What happened
Original notice title
Fresh Nutrition Inc MARCS-CMS 612984, May 27, 2021
From the archived source record
Based on our review, we have found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). Unapproved New Drugs and Misbranded Drugs The claims on your website and Amazon product pages establish that your Berberine, Echinacea, European Elderberry, Milk Thistle, Lion’s Mane Mushroom, Turmeric Curcumin, Fish Oil and Green Lipped Mussels products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. When it comes to colds, flu … elderberry is very popular.” “In addition to suppressing influenza viruses and relieving cold symptoms, Elderberry...” On your Milk Thistle product page at [see original source] “Milk Thistle is… acknowledged for its ability as an anti-inflammatory, to assist with side effects during cancer treatments, protect from bone loss” “When overconsumption of alcohol, an antioxidant called Glutathione becomes depleted leading to common symptoms of a hangover. 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 products Berberine, Echinacea, European Elderberry, Fish Oil, Lion’s Mane Mushroom, Milk Thistle, and Turmeric Curcumin 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)]. Unapproved New Animal Drugs During our review of your website ([see original source] and Amazon product pages, FDA determined that your Green Lipped Mussels product is also intended for use in the mitigation, treatment, or prevention of diseases in animals, which makes it a drug under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)].
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
- 5883c57e7df6
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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