ChromaDex Reports FDA’s Conclusion that Nicotinamide Mononucleotide (NMN) May Not Be Sold or Marketed as a Dietary Supplement in the United States

Rhea-AI Summary

ChromaDex Corp. (NASDAQ:CDXC) announced that the U.S. FDA has determined that nicotinamide mononucleotide (NMN) cannot be marketed as a dietary supplement, as it has been first investigated as a drug since November 4, 2022. This decision impacts ChromaDex's NMN offerings, while its proprietary ingredient Niagen®, a form of nicotinamide riboside (NR), remains a viable NAD+ precursor backed by over 20 clinical studies. ChromaDex continues its focus on NAD+ research and has established extensive partnerships for its CERP™ program.

Positive

• ChromaDex’s Niagen® is recognized as an efficient NAD+ precursor, supported by over 20 clinical trials and a robust patent portfolio.
• The company has secured over 250 material transfer agreements through its ChromaDex External Research Program (CERP™), indicating strong research collaboration.

Negative

• The FDA ruling restricts ChromaDex's ability to market NMN as a dietary supplement, potentially affecting product sales.
• The company faces uncertainty due to the FDA's classification of NMN, impacting its overall market strategy.

U.S. FDA declares NMN ingredient may not be sold or marketed as a dietary supplement in the U.S. since first investigated as a drug

LOS ANGELES--(BUSINESS WIRE)-- ChromaDex Corp. (NASDAQ:CDXC), a global bioscience company dedicated to healthy aging, today announced that on November 4, 2022, the U.S. FDA declared nicotinamide mononucleotide (NMN) may no longer be sold or marketed as a dietary supplement in the United States since it was first investigated as a drug.

NMN cannot cross the cell membrane directly and must first be converted to nicotinamide riboside or NR, making NR a more efficient nicotinamide adenine dinucleotide (NAD+) precursor. ChromaDex’s proprietary ingredient, Niagen^®, patented nicotinamide riboside or NR and the key active ingredient in the consumer supplement Tru Niagen^®, is the most efficient NAD+ precursor in the world and is one of the most promising ingredients to have entered the healthy aging supplement space. Supplementation with Niagen^® is backed by over 20 published and peer-reviewed clinical trials, over 200 published scientific studies and over 40 owned and licensed patents.

NAD⁺ levels have been shown to decline by up to 65% between age 30 and 70, and is linked to all nine hallmarks (cellular and molecular mechanisms) of aging, making NAD⁺ a likely contributor to age-related health decline. ChromaDex continues to be an industry leader in NAD⁺ research through the ChromaDex External Research Program (CERP^TM), which achieved over 250 material transfer agreements (MTAs) this past Spring featuring Niagen^® and other proprietary ingredients. Clinical research advances through CERP^TM have demonstrated NAD⁺ boosting benefits following supplementation with Niagen^® for age-related conditions, paving the way for future research.

For additional information on the science supporting Niagen^® visit www.chromadex.com.

About ChromaDex:

ChromaDex Corp. is a global bioscience company dedicated to healthy aging. The ChromaDex team, which includes world-renowned scientists, is pioneering research on nicotinamide adenine dinucleotide (NAD+), levels of which decline with age. ChromaDex is the innovator behind NAD+ precursor nicotinamide riboside (NR), commercialized as the flagship ingredient Niagen^®. Nicotinamide riboside and other NAD+ precursors are protected by ChromaDex’s patent portfolio. ChromaDex maintains a website at www.chromadex.com to which ChromaDex regularly posts copies of its press releases as well as additional and financial information about the Company.

Forward-Looking Statements:

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, including statements related to Tru Niagen being the most efficient nicotinamide adenine dinucleotide (NAD⁺) precursor in the world and one of the most promising ingredients to have entered the healthy aging supplement space. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as "expects," "anticipates," "intends," "estimates," "plans," "potential," "possible," "probable," "believes," "seeks," "may," "will," "should," "could" or the negative of such terms or other similar expressions. Risks that contribute to the uncertain nature of these forward-looking statements include the impact of the COVID-19 pandemic on our business and the global economy; our history of operating losses and need to obtain additional financing; the growth and profitability of our product sales; our ability to maintain sales, marketing and distribution capabilities; changing consumer perceptions of our products; our reliance on a single or limited number of third-party suppliers; and the risks and uncertainties associated with our business and financial condition. More detailed information about ChromaDex and the risk factors that may affect the realization of forward-looking statements is set forth in ChromaDex's Annual Report on Form 10-K for the fiscal year ended December 31, 2021, ChromaDex's Quarterly Reports on Form 10-Q and other filings submitted by ChromaDex to the SEC, copies of which may be obtained from the SEC's website at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and ChromaDex undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221111005150/en/

ChromaDex Media Contact:

Kendall Knysch, Director of Media Relations

310-388-6706 ext. 689

kendall.knysch@chromadex.com

ChromaDex Investor Relations Contact:

Tom Shumaker, LifeSci Advisors, Managing Director

1-917-929-7600

tshumaker@lifesciadvisors.com

Source: ChromaDex Corporation

FAQ

What did the FDA declare about NMN for ChromaDex (CDXC) on November 4, 2022?

The FDA ruled that nicotinamide mononucleotide (NMN) cannot be sold or marketed as a dietary supplement because it has been investigated as a drug.

How does the FDA ruling impact ChromaDex's product offerings?

The ruling limits ChromaDex's ability to market NMN, which may affect its sales strategy and product positioning.

What is Niagen® and its significance for ChromaDex (CDXC)?

Niagen® is ChromaDex’s proprietary nicotinamide riboside (NR), recognized for its efficiency as an NAD+ precursor and backed by numerous clinical studies.

How many studies support ChromaDex's Niagen®?

Niagen® is supported by over 20 published and peer-reviewed clinical trials.

What is the ChromaDex External Research Program (CERP™)?

CERP™ is ChromaDex's initiative that has facilitated over 250 material transfer agreements to advance NAD+ research.