Regulatory review: Amazon cGMP requirement, NMN, non-novel probiotic strains

Find out the latest regulatory updates concerning nutraceuticals and health supplements in this round-up.
Find out the latest regulatory updates concerning nutraceuticals and health supplements in this round-up. (Getty Images)

Amazon’s cGMP requirement for all health supplement products, Australia’s Therapeutic Goods Administration approval of NMN for use in dietary supplements, and the expansion of non-novel probiotic strains by the European Commission are some of the latest updates in the first nutraceutical regulatory round-up of the year 2026.

Amazon expands TIC cGMP requirement to all supplement products, plus fast-track option

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Amazon is rolling out its compliance requirements for all dietary supplement sellers (HJBC/Getty Images)

Amazon is rolling out its requirements for all dietary supplement sellers on the platform to use a third-party testing, inspection, and certification (TIC) organization to demonstrate cGMP compliance.

In an update sent last month, the American Herbal Products Association (AHPA) noted that the new cGMP requirement is in addition to and separate from the testing requirements that Amazon announced previously for several “problematic” categories, including sexual enhancement, weight management, bodybuilding, sports nutrition, and joint health products.

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Amazon will conduct outreach to covered companies as part of this phased rollout, it added.

European Commission assigns 34 probiotic strains ‘not novel’ status

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Companies already using these strains can confidently market products across the EU and new entrants can leverage these strains for innovation without regulatory delay (Jorisvo/Getty Images/iStockphoto)

The European Commission has updated its Novel Food Catalogue to add 34 probiotic strains considered ‘not novel’ when used in food or food supplements.

An official non-novel status has been assigned to species that previously had no formal designation, including Kluyveromycesmarxianus, Enterococcusfaecalis, Rhizopusoryzae, Hafniaalvei, and Corynebacteriumflavescens.

A total of 50 strains are now considered not novel and do not require formal pre-market Novel Food authorization, due to the strains having a history of consumption in the EU prior to May 15, 1997.

‘NMN for cell repair, lesser white hair’: MFDS clamps down on AI fake experts ads

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South Korea’s Ministry of Food and Drug Safety (MFDS) has been actively inspecting online ads featuring health supplements with false or exaggerated claims. ©Getty Images (Olivier Le Moal/Getty Images/iStockphoto)

South Korea’s Ministry of Food and Drug Safety (MFDS) has blocked online advertisements featuring AI-generated advertisements of doctors making misleading product claims, such as how nicotinamide mononucleotide (NMN) supplementation can promote cell self-repair and reduce white hair.

One of the artificial intelligence (AI)-generated videos showed a man clad in a physician’s outfit explaining how NMN supplementation could lead to a 178% reduction in white hair.

The regulator also said that it would step up its supervision of AI-generated expert advertisements from the year 2026.

Australia’s TGA approves NMN ingredient for supplement use

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The China health foods industry has set self-regulating standards to safeguard the quality of nicotinamide mononucleotide (NMN) products. ©Getty Images

Australia’s regulator, the Therapeutic Goods Administration (TGA) has approved NMN for use in dietary supplements for the first time.

The ingredient, often associated with anti-aging and longevity, was added to the TGA’s Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2025 last month.

Prior to this, NMN dietary supplements could be made in Australia, but only for exports.

FDA reinstates NDI status of NMN with new letters to ingredient players

Nicotinamide mononucleotide supplement, niacin, anti ageing vitamin. White pills forming shape to NMN letters on yellow background, copy space, top view.
NMN (beta-nicotinamide mononucleotide) is one of the forms of vitamin B3, or niacin (Mizina/Getty Images)

The U.S. Food and Drug Administration has sent letters to specific NMN ingredient suppliers confirming it has set aside previous determinations that the vitamin B3 form is excluded from the definition of a dietary supplement.

Two companies, SyncoZymes and Inner Mongolia Kingdomway, have both now received letters from the FDA confirming that it has reconsidered its stance and NMN is no longer excluded from the dietary supplement definition.

In late 2022, the two companies were informed by the FDA that NMN was not allowed as a dietary ingredient because of its prior investigation as a drug.