Regulatory review: Health foods export, magtein approval and more

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Find out the latest regulatory updates impacting the nutraceutical industry.

China’s factory registration policy for overseas-made health foods, magtein approval in the UK and EFSA’s public consultation on berberine-containing plants are some of the latest updates in this regulatory news round-up.

Fighting fake imports? Health foods exported to China still need local authority recommendation

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An employee carrying out factory inspection. ©Getty Images

Overseas-made health foods entering China via the general trade route will still require official recommendation letters from their local authority when registering their manufacturing facility with the Chinese authorities - a move an industry expert said could be in response to concerns around fake imports.

The General Administration of Customs of China (GACC) announced the finalized “Catalogue of Foods that Require Official Recommendation Registration Letters” last week.

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Health foods, including health supplements, which were previously not included in the Catalogue during the GACC’s public consultation, were included in the finalized Catalogue.

Is FDA opening the long‑shut DSHEA ‘innovation door’?

Light bulb shape with pills.
The March 27th FDA Public Meeting will explore the scope of dietary supplement ingredients (kemalbas/Getty Images)

An upcoming public Food and Drug Administration (FDA) meeting exploring the scope of dietary supplement ingredients will revisit one of the most contested and, according to DSHEA’s architects, most misunderstood phrases in the U.S. dietary supplement law.

The March 27 meeting will open by discussing the scope of the phrase “dietary substance for use by man to supplement the diet by increasing the total dietary intake” (Section 201(ff)(1)(E)), as used in the Dietary Supplement Health and Education Act (DSHEA).

FDA is particularly interested in responses to whether this phrase can include substances that have never been part of the diet.

Magtein approved as a novel food in the UK, two years after EU approval

White magnesium pills spread out on s white background
Magnesium L-Threonate approved for EU supplements as Orotate dihydrate fails EFSA safety review (Ibrakovic/Getty Images)

Magtein, a branded form of magnesium L-threonate, has been approved as a novel food in the UK by Food Standards Agency (FSA) and has secured a five-year data protection period.

Magtein was originally developed in 2010 to increase magnesium levels in the brain and is now used in multiple products globally.

It already holds approvals in multiple markets, including EU novel food status (2024) and FDA GRAS status in the US (since 2012), as well as acceptance in countries like Canada, Japan and India.

‘No safe intake’ level for berberine: EFSA opens consultation

EFSA concluded that safe intake levels cannot be set for these substances or plant preparations.
EFSA concluded that safe intake levels cannot be set for these substances or plant preparations. (Getty Images)

Experts have warned that the future for berberine-containing plants looks bleak after EFSA published a draft opinion questioning their safety, with a stakeholder consultation now open until May. 4.

The opinion, brought about by The French Agency for Food, Environmental and Occupational Health & Safety (ANSES), concludes that no safe intake levels can currently be established for multiple plant species, including Berberis, Chelidoniummajus, Hydrastiscanadensis and phellodendronamurense.

Key concerns include genotoxicity signals for berberine in vitro, indicating gene mutation and chromosomal damage.

S’pore HSA urges collaboration to tackle ‘unique complexities’ of longevity sectors

dsm-firmenich has launched a nutrition research grant focusing on how nutritional supplementation could support healthy longevity among APAC populations.
dsm-firmenich has launched a nutrition research grant focusing on how nutritional supplementation could support healthy longevity among APAC populations. (airdone/Getty Images)

The Health Science Authority (HSA), which regulates health supplements in Singapore, is urging stronger collaboration between industry and academia to tackle the unique complexities of the booming longevity supplement sector.

Longevity supplements have gained traction in the post-COVID era, with the rise of nicotinamide mononucleotide (NMN) a classic example.

However, the scientific framework for evaluating the efficacy of these products is still in its early stages, said Dr. Raymond Chua, CEO of HSA.