# Regulation of Food Supplements and Pharmacists’ Responsibility in Professional Practice: A Review

## TL;DR

This paper reviews global regulations for food supplements and examines pharmacists' responsibilities and malpractice cases, highlighting a lack of standardized rules and professional challenges.

## Contribution

The study provides a comprehensive five-year analysis of pharmacist malpractice and food supplement regulation gaps, emphasizing the need for unified frameworks.

## Key findings

- Pharmacist malpractice cases are relatively low but more common in private sectors and among male pharmacists.
- Food supplement regulations lack standardized terminology and harmonized legislation across jurisdictions.
- Consumer safety issues include non-compliance in product composition and misleading advertising practices.

## Abstract

(1) Background: Regulations governing food supplements vary considerably across countries, allowing products that are prohibited in one jurisdiction to be legally sold in another. Furthermore, online sales enable and facilitate this practice. Regarding pharmaceutical malpractice, the absence of a standardized European framework complicates the evaluation of pharmacist liability. As a result, the specific elements of the liability framework are defined by the national legislation of each Member State. The aim of our review is to map the global regulatory landscape of food supplements and to examine the pharmacist’s professional responsibilities, including instances of malpractice related to this area. (2) Methods: A literature review covering publications from January 2020 to December 2024 was performed using four databases: Scopus, PubMed, Embase, and Web of Science. The search retrieved 8243 records, of which 77 studies fulfilled the eligibility criteria. The extracted data were organized into five main themes: pharmacist responsibility and malpractice, food supplement regulation, consumer safety, health claims, and pharmacist knowledge. (3) Results: The literature reviewed indicated a relatively low number of malpractice cases within the pharmacy profession compared to other professions. A higher incidence of cases is observed among male pharmacists and those practicing in the private sector. Notably, no cases have been identified addressing pharmacists’ responsibilities in the dispensing of food supplements. In the context of food supplement regulation, the reviewed literature highlights a lack of standardized terminology and harmonized legislation across different jurisdictions. Therefore, products may be classified differently across jurisdictions. Another observed barrier is the considerable variation in market access requirements across countries. Regarding consumer safety, several irregularities have been observed. Substantial non-compliance in both product composition and labeling has been observed, reflecting insufficient quality control measures. Concerning health claims, significant regulatory non-compliance with European Union regulations has been documented. In addition, widespread misleading advertising practices have been observed. With respect to pharmacists’ knowledge, the reviewed literature identifies several professional challenges within pharmacy practice, particularly those concerning the dispensing of food supplements. (4) Conclusions: This research offers a comprehensive analysis of the literature published over the past five years concerning pharmaceutical malpractice cases, as well as an examination of food supplement regulation and the professional responsibilities of pharmacists. A recurring barrier identified is the absence of unified regulatory frameworks worldwide. This results in uncertainty concerning the pharmacist’s professional role and responsibilities.