Patterns of Using Dietary Supplements Under Law in Virginia and Maryland

In addition, manufacturers are not required to submit proof of the products safety to the FDA prior to marketing the dietary supplement, except when the supplement contains new food ingredients (dietary ingredients not sold in this country before Oct. 15, 1994) which has not been introduced into the food supply in the form of food used for purposes of which food has not been chemically altered. Further, there is no requirement for manufacturers to provide evidence of product safety to Food and Drug Administration prior to marketing a dietary supplement, unless the supplement contains a new dietary ingredient (a dietary ingredient that was not marketed in this country before October 15, 1994) that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered. If a dietary supplement includes claims about an effect on body structure or function, claims about overall health, or claims about benefits related to classic nutritional deficiencies, the food supplement also bears a disclaimer that indicates the claims are untested by FDA, or claims about benefits related to classic nutritional deficiencies), the FDA has not evaluated these claims, and that a claim about the effects on body composition, the claims are intended to diagnose, cure, cure, or prevents disease. The basic structure of DSHEA allowed all products marketed as dietary supplements at the time the Act was enacted to remain on the market unless the FDA could show safety problems with a particular product or line of products — this is the so-called grandfather provision; manufacturers must notify the FDA before any new ingredients are marketed. Importantly, DSHEA established a new regulatory structure for dietary supplements, which limited the FDAs authority over such products to that of traditional foods, compared to the FDAs authority over additives to foods or novel drugs.

DSHEA established the first comprehensive definition of dietary supplements, which led to botanicals and amino acids being considered foods by intended use, just like vitamins and minerals, which were already classified as foods by intended use. The Sloan survey examined overall patterns of drug use among ambulatory adult populations in 1998-1999, and examined use of vitamins, minerals, botanicals, and other dietary supplements, as well as drugs. Previous studies have also shown that supplement users had higher levels of most vitamins and minerals in food choices alone compared with nonusers. Thus, disentangling effects of healthful food and lifestyle choices from use of dietary supplements is generally challenging in epidemiologic studies. Randomized controlled trials are ideal for investigating the use of supplements and health outcomes, but often yield inconsistent results. In the United States, reasons given for supplement use by the National Health and Nutrition Examination Survey are related to prevention/treatment of diseases/nutrition, and diet supplements (references Bailey, Gahche, & Miller6).

Dietary Supplements Under Law

In adults, use of herbs and botanical supplements has been associated with being uninsured, using more prescription and nonprescription medications, and using them to manage specific health conditions. Data from national surveys indicate that the majority of herbal supplement users did not disclose these facts to their healthcare provider. This could be cause for concern as certain herbal supplements may potentially have negative interactions with prescribed medications. Some consumers report using supplements due to the belief that these products will provide good health. Many individuals consume high amounts of zinc supplements due to the potential health benefits, which are promoted by business interests. In fact, the medical community is increasingly concerned that the current use of some supplements may cause health crises in the future.

With over 90,000 different supplements on the market, it can be confusing to figure out which ones are safe and which ones are not. The fact that supplements are still used means the population as a whole gets its nutrients from food as well as supplements, and supplement contributions may be significant. Dietary supplements were used by approximately half of adults (49%), in 2007-2010, though that was somewhat lower than 2003-2006 (53%). Dietary supplements are defined under law as products intended to complement the diet; they are not medications, and thus are not intended to prevent, diagnose, treat, alleviate, or cure diseases. These views are at odds with the guidelines on public health in these countries, which generally do not see any role for the use of supplements by adults except for diseases/special conditions, and, most recently, vitamin D supplements for high-risk groups in the United Kingdom.

The Physicians Health Study II (PHSII), a long-term, randomized, controlled trial with men physicians, found neither vitamin E supplementation nor vitamin C supplementation reduced risk for prostate or other cancers. The SELECT trial found no protective effects from vitamin E, taken either alone or combined with selenium. Ultimately, SELECT found significant increases in the risk of prostate cancer among healthy men taking vitamin E supplements. The Prostate, Lung, Colorectal, and Ovarian Screening Trial (PLCO) studied the dietary intakes of vitamin E, beta-carotene, and vitamin C and assessed the risk of prostate cancer, but results did not provide solid evidence of consuming high amounts of antioxidants, whether dietary or from supplements, to prevent prostate cancer, though there were some benefits to smokers. Of additional interest, in the SELECT trial, selenium supplementation did not lower prostate cancer risk among men with baseline low selenium status, but the addition of selenium to men who were already high in selenium from dietary sources increased their risk for aggressive prostate cancer. Use of LC-PUFA and folate-based omega-3 supplements may lower the risk for certain cardiovascular outcomes in adults. Other nutritional supplements, such as vitamin B 6, vitamin A, multivitamins, antioxidants, and iron, and dietary interventions, such as reductions in dietary fat, had no appreciable effects on mortality or cardiovascular outcomes (very low-to-medium confidence evidence). Court actions required lengthy periods of time and significant resources; therefore, during the 1970s, the FDA attempted to exert broad influence over dietary supplement use through tighter regulation of vitamins and mineral supplements, in line with a 1973 US Supreme Court approval of FDA actions aimed at controlling whole classes of products through regulation, instead of relying on litigation alone (FDA, 2002).