Regulatory intelligence
Longevity ingredients, who allows what, when.
NMN, NR, spermidine, urolithin A, melatonin, berberine and other longevity actives sit in a moving regulatory framework. Each ingredient below has its own regulatory journey with dated events, sources, and current status across US, EU, UK, and Canada. Click any card to expand its timeline.
This is an aggregated database. We monitor continuously but cannot guarantee completeness. Always verify with the relevant authority before acting.
Our take
US: FDA reversed exclusion 29 September 2025; NDIN 1247 and NDIN 1259 reinstated 2 December 2025; NDIN 1444 (β-NMN, Effepharm) response 28 January 2026. NMN is a dietary ingredient again; each marketer still needs NDIN coverage. · EU: Unauthorised Novel Food; EFSA positive safety opinion adopted 4 March 2026 at up to 300 mg/day (β-NMN, EffePharm dossier). Commission listing pending. · UK: Not authorised as Novel Food. · CA: Not permitted as NHP.
A NAD+ building block that has become the most-hyped longevity molecule.
The biology is real. The evidence for actual longevity or muscle/cognitive benefits in humans is thinner than the marketing suggests. Well-studied for safety at 250 to 2000 mg/day; efficacy band 250 to 900 mg/day.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2022-11
US
FDA excludes NMN from the definition of a dietary supplement
The FDA notified two companies that NMN was excluded from the supplement definition under the Federal Food, Drug, and Cosmetic Act because a new drug application referencing NMN preceded any legitimate marketing as a supplement. This triggered market confusion in the US.
2023-01
UK
regulator queries NMN under Novel Food rules
The UK Food Standards Agency (post-Brexit) began treating NMN as an unauthorised novel food, echoing the EU position, though enforcement in practice has remained inconsistent and .com sellers continue to ship to UK consumers.
2024
CA
Health Canada, NMN requires product licence (NPN)
Health Canada regulates NMN under the Natural Health Products Regulations; a product needs an NPN to be sold legally. Very few NMN products carry an NPN, so most are technically not authorised for sale in Canada.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
2025-09
US
FDA reverses position, NMN can be marketed as a supplement
After industry pressure and clarifying legal action, the FDA reversed its earlier stance and allowed NMN to be sold as a dietary supplement in the United States.
2025-12
US
FDA re-affirms NMN's legal supplement status
In a follow-up statement, the FDA re-confirmed that NMN was legally marketable as a dietary supplement, ending most of the market uncertainty for US retailers.
2026-07
US
Reported FDA reversal, unverified
A source reported that the FDA once again pulled its supplement-status ruling on NMN. NO1GEVITY has not been able to confirm this reversal with a primary source and treats it as unverified pending confirmation.
unverified No source link
Our take
US: GRAS, NDI accepted · EU: Authorised Novel Food (Commission Reg 2020/16) · UK: Authorised Novel Food · CA: NHP licensed
The NAD+ precursor with the strongest safety file and EU approval.
The safer, more boring cousin to NMN. If you want a NAD+ booster and care about approvals, NR is the pragmatic choice.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
Our take
US: FDA GRAS · EU: Authorised Novel Food (EU 2021/85) · UK: Authorised · CA: NHP licensed
A mitophagy-activating metabolite with early human data; both flagship RCTs missed their primary endpoints.
The strongest evidence in the field right now. Missing from most 'longevity stacks' because it's expensive and patented, Timeline Mitopure® is the only serious supplier of the licensed compound.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2021-03
EU
EFSA opinion clears urolithin A as a novel food
EFSA published a positive safety opinion on urolithin A as a novel food, supporting its authorization for use in food supplements. The opinion assessed safety, bioavailability, and manufacturing specifications.
2022-06
EU
EFSA opinion clears urolithin A as a novel food
The European Food Safety Authority issued a positive scientific opinion on urolithin A (as sold by Amazentis / Timeline) as a novel food ingredient, subject to specified conditions of use. This is what allowed Mitopure to be sold in the EU.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
Our take
US: Dietary supplement · EU: Novel Food status for concentrates >7 mg; wheat-germ traditional food · UK: Food supplement · CA: NHP
The autophagy-inducing polyamine; the largest human trial found no cognitive benefit.
One of the more promising 'gerotherapeutics' with human data. Wheat-germ extract products vary widely in actual spermidine content, insist on assay-verified milligrams.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2019-01
EU
Wheat-germ-derived spermidine allowed as novel food (limits apply)
Wheat-germ extract containing spermidine was permitted as a traditional food ingredient. Concentrated spermidine supplements exceeding 7 mg per daily portion require Novel Food authorization. This creates a split market: wheat-germ extracts are legal, pure spermidine concentrates are not.
2020
EU
Wheat-germ-derived spermidine allowed as novel food (limits apply)
Spermidine-rich wheat-germ extract (Longevity Labs' spermidineLIFE) was authorised as a novel food in the EU with maximum daily intake limits, allowing legal EU sales of spermidine-based supplements.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
Our take
US: Dietary supplement · EU: Authorised Novel Food (2016/1866) · UK: Authorised · CA: NHP
The famous red-wine molecule; longevity claims have outrun the human evidence.
Overhyped but not useless. If you take it, choose products that use trans-resveratrol (not blends) and pair with a fatty meal for absorption.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2016-11
EU
authorizes trans-resveratrol as Novel Food
The European Commission authorized trans-resveratrol as a Novel Food under Regulation (EU) 2016/1866. Synthetic and fermentation-derived trans-resveratrol are permitted in food supplements at specified maximum levels. Grape-extracted resveratrol was already on the market.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
Our take
US: Dietary supplement · EU: Food supplement (extract-dependent) · UK: Food supplement · CA: NHP
Best-studied 'senolytic' ingredient, though evidence is early.
Safe, cheap, mild anti-inflammatory. Don't expect miracle rejuvenation from daily 500 mg capsules, the interesting senolytic protocols are periodic and use quercetin as part of a combo.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2021-11
EU
classifies encapsulated quercetin-zein as novel food
The EU Commission classified encapsulated quercetin-zein as a novel food because the encapsulation process significantly increases oral absorption and bioavailability, allowing quercetin to cross the blood-brain barrier. Standard quercetin from chemical synthesis or extraction from onions (Allium cepa) remains permitted as a food supplement without novel food authorisation. Quercetin (95%) derived from Dimorphandra mollis was also classified as novel.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
Our take
US: Dietary supplement · EU: Food supplement · UK: Food supplement · CA: NHP
Highly-hyped senolytic; the strong evidence is in mice, not people.
The most-hyped 'senolytic' with the weakest human evidence. If used, biohackers typically pulse it (2 days on / month off) rather than daily.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
Our take
US: Dietary supplement + Rx (Vascepa/Lovaza) · EU: Food supplement, health claims authorised · UK: Food supplement · CA: NHP + Rx
The single best-supported longevity supplement most people don't take enough of.
If you can only pick one supplement for longevity, omega-3 is a strong candidate, especially if you don't eat fatty fish 2× a week.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2004
US
FDA allows first qualified health claim for EPA/DHA omega-3 and heart disease
The FDA permitted a qualified health claim stating that supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. This was the first time the FDA allowed a heart-related claim for omega-3 supplements, though with qualifying language acknowledging the evidence was not definitive.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2012
EU
authorises health claims for DHA and EPA
Regulation (EU) 432/2012 established a list of authorised health claims for DHA and EPA, including contributions to normal brain function (250 mg/day DHA), normal vision (250 mg/day DHA), normal heart function (250 mg/day EPA+DHA), maintenance of normal blood triglyceride levels (2 g/day EPA+DHA), and maintenance of normal blood pressure (3 g/day EPA+DHA). Products must contain at least 40 mg EPA+DHA per 100 g and per 100 kcal to bear the source claim.
2019-06
US
FDA adds qualified health claims for EPA/DHA and blood pressure
The FDA announced it would not object to qualified health claims stating that consuming EPA and DHA combined may reduce blood pressure and the risk of hypertension, a risk factor for coronary heart disease. The agency found some credible evidence but concluded it was inconsistent and inconclusive. Products bearing the claim must contain at least 0.8 g EPA+DHA per serving. The FDA also raised the safe upper intake limit from 3 g/day to 5 g/day for supplements using the claim.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
Our take
US: Dietary supplement · EU: Food supplement, no Novel Food status needed · UK: Food supplement · CA: NHP licensed
A well-established mitochondrial cofactor, especially useful on statins.
One of the most defensible ingredients in any stack. Choose ubiquinol form if you're over 40, it absorbs better than ubiquinone.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2010-10
EU
EFSA rejects most CoQ10 health claims
EFSA published a scientific opinion on coenzyme Q10 health claims, rejecting claims related to energy metabolism, blood pressure, cognitive function, DNA protection, and endurance capacity. The panel concluded that a cause and effect relationship was not established for any of the claimed effects. CoQ10 remains legal as a food supplement in the EU but cannot bear authorised health claims.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
Our take
US: Dietary supplement · EU: Restricted in Italy (drug status ≥10 mg); food supplement elsewhere · UK: Food supplement · CA: NHP
Plant-derived AMPK activator; near-drug-strength effects on blood sugar and lipids.
The most drug-like supplement in the longevity space, for better and worse. Take with food, split doses, and don't combine with prescription diabetes meds without a doctor.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
2025-08
EU
Italy restricts berberine as drug at doses >=10 mg
Italy classified berberine as a drug at doses of 10 mg or higher, restricting its sale as a food supplement. Other EU markets still allow berberine as a food supplement. The restriction creates a fragmented regulatory landscape within the EU.
Our take
US: Dietary supplement · EU: Restricted in Italy/EU (safety review); food supplement elsewhere · UK: Food supplement · CA: NHP
Mitochondrial cofactor with genuine efficacy in diabetic neuropathy.
Solid choice if you're specifically targeting nerve health or mitochondrial support. R-ALA (natural isomer) absorbs ~2× better than the racemic mix most products sell.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
2025-11
EU
safety review of alpha-lipoic acid restricts use in Italy
Italy classified alpha-lipoic acid as a drug at therapeutic doses, restricting its sale as a food supplement. Other EU member states vary in enforcement. The Italian precedent creates uncertainty for cross-border supplement sales.
Our take
US: Dietary supplement (FDA position volatile) · EU: Food supplement; drug in some countries at doses ≥200 mg · UK: OTC drug + food supplement · CA: NHP
Cysteine donor for glutathione synthesis; drug-strength efficacy for specific uses.
Solid, cheap, well-studied. FDA occasionally hassles supplement sellers about NAC being a 'drug', but availability continues.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2020-07
US
FDA sends warning letters declaring NAC excluded from supplement definition
The FDA sent warning letters to seven companies selling NAC-containing hangover products, declaring that NAC is excluded from the dietary supplement definition under 21 U.S.C. 321(ff)(3)(B)(i) because it was first approved as a new drug in September 1963. Amazon subsequently removed NAC products from its marketplace. The FDA stated it was unaware of any evidence that NAC was marketed as a dietary supplement or food before the drug approval.
2022-08
US
FDA issues final guidance: enforcement discretion for NAC supplements
The FDA issued final guidance (FDA-2022-D-0490) announcing its intent to exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing products labeled as dietary supplements. This reversed the de facto ban from the 2020 warning letters. Amazon resumed sales of NAC products. The legal status remains ambiguous: NAC is technically excluded from the supplement definition, but the FDA chooses not to enforce against compliant products.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
Our take
US: Dietary supplement · EU: Prescription drug ≥2 mg; food supplement 0.5 to 1.9 mg · UK: Prescription drug · CA: NHP
The circadian rhythm hormone; low doses (0.3 to 1 mg) work best.
Take much less than the label suggests. US 5 mg tablets are massive overdoses; European Rx melatonin is 0.5 to 2 mg.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2024-06
EU
heads of food safety agencies prioritize melatonin for restriction
The HoA Working Group on Food Supplements identified melatonin among 12 substances prioritized for Article 8 restriction. French and Norwegian national risk assessments raised concerns about headaches, dizziness, drowsiness, and cardiovascular, neurological, digestive and psychological symptoms at supplement doses.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
2025-06
EU
classifies melatonin as prescription drug at doses >=2 mg
In the EU, melatonin is classified as a prescription drug at doses of 2 mg or higher. Lower doses (0.5 to 1.9 mg) remain available as food supplements. The UK treats melatonin as a prescription drug entirely. The US allows melatonin as a dietary supplement without a prescription.
Our take
US: Dietary supplement · EU: Food supplement, health claim authorised (3 g/day) · UK: Food supplement · CA: NHP
The most-studied supplement in existence; muscle, brain, and mood benefits.
Absurdly well-established. Cheap, safe, works for almost everyone at 3 to 5 g/day. Longevity link: preserved muscle mass is one of the strongest predictors of healthy aging.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2012-05
EU
authorises health claim for creatine at 3 g/day
Commission Regulation (EU) 432/2012 authorised the claim: "Creatine increases physical performance in successive bursts of short-term, high intensity exercise." The claim applies to foods providing 3 g of creatine per daily intake, targeting adults performing high intensity exercise. This was the first authorised EU health claim for a sports supplement ingredient.
2017-04
EU
adds second creatine health claim for adults over 55
Commission Implementing Regulation (EU) 2017/672 authorised a second health claim for creatine: creatine in combination with resistance training improves muscle strength in adults over 55. The EFSA scientific opinion was published in February 2016, establishing a cause and effect relationship between creatine plus resistance training and muscle strength improvement.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
Our take
US: Dietary supplement · EU: Food supplement, health claims authorised · UK: Food supplement · CA: NHP
One of the most common deficiencies; corrects sleep, muscle cramps, and blood pressure.
The form matters more than the amount. Glycinate and threonate are the best-tolerated and best-absorbed; oxide is a laxative that barely gets absorbed.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2012-05
EU
authorises 9 health claims for magnesium
Commission Regulation (EU) 432/2012 authorised nine health claims for magnesium, covering: reduction of tiredness and fatigue, electrolyte balance, energy-yielding metabolism, nervous system function, muscle function, protein synthesis, psychological function, maintenance of normal bones, and maintenance of normal teeth. Claims require the food to be at least a source of magnesium per Regulation (EC) No 1924/2006.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
Our take
US: Dietary supplement · EU: Food supplement (upper limit 100 μg/day) · UK: Food supplement · CA: NHP
Cheap, safe, and correcting a deficiency you probably have.
Test-then-treat is the right approach. If your level is <30 ng/mL, supplement 2000 to 5000 IU/day. Above 50 ng/mL, more isn't better.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2008-09
US
FDA authorises health claim for calcium + vitamin D and osteoporosis
The FDA published a final rule (73 FR 56477) amending 21 CFR 101.72 to include vitamin D in the calcium and osteoporosis health claim. The authorised claim states: "Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis." Foods must contain at least 200 mg calcium and 80 IU vitamin D per serving. The rule became effective January 1, 2010.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
Our take
US: GRAS · EU: Food supplement · UK: Food supplement · CA: NHP
Turmeric's active compound; genuinely anti-inflammatory but only in absorbable forms.
One of the best-supported anti-inflammatories in the supplement world, but only if you buy the enhanced-absorption forms.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2021-12
EU
EFSA gives positive opinion on tetrahydrocurcuminoids from turmeric
EFSA published a positive safety opinion on tetrahydrocurcuminoids (THCus) from turmeric (Curcuma longa L.) as a novel food, at a maximum of 140 mg per day for adults excluding pregnant and lactating women. THCus are produced by hydrogenation of curcuminoids extracted from turmeric rhizomes. Standard curcumin/curcuminoid extracts from turmeric remain non-novel and legal as food supplements.
2022-07
EU
authorises tetrahydrocurcuminoids as Novel Food
The European Commission authorised tetrahydrocurcuminoids from turmeric as a Novel Food, granting Sabinsa Europe 5-year data exclusivity. Maximum level: 140 mg/day for adults. Labelling must warn against concurrent use with other curcumin/curcuminoid supplements. Standard turmeric extracts and curcumin remain permitted without novel food authorisation.
2024-06
EU
heads of food safety agencies prioritize curcumin for restriction
The HoA Working Group on Food Supplements identified curcumin in Curcuma preparations among 12 substances prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The report flagged curcumin for possible carcinogenic, mutagenic, or reprotoxic properties at supplement doses exceeding normal dietary intake. The Article 8 procedure has not yet been formally initiated by the European Commission.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
Our take
US: Dietary supplement · EU: Novel Food authorised · UK: Authorised · CA: NHP
Promising cofactor for mitochondrial biogenesis; human evidence remains thin.
Interesting but unproven. Cheap enough to try as a 'stack ingredient' alongside CoQ10; don't count on it as a standalone longevity intervention.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2016
US
FDA issues no-questions letter for PQQ disodium salt GRAS notice
The FDA issued a "no questions" response to GRAS Notice GRN 000641 for pyrroloquinoline quinone (PQQ) disodium salt, filed by Hisun. PQQ disodium salt was determined to be Generally Recognized as Safe for use as an ingredient in beverages at up to 0.083 percent. A subsequent GRAS notice (GRN 694, Fuzhou Contay) received a no-questions letter in September 2017. PQQ is sold as a dietary supplement in the US under DSHEA.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
Our take
US: GRAS notice filed · EU: Novel food approved (2017) · UK: Novel food approved (retained) · CA: NHP permitted
A rare mushroom-derived amino acid that accumulates in tissues under oxidative stress, blood levels drop with age.
One of the more scientifically credible 'longevity-vitamin' candidates. Safe, mechanistically interesting, but human outcome data still limited. Reasonable as an add-on for those with low mushroom intake.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2017-07
EU
authorizes ergothioneine as Novel Food
The European Commission authorized L-ergothioneine as a Novel Food, permitting its use in food supplements. The US has a GRAS notification filed. Ergothioneine's authorization covers specific production methods and purity standards.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
Our take
US: Dietary supplement · EU: Novel food authorized (pasteurized, 2022) · UK: Permitted · CA: NHP pathway pending
Gut bacterium linked to leanness and metabolic health. One human trial — pasteurized, overweight adults, positive metabolic signals.
The most scientifically interesting 'next-gen probiotic', with exactly one human trial behind it. Early days.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2022-07
EU
authorizes pasteurized Akkermansia muciniphila as Novel Food
The European Commission authorized pasteurized Akkermansia muciniphila as a Novel Food, making it the first next-generation probiotic bacterium to receive EU authorization. Live (non-pasteurized) cells require separate authorization.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
Our take
US: Sold as a dietary supplement under DSHEA; TA-65 branded product has GRAS status for use in medical food, not FDA drug-approved. · EU: Novel Food status — high-purity cycloastragenol (≥98%) extract classified as unauthorized/under review as of January 2026 (nutraingredients.com). · UK: Similarly treated as a Novel Food requiring authorization for high-purity extracts, following EU precedent post-Brexit retained law. · CA: Available as a Natural Health Product (NHP) in some formulations; not broadly licensed for lengthened-telomere health claims.
A triterpenoid saponin derived from Astragalus membranaceus that activates the enzyme telomerase, marketed as the first natural compound shown to lengthen telomeres in humans.
One small human RCT (using the patented TA-65MD formulation) showed measurable telomere lengthening over about a year, which is a genuinely novel result, but the study was small, industry-linked, and has not been independently replicated at scale. The evidence is promising but far from conclusive, a...
Salvador L, et al. (2016). A Natural Product Telomerase Activator Lengthens Telomeres in Humans: A Randomized, Double Blind, and Placebo Controlled Study. Rejuvenation Research. PMID 26950204.Cycloastragenol is a potent telomerase activator in neuronal cells: implications for depression management. PMID 25095809.Full evidence page
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
2026-01
EU
High-purity cycloastragenol classified as unauthorized Novel Food in EU
High-purity cycloastragenol (>=98%) extracts were classified as unauthorized or under review as Novel Food in the EU. Traditional whole-herb Astragalus preparations remain widely available, but concentrated telomere-activating extracts face EU market restrictions.
Our take
US: Dietary supplement · EU: Food supplement · UK: Food supplement · CA: NHP
The 2023 sensation; species-wide lifespan extension in mice, humans unproven.
Interesting but early. If you take it, 3 to 6 g/day (not the marketing 500 mg) is closer to what mouse studies suggest, scaled down.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2009-02
EU
EFSA confirms taurine in energy drinks is not a safety concern
EFSA's ANS Panel published a scientific opinion confirming that taurine as an ingredient in energy drinks is not of safety concern at current intake levels. The NOAEL was established at 1,000 mg/kg body weight/day. The opinion resolved outstanding concerns raised by the EU Scientific Committee on Food in 2003 about potential harmful effects of taurine on the brain.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
Our take
US: Dietary supplement · EU: Food supplement · UK: Food supplement · CA: NHP
Carnitine crossing into the brain; neurological support.
Reasonable choice for brain-focused stacks, especially with alpha-lipoic acid.
1997
EU
introduces the Novel Food Regulation
Regulation (EC) No 258/97 required any food or food ingredient without a history of consumption in the EU before 15 May 1997 to be authorised before being placed on the market. This is the framework that captures NMN, spermidine as a supplement ingredient, urolithin A, and many other longevity actives.
2006-12
EU
Health Claims Regulation adopted
Regulation (EC) No 1924/2006 laid down harmonised rules for nutrition and health claims made on foods, including supplements. Only claims listed in the EU Register of authorised claims can be used. Rejected botanical claims are held in a separate on-hold list.
2021-01
EU
refuses to authorise health claim for L-carnitine and lipid metabolism
Commission Regulation (EU) 2021/77 refused to authorise the health claim "L-carnitine contributes to normal lipid metabolism." EFSA concluded in January 2018 that a cause and effect relationship had not been established between L-carnitine consumption and normal lipid metabolism. All previously submitted L-carnitine health claims (energy production, fat burning, muscle recovery) were also rejected.
2024-06
EU
report identifies 117 supplement substances as potential health risks
The HoA Working Group on Food Supplements (26 European countries) published its first report evaluating 117 substances used in food supplements. Of these, 65 were assessed as likely novel foods, 6 were already regulated, 34 had insufficient data, and 12 were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. The 12 priority substances include ashwagandha, curcumin, melatonin, piperine, St. John's wort, coumarin, p-synephrine, maca, holy basil, Melaleuca, black cohosh, and L-tryptophan. The report drew on 1,500 RASFF alerts reviewed between 2017 and mid-2022.
2025-04
EU
Court sharpens the bar for botanical health claims
A Court of Justice of the European Union ruling in April 2025 further tightened the requirements for how botanical ingredients (herbs, plant extracts) can be marketed with health claims in the EU, effectively removing much of the flexibility of the on-hold list.
unverified No source link
What this means for you
Regional summaries covering the ingredients where the rules matter most.
US
NMN: Legal as a dietary supplement following the FDA's December 2025 re-affirmation, after the agency flip-flopped on whether it was excluded from DSHEA.
NAC: FDA position remains volatile. The agency first said NAC was not a dietary supplement in 2020, reversed in 2022, and the legal status is still ambiguous.
Melatonin: Sold freely as a dietary supplement, unlike the EU and UK where it is a prescription drug at higher doses.
Omega-3: Qualified health claims authorised for cardiovascular benefits. Vascepa and Lovaza are Rx versions for specific indications.
Creatine: Sold as dietary supplement. No FDA health claim, but EU has authorised two health claims.
PQQ: GRAS self-determination for use in beverages. No FDA-approved health claims.
EU
NMN: Not on the Novel Food catalogue. Unlawful to place on the EU market as a food supplement without authorisation. EFSA gave a positive opinion in May 2026, but no Commission listing yet.
NR: Authorised as Novel Food (Commission Reg 2020/16). The only NAD precursor legally cleared for the EU market.
Berberine and alpha-lipoic acid: Italy restricts both as drugs at therapeutic doses. Other member states vary, creating a fragmented market.
Melatonin: Prescription drug at 2 mg or higher. Only 0.5 to 1.9 mg doses are available as food supplements.
Cycloastragenol: High-purity extracts classified as unauthorized Novel Food. Traditional Astragalus herb remains legal.
Spermidine: Wheat-germ extracts are traditional food. Pure concentrates above 7 mg per daily portion require Novel Food authorisation.
Creatine: Two authorised health claims (Reg 432/2012, Reg 2017/672). Best-regulated longevity-adjacent ingredient in the EU.
Magnesium: Nine authorised health claims under Reg 432/2012. One of the most claim-rich minerals in EU law.
CoQ10: EFSA rejected all health claims in 2010. Legal as supplement, but no authorised claims.
Curcumin: Standard turmeric extract is legal. Tetrahydrocurcuminoids authorised as Novel Food in 2022 (140 mg/day max).
Taurine: EFSA confirmed safe in energy drinks (NOAEL 1,000 mg/kg bw/day). No novel food concern.
L-carnitine: EU rejected health claim for lipid metabolism in 2021. Legal as supplement, no authorised claims.
Quercetin: Standard quercetin from synthesis or onions is legal. Encapsulated forms are classified as Novel Food.
UK
NMN: Post-Brexit divergence: the UK FSA treats NMN like the EU does, but enforcement is inconsistent and .com sellers continue to ship.
Melatonin: Prescription drug entirely, unlike the US. No OTC availability at any dose.
Spermidine: Wheat-germ extract from spermidine is separately authorised.
NR and urolithin A: Both authorised as Novel Foods, retained from EU law post-Brexit.
CA
NMN: Health Canada requires an NPN (Natural Product Number) for NMN products. Most global NMN brands do not carry one, meaning most NMN sales into Canada are technically not authorised.
Akkermansia: NHP pathway pending for this next-generation probiotic. EU has already authorised the pasteurised form.
C15:0 and cycloastragenol: Both have NHP pathways pending or unclear status in Canada.
Important: this is an aggregated database, not legal advice
This regulatory tracker is NO1GEVITY's own search engine and database that aggregates publicly available regulatory information from FDA, EFSA, UK FSA, Health Canada, and other authorities. We monitor these sources continuously, but we cannot guarantee that every entry is current or complete. Regulatory frameworks change frequently, sometimes without public notice, and we may miss updates or interpret them incorrectly. Nothing on this page constitutes legal advice. Before importing, selling, or marketing any ingredient, always verify the current status directly with the relevant national authority or a qualified regulatory lawyer. If you spot an error or an outdated entry, tell us and we will correct it.