What happened
Original notice title
Ozark Country Herbs MARCS-CMS 542508, March 30, 2018
From the archived source record
Based on the inspection, a review of your product labels collected during the inspection, and a review of your mail order catalog, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs/Misbranded Drugs FDA reviewed your product labels and your firm’s mail order catalog following the November 9-13, 2017 inspection of your facility. If so, this formula is for you!” Ladies Formula: “This combination of herbs is designed for those who have a problem with infertility . . . .” Baby Calm: “An all-purpose childhood remedy – from colds and fevers . . . .” Rescue Remedy: “[U]seful for . . . flu, fever, colds, pain . . . .” Eldermint: “A wonderful remedy for children and adults when trying to avoid the flu or when you already have it.” “[K]eeps fever under control . . . also for colds . . . .” Diarrhea -X: The product’s name. I think it works well for cold and flue [sic].” Testimonial for Natural Antibiotic – LDM: “Last week our baby was so sick we started for the hospital with her. 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, Allergy/Energy Combo, Natural Antibiotic (LDM), Pain Relief, Anti-Yeast, Heart Tonic x, Lung & Respiratory, Concentration Aid, Liver/Gallbladder, Hormone Health, Nerve and Stress, Ear Oil, Calendula Salve, Chickweed Salve, and Congestion Salve 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 If your products did not have therapeutic claims which make them unapproved new drugs and/or misbranded drugs, and if the products were properly labeled as dietary supplements, certain of your products [1] would be adulterated dietary supplements within the meaning of Section 402(g)(1) of the Act [21 U.S.C § 342(g)(1)] because the products have been manufactured, packag
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
- add5027b6f2b
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.
Sources, dates, and coverage →