Demand for dietary and nutritional supplements worldwide continues to increase, with steady growth in the established markets and more rapid growth in emerging markets. The annual growth rate of dietary supplements in the U.S. was 7.1% between 2008 and 2012. According to one survey, the U.S. and Asia lead the world in supplement usage, with 54% of North Americans consuming a supplement and 43% of Asians consuming a supplement. In another survey, the U.S. was the largest market for nutritional supplements in 2010, followed by Western Europe and Japan. Eastern Europe, Asia and Latin America have low market penetration, but are increasing in usage. Dietary supplements, which are also termed nutritional supplements in other countries, include vitamins, minerals, meal supplements, herbs, natural food supplements, and other products that are consumed to boost the nutritional content of the diet.
Dietary supplements are touted to benefit the body, but how dietary supplements are regulated by various governing bodies may not always be similar to U.S. regulations. Is there any consistency in the governing of dietary supplements, and are ingredients that go into dietary supplements evaluated for safety? The following is a general overview of the regulatory process for dietary supplements and the ingredients that are added to dietary supplements in the U.S., compared to various areas of the world.
United States Dietary Supplement Health and Education Act (DSHEA) of 1994 compared to other international laws
The United States Congress defined the term “dietary supplement” in the Dietary Supplement Health and Education Act (DSHEA) of 1994,1 as a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet, and is intended to be ingested (not rubbed on the body, taken as a mouth wash and expectorated, injected or placed into any other orifice but to be placed in the mouth and swallowed). A dietary supplement was defined by Congress as “a product (other than tobacco) that contains one or more of the following dietary ingredients: (a) a vitamin; (b) a mineral; (c) an herb or other botanical; (d) an amino acid; (e) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (f) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in (a) – (e) above.” At the heart of the matter is that because dietary ingredients are substances already available in the diet, they are considered food and are treated as such, according to food regulations and, not as drugs or food additives. Further, a dietary ingredient need not have taste, aroma or nutritive value, but must have a documentable presence in a food (a food is something that is normally consumed as such, with the exception of spices) and not a leaf, twig, mold, etc., that has no history of consumption or is considered unfit for human consumption. Also in the U.S., a dietary supplement is not a “nutrient supplement” (21CFR173.3(o)(20)), a food for special dietary use (21CFR105) or a medical food (21 U.S.C. 360ee (b)(3)).
Other countries regulate supplements, but do not always consider supplements only as food products, but also as drugs, depending on the claims stated in the marketing or on the label. Brazil does consider supplements as food products, termed “Food for Physical Activity Practitioners”, but can only contain vitamins, minerals, carbohydrates, protein, fats, or branched chain amino acids. In Japan, registration of supplements are required, with supplements marketed as Food for Specified Health Uses (FOSHU), similar to in India, where they are considered primarily for persons with special dietary needs. Supplements must also be registered in China before manufacture, importation, or marketing, but are referred to as health foods. In the Philippines, supplements are defined as processed food products; Indonesia considers supplements as functional foods. The European Union defines supplements as foodstuffs to supplement the normal diet, but have a nutritional or physiological effect. In the U.S., the claims associated with a product will define its regulatory category – either the product is a food or a drug. The same is true in Hong Kong and Malaysia, as Hong Kong classifies supplements as pharmaceuticals, proprietary Chinese medicines or food, depending on the claims associated with the product. Supplements in Malaysia may also be “food-drug interphase products.”
Safety is an over-riding focus for governing bodies
Dietary supplement products are not required by U.S. law to undergo FDA pre-market approval, in fact, the law is nearly turned on its head, as the FDA must determine the “new dietary ingredient” is unsafe before requiring removal from the market. Ironically, even though according to the law, there does not need to be concurrence of safety by FDA of the new dietary ingredient, FDA has determined however, that all the “inactive” dietary supplement ingredients (i.e., the excipients, such as buffers, preservatives or colors) must be evaluated for safety and must be determined generally recognized as safe (GRAS) or undergo the food/color additive petition process. This requirement to evaluate the safety of an excipient utilized in the product formulation is the same as the evaluation of the safety for food. That is, a company must evaluate the safety of the ingredients that are used in the production of a cereal, at the intended levels of use in the product and all the ingredients are held to the same safety standard – “reasonable certainty of safe use”. In contrast, there are two standards of safety in play with supplements – a “reasonable expectation of safety” for the dietary supplement “active” ingredients and the higher food standard of a “reasonable certainty” for the inactive ingredients. The ability of a person/company (not the FDA) to determine the reasonable expectation of safety of a dietary supplement containing a new dietary ingredient is the basis of FDA’s New Dietary Ingredient Notification (NDIN) process, in which the person/company files a petition with the Secretary proposing the issuance of an order prescribing the conditions under which a new dietary ingredient under its intended conditions of use will reasonably be expected to be safe.
In the E.U., the legislation focuses on vitamins and minerals used as ingredients of food supplements. Supplements may be used to correct nutritional deficiencies or maintain an adequate intake of certain nutrients. The European Commission has published a list of permitted vitamin or mineral substances that may be added for specific nutritional purposes in food supplements, and with safety being an overriding concern for EFSA, companies wishing to market a substance not included in the permitted list need to submit an application discussing the safety and bioavailability of the individual substance to the European Commission. In Japan, supplements under FOSHU must be registered, with a complete safety dossier submitted upon registration.
Dietary Supplements and Structure/Function Claims
One of the main conclusions made by the U.S. Congress in the passing of DSHEA in 1994 was of the importance that the benefit of dietary supplements to health promotion had been documented in scientific studies, and that consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements. To this end, certain claims, termed “structure/function” claims, may be stated on dietary supplement labels, which describe (1) the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans, (2) characterize the means by which a nutrient or dietary ingredient acts to maintain the body’s structure or function, or (3) may describe general well-being from consumption of a nutrient or dietary ingredient.2 The manufacturer or distributer is responsible for making sure the structure/function claim is truthful and not misleading. Structure/function claims are not pre-approved by FDA, but any label that contains such a claim must also contain a “disclaimer” that FDA has not evaluated the structure/function claim, and that the dietary supplement is not intended to “diagnose, treat, cure, mitigate or prevent any disease” (the basic tenants of a drug). Dietary supplement manufacturers that include structure/function claims on labels or in labeling are required to submit a notification to FDA no later than 30 days after marketing a dietary supplement that contains the said structure/function claim.
Other countries also allow claims for supplement products, but the claims are typically reviewed by the governing body prior to approval and use. In Japan, FOSHU-regulated supplements, food for special dietary uses (FOSDU), and food with nutrient function claims are allowed to indicate claims, but other dietary supplements and health-related products are prohibited from utilizing health or function claims. Any claims must be approved by the Japanese Consumers Affairs Agency (CAA). In the E.U., any claim made on foods (including supplements) is scientifically assessed by EFSA and if the claim is given a favorable opinion, the claim is then authorized for use in the E.U. and placed on a permitted list. In China, supplements that go through registration with the Chinese Food and Drug Administration (CFDA) are allowed certain approved claims and the ability to advertise, but it is a costly, time-consuming process). However, supplements imported into China as food (which has minimal costs associated with the practice) cannot contain any claims and cannot be advertised.
Global sales of dietary supplements is on the rise, as consumers are more than ever focused on a healthy lifestyle, maintaining optimal health through better food choices and supplementing the diet with products that benefit health and performance. The U.S. Congress enacted DSHEA in 1994 to better regulate the safety of dietary supplements, defining the ingredients that are able to be included in dietary supplements, and providing a general framework for the determination of the safety of dietary ingredients when consumed as directed in a dietary supplement. Other countries throughout the world allow the sale of supplement products, but depending on the claim, these products may be considered food, drugs, or something in-between. Any claims to the benefits of the dietary ingredient (or the supplement as a whole) must be submitted to the FDA, which is similar to other countries; however, most other countries require the approval of claims by the governing body prior to use of the claim on the label. Overall, the production and sale of dietary supplements in the U.S. and in many other countries is a highly regulated process that is meant to produce a quality product to supplement the diet with beneficial substances with claims that are truthful and not misleading.
- http://ods.od.nih.gov/About/DSHEA_Wording.aspx#sec3; site last visited September 18, 2013.
- http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm2006881.htm; site last visited September 18, 2013.