Last week’s headlines included news of a big shake-up at the top of the U.S. Food and Drug Administration, EFSA positive safety opinion on NMN, and Suannutra USA partnering with Fitoplancton Marino to distribute TetraSOD in the US.
FDA Shakeup: Makary steps down, Diamantas steps up
The White House announced last week that FDA Commissioner Dr. Marty Makary is stepping down following a 13-month run leading the agency. Dr. Makary was a longtime surgeon at Johns Hopkins Hospital and is a professor emeritus at the Johns Hopkins School of Medicine.
Kyle Diamantas, JD, the agency’s deputy commissioner for food, has been appointed acting commissioner. Given his background in food policy and familiarity with the dietary supplement industry, some industry observers said Diamantas’ appointment could provide continuity for food and supplement-related issues during the leadership transition.
“With Kyle Diamantas serving as Acting Commissioner, it seems that we can be assured that supplement and food issues will not be short-changed at the Commissioner level while he holds the position,” commented Ivan Wasserman, Managing Partner, Amin Wasserman Gurnani LLP.
During a fireside chat hosted by the Natural Products Association (NPA) last month, Diamantas stated that dietary supplement modernization is “top of mind,” adding that “The supplement industry has just grown tremendously, not just in size, but in scope and scale over the last 30 years, and our regulatory framework just really has not adapted adequately to address that.”
EFSA issues positive safety opinion on EffePharm’s NMN
The European Food Safety Authority (EFSA) has issued a positive safety opinion on EffePharm’s β-NMN, finding a daily intake of 300 mg safe for most people, except pregnant and lactating women.
This decision moves NMN closer to EU approval, expected within five to seven months, and is seen as a significant milestone for EffePharm, which is currently the only company allowed to communicate the news.
NMN is recognized as a source of vitamin B3 and is already popular in the US and Asia for healthy aging
If approved, NMN will be widely adopted in EU supplements, predicted Jerome Le Bloch, head of scientific affairs at FoodChain ID.
At this stage, only the applicant, biotech company EffePharm, can communicate the positive EFSA opinion, as other NMN producers are still subject to Novel Food restrictions.
“The market is asking for NMN, and this will be a best seller,” he said.
Suannutra USA partners with Fitoplancton Marino
Suannutra USA has partnered with Fitoplancton Marino to distribute TetraSOD, a bioactive marine complex derived from microalgae, in the US.
TetraSOD, derived from the microalgae Tetraselmis chuii, is positioned to support cellular and metabolic health, with benefits in body composition and energy metabolism. The ingredient delivers high superoxide dismutase (SOD) activity and is reported to activate the body’s endogenous defense and adaptive response mechanisms. Cellular health is foundational to the function of tissues, organs, and physiological systems, influencing metabolism, immune function, and physical performance.
The algae extract also contains polyunsaturated fatty acids (PUFAs), vitamins, carotenoids, polyphenols, and phytosterols.
“TetraSOD represents a strong addition to Suannutra USA’s portfolio of science-backed ingredients,” said Anthony Weston, CEO of Suannutra. “With its solid clinical evidence, low effective dose, and benefits that were perceived by subjects in under a month, we believe TetraSOD has the potential to become a true hero ingredient in the US market.”
