Last week’s headlines included a new consultation by Australia’s TGA about Andrographis, the need for well-designed clinical trials focused on active women, and the introduction of dietary supplement listing bill in the U.S. House of Representatives.
Centre for Nutraceuticals designing clinical trials for active women
The Centre for Nutraceuticals is on a mission to ensure supplements marketed to women are actually researched in women, with a focus on the sports nutrition field in which just 4-13% of studies are conducted in females.
This was a key message from Dr Helena Tiekou Lorinczova, research and trial coordinator, and Dr Stephanie Ho Yi Chan, postdoctoral research fellow at the Centre based in the University of Westminster, London, during their presentation at Making Nutraceuticals in Coventry, UK, this week (April 21).
“The main aim of our center is to bridge the gap between industry and academia,” Dr. Lorinczova told attendees, noting that the lack of research into women’s health may be a factor in them spending 25% more of their lives in poor health compared to men.
“There’s a great need to better understand women’s nutrition needs and a need for well-designed clinical trials.”
The academics at the Centre are implementing protocols to help close the gender gap, which is particularly significant in the sports nutrition arena.
Dr. Chan explained one of the toughest challenges with studying women is their hormonal fluctuations through their monthly and life cycles which impact their supplement requirements.
Australian regulator consults on removal of Andrographis as low-risk ingredient
Australia’s Therapeutic Goods Administration (TGA) has begun a consultation with stakeholders on removing Andrographis paniculata (Andrographis) from the list of low-risk ingredients permitted for use in listed medicines, including health supplements.
The move follows reports of anaphylaxis - a severe allergic reaction which may be potentially life-threatening.
Andrographis can be found in a range of herbal medicines intended to relieve cold and flu. Such products can be purchased in Australia without a prescription at pharmacies, supermarkets and health food stores.
A search on the Australian Register of Therapeutic Goods (ARTG) shows 84 results on Andrographis products. Most of these products claim to support immune health.
“The sustained high reporting [of adverse events] since 2019 supports the conclusion of the Andrographis updated safety review, that current risk mitigation measures have not reduced the risk of anaphylaxis associated with Andrographis for it to be suitable for inclusion as an ingredient in listed medicines,” the TGA wrote in its adverse event report on Andrographis paniculata and anaphylaxis.
The consultation ends on April 30.
Dietary Supplement Listing Bill introduced in the House
A first-term member of Congress has introduced the Dietary Supplement Listing Act of 2026 in the U.S. House of Representatives to require dietary supplement manufacturers to list their products with the Food and Drug Administration (FDA).
“More than three-quarters of Americans take dietary supplements. As a physician, I’ve seen countless patients assume these products are vetted for safety,” said Rep. Maxine Dexter, M.D. (OR-03). “Unfortunately, our regulatory bodies don’t have access to the most basic information about these products. My common sense legislation brings transparency to consumers and regulators alike to keep our communities safe.”
The bill would require companies to provide FDA with information about their products, including product names, a list of all ingredients (including details of proprietary blend), an electronic copy of the label, allergen statements, and health and structure/function claims.
The bill also calls for the creation of a database within two years of enactment and the provision of a Dietary Supplement Listing Number for each product. Failure to list would result in a product being classified as “misbranded”.
The issue of mandatory product listing for dietary supplements has divided the industry, with some trade associations opposing the proposals and other supporting.
Dr. Daniel Fabricant, president and CEO of the Natural Products Association, said: “This misguided bill would only divert critical resources away from scientific research, product innovation and quality improvements, ultimately slowing development of the next generation of dietary supplements that consumers rely on to promote their health.”
On the other hand, a spokesperson for the Council for Responsible Nutrition stated: “CRN has been clear and consistent in its support for Sen. Durbin’s Senate legislation, which we believe strikes the right balance — advancing a transparent, workable framework that strengthens FDA oversight while remaining feasible for responsible manufacturers to implement.”
