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Two markets. Two compliance gaps. Neither required regulatory enforcement to cause commercial damage. A cease and desist from a German trade association triggered one; a flagged NDI gap from a US distribution partner triggered the other. The combined financial impact exceeded $400,000 — for issues that a structured pre-launch regulatory review would have identified and resolved before a single unit shipped.

The Company

A UK-based supplement brand with five years of domestic market history, a strong e-commerce presence, and an established product range covering sleep, cognitive function, and immune support. Having built a profitable UK business, the brand identified Germany, the Netherlands, and the United States as expansion markets in 2023. A distribution partner was secured in each market, and products were adapted from the UK formulation with reformulation work completed in 2022–2023.

The sleep support product was the flagship export — a botanical blend containing valerian root, lemon balm, and passionflower, with health claims referencing relaxation and normal sleep. The US variant included a standardised passionflower extract that had been added to the formulation in 2019. Both variants had been trading in their respective markets for 12–18 months before either compliance issue surfaced.

The EU Botanical Claims Issue

The brand's EU labelling and marketing materials used health claims referencing valerian's contribution to normal sleep and lemon balm's contribution to relaxation. Both claims are on the EU botanical health claims on-hold list — a list of over 1,500 botanical claims that have been in a suspended state since 2012 while the European Commission sought a revised scientific assessment framework.

The brand's regulatory position was that the on-hold status implied tolerance: that the claims were permissible while evaluation was pending, as the Commission had not explicitly prohibited their use. This interpretation was consistent with the position taken by a significant portion of the EU supplement industry — and it was wrong.

On 30 April 2025, the Court of Justice of the European Union issued its ruling in Case C-386/23 (Novel Nutriology v Verband Sozialer Wettbewerb). The Court confirmed that the on-hold status of botanical health claims does not constitute permission to use those claims — the prohibition applies during the entire period of suspension. Within six weeks of the ruling, a German trade association issued a formal Abmahnung (cease and desist notice) against the brand's German-market product descriptions and advertising.

What a cease and desist required

1
Immediate removal of all EU-facing botanical claims All product descriptions, e-commerce listings, social media content, and printed materials referencing valerian, lemon balm, or passionflower health claims were required to be withdrawn from the German and Dutch markets. This included removing claims from the brand's own website for any page visible to EU users.
2
Physical product recall from German distribution Packaging already in the German distribution network carried the prohibited claims on label. All stock had to be recalled from the German distributor and physically relabelled before re-entry to market. The relabelling process took 11 weeks.
3
Reformulation of marketing strategy With botanical health claims prohibited, the brand had to identify compliant alternative claims from the EU authorised register. The authorised equivalents — covering vitamins and minerals rather than botanicals — required product reformulation to justify the claims, or a purely descriptive marketing approach that could not reference any health benefit.
4
Legal costs and penalty Compliance with the Abmahnung required a signed declaration of undertaking (Unterlassungserklärung) committing to cease use of the prohibited claims. Legal representation in Germany to review and negotiate the undertaking added to the cost. Failure to sign and comply within the required timeframe would have escalated to an injunction application in the German courts.

The US NDI Gap

While the EU crisis was unfolding, the brand's US distribution partner conducted a compliance review of its own supplier portfolio, prompted by increased FDA enforcement activity in the dietary supplement sector. The review identified that the passionflower extract in the US-market sleep support product — a standardised extract introduced to the formulation in 2019 — had no New Dietary Ingredient (NDI) notification on file with the FDA.

Under DSHEA 1994, any dietary ingredient first marketed in a US dietary supplement after 15 October 1994 is a New Dietary Ingredient and requires a pre-market notification to the FDA at least 75 days before first marketing. The obligation applies to the ingredient in its specific form and concentration — a standardised extract of an otherwise familiar botanical can still qualify as a New Dietary Ingredient if the specific form was not in the US market before October 1994.

The product had been sold in the US for over two years without the notification. A product sold without a required NDI notification is adulterated under the Federal Food, Drug, and Cosmetic Act — a designation that creates liability for the US distributor regardless of whether the FDA has taken enforcement action. The distributor suspended purchases pending resolution.

What resolving the NDI gap required

1
Ingredient date-of-introduction review A formal review of the full formulation to determine the US introduction date of every component — not just the passionflower extract — and to identify whether any other ingredients required NDI notifications. Two additional minor ingredients required notifications.
2
NDI dossier preparation and submission Three NDI notifications were prepared and submitted to the FDA, covering the standardised passionflower extract and two additional ingredients. Dossier preparation required safety data compilation, historical use documentation, and proposed conditions of use statements.
3
75-day marketing hold US marketing was suspended for the mandatory 75-day pre-market notification window from the date of each submission. The distributor did not resume orders during this period. No new stock was accepted into the distribution network until the window had elapsed and the FDA had not issued a response letter raising safety concerns.
4
Retrospective supply chain liability review The distributor required a legal opinion on the liability exposure from the two years of prior sales. While the FDA had not initiated enforcement action, the adulterated status of the product during the period without notifications created potential liability that required documented risk assessment and legal advice.

The Full Cost

Cost item Market Estimated cost
German legal representation — Abmahnung response EU (Germany) ~$22,000
German stock recall and physical relabelling EU (Germany) ~$31,000
Lost German and Dutch sales during 11-week relabelling period EU ~$58,000
EU marketing strategy rebuild and new creative EU ~$18,000
NDI dossier preparation and submission (3 ingredients) US ~$34,000
Lost US sales during 75-day NDI notification hold US ~$74,000
US distributor relationship remediation and legal review US ~$26,000
Formulation review and reformulation work (EU claims strategy) EU · UK ~$19,000
Internal management time (estimated 3 months at senior level) All markets ~$38,000
Total estimated commercial impact EU + US ~$320,000
Unquantified reputational impact (distributor confidence, retailer delisting risk) All markets $80,000+

What a Pre-Launch Review Would Have Caught

Both compliance gaps were identifiable before market entry. The EU botanical health claims on-hold list is publicly accessible, and the status of valerian, lemon balm, and passionflower claims has been documented since 2012. A pre-launch EU claims assessment would have identified that all three botanical claims were on the on-hold list and recommended authorised alternatives or a reformulated marketing approach from launch.

The NDI status of the passionflower extract required a date-of-introduction review against the US market — a standard step in US market entry for any supplement product containing ingredients introduced to formulation after 1994. The review would have identified the NDI obligation within a few weeks, allowing the notification to be submitted during product development rather than after two years of sales.

Prevention Checklist for Supplement Market Entry

  • Review all botanical health claims in your formulation against the EU authorised claims register and the on-hold list before finalising EU-facing labelling and marketing
  • Conduct an ingredient date-of-introduction review for the US market — covering the specific form and concentration of each ingredient, not just the base substance
  • Submit NDI notifications for all post-1994 ingredients at least 75 days before first US marketing, not at the point of first sale
  • Identify whether any ingredients trigger Novel Food requirements in the EU or UK based on pre-1997 consumption history
  • Verify all ingredient forms against the EU Annexes and the UK permitted list separately — they are no longer equivalent
  • Assess whether any claims in your marketing materials could lead to MHRA borderline classification in the UK
  • Build China Blue Hat registration planning into initial market entry timelines if domestic retail is part of the China strategy
  • Review cGMP documentation for 21 CFR Part 111 compliance before any US distribution partner conducts its own audit

Key Regulatory Dates

30 April 2025 — CJEU Case C-386/23 ruling prohibits use of on-hold botanical health claims in EU advertising and labelling.

15 October 1994 — DSHEA cut-off date; dietary ingredients not in the US supplement market before this date require NDI notification.

75 days — Minimum pre-market window required for NDI notification before first US marketing.

10 August 2024 — UK permitted vitamins and minerals list updated independently of EU Annex II.

Launching a supplement into EU or US markets?

TGC's pre-launch supplement review covers EU botanical claims assessment, UK ingredient verification, US NDI status review, and labelling compliance across all your target markets — before any stock ships.

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