A Compliant Natural Pain-Relief Ingredient — Palmitoylethanolamide (PEA)

Pain is a common challenge that almost everyone may experience. It not only causes physical discomfort but also affects mood and overall quality of life. Whether acute injury-related pain or long-term chronic pain, pain can interfere with normal work, rest, and enjoyment of daily life. As consumer demand continues to shift toward safer and more natural solutions, natural approaches to pain relief have become a clear market trend.

Palmitoylethanolamide (PEA) is a potent natural pain-relief ingredient first identified in the 1950s and has been used for many years in Europe as a dietary supplement. As an endogenous fatty acid amide, PEA is naturally produced by the human body in response to injury and stress. It is also found in foods such as animal organs, egg yolk, olive oil, safflower, soy lecithin, and peanuts.

Research has shown that PEA is part of the endocannabinoid system (ECS) and interacts with this system, exerting benefits similar to those of cannabidiol (CBD). The ECS plays a crucial role in maintaining physiological balance and is involved in regulating pain, mood, sleep, stress, and immune function ^[1]. Unlike CBD, however, PEA has a long history of safe use and has received regulatory recognition in multiple countries worldwide.

 Regulatory Status

Products containing PEA are approved in different countries for use as nutraceuticals, dietary supplements, or foods for medical purposes.

In the United States, PEA is categorized as a dietary supplement ingredient. The U.S. FDA applies a relatively flexible regulatory framework to dietary ingredients. Under federal law, dietary supplements are not required to obtain pre-market safety approval from the FDA. As long as a substance can be found in normal human metabolic processes, it is generally regarded as safe for use as a dietary ingredient.

PEA is not intended to diagnose, treat, cure, or prevent disease, and it currently does not have a GRAS notification. Nevertheless, the use of PEA as a dietary supplement is considered safe under existing regulatory practice.

In several European countries such as Italy, Germany, and Spain, PEA was initially marketed as a dietary food for special medical purposes (FSMP/AFMS). In 2017, Italy included PEA in the List of Permitted Substances for Food Supplements, reclassifying PEA as a food supplement ingredient.

Normast®, introduced to the European market by Epitech, was the first finished PEA product available in the region. Today, multiple PEA brands are commercially available across Europe, including OptiPEA®, Levagen®, and Levagen™+.

Subsequently, PEA received approvals from the Food Safety and Standards Authority of India (FSSAI) and Natural Health Products Directorate (NHPD).

In 2020, Gencor’s PEA was approved by the Therapeutic Goods Administration (TGA) and added to the Australian Register of Therapeutic Goods (ARTG), allowing health claims related to joint care and the reduction of bodily pain. In the same year, PEA also received approval as a novel food from Agência Nacional de Vigilância Sanitária (ANVISA).

Safety

PEA is naturally present in the human body and can also be found in various food sources, making supplementation safe and well tolerated. Extensive preclinical studies (including in vitro assays and animal models) have demonstrated that PEA does not produce adverse effects, confirming its profile as a highly safe ingredient ^[3].

In Italy, the Italian Ministry of Health revised two food supplement guidelines concerning the maximum daily levels of vitamins, minerals, nutrients, and other substances with nutritional or physiological effects. Based on the evidence showing no adverse effects, even with long-term use and administration to vulnerable populations, PEA was included in the List of Substances Permitted for Use in Food Supplements, without a specified maximum upper intake level.

About L&P Food Ingredient Co., Ltd

L&P Food Ingredient Co., Ltd (L&P Foods) is a professional manufacturer specializing in food additives and functional food ingredients. The company holds comprehensive production qualifications, including valid manufacturing licenses and a full range of internationally recognized management system certifications, including Quality Management (ISO 9001), Food Safety Management (ISO 22000), Religious Certifications (KOSHER and HALAL), Occupational Health and Safety (ISO 45001), Environmental Management (ISO 14001), as well as the Global Standard for Food Safety (BRC). With consistent and reliable product quality, a well-established after-sales service system, and the capability to provide customized solutions tailored to customer needs, L&P Foods has become a trusted and preferred supplier for downstream manufacturers.

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