Understanding the new FSA Guidance Update on CBD – Unspun

Understanding the new FSA guidance update on CBD

The Food Standards Agency (FSA) regulates CBD in the UK. They have previously recommended no more than 70mg CBD per day, but this was updated to 10mg CBD per day in October 2023.

Setting the context

The FSA updated guidance of a 10mg Adult Daily Intake (ADI) for CBD, down from the 70mg, has stirred conversations in the CBD community. With this new FSA guidance, it's essential to understand how the FSA got to this number and understand the wider context of CBD usage around the world. This article aims to unpack the nuances of the FSA guidance and provide perspective on the matter to encourage informed discussions and decisions. 

Though we strive for a balanced perspective, this article is an opinion piece and should not be taken as advice.

It is important to note that there is no change in the legal status of our products and regulators are not advising on any de-listings or product recalls. We take quality and safety very seriously. Our products are clearly labelled so you know exactly how much you are taking. We recommend familiarising yourself with the FSA advice and industry response as this topic is likely to evolve over time.

Note: the numbers in brackets refer to references listed in the "Further Reading" section at the end of the article.

Understanding the FSA guidance is provisional

The current FSA guidance for CBD, derived from three 90-day studies, is explicitly labelled as "provisional" and there are no changes to the products that are allowed on sale. The FSA guidance does suggest that additional data might be best provided by "post-marketing surveillance." Post-market surveillance is the monitoring of drugs once they reach the market. The FSA suggests in its paper that data from additional studies and post-marketing surveillance "could help in reducing uncertainty and as such, the uncertainty factors and provisional Adult Daily Intake (ADI) would be revised accordingly if new data supported such a change." (1). For more details on the FSA guidance, you can refer to this joint position paper (1). 

The 300-fold uncertainty factor

Central to the FSA guidance for an Adult Daily Intake (ADI) of CBD is the 300-fold uncertainty factor. This factor plays a pivotal role: with more comprehensive data, this multiplier might decrease, potentially leading to a higher recommended ADI.

To fully understand this, let's delve into the foundational 100-fold uncertainty rule that the FSA guidance has at its core.This rule serves as a safety buffer, frequently employed in toxicology and risk assessments. Its main function is to account for potential inconsistencies and unknown factors, especially when using animal study results to predict human outcomes. Put simply, when a study identifies a dose with no adverse effects, that dose is divided by 100 to determine a safe level for human consumption. The United States National Library of Medicine offers a detailed overview of this concept (2). 

For CBD, the FSA guidance uses an additional uncertainty factor of 3 to address data gaps and uncertainties not covered in the initial studies. By multiplying the standard 100-fold rule with this factor, we get the 300-fold uncertainty factor that underpins the 10mg ADI recommendation.

It's crucial to recognise the purpose of these safety buffers: they exist primarily to safeguard consumers. However, such safety margins can lead to very conservative ADI recommendations.

The most significant dose referenced by the FSA was 72 mg per kg of body weight per day. To give context for a 70kg human, that would equate to a massive dose of 5040mg per day. Even at this dose the FSA saw  "No Observed Adverse Effect Levels (NOAELs)" in the test animals. To arrive at an ADI, this value was divided by the 300-fold factor, resulting in a suggested of 17mg per day for an average 70kg human (1). This figure was then adjusted lower by incorporating data from the two other studies that examined lower doses. It's worth noting that the FSA takes into account some studies indicating that humans have similar or higher liver sensitivity than the test animals, and that this forms part of the rationale for the 300 fold risk factor.

International perspectives on CBD intake

Across the globe, the embrace of CBD products is clear. What's notable is that most countries haven't set strict upper dosage limits despite many having conducted research.   

Several factors can influence CBD dosages, from an individual's body weight and metabolism to the severity of the condition being addressed. The overarching theme in many countries such as the USA (though we note that this varies by state), Canada and Germany is that dosing is personal and an individual should contact a healthcare professional for further guidance. In each instance regularity bodies have chosen not to provide upper limits.

Australia stands out in this global landscape. Their Therapeutic Goods Administration (TGA) has approved CBD products with a daily dose reaching up to 150 mg/day. This threshold is a staggering 15 times higher than the FSA guidance in the UK (3).

This global stance prompts reflection. If various countries, with their diverse research and regulatory approaches, have refrained from setting stringent CBD limits, this may underscore a broader confidence in CBD's safety profile. Supporting this perspective, the World Health Organization (WHO) has made statements recognising CBD's favourable safety profile (4).

So, what might happen next?

In the ever-evolving landscape of CBD regulation, our perspective is that we anticipate an upward revision in the FSA's recommended Adult Daily Intake (ADI) for CBD in the UK. Several factors inform our belief:

  • 300-fold uncertainty factor - we expect a reduction in this factor as new data emerges, potentially leading to an increase in the recommended Adult Daily Intake (ADI) (1,2).
  • Global regulation - the more accommodating regulatory stances in countries like Australia suggests a broader international confidence in the safety of CBD (3).
  • World Health Organization's (WHO) stance - the WHO's statements recognise CBD's favourable safety profile (4).
  • Historical medical studies - past research has demonstrated a favourable safety profile, even at elevated dosages of CBD (5,6).

Concluding thoughts

By actively participating in informed dialogues, advocating for robust research, and staying attuned to global trends, we remain optimistic about the future of CBD regulation. Our aspiration is a regulatory framework that not only emphasises safety but also acknowledges CBD's longstanding safety record and its significant potential to benefit people.

Explore our range of CBD products that you can rely on, or read more about CBD

Further reading

The articles referenced throughout this article are provided below.

  1. Joint position paper from ACNFP & COT on establishing provisional ADI for pure form CBD in foods (2023).
  2. Data-derived safety factors for the evaluation of food additives and environmental contaminant (1993).
  3. Therapeutic Goods Administration - Australia CBD Guidance
  4. World Health Organization - Cannabidiol (CBD) Critical Review Report (2018).
  5. Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome (2017).
  6. Safety and side effects of cannabidiol, a Cannabis sativa constituent (2011).

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