Supplement industry counsel talk regulatory patchworks, legal risks and free riders
Federal changes to dietary ingredient policy, a growing patchwork of state rules and more aggressive litigation could reshape innovation, access and compliance, industry lawyers warned.
Speaking at the Business Leaders Forum hosted last month by NutraIngredients+, Christine Burdick-Bell, executive vice president and chief legal officer at Pharmavite, Mike DiMaggio, chief legal officer and general counsel at Nutrabolt, and Carlos Lopez, senior vice president and general counsel at Niagen Bioscience, walked through legal and regulatory priorities for 2026 and beyond.
A key topic discussed was how potential changes to the GRAS pathway could be one of the most consequential developments for supplement companies.
MFDS proposes lifting probiotic CFU upper limits, revising ingredient formulation rules
South Korea’s Ministry of Food and Drug Safety (MFDS) has proposed several changes to the rules governing health functional foods, including removing upper limits on probiotic daily intake.
The ministry said removing the current upper limit of 100 billion CFU for daily probiotic intake could better meet consumer needs.
“Doing so could expand consumer choice through the launch of various products and promote manufacturing autonomy and global competitiveness in the industry,” it said.
FSSAI enforces labeling rules for coffee, neem and other plant nutraceuticals
The Food Safety and Standards Authority of India (FSSAI) is enforcing labeling requirements for nutraceuticals containing certain botanicals and plant parts, including coffee and neem, amid cases of non-compliance.
In an advisory, the FSSAI said it was aware of nutraceutical manufacturers and retailers failing to comply with mandatory labeling requirements, including required warning statements for products containing certain plant ingredients.
These include products containing coffee seed and the leaf and fruit of neem or the Margosa-leaf tree, where permitted dosage and warning statements should be stated on the product labeling.
New Zealand considering changes to natural health product rules
The New Zealand government is seeking public feedback on proposed requirements for natural health products, including how it evaluates and permits health claims.
The consultation document released last month outlined its approaches to allowing and defining health claims, such as automatically recognizing health claims from specified countries.
It also proposed allowing industry to self-substantiate claims based on certain types of scientific evidence and/or evidence of traditional use.
Brands begin andrographis recalls, product reformulation in Australia
Brands in Australia have begun voluntarily recalling listed medicines containing andrographis after the Therapeutic Goods Administration (TGA) issued a ban over concerns that the herb may trigger anaphylactic reactions.
BioCeuticals, known for its ArmaForce andrographis tablets marketed for the relief of common cold/flu and mild upper respiratory tract infection, was one of the brands that has begun voluntary recalls.
Brands are also exploring alternative ingredients such as echinacea and probiotics to reformulate their immune health products, said Wayne Coote, founder and chairman of ingredient distributor Pathway International.
