The UK’s CBD novel foods programme enters 2026 with its autumn ministerial approval target still nominally intact, but facing increasing pressure on multiple fronts.
Updated regulatory guidance, a busy period of safety assessments, and an emerging regulatory chasm with Europe’s food standards authority have all landed in quick succession, each adding further complexity to an already protracted and frustrating process.
While the process is now finally moving forward, what successful companies will have to show for it when all is said and done is still in flux.
Reformulation guidance provides route for those still in process
This week, the FSA updated its guidance to allow CBD products on the Public List to be reformulated under defined conditions.
Until mid-2025, products on the Public List were effectively frozen in place. The FSA had not permitted amendments to reflect any changes to listed products, including name changes or concentration adjustments, on the basis that alterations would render them new products and therefore ineligible for inclusion.
This is despite the fact that the FSA’s own requirements and upper limits had changed mid-process, leaving hundreds of applicants in limbo, with no mechanism to bring existing products into line with updated guidance without risking removal from the market.
That changed in July 2025, when the FSA’s new management team signalled for the first time that a reformulation pathway was under consideration, part of a broader shift in posture that also saw the agency soften its stance on THC thresholds.
This week’s update establishes the specific conditions under which reformulation is now permitted, while clarifying the switching mechanism, allowing products linked to applications that are no longer progressing to move to an active application, provided the product meets that application’s specification and food category.
Businesses may now reduce the concentration of their products to align with the 10mg/day ADI and a safe upper limit of 70 micrograms per day of delta-9-THC without automatically losing their place on the list. Where reformulation does not change the product details recorded on the list, businesses are not required to notify the regulator.
The Cannabis Trades Association (CTA) has long advocated for a reformulation pathway of this kind, and welcomed the guidance as a significant step forward for the sector. The organisation characterised the development as formal recognition of its Switching Protocol, submitted to the FSA in January, and described it as a significant win for its advocacy.
The FSA’s published rationale is anchored in the Joint Advisory Committee’s evidence review rather than industry proposals, framing the change as a consumer protection measure driven by evolving safety advice.
The reformulation guidance also reiterates the controversial 10mg ADI as the standard to which businesses are being asked to align.
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15 dossiers now in final ‘risk management’ phase
The scale of the FSA’s output over the past year is often overlooked amid the noise around delays and consultations.
The agency has now published 14 positive safety assessments for CBD isolate applications, alongside one synthetic CBD application from Pureis.
Not all applications have survived the process, however. In January 2026, the FSA issued negative conclusions for RP61 (Farmabios) and RP194 (Dragonfly Biosciences), both submitted in early 2021.
In each case, the failure was attributed to insufficient data due to a lack of administrative provenance, meaning the applicants could not demonstrate adequate data integrity and study quality, and therefore, safety could not be established. Products linked to those applications now face removal from the market.
POSITIVE ASSESSMENTS (15)
April 2024:
- RP07 (Pureis) — synthetic CBD
- RP350 (Cannaray) — CBD isolate
August 2024:
- RP427 (EIHA Consortium) — CBD isolate
January 2025:
- RP11 (BSPG Laboratories)
- RP349 (Mile High Labs)
February 2025:
- RP354 (Bridge Farm Group)
- RP521 (TTS Pharma)
- RP793 (CBD Industries LLC/CBDMD) — 24mg rejected, 10mg approved
April 2025:
- RP176 (Curesupport Holding B.V.)
- RP294 (Deep Nature Project GmbH)
- RP340 (The London Company Ltd)
June 2025:
- RP343 (CBD Health Ltd)
- RP345 (Medicanna Ltd)
- RP346 (CBD Health Ltd)
November 2025:
- RP225 (Eusphera Nutraceuticals)
NEGATIVE ASSESSMENTS (2)
January 2026:
- RP61 (Farmabios) — insufficient data, administrative provenance
- RP194 (Dragonfly Biosciences) — insufficient data, administrative provenance
Two assessments stand out from the broader batch. TTS Pharma (RP521) received approval across a notably wider range of food categories than most applicants — including beverages, chewing gum, gummies, preserves, and sports gels — rather than the standard food supplements-only scope.
CBD Industries LLC (RP793) also had its application approved at 10mg but saw its bid for a 24mg daily intake explicitly rejected, with the FSA concluding that safety at the higher level could not be assured even in the context of a high-quality isolate dossier.
The road ahead
The FSA’s autumn 2026 target for ministerial recommendations remains the industry’s organising deadline, but conditions have become more complex.
Food Standards Scotland’s separate consultation, expected to run for 12 weeks from early 2026, concluding in late March or April, must conclude before the four-nation alignment required for ministerial sign-off can be achieved.
The Scottish Parliament elections add an additional layer of political uncertainty to final approval, even if FSS has told Business of Cannabis that a change of administration would not affect its independent advisory role.
The more fundamental question is what authorisation, if and when it comes, will actually mean. The FSA has now published 15 positive safety assessments, and its reformulation guidance signals a willingness to get this process over the line. But the highly restrictive 10mg ADI shows no sign of moving.
The SPS dynamic alignment risk means that even a successful UK authorisation could be superseded by EU rules relatively quickly, particularly given EFSA’s 2mg provisional level. A company that secures UK authorisation in autumn 2026 could still find the regulatory ground shifts beneath them in no time at all.
