Eur J Clin Pharmacol (2001) 57: 353±355 DOI 10.1007/s002280100327

COMMENTARY

E. Ernst

Functional foods, neutraceuticals, designer foods: innocent fad or counterproductive marketing ploy?

Received: 16 May 2001 / Accepted in revised form: 17 May 2001 / Published online: 5 July 2001 Ó Springer-Verlag 2001

Keywords Functional foods á Neutraceuticals á Designer foods á Marketing Numerous food products have recently become available to which medicinal herbs have been added. In view of the increasing popularity of herbal remedies and the desire of commercial enterprises to make pro®ts, the appearance of such products seems understandable. This article is aimed at assessing whether such products provide a service or a disservice to the consumer or to the ®eld of herbal medicine. The terminology for the products in question is not uniform and ranges from `nutraceuticals' to `functional foods', and `designer foods' to `medicinal foods'. Neither is there a clear de®nition of functional foods (FFs, the term used in the following discussion). Tentatively, FFs could be described as products marketed as foods enriched with (herbal) substances known or assumed to be associated with health bene®ts. Even though no health claims can legally be made for FFs, the industry usually ®nds ways of making sure the consumer associates them with certain health bene®ts. They obviously create a consumer expectation of some type of physiological action relating to therapeutic or preventative value. The range of FFs varies from ginkgo biloba breakfast cereals to kava candy bars and from St John's wort tortilla chips to echinacea fruit drinks [1]. Often they are designed to have a special appeal to children [2].

E. Ernst Department of Complementary Medicine, School of Postgraduate Medicine and Health Sciences, University of Exeter, 25 Victoria Park Road, Exeter EX2 4NT, UK E-mail: [email protected] Tel.: +44-1392-424989

There are few reasons (other than the manufacturer's urge for pro®t) in favour of FFs. One might argue that they increase consumers' choices. The real question, however, is whether such a choice would o€er the expected bene®t to the consumer. FFs might improve the health of those individuals who use them. In fact, this is the implicit assumption with which FFs are marketed. It amounts to an interesting hypothesis which would require testing for every single product. Sadly such research is not being (and probably never will be) done, at least not in a rigorous fashion. The few and unconvincing arguments in favour must be seen in the context of several arguments against FFs. Perhaps the most obvious limitation lies in the fact that the pharmacologically active ingredients in FFs are invariably under-dosed. The raw materials are often costly, and this often means that only minimal amounts are being used in FFs. V. Tyler, for instance, calculated that one would need to drink 27 litres of a speci®c herbal beverage containing St. John's wort in order to receive a therapeutic dose of this herb [3]. Moreover, the manufacturing process of FFs is likely to destroy the small amount of active ingredient contained. Thus, it is not possible to treat depression with St. John's wort tortilla chips or alleviate anxiety with kava candy bars. Furthermore, at present it is technically almost impossible to properly analyse the exact content of herbal ingredients in FFs [2]. Another powerful argument against FFs is that they may put consumers at risk. Virtually all medicinal herbs are associated with some adverse e€ects [4, 5]. Obviously no post-marketing surveillance system exists (or is being planned) for FFs. St. John's wort, for instance, interacts with prescription drugs leading to potentially serious consequences [6]. Such e€ects may or may not be dose related. Even if they are, it is conceivable that one individual may regularly consume suciently large amounts of, for instance, a St. John's wort candy bar and thus experience a herb±drug interaction. A recent case describes a kidney transplant patient whose cyclosporin level dropped dramatically and dangerously after

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self-medicating St. John's wort extract at only one-third of the recommended dose [7]. Most medicinal herbs may cause allergic reactions [5], and such responses are not dose related. Thus, there is reason to believe that the consumption of FFs is associated with ®nite risks to the consumer. FFs may also contain unhealthy ingredients that are non-herbal by nature and origin (e.g. high content of saturated fat in tortilla chips). Thus, an unhealthy food product could be marketed with the implication of a health bene®t. These risks may appear to be small but they still outweigh the bene®ts of FFs which are close to zero (see above). The lack of quality control is a further important concern. Conventionally registered herbal medicinal products are rigorously quality controlled in some countries and are gradually moving towards this stage in other parts of the world [8]. In contrast, the quality of the plant material and the manufacturing processes used for FFs are regulated by food laws which lack the speci®city required for botanical drugs. This can have serious consequences. Contamination, for instance, with toxins after fungal infection of the raw plant material (e.g. during transport) or with other ingredients has been repeatedly reported and can have potentially fatal consequences [9, 10]. Adulterations, due to a lack of pharmaceutical quality control, have been reported in the medical literature with some regularity, and may result in very serious complications [11]. Numerous other types of impurity of FFs conceivably remain undetected simply because there is an almost total absence of speci®c quality control. Absence of quality control not only increases the risk to the consumer, it also results in a total lack of impetus to conduct adequate research that demonstrates the potential bene®ts of FFs or ensures their safety. In this context, it is relevant to note that consumers do care about safety aspects related to dietary supplements. The majority of Americans, for instance, would like the authorities to review the safety of new dietary supplements prior to their sale. They also favour increased power for removing unsafe products from the market and want the government to ensure that advertising claims about the health bene®ts of dietary supplements are true [12]. While these data strictly speaking relate only to dietary supplements, there is little reason to believe that the consumer's opinion regarding FFs would be markedly di€erent. There are further, less obvious arguments against FFs as well. If someone is led to believe (e.g. through indirect promotion) that the consumption of a FF is promoting health, this person might use this option as a true alternative to an e€ective preventive health measure [13]. Such individuals might, for instance, use FFs as an excuse not to reduce weight, give up smoking, do regular exercise, etc. In such cases, FFs can represent a hindrance to preventative interventions of proven e€ectiveness.

Finally, one might argue that FFs will, in the long run, deter people from using adequately formulated medicinal herbal products some of which, after all, have shown to be bene®cial in several clinical situations [14, 15]. As consumers will not perceive any bene®t from an under-dosed FF (see above), they are likely to conclude that the speci®c herb contained in that FF is not e€ective. This experience, in turn, will discourage them from using this or other e€ective herbal remedies in situations where they could conceivably bene®t from them. The balance of the arguments is thus clearly not in favour of FFs. Does this mean that all food products containing herbs associated with health bene®ts should be banned? The answer is clearly no [1]. Some products might be safely enhanced through the ¯avour of added medicinal herbs, e.g. garlic-¯avoured potato chips. Other products might be traditionally used foodstu€s without a real possibility of harm when used with reason, e.g. the regular consumption of green tea [8]. It is therefore crucial to distinguish between FFs where medicinal herbs have been added to imply a health bene®t (e.g. St John's wort tortilla chips) and botanical products that have been in traditional use and can be shown to be useful in one way or another. The arguments detailed above apply only to the former category. In conclusion, the present fad for FFs seems to bene®t exclusively the manufacturers of such products. In the interests of the consumer, and of (herbal) medicine as well as plain honesty, the product class of FFs must be classi®ed as regressive and should be discouraged.

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14. Linde K, Ramirez G, Mulrow CD, Pauls A, Weidenhammeer W, Melchart D (1996) St John's wort for depression ± an overview and meta-analysis of randomised clinical trials. BMJ 313:253±258 15. Pittler MH, Ernst E (2000) Ecacy of kava extract for treating anxiety: systematic review and meta-analysis. J Clin Psychopharmacol 20:84±89