What happened
Original notice title
EarthLab, Inc., dba Wise Woman Herbals MARCS-CMS 634872, April 27, 2023
From the archived source record
Based on inspectional findings and a review of your websites www.wisewomanherbals.com and www.facebook.com/WiseWoman Herbals, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs We reviewed your website at www.wisewomanherbals.com in September and November 2022, and we determined you take orders for your products Green Tea Solid Extract, Curcuma Spp. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act Examples of some of the website claims that provide evidence that your products are intended for use as drugs include: Green Tea Solid Extract [see original source] “Studies also show that green and black tea are helpful. Drinking three cups or more daily can reduce stroke risk by as much as 21% . . .. Organic Turmeric [see original source] “Can Turmeric Help Reduce the Risk of Strokes? Curcumin, which is extracted from turmeric, may reduce the risk factors of stroke by reducing total cholesterol and improving vascular function . . .. All these factors help reduce stroke risk.” PSA Capsules [see original source] “PSA Capsules contain a blend of adaptogenic herbs like reishi… The reishi mushroom, also known as ganoderma lucidum, has been shown to have anticancer effects, especially in those with prostate cancer. 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). Organic Turmeric, PSA Capsules, and Elderberry Plus Syrup 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)].
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
- 1e60faf841a7
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 →