Do We Need Plant Food Supplements? A Critical Examination of Quality, Safety, Efficacy, and Necessity for a New Regulatory Framework

Abstract

Given the expanding market of plant food supplements (PFSs) not undergoing any pre-marketing authorization, the overall quality, safety and efficacy of PFSs were subjected to a critical examination. Although many high-quality PFSs exist on the legal market, quality concerns are in general justified. Besides economic adulteration, active ingredients dramatically differing from label claims and among products were reported in several studies. In addition, PFSs sold via the Internet may be intentionally adulterated with undeclared prescription drugs. Compared to PFSs with only one single herb, PFSs containing herbal mixtures were more involved in moderate and severe clinical courses. Although prohibited by regulation, misleading labels on PFSs are common. Above all, only vague evidence for the efficacy of PFSs exists. Notwithstanding the unproven efficacy and insufficient safety assessment, PFSs represent a relevant source for consumers to get access to herbal preparations in the United States and meanwhile also in Europe, as launching of licensed/registered European herbal medicinal products (HMPs) has steadily decreased. However, being non-vitamin, non-mineral products, PFSs are neither food nor drugs. In terms of protecting public health and providing the consumer with high-quality, effective, and safe PFSs, possibilities are shown how to deal with the many challenges of PFSs. Last but not least, suggestions are made for assigning PFSs a separate regulatory category being less regulated compared to HMPs but more strictly regulated compared to food laws including implementation of good manufacturing practices and a scientific pre-marketing review process by an expert commission.

Herbal supplements in the print media: communicating benefits and risks

“…In part this was to provide diversity of language, culture and tradition of HS use, as well as different patterns of current use and regulation. This decision was difficult because, as Abdel-Tawab [10] points out, data comparing levels and type of use of plant-based remedies across countries without conflating them with related products such as vitamins and minerals is thin on the ground. Abdel-Tawab maintains that the only really useful study currently available in this respect is Garcia-Avarez et al’s [48] survey of consumers in six European countries (Finland, Germany, Italy, Romania, Spain and the United Kingdom).…”

“…UK Healthcare institutions and the MHRA are only now beginning to fully engage with the complexities of classifying and regulating herbal products [10]. While the UK’s Medicines and Healthcare products Regulatory Agency has compiled a list of botanical ingredients and their uses, unlike Italy and Romania this list exists purely for information and lacks any legal status.…”

“…The same botanical ingredients therefore often end up being used in products classed as food supplements in one state and medicines in another. This has huge implications for the ways in which information about what they are for and how to use them appropriately can be communicated to consumers [10].…”

Eurycoma longifolia—Infused Coffee—An Oral Toxicity Study

“…Furthermore, the addition of therapeutically claimed traditional ingredients have clouded the definitions between the food and drug regulations. It is often unclear which testing standards are required and the sets of regulations to abide by for the herbal additives in food products [ 17 , 18 , 19 ]. Consequently, without safety testing, marketing of such coffee outside of Malaysia is restricted due to strict import regulations with various levels of evidence requirements.…”

“…Safety testing adds value to the product, elevates the product safety information, improve consumer trust and may prevent potential incidents such as interaction between pharmaceutical drugs and herbal-incorporated food products, where occurrence may have gone unnoticed [ 17 , 18 , 20 , 21 ]. The aim of this paper is to investigate the safety of a commercial TA coffee, with reference to the Organization for Economic Cooperation and Development (OECD) testing guidelines 420, 407 and 452 [ 22 , 23 , 24 ].…”