What happened
Original notice title
ByPro Nutrition LLC MARCS-CMS 646308, April 04, 2023
From the archived source record
Unapproved New Drugs/Misbranded Drugs Examples of some of the claims on your product label and website that provide evidence that your Dodecin product is intended for use as a drug include: On the product label: “DODECIN: The ingredients in Dodecin are formulated to address multiple pain and inflammation pathways.” On your website www.bypronutrition.com: On your Order Now page, for the single product Dodecin: “Dodecin - Pain and Inflammation Relief” “When you're in pain, there's only one thing you care about - RELIEF. It also detoxifies your body; fighting…toxic metals, such as Mercury.” “Medical research studies show that Silymarin, found in Milk-Thistle, decreases inflammation of tissue and relieves associated pain.” “Trypsin…Combined with bromelain, it helps treat conditions such as osteoarthritis.” “CMO also regulates inflammation -reducing pain.” “Bromelain is a powerful anti-inflammitory nutrient. Examples of such testimonials include: On your Testimonials page: “My pharmacist recommended this product to me after I complained about pain all the time all over from osteoarthritis. 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 Dodecin product fails 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)]. This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
What the official notice says to do
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Read the official notice →Status and source details
- Status recorded in the archive
- FDA closeout listed
- Source checked
- Jul 16, 2026
- Record revision
- 1e207bf19598
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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