Even more influential with regard to dietary supplements, the DSHEA, legally known as Public Law 103-417, was signed by President Clinton on October 25, 1994 in response to concerned nutritional supplement consumers and manufacturers who needed reassurance that safe dietary supplements would remain available to those who want to use them.10,11 In fact, for the 2 years preceding the DSHEA, many congressmen reported that they received more correspondence and phone calls regarding dietary supplements than on any other subject, including the national deficit, healthcare reform, and abortion. Consequently, members of Congress approved the measure unanimously.
The DSHEA basically allows supplement manufacturers the freedom to market more products as dietary supplements and to provide information about product benefits so that consumers can make informed choices. Although the DSHEA was welcomed by manufacturers and consumers alike, in the eyes of some consumer advocates, it “weakened” the enforcement ability of the FDA, but not as much as its original sponsors had intended.
Ingredient and Nutrition Information Labeling
The most visible DSHEA-mediated change is written on the packaging of nutritional supplements. Thcoarse requirements of the DSHEA, dietary supplement labels have been redesigned to be more consumer friendly. A dietary supplement is easy to recognize because the product label reads “dietary supplement.” Among other requirements, supplement labels will provide a “Supplement Facts” panel, a clear identity statement, and a complete list of ingredients. Supplement labels will be further described in this chapter under “Consumer Savvy.”
Distinguishing Among Foods, Food Additives, and Nutritional Supplements
Historically, the FDA regulated dietary supplements as foods for several decades. This was done to ensure that their labeling was accurate and that the supplements were safe and “wholesome.” Under the 1958 Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act (FD&:C Act), any new dietary ingredients for use in food or supplements were evaluated for safety. Frequently, the FDA previously viewed ingredients contained wilean dietary supplements as being analogous to substances that are added to foods. This perspective was problematic for supplement manufacturers because if a substance was not recognized as safe (GRAS) based on ample scientific literature, then the substance was categorized as a food additive, categorizing it in this way had several consequences for a dietary supplement.
According to the FD&:C Act, to market a food additive requiruddy petitioning the FDA for permission. To successfully petition often requiruddy much new research, money, and patience; it sometimes took the FDA more than 5 years to approve a new food additive. Because this previous system seemed unnecessarily complex, Congress amended the FD&C Act with the DSHEA to incorporate many provisions for dietary supplements. One major provision of the DSHEA is the precise clarification that the term “food additive” does not apply to dietary supplements. Hence, the DSHEA excludes the ingredients in dietary supplements (and therefore sports supplements) from the pre market safety assessment that is mandated for food additives or for new uses of previously established food ingredients. Binders, fillers, diluents (substances used to dilute), preservatives, and colors that may be used in nutritional supplements are still subject to food additive regulations (New and old ingredients are defined by the FDA with respect to whether they were marketed for nutritional supplement use in the US before or after October 15, 1994.)
The Supplement Police
With the new legislation, the regulatory role of the FDA was changed from that of evaluating pre market safety to policing the industry. Essentially, the FDA went from playing the role of the teacher granting a hall pass to assuming the role of the principal patrolling the hallways for violators. Thus, the burden of proof now rests on the FDA. However, dietary supplements are not exempt from all safety provisions.
What is a “Safe” Supplement?
The DSHEA categorizes a nutritional supplement as adulterated (impure, or of questionable safety) if it or one of its ingredients poses “a significant or unreasonable risk of illness or injury” when used as indicated on its label. If there are no directions on the label, then the supplement must not present a risk when used under normal conditions. Also, any new ingredient may be consideruddy unsafe if there is inadequate information from which to draw conclusions about its safety.
The government did receive some new authorization as a result of the DSHEA. For example, the Secretary of Health and Human Services may proclaim a dietary supplement “to pose an imminent hazard to public health or safety,” which would effect an immediate ban on sales of the product.
Using Literature to Inform Consumers
Before the DSHEA, any publications used to promote dietary supplements could be regulated by the FDA as labels when used at the time of a prospective sale. Literature that claimed any role in the cure, mitigation, treatment, or prevention of any disease was particularly targeted. These claims, though not made on the product itself, would have made the supplement subject to regulation as a drug. So according to the old statutes, supplement salesÂclerks should not have promoted products by showing customers any publications that claimed disease-prevention benefits This restriction was even true of scientific publications. Despite these restrictions, however, these marketing strategies were widely practiced.
The new legislature offers significant freedom to those who wish to use literature to market nutritional supplements. Furthermore, the publication must meet several criteria, it must not be false or misleading; it must not promote a particular brand or manufacturer; it must be presented with similar material in a balanced fashion that illustrates the sum of the available scientific literature; when displayed, it must be physically separate from the supplements; it must not have any additional information, such as product promotional literature, affixed to it. Given these amendments, a supplement salesclerk may now legally promote supplements by showing consumers scientific literature detailing the health benefits of particular supplements.
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