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that the products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Our review of your product labeling and Internet website where you market your products revealed serious violations of the Act and applicable regulations. Unapproved New Drug Violations and Misbranded Drugs This is to advise you that we reviewed your website at the Internet address www.capefearnaturals.com and your online store at Amazon.com in November 2016 and have determined that you take orders there for the products Acidophilus, Beta Carotene, Curcumin Extract, DIM capsules, NAC capsules, Beta Glucan capsules, and Quercetin, as well as your topical creams including Beta Glucan cream, Kojic Acid cream, 1% a-Arbutin cream, 2% super a-Arbutin cream, and Retinol-A cream. 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, Acidophilus capsules, DIM capsules, and NAC capsules 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 The inspection revealed the following significant violations of the CGMP 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
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 4789943c72d0
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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