FDA issued four warning letters to dietary supplement companies which were posted on the Agency’s site on Dec. 1. The companies were added to the list of firms that have received such warning letters, a list that now has 146 entries. The list includes companies selling medical devices as well as ingestible products.
Along with ChromaDex, three other dietary supplement marketers received warning letters in the recent set. Those companies are Sage Consulting & Apothecary, Innovative Medicine LLC and Red Moon Herbs. The letters were issued as part of a cooperative ongoing enforcement action in conjunction with the Federal Trade Commission.
How research results were communicated at heart of issue
In ChromaDex’s case, FDA took issue with the company’s repeated references to research ChromaDex says shows a connection to NAD+ levels and better COVID-19 outcomes. ChromaDex markets a finished dietary supplement branded as TruNiagen that features the company’s flagship branded nicotinamide riboside ingredient. ChromaDex has been developing the ingredient for a number of years after licensing the technology. That effort has included the development of an extensive list of university research partners, which rests on the work of ChromaDex’s scientific advisor Dr. Charles Brenner, who has been looking into the molecule’s health effects since 2004.
The ingredient Niagen has been researched for its ability to boost NAD+ levels in cells, which is part of the body’s cellular energy production and repair machinery. More recently, the ingredient has been researched for its effects on inflammation and body composition.
Keeping the body’s cellular mechanisms, including the immune system, operating at peak efficiency has been one of the ways that natural product marketers have tried to address consumers’ desire for things that can help in the current pandemic, especially in light of the fact that at the moment there are no FDA approved drug treatments. But communicating those benefits without crossing the COVID-19 treatment claims line in the eyes of FDA has proven difficult.
Alleged non compliant statements
In its warning letter to ChromaDex, which the company said it received on Nov. 17, FDA took the company to task for statements related to Dr Brenner’s work including:
- “Early preclinical data suggests that increasing cytoplasmic NAD levels through a NAD precursor, such as NR, may support innate immunity to coronaviruses and other viruses.”
- “A recent preclinical study showed SARS-CoV-2 infected cells suffer significant NAD+ depletion leading to disruption of innate anti-viral immune activity, while other preclinical data suggest that modulation of inflammasome activity in immune cells by NAD+ may be important in the severe inflammation observed in patients infected with COVID-19. ChromaDex’s Niagen is proven to effectively restore and maintain NAD+ levels.”
- “Dr. Charles Brenner and a team of scientists from three US universities find that Niagen® decreases Coronavirus replication in animal cells.”
As in other warning letters of this type, ChromaDex was given 48 hours to correct the alleged violations. ChromaDex, being a prominent publicly traded company, issued an 8-K statement in response to FDA’s letter. In it, the company had this to say:
“On November 18, 2020, the Company provided a response (the “Response”) to the Letter stating that the Company disagrees with the assertion in the Letter that the Company’s products are intended to mitigate, prevent, treat, diagnose or cure COVID-19 in violation of certain sections of the FD&C Act and the FTC Act. The Response notes that the Public Disclosures accurately describe the scientific research regarding NR and COVID-19, and that such Public Disclosures were not intended to suggest the use of the Company’s products for therapeutic purposes. However, in order to address the concerns from the Letter, the Company has deleted certain social media posts and removed certain press releases from its website, including the Public Disclosures. The Company believes that such corrective actions address the Letter in full, and the Company intends to seek guidance, as needed, from the FDA and FTC to ensure that statements made about the scientific research related to the Company’s products are appropriately disseminated in the future.”