Health and Structure Functions of Dietary and Herbal Supplements Under Law in Maryland

Health and Structure Functions of Dietary and Herbal Supplements in Maryland

Dietary supplements used orally can legally be sold by making statements which (1) state benefits related to classic nutritional deficiencies, (2) state how the product is intended to affect human structure or function (but not illness), (3) characterize a documented mechanism of action, and (4) state a general sense of wellbeing as a result of the products intake . If a product marketed as a dietary supplement has a claim related to a disease, as defined in subsection (g) of this Section, then the product would be regulated as a medication, unless that claim is a licensed health claim that the product qualifies.

The products intended use will determine whether it is regulated as a food, a dietary supplement, or a medication. If claims are made regarding a products effect on diagnosis, treatment, mitigation, cure, or prevention of disease or a health-related condition, then that product will be regulated as a medication. FDA does not consider a studies objective therapeutic when the study simply measures the effects of the nutritional product on body structure or function, or investigates the mechanisms through which the product produces its effects. As discussed more fully, below, regardless of whether the nutrient product is marketed legitimately as food or as a food additive, a researcher should contact FDA for determination whether a study is required if the proposed research involves indications or evaluations of an endpoint that meets the definition of a claim to treat or cure disease (with limited exceptions for certain nutritional products already approved as medicines, discussed further below).

Marketing or selling novel dietary ingredients requires notification to FDA, including scientific data supporting the safety of those novel dietary ingredients, or supplements containing them, in accordance with the conditions of use stated on their labels. New dietary ingredients are regulated under the Food and Cosmetic Act (FDCA) and are defined by FDA as those that were not available in the U.S. food supply as chemically undamaged prior to Oct. 15, 1994.

FDA regulates dietary supplements under a set of regulations distinct from the regulations governing conventional foods and drugs. Because of the number of different supplements and the scope of use, it is difficult and often ineffective to test and regulate these products. I believe consumers deserve to be exposed to a wide range of supplements, but they should also have confidence in these products being safe. Because the FDA is not in a position to oversee and regulate thousands of separate products, the public is effectively left without protection from supplements and herbs that are unsafe.

Rather than assuming all companies produce unsafe products, the law operates under the assumption that the majority of products are safe, with the FDA being required to prove otherwise. Supplements are only lightly regulated; most of the time, the FDA cannot step in to take products off shelves until after they have received reports that a product has hurt consumers. Under DSHEA, supplement manufacturers are not required to prove safety or effectiveness; Rather, DSHEA deliberately minimizes the supervision by the U.S. Food and Drug Administration, and it emphasizes the value the industry provides to the U.S. economy.

For purposes of labeling of food additives, Section 5 of DSHEA provides exemptions from labeling requirements for scientific journal articles, books, and other publications used to market food additives, provided that scientific journal articles are reprinted in full, are not misrepresentative or misleading, do not promote any particular brand or manufacturer, are presented alongside other materials to provide a balanced representation of the scientific information, are presented alongside other materials that provide a balanced representation of the scientific information, and are physically separated from the supplements being sold. For purposes of dietary supplement labeling, Section 5 of DSHEA provides an exemption from labeling requirements for scientific journal articles, books and other publications used in the sale of dietary supplements, provided scientific journal articles are reprinted in their entirety, are not false or misleading, do not promote a specific brand or manufacturer, are presented with other materials to create a balanced view of the scientific information, and are physically separate from the supplements being sold. In 1994, the Dietary Supplement Health and Education Act (DSHEA) was passed, which allows the marketing of food additives, such as botanicals, is marketed without submitting them to FDA, but makes it the manufacturers responsibility for product safety, and places the burden of proof on the FDA to enforce it . At the time of enactment, lawmakers believed that since many dietary supplements came from natural sources, such as plants, and had been used by practitioners of complementary and alternative medicine (CAM) for hundreds of years, such products did not require the same strict regulation as prescribed, over-the-counter drugs used in mainstream medicine.

The law directed FDA to create a definition of conventional foods, clarifying which products are foods and must be regulated as such, and which products are intended to promote health and must be regulated as dietary supplements . This bill would include an amendment to the federal Food, Drug, and Cosmetic Act requiring manufacturers of dietary supplements to register the products they make with FDA and to modify the labeling requirements regarding dietary supplements. The JHM IRB is receiving a growing number of applications proposing the use of dietary supplements, foods, foods-derived products, or other products that are regulated as food ingredients (e.g., spices) (referred to for purposes of this paper as dietary products).

The FTCs approach to supplement advertising is best illustrated by its enforcement policy statement regarding food advertising (the Food Policy Statement). Although the Food Policy Statement does not refer specifically to supplements, the principles that guide FTCs rulemaking regarding health claims in food advertising are pertinent to the agencys approach regarding health claims in supplement advertisements. For all substances added to food, including dietary supplements, that are claimed to affect a consumers dietary or health status, EFSA conducts assessment in accordance with Regulation (EC) No 1924/2006 on Nutritional and Health Claims. In Australia, most dietary supplements are regulated in a complementary medicines category, including vitamins, minerals, herbs, aromatherapy, and homeopathic products, though some products can be considered foods with specific uses and are regulated by the Food Authority.