Regulatory review: Vitamin B6 in Australia, tariff exemption, IPA on self-GRAS

Find out the latest regulatory updates regarding Asia-Pacific's nutraceutical industry.
Find out the latest nutraceutical regulatory updates in this round-up. (Getty Images)

Australia’s implementation of ‘pharmacist-only’ scheme for vitamin B6, the US expanding tariff exemption list to include botanicals like turmeric, and the International Probiotics Association’s efforts in addressing expected changes to the USFDA GRAS affirmation pathway are some of the latest updates in this regulatory news round-up.

Australia implements ‘pharmacist-only’ scheme for vitamin B6 from Jun 2027

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Vitamin B6 with a recommended daily dose of over 50mg but 200mg or less will be sold as 'pharmacist-only' supplements in Australia from June 2027. (Bet_Noire/Getty Images/iStockphoto)

Vitamin B6 supplements with a recommended daily dose of over 50mg but 200mg or less will be sold as ‘pharmacist-only’ products in Australia from June 2027.

Over 100 products will be affected by the new regulation.

Australia’s Therapeutic Goods Administration (TGA) announced the above today (Nov 25), after considering feedback from the industry and the public over the risk of peripheral neuropathy associated with vitamin B6 supplementation.

3 crucial steps to harmonise halal standards across regions

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The lack of a synchronised halal certification system has increased certification costs for food firms, said the State of the Islamic Economy Report 2018/19. ©Getty Images (koksikoks/Getty Images/iStockphoto)

Experts have outlined three key steps to move toward a unified halal standardization system crucial for supporting exports.

These include the basics of helping applicants understand the halal certificate application process, introducing a digitalized system for document submission, and a standardized approach to certifying halal products across different parts of the world.

Currently, there are different authorities and regulatory requirements for halal certification globally. Examples include Malaysia’s Department of Islamic Development Malaysia (JAKIM), Indonesia’s Halal Product Assurance Organising Body (BPJPH), and the United Arab Emirates’ Emirates Authority for Standardization & Metrology (ESMA).

White House updates tariffs with relief for some botanicals

US tariffs
US tariffs (J Studios/Getty Images)

The Trump Administration has revised and expanded the tariff exemption list to include botanicals such as green and black tea, cinnamon, ginger and turmeric.

As part of an Executive Order issued Nov.14, the White House updated its list of exemptions to include many spices, coffee and tea (including extracts, essences and concentrates). Also added to the Annex II (fully exempt from the reciprocal tariff regime) are cinnamon, ginger and turmeric.

Psyllium husks (Plantago ovata) and Boswellia, on the other hand, are listed under “Potential Tariff Adjustments for Aligned Partners”, which means the product may be exempt if a country has a trade agreement with the United States.

IPA chief on the end of self-GRAS, China’s probiotic growth and global regulatory uncertainty

George Paraskevakos, executive director of IPA (left) speaks with NutraIngredients at SupplySide Global 2025
George Paraskevakos, executive director of IPA (left) speaks with NutraIngredients at SupplySide Global 2025 (NutraIngredients)

The International Probiotics Association (IPA) has mobilized its regulatory affairs committee to address expected changes to the GRAS affirmation pathway.

The leadership of the US Department of Health & Human Services has been pushing the U.S. Food and Drug Administration to explore the elimination of self-affirmed GRAS (General Recognized as Safe) for food ingredients.

“Everybody’s concerned, obviously, and it doesn’t only affect probiotics, it affects the entire supplement space. So, we’ve been very active, proactive,” said George Paraskevakos, IPA’s executive director.

TGA to work on updating guidance for listed medicines permitted indications

A photo showing a bottle of a health supplement.
A photo showing a bottle of a health supplement. (constantinopris/Getty Images)

Australia’s Therapeutic Goods Administration (TGA) has plans to update guidance around permitted indications for listed medicines, amongst others, as part of upcoming plans for year 2025/2026.

Avinash Clarke, assistant secretary of the Complementary and Over-The-Counter Medicine at TGA, said the above during a keynote address at the Natural Products Futures Forum organized by the Southern Cross University’s National Centre for Naturopathic Medicine at Ballina, New South Wales, Australia, on Oct 23.

There are currently 778 permissible indications under the listed medicines framework, which could be further increased.