ChromaDex – FDA Warning Letter, Nov 17, 2020
The FDA and FTC issued a Warning Letter to ChromaDex, Inc. on November 17, 2020, following reviews of their websites (www.chromadex.com, www.truniagen.com) and social media (www.facebook.com/Chromadex) since September 16, 2020. The letter states that Tru Niagen 300mg, Tru Niagen 150mg, and Tru Niagen Stickpacks are offered for sale with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.
These products are cited as unapproved new drugs under section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) and misbranded drugs under section 502 (21 U.S.C. § 352). The introduction into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The letter highlights claims linking nicotinamide riboside (NR) and increased NAD/NAD+ levels to COVID-19 treatment or prevention, citing specific examples from their Facebook page and linked articles.
ChromaDex is required to take immediate action to cease the sale of these unapproved products and correct all violations. Within 48 hours, the
ID · 5c2c2a8a-4e2d-40ee-b308-c6e1df86d0d2
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.