Regulation


In most countries or regions, there is a governing body or bodies that regulate the manufacture and market- ing of foods and therapeutic agents. Such organizations provide a legal definition of a dietary supplement and regulate what can be sold as a dietary supplement and what claims can be made about the product in relation to improving health and function. Specifically, in the United States, a dietary supplement is defined by the Dietary Supplement Health and Education Act of 1994 as1


:


a pout (o r tha oaco) ine e o splmet the dit tha ers o ota floin e r ge ets: a vta


rdc the n tb c


olw g ditay inrdin sbs nc o e b


tndd t upe n i min; a minea n he


rl; a n t upe n e e in t ba r cn ins o rb o the o nia n a


u ta e fr us y ma o splmet the dit be y incras g the tta e r ta me blie o ttet xtac, o o b to f ay inrdin es bd peius .


taot, cnsiun, e r t r cminain o n ge et d crie rvo ly Such supplements fall within the jurisdiction of the Office of Dietary Supplement Programs within the


US Food and Drug Administration (FDA). Recent changes within this branch have meant an increased scope and function of this division. Tis has led to increased resources to regulate and, in some cases, pros- ecute companies and products that have traditionally traded around the edges of the supplement definition. Te definition of dietary supplements is well known in the United States, but they are defined and regu-


lated differently in Europe. Te European Union defines a dietary supplement as foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients (meaning vitamins and minerals) or other substances with a nutritional or physiological effect, alone or in combination, mar- keted in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities2


:


Tes od splmets cnno a ooia


l trl e fo upe n a t clim the ait o c e o ra


ilgcl funcin. Fr e ml, a fo upe n a t clim t ur at disas u rdceue choeseo.


to o xa pe od splmet cnno a o c e her


bliy t ur r tet a disas u y clim t ffc hs y clim t


e e bt ma a o aet a py- e e bt ma a o


In contrast, the definition of a dietary supplement in Australia is based on the form and proposed purpose


of the product rather than the specified ingredients or components. Products are regulated by two bodies, which separate them into foods and therapeutic agents. Formulated sports foods are regulated by the Food Standards Australia and New Zealand, and other dietary supplements are considered therapeutic goods taken for the purpose of preventing, curing, or alleviating a disease, ailment, defect, or injury or influencing, inhibit- ing, or modifying a physiological process and are regulated by the Terapeutic Goods Administration (TGA). Sports nutrition practitioners need to have an appreciation for global issues around supplement manu-


facture, marketing, and regulation for several reasons. First, many athletes are now seasoned international travelers and have direct access to products that can be purchased from markets outside their own coun- tries. In addition, via the internet, athletes can purchase products that may be prohibited or unavailable in their local environments; many remain unaware of the implications of the import of such products according to their customs regulations. Finally, free-trade agreements are adding a new challenge to the availability of products in the local environment. In Australia, for example, what is recognized and sold as a dietary supplement is uniquely affected by trade agreements between Australia and its neighbor, New Zea- land. In short, a product deemed a dietary supplement in Australia, due to form and composition, may be deemed a food in New Zealand due to differing interpretations of what constitutes a food source or a com- plementary medicine. Under trade agreements between these countries, a dietary supplement imported or manufactured as a food in New Zealand may be sold as such in Australia and bypass TGA regula- tion. Tis ambiguity has allowed products that would otherwise be considered not fit for sale within TGA guidelines to become available for purchase in Australia; some of these products have resulted in positive doping tests by athletes.3


Although this seems trivial and unique to Australasia, recent global free-trade


agreements between all countries and regions mentioned previously have meant that products flow more liberaly between jurisdictions. It is now possible for products to be imported and available for on-shelf pur- chase before regulatory bodies become aware of their existence. Tis has meant that sports dietitians need to be extremely well-versed in global supplement issues.


CHAPTER 7: SUPPLEMENTS AND SPORTS FOODS 135 ne o r moe o


r o r bta cl; a mino aci o l ditay in ke; o


r f the r a cncnrt,


d; a ditaye r o etae


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