According to food and nutrition industry experts, regulators often lag behind consumer and industry trends, leaving compliant firms disadvantaged while non-compliant or overseas competitors move faster.
This has caused confusion and frustration in the region, according to CEO of Complementary Medicines Australia (CMA) John O’Doherty.
He was speaking at our Growth Asia Summit 2025 in a panel discussion on the latest regulatory opportunities and challenges across the food, beverage, and nutraceutical sectors.
Panellists discussed how strict standards are a double-edged sword that upholds credibility and ironically disadvantages compliant firms at the same time.
A blessing or a curse?
O’Doherty noted that the TGA’s strict standards are “both a blessing and a curse” – they have earned Australian firms global credibility but restrict innovation because they are not aligned with consumer trends.
“This makes it difficult for companies to respond quickly to demand when regulations are holding them back,” he said.
“One of the big frustrations we face is the idea that regulations should be proportionate to risk. That’s something the TGA struggles with. They often focus on issues we consider minor, while ignoring areas where the industry is calling for compliance action,” said O’Doherty.
“At the top of our list is removing what’s known as the Personal Importation Scheme. Currently, Australians can purchase unregulated therapeutic goods – such as vitamins and dietary supplements – from overseas websites for personal use. These imports don’t need to meet the same compliance requirements as Australian-made products, creating an uneven playing field.”
Australia’s Infant Nutrition Council (INC) CEO Jonathan Chew agreed, stressing that while safety must always come first, regulators also need to ensure rules do not undermine industry competitiveness or export growth.
One of the other key hurdles that limits export growth is the lengthy approval process for products and ingredients in the importing country.
Long drawn processes and unclear regulations hinder progress
Chao Wang, Senior Registration & Regulatory Consultant at China’s Food Safety Compliance Service, pointed out that the country’s lengthy approval process is a big hurdle for importing brands.
China classifies health foods, infant formula, and foods for special medical purposes as “special foods”, all of which must be registered with authorities before entering the market.
“The main issue is time. Filing for approval can be completed in as little as six months, but registration typically takes three to five years. This lengthy timeline is the biggest obstacle for imported products,” said Chao.
This discourages international firms from bringing new products into China, limiting consumer access to innovation and slowing the country’s ability to keep pace with global nutrition trends. This can also dampen investment and competitiveness in the local health food sector.
The Chinese government has been trying to improve the approval process in recent years by expanding the list of approved ingredients and claims.
However, this move benefitted only domestic brands while imported products continued to face difficulties.
“From 2021, the number of filed domestic products has increased significantly. In the first half of this year alone, around 1,900 products were filed, of which about 900 included functional claims beyond vitamins and minerals. However, imported products still face difficulty – most must go through the much longer registration process,” said Chao.
While China’s lengthy approval timelines create barriers to innovation, India’s challenge lies in regulatory ambiguity – particularly around whether nutraceuticals should be treated as food or drugs.
In India, the main regulatory hurdle is ambiguity over whether nutraceuticals should be treated as food or drugs.
“There is scepticism about whether regulation falls under food or drug authorities. Much of the debate centres on multivitamins. When formulations exceed the Recommended Dietary Allowance (RDA), they are treated as drugs. Clause 21 in the current regulation is particularly important, as it impacts global firms entering the market. Companies must carefully demarcate their formulations to avoid being classified incorrectly,” said Sandeep Gupta, Founder and CEO of the Expert Nutraceutical Advocacy Council.
“Right now, products with higher levels of multivitamins are usually treated as drugs, while combinations with nutraceuticals tend to be left in a grey area. The line between drug and nutraceutical remains thin, and this lack of clarity has stalled innovation. Many products that could have been launched two years ago are still on hold. Industry progress has effectively gone backward rather than forward due to this uncertainty.”
Panellists agreed that overcoming these regulatory hurdles will require not only reform but also stronger industry collaboration.
Elise Giles, Senior Manager at H&H Group, stressed that responsibility for navigating regulatory challenges does not fall on individual companies alone.
Instead, it requires alignment across internal teams and strong collaboration with industry bodies such as CMA and INC, which serve as the sector’s collective voice.
She added that firms, including competitors, must actively support these organisations to ensure the industry can present a united front to regulators and work toward common goals.
