Ashwagandha Ireland: Legal Status, Safety, Evidence and Where to Buy (2026)
Ashwagandha is one of the most searched supplements in Ireland and one of the most misunderstood. This guide starts with the Irish legal and regulatory position, then covers safety and who should avoid it, what the research has actually examined, dosage, and where to buy. It answers the Irish question first, because that is what most people searching are asking.
- Sold in Ireland in food-supplement products, subject to Irish and EU food law.
- Finished supplements placed on the Irish market must be notified to the FSAI [8].
- FSAI notification is a filing, not product approval of safety, ingredient or claims [8].
- Ashwagandha is not a licensed medicine.
- No EU-authorised health claim exists for ashwagandha; botanical claims are on hold under Regulation 1924/2006 [9].
- Denmark does not permit ashwagandha to be sold as food (prohibited 2023).
- The UK Committee on Toxicity review was ongoing, with no final statement published as of April 2026 [6].
- Not suitable during pregnancy or breastfeeding, or for under-18s.
Ashwagandha (Withania somnifera) is a herb long used in Ayurvedic tradition and sold in Ireland as a food supplement, not a medicine. Individual products must be notified to the FSAI, but notification is not approval, and there are no EU-authorised health claims for it, so nothing on this page is a claim that ashwagandha treats or improves any condition. It is under active safety review: Denmark prohibited it in food in 2023, and the UK Committee on Toxicity review was unfinished as of April 2026, examining possible effects on the liver, thyroid and blood glucose. Clinically apparent liver injury has been reported rarely with ashwagandha products [7]. Human trials of standardised root extract (typically 300-600 mg/day) have examined stress and sleep outcomes; these are research findings on the extract, not evidence that any product will do the same for you. It is not suitable during pregnancy or breastfeeding. Products stocked in Ireland include Swanson Ashwagandha KSM-66 250 mg (60 veg caps, €17.45), dispatched from Dublin.
Ashwagandha (Withania somnifera, winter cherry or Indian ginseng) definition: the root of a small evergreen shrub native to India, the Middle East and Africa, used for centuries in Ayurvedic tradition and sold today as a dried root powder or a standardised root extract in capsules, tablets and gummies.
Ashwagandha-containing food supplements are currently sold in Ireland under Irish and EU food law. They are food supplements, not licensed medicines. Individual products placed on the Irish market must be notified to the FSAI, but notification does not mean the FSAI has approved the ingredient, product or any claimed effect. No EU-authorised health claim for ashwagandha was identified for this guide. On safety, evidence and long-term safety remain limited: regulators are assessing possible thyroid, blood-glucose and rare liver effects, clinically apparent liver injury has been reported rarely, Denmark does not permit ashwagandha to be sold as food, and the UK Committee on Toxicity review was unfinished as of April 2026. It is not suitable during pregnancy or breastfeeding. If you choose to take it, follow the product label and speak to your GP or pharmacist if you have a health condition or take medication.
These are food supplements, not medicines, and no health claim is made for them. The products supply 200-250 mg per capsule, which is not the 600 mg/day used in the cited 2012 study; study results should not be applied to these products.
- What it is: the root of Withania somnifera, an Ayurvedic herb
- Common forms: root powder, standardised root extract (KSM-66, Sensoril), capsules, tablets, gummies
- Active compounds: withanolides (extracts standardised to ~5-10%)
- Typical trial dose: 300-600 mg/day standardised extract over 8-12 weeks (varies by extract)
- Is it a stimulant or a medicine? No. Food supplement, not a medicine, and not a stimulant.
- EU-authorised health claims: none (botanical claims on hold since 2010)
- Irish market position: sold as a food supplement; finished products must be notified to the FSAI (notification is not approval)
- Under review: Denmark prohibited it in food (2023); UK COT review unfinished as of April 2026
- Not suitable for: pregnancy, breastfeeding, under-18s; avoid in advanced liver disease
- Irish VAT on supplements: 13.5% (source: Irish Revenue)
- Ashwagandha is not a medicine and is not a treatment for stress, anxiety, insomnia or any diagnosed condition.
- Ashwagandha does not carry any EU-authorised health claim — online claims that it "lowers cortisol" or "improves sleep" are not authorised.
- FSAI notification of a product is not FSAI approval of its safety, ingredient or claims.
- Ashwagandha is not confirmed safe for everyone: regulators are actively reviewing thyroid, blood-glucose and rare liver effects.
- Ashwagandha is not suitable during pregnancy or breastfeeding, and not for under-18s.
- A clinical-trial result on one standardised extract at a given dose is not a guarantee that a different shop-bought product will behave the same way.
- It is sold in Ireland as a food supplement, not a medicine.
- No EU health claim is authorised for it.
- Small RCTs have examined stress, cortisol and sleep with standardised extract.
- Rare liver-injury cases are documented in the literature.
- Denmark prohibits it as food; other EU/UK reviews are active.
- Long-term safety (most trials ran 8-12 weeks).
- Effects in the general healthy population.
- How much day-to-day "perceived stress" actually changes.
- The full picture on thyroid, blood-glucose and liver risk — under review.
- Whether one extract's results transfer to another product.
- Ashwagandha in Ireland: legal and regulatory status
- What ashwagandha is
- Root powder vs standardised extract (KSM-66)
- What the research has examined
- Safety, side effects and who should not take it
- Ashwagandha and medications
- Dosage in studies
- How to assess an Irish ashwagandha product
- Buying ashwagandha in Ireland
- Frequently asked questions
The clinical and mechanistic research discussed in this article relates to ashwagandha as a studied compound. It is not a claim that Swanson Ashwagandha KSM-66, or any product, produces these effects. These products are food supplements, not medicines. No authorised EU health claim is made for ashwagandha, and the product dose is not the same as the doses used in the cited studies.
Swanson Ashwagandha KSM-66 250 mg
Certified-organic, root-only KSM-66 standardised extract. One vegetarian capsule a day. Dispatched from Dublin.
€17.45 including Irish VAT at 13.5%. Food supplement, not a medicine. Not suitable during pregnancy or breastfeeding.
Ashwagandha in Ireland: legal and regulatory status
Ashwagandha-containing food supplements are currently sold in Ireland, subject to Irish and EU food law. The legal position attaches to the finished product and its precise composition, preparation, labelling and claims — not to ashwagandha as an ingredient in the abstract.
Food supplements placed on the Irish market for the first time must be notified to the Food Safety Authority of Ireland (FSAI) [8]. This is important: notification is a regulatory filing, and it does not mean the FSAI has approved the product's safety, the ingredient, or any claimed effect. Products are checked on a risk basis after they are on the market.
There are no EU-authorised health claims for ashwagandha. Health claims for botanical ingredients have been on hold at EU level since 2010 [9]. In Case C-386/23, decided on 30 April 2025, the Court of Justice of the EU examined how Regulation 1924/2006 applies to botanical claims whose EU assessment remains suspended, including the Regulation's transitional rules. Probiotic.ie's own policy is conservative: we do not use stress, sleep or other health claims for ashwagandha unless expressly authorised under applicable EU law.
On safety, the picture is unusually active. Denmark prohibited ashwagandha in food supplements in 2023, and several other EU authorities advise caution. The UK Food Standards Agency asked its Committee on Toxicity (COT) to assess the herb; its discussion paper noted possible effects on reproduction, the thyroid and blood glucose, and considered reported liver effects consistent with an idiosyncratic (unpredictable) response [6]. That review was ongoing, with no final statement published as of April 2026. At EU level, an "Article 8" review under Regulation 1925/2006 — which could lead to restrictions, label requirements or a ban — has been discussed and recommended in industry and regulatory commentary, though no formal Commission procedure was confirmed for this guide.
On novel-food status, one point is often stated too confidently online, so here is the careful version:
Novel-food status depends on the exact ashwagandha preparation, manufacturing process and intended use. The European Commission's Novel Food Catalogue is a non-binding reference, not an approval list. A food-business operator must be able to establish that its ingredient has a relevant history of consumption in the EU before 15 May 1997, or hold an applicable authorisation where required. The status of a whole root, an aqueous preparation and a concentrated extract should therefore not be assumed to be identical.
Ashwagandha is legal to buy in Ireland today, as a food supplement, not a medicine, with no authorised health claims. Its regulatory status is under active review and could change. If you choose to take it, follow the label, respect the safety cautions below, and speak to your GP or pharmacist if you have a health condition or take medication.
What ashwagandha is
Ashwagandha is the root of Withania somnifera, a small shrub in the nightshade family native to India, the Middle East and parts of Africa. In Ayurvedic tradition it has been used for centuries and is described as a "rasayana" (rejuvenator) and an "adaptogen" — traditional herbal terms, not health benefits recognised under EU food law.
The compounds most associated with ashwagandha in research are the withanolides, a group of naturally occurring steroidal lactones. Standardised extracts are concentrated to a set withanolide level, usually around 5%, so each capsule delivers a consistent amount.
Root powder vs standardised extract (KSM-66)
Not all ashwagandha is the same, and the difference matters for both dosing and regulation.
Whole root powder
Dried, milled ashwagandha root — closest to the traditional form, typically taken in gram quantities. It is not standardised, so withanolide content varies batch to batch.
Standardised root extract (KSM-66)
KSM-66 is a proprietary root-only extract standardised to at least 5% withanolides, produced without alcohol or chemical solvents. It has been used in several published human studies, and both products stocked at Probiotic.ie use it.
Root-and-leaf extract (Sensoril)
Sensoril is a different extract, made from root and leaf and standardised to around 10% withanolides, so its typical serving is smaller. It is a distinct ingredient from KSM-66.
| Form | Part used | Standardised? | Typical dose | Note |
|---|---|---|---|---|
| Whole root powder | Root | No | 3-5 g/day | Closest to traditional food use |
| KSM-66 extract | Root only | ~5% withanolides | 250-600 mg/day | Concentrated extract — see novel-food note above |
| Sensoril extract | Root + leaf | ~10% withanolides | 125-250 mg/day | Concentrated extract — distinct ingredient |
What the research has examined
Human research on ashwagandha has concentrated on standardised root extract and on stress, cortisol and sleep outcomes. The findings below are results in specific trials on the extract as a studied compound. They are not claims about what any product will do for you, and no EU-authorised health claim exists for ashwagandha.
How to read the certainty labels below: our grading reflects study size, randomisation, replication, consistency, duration, risk of bias and commercial involvement. It is an editorial assessment, not a formal GRADE review. Most positive trials are small, short, single-centre, conducted in India and linked to ingredient suppliers, which lowers certainty.
| Study | Extract / part | Dose | Duration | Population | Main outcome reported | Funding / conflict |
|---|---|---|---|---|---|---|
| Chandrasekhar 2012 [1] | KSM-66 (root) | 600 mg/day | 60 days | 64 chronically stressed adults | Serum cortisol −27.9% vs −7.9% placebo (P=0.0006) | Industry-linked (KSM-66 supplier); single-centre |
| Lopresti 2019 [2] | Standardised root extract | 240-600 mg/day | 60 days | 60 adults | Lower stress-scale scores; cortisol change | Industry-funded |
| Salve 2019 [3] | Root extract | 250-600 mg/day | 8 weeks | 58 healthy adults | Reduced stress-scale scores; cortisol change | Industry-funded |
| Cheah 2021 (meta) [4] | Mixed extracts | ≥600 mg/day subgroup | 5 RCTs pooled | 400 participants | Small significant sleep effect (SMD −0.59) | Academic; no industry funding declared |
Stress and cortisol: in a 2012 single-centre RCT, 600 mg/day KSM-66 for 60 days was associated with a 27.9% fall in serum cortisol versus 7.9% on placebo, with lower stress-scale scores. Later industry-funded RCTs (Lopresti 2019, Salve 2019) reported similar directional findings. Small, short, supplier-linked trials.
This is research on the extract, not a claim about any product.
Chandrasekhar 2012, DOI 10.4103/0253-7176.106022; Lopresti 2019, PMID 31517876; Salve 2019, PMID 32021735.
Sleep: a 2021 academic meta-analysis pooling five RCTs (n=400) found a small but statistically significant effect on overall sleep, more prominent at ≥600 mg/day and ≥8 weeks. The authors noted heterogeneity between trials.
This is research on the extract, not a claim about any product.
Cheah 2021, DOI 10.1371/journal.pone.0257843.
Liver: clinically apparent liver injury has been reported rarely with ashwagandha-containing products, typically 2-12 weeks after starting, usually with jaundice and itching that resolved after stopping; rare severe cases occurred, particularly with pre-existing liver disease. NIH LiverTox rates ashwagandha a probable cause of clinically apparent liver injury.
NIH LiverTox (NBK548536); Björnsson et al. Liver Int. 2020;40(4):825-829.
No EU-authorised health claim exists. Long-term safety and effects in the general healthy population are not established. Effects on cortisol are more consistent than effects on day-to-day perceived stress. Denmark prohibits ashwagandha as food; the UK COT review was unfinished as of April 2026.
FSA/COT review; EU Regulation 1924/2006; national measures.
Safety, side effects and who should not take it
This is the part that gets least attention online and matters most. In trials, ashwagandha root extract was generally well tolerated, with mild effects such as drowsiness, stomach upset or loose stools in some participants. But there are more serious signals to be aware of.
Do not take ashwagandha if you are pregnant or breastfeeding. It is not recommended for children or under-18s.
Liver: rare cases of clinically apparent liver injury have been reported with ashwagandha-containing products, typically 2-12 weeks after starting, with jaundice and itching [5][7]. Its use should be avoided in cirrhosis or advanced liver disease.
Thyroid and blood glucose: safety authorities have identified possible effects on thyroid hormones and blood glucose [6]. Speak to your GP or pharmacist first if you have a thyroid, diabetes or liver condition.
Stop use and seek medical advice if you feel unwell — in particular with yellowing of the skin or eyes, dark urine, persistent nausea or itching, or unusual confusion or drowsiness.
Ashwagandha and medications
Because of the signals above, caution is advised when combining ashwagandha with several types of medication. This is general information, not personal advice — check with your GP or pharmacist.
- Thyroid medication (e.g. levothyroxine / Eltroxin): possible effect on thyroid hormones.
- Diabetes or blood-sugar medication: possible effect on blood glucose.
- Sedatives, sleep medication and alcohol: may add to drowsiness.
- Antidepressants and other CNS medicines: discuss before combining.
- Immune-suppressing medication: discuss before combining.
Ashwagandha is not a substitute for prescribed treatment, and should not be used to self-treat a diagnosed condition.
Dosage in studies
Clinical studies have used a range of preparations and doses. Several trials of standardised root extract used daily doses between 300 mg and 600 mg over 8-12 weeks, but results from one proprietary extract or dose should not be applied automatically to another product. These are research doses, not a recommendation.
Study protocols also differed in when and how the extract was taken. Consumers should follow the directions on the specific product label rather than infer a schedule from a different clinical trial, and should not exceed the stated dose. As a precautionary measure, Poland reportedly set a limit of 3 grams per day for ashwagandha in 2020 (secondary reporting; the exact scope was not independently confirmed for this guide).
How to assess an Irish ashwagandha product
Rather than chasing a single "best" brand, check these before you buy. A transparent listing should make all of them easy to find.
- Exact plant part (root, or root and leaf)
- Extract name (e.g. KSM-66, Sensoril) or whether it is whole root powder
- Milligrams per serving and withanolide standardisation
- Full ingredient list and any allergens
- Batch and best-before information
- An Irish-market label and responsible food-business operator details
- Pregnancy, breastfeeding and medication warnings
- That the seller dispatches within Ireland (avoids customs surprises)
The research summarised above relates to ashwagandha as a studied compound and is not a claim that any product produces these effects. The products below are food supplements, not medicines, at doses different from the cited studies, and no authorised EU health claim is made for ashwagandha.
Buying ashwagandha in Ireland
Probiotic.ie stocks ashwagandha in Ireland, dispatched from Dublin with nationwide tracked delivery. Both products below use KSM-66 standardised root extract.
Swanson Ashwagandha KSM-66 250 mg
Certified-organic, root-only KSM-66 standardised extract. One vegetarian capsule daily. Tracked delivery from Dublin.
€17.45 including Irish VAT at 13.5%. Food supplement, not a medicine. Not suitable during pregnancy or breastfeeding. Browse the full range at probiotic.ie/collections/ashwagandha.
Product details on this page — including dose (250 mg KSM-66 root extract per capsule), capsule count (60), source (certified-organic Withania somnifera root), and price (€17.45 inc. VAT at 13.5%) — were verified by Probiotic.ie from the current Swanson listing on 16 July 2026. The Osavi KSM-66 200 mg (180 veg caps, €29.95) details were verified the same day. Product details should always be checked against the current label before use, as formulations and pricing may change.
- Ashwagandha (Withania somnifera) is the root of an Ayurvedic herb, sold in Ireland as a food supplement, not a medicine.
- Finished ashwagandha supplements must be notified to the FSAI; notification is a filing, not FSAI approval.
- There are no EU-authorised health claims for ashwagandha; botanical claims have been on hold since 2010.
- Most human trials used 300-600 mg/day of standardised root extract over 8-12 weeks; one extract's result should not be applied to another.
- The strongest single finding is a 27.9% serum cortisol reduction versus placebo in a 2012 KSM-66 trial — a trial result, not proof any product works.
- Clinically apparent liver injury has been reported rarely with ashwagandha products (NIH LiverTox; Björnsson 2020); avoid in advanced liver disease.
- Regulators are reviewing possible thyroid and blood-glucose effects; Denmark prohibited ashwagandha as food in 2023; the UK COT review was unfinished as of April 2026.
- Ashwagandha is not suitable during pregnancy or breastfeeding, or for under-18s.
- In Ireland, ashwagandha is regulated by the FSAI as a food supplement; VAT is 13.5% (Irish Revenue).
- Swanson Ashwagandha KSM-66 250 mg (60 veg caps, €17.45) is available from Probiotic.ie with tracked delivery from Dublin.
Frequently asked questions
Is ashwagandha legal in Ireland?
Ashwagandha-containing food supplements are currently available for sale in Ireland, subject to Irish and EU food law. The legal position applies to the finished product and its precise composition, preparation, labelling and claims. Individual products must be notified to the FSAI, but notification does not amount to regulatory approval. Ashwagandha is not a licensed medicine, and no EU-authorised health claim exists for it.
Does ashwagandha have any approved health claims in the EU or Ireland?
No. There are no EU-authorised health claims for ashwagandha. Botanical claims have been on hold since 2010 and none are authorised for Withania somnifera. Under Regulation 1924/2006, health claims may only be used if authorised, so Probiotic.ie makes no claim that ashwagandha treats or improves any condition.
What are the side effects of ashwagandha?
In trials it was generally well tolerated, with mild effects such as drowsiness, stomach upset or loose stools in some people. More seriously, clinically apparent liver injury has been reported rarely with ashwagandha products (NIH LiverTox; Björnsson 2020), typically 2-12 weeks after starting, with jaundice and itching that resolved after stopping. Regulators are also assessing possible thyroid and blood-glucose effects. Stop use and seek medical advice if you feel unwell, especially with yellowing skin or eyes, dark urine, or persistent itching or nausea.
Who should not take ashwagandha?
Do not take it if you are pregnant or breastfeeding, and it is not recommended for under-18s. Avoid it in cirrhosis or advanced liver disease. Speak to your GP or pharmacist first if you have a thyroid, diabetes or liver condition, or take prescription medication including thyroid medicine (such as Eltroxin), diabetes medication, sedatives, antidepressants or immune-suppressing drugs.
Does ashwagandha interact with medications?
Possibly. Because it has been associated with sedation and with possible thyroid and blood-glucose effects, caution is advised alongside thyroid medication, diabetes medication, sedatives and alcohol, and it may affect immune-modulating medicines. It is not a substitute for prescribed treatment. Always check with your GP or pharmacist before combining it with any medication.
How much ashwagandha per day is used in studies?
Studies used a range of preparations and doses; several standardised-root-extract trials used 300-600 mg/day over 8-12 weeks, but one extract's result should not be applied to another product. These are research doses, not a recommendation. Follow your product's label and do not exceed it.
What is the difference between root powder and KSM-66 extract?
Whole root powder is the traditional, unstandardised form taken in gram quantities. KSM-66 is a proprietary standardised root-only extract (~5% withanolides) used in several published trials. Sensoril is a root-and-leaf extract at ~10% withanolides, so its dose is lower. Novel-food status depends on the exact preparation, so these forms should not be assumed to be treated identically.
Is ashwagandha safe to take long term?
Long-term safety is not established; most trials ran only 8-12 weeks. This is part of what EU and UK regulators are assessing, alongside possible thyroid, blood-glucose and rare liver effects. Follow the product label and speak to your GP or pharmacist if you have a health condition or take medication.
Where can I buy ashwagandha in Ireland?
Probiotic.ie stocks ashwagandha in Ireland, including Swanson Ashwagandha KSM-66 250 mg (60 vegetarian capsules) and Osavi Ashwagandha KSM-66 200 mg (180 vegetarian capsules), both certified standardised root extracts, dispatched from Dublin with nationwide tracked delivery. Ashwagandha is a food supplement, not a medicine.
This guide was prepared by Probiotic.ie using the following process:
- Reviewed primary human trials (Chandrasekhar 2012, Lopresti 2019, Salve 2019) and the Cheah 2021 sleep meta-analysis, recording dose, duration, population, outcome and funding.
- Reviewed the regulatory position: the FSA/Committee on Toxicity review, the EU botanical-claims position and CJEU Case C-386/23, and Denmark's 2023 prohibition.
- Reviewed liver-safety evidence via NIH LiverTox and the Björnsson 2020 DILIN case series.
- Graded evidence certainty editorially (study size, randomisation, replication, duration, bias, commercial involvement) — not a formal GRADE review.
- Separated published research on the compound from any suggestion of product effect throughout.
- Verified every PMID and DOI against PubMed/PMC, and verified product details against the live listings on 16 July 2026.
- Made no disease-treatment or health claim for ashwagandha, and led with the Irish regulatory position and safety.
Corrections: if you spot an error, email the address on our contact page and we will review it. Regulatory facts last checked 16 July 2026.
This guide is for educational purposes only and does not constitute medical advice. Ashwagandha is a food supplement regulated under FSAI food-supplement guidelines and is not intended to diagnose, treat, cure or prevent any disease or medical condition. FSAI notification of a product is not FSAI approval. There are no EU-authorised health claims for ashwagandha, and it is under active EU and UK safety review. Do not use during pregnancy or breastfeeding. If you have a health condition, take medication, or have persistent or worsening symptoms, consult your GP or pharmacist. Probiotic.ie is operated by TenX Tech Ltd and is regulated under FSAI food-supplement guidelines.
| Item | Last verified | Next review |
|---|---|---|
| FSAI notification position | 16 Jul 2026 | On COT final statement |
| UK COT review status | 16 Jul 2026 | On publication of COT statement |
| Denmark position | 16 Jul 2026 | Quarterly |
| EU claims / CJEU position | 16 Jul 2026 | Quarterly |
| Product price & specification | 16 Jul 2026 | Monthly |
Sources
- Chandrasekhar K, Kapoor J, Anishetty S. A prospective, randomized double-blind, placebo-controlled study of safety and efficacy of a high-concentration full-spectrum extract of ashwagandha root in reducing stress and anxiety in adults. Indian J Psychol Med. 2012;34(3):255-262. — DOI: 10.4103/0253-7176.106022
- Lopresti AL, Smith SJ, Malvi H, Kodgule R. An investigation into the stress-relieving and pharmacological actions of an ashwagandha extract. Medicine (Baltimore). 2019;98(37):e17186. — PMID 31517876
- Salve J, Pate S, Debnath K, Langade D. Adaptogenic and anxiolytic effects of ashwagandha root extract in healthy adults. Cureus. 2019;11(12):e6466. — PMID 32021735
- Cheah KL, Norhayati MN, Yaacob LH, Rahman RA. Effect of ashwagandha extract on sleep: a systematic review and meta-analysis. PLoS One. 2021;16(9):e0257843. — DOI: 10.1371/journal.pone.0257843
- Björnsson HK, Björnsson ES, Avula B, et al. Ashwagandha-induced liver injury: a case series from Iceland and the US Drug-Induced Liver Injury Network. Liver Int. 2020;40(4):825-829. — PMID 31991029
- Committee on Toxicity (COT) / Food Standards Agency. Review of the safety of ashwagandha (Withania somnifera) in food, drinks and food supplements (discussion paper P26-04); call for evidence, 2024-2026. — food.gov.uk
- Ashwagandha. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. NIDDK (NIH). — NCBI Bookshelf NBK548536
- Food Safety Authority of Ireland. Food Supplements: notification, legislation and health claims. — fsai.ie
- EU botanical health claims "on hold" (since 2010) under Regulation (EC) No 1924/2006; Court of Justice of the EU, Case C-386/23 (Novel Nutriology), decided 30 April 2025. — EFSA: Article 13 health claims (on-hold botanical claims).