Palmitoylethanolamide: in some countries classified as food for special medical purposes

Palmitoylethanolamide: Classified as food for special medical purposes

PEA notifications as food for special medical purposes in Europe

Palmitoylethanolamide (PEA) is notified in Europe food for special medical purposes (FSMP) in Italy, Spain, Germany and Check republic. Elsewhere PEA is available as a supplement.

PEA: food component and its physiological function

PEA is a food component known already for more than 50 years (1957). Palmitoylethanolamide is synthesized and metabolized in animal and human cells via a number of enzymes and it exerts a multitude of physiological functions, related to metabolic homeostasis.
PEA and has been identified already in the 50s of last century as a physiological principle with potent anti-inflammatory properties. Between 1972-1979 its anti-inflammatory properties were explored in a 5 clinical trials in flu and common cold in adults and in one trial in children, in a total of 4000 patients. The dose used was 600-1800 mg/day. In the scientific papers published describing the findings of these trials its medical use was supported as well as its safety. There were no side-effect concerns.

In the period 1992-2013 PEA has been evaluated in a number of clinical studies, in a total of 2000
patients, mostly suffering from chronic pain, and in two separate clinic trials in glaucoma. In one key study, published in 2010, 636 patients suffering from sciatic pain were treated. The medical use was clearly documented, with a numbers needed to treat of 1.5 and with no concern of any side effects.

Research related to PEA

Research on PEA has been conducted for more than 50 years and around 400 papers are referenced in Pubmed, describing the physiological properties of this endogenous modulator and its pharmacological and therapeutical profile.

Safety monitoring

Consumers have used PEA in the 70s, but no data exist of how many patients used PEA at that time, apart of the 4000 patients and volunteers taking part in the various trials.

PEA has been used by around 1 million consumers since 2007, most of them in Italy and Spain, and some of them in Germany and the Netherlands. No safety concerns have been documented since this period.

In the Netherlands since 2011, many thousands of patients have used PEA, without safety concerns. In the clinic for neuropathic pain in the Netherlands many hundreds of patients have been followed since their use of PEA (from 2011 onwards), in doses up to 2400 mg/day and some for long periods of time (2-4 years). No safety concerns have been documented, neither any relevant drug-drug interaction. It is also clear that many patients suffering from chronic neuropathic pains can be supported by PEA without side effects, and thus are not in need of taking analgesics and suffer from side effects. Furthermore, many patients have proven to be responders to PEA, while they were non responders on compounds such as amitrityline and pregabalin. If these patients stop taking PEA the chronic pain conditions re-emerge, and there are no safe and known alternatives for these patients available.

Dietfood for special medical purposes

PEA is a compound synthesized in animal (and plant) cells having a physiological function in conserving homeostasis.

PEA is FSMP according to the definition of Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes, and qualifies according to the definition of category 3, and we highlight the most relevant parts:
nutritionally incomplete foods with a standard formulation or a nutrient-adapted formulation specific for a disease, disorder or medical condition which are not suitable to be used as the sole source of nourishment. These foods may also be used as a partial replacement or as a supplement to the patient’s diet.

PEA is
‘ intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by other foods for particular nutritional uses, or by a combination of the two.’ (definition Dietary foods for special medical purposes Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes)

In the disturbed states of chronic pain and/or chronic inflammation the body cannot produce sufficient PEA to counteract these pathological states. This is due to the fact that the on demand synthesis of PEA is not sufficient and can even be compromised by pathological states, and normal food cannot supply the body with sufficient PEA to counteract this deficiency. Furthermore, PEA is a simple saturated fatty amide, which is synthesized in the cell membranes on demand.

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