Role of Dietary Supplements law in Virginia and Maryland

Dietary Supplements

Virginia Revenue Bulletin 05-7, 5/31/2005, provides additional clarity regarding food determinations. SS 67-6-228 provides a distinction between low- and high-tax rates on food products. R.I. General Laws SS 44-18-30(9) provides an exemption from sales tax on foodstuffs and food ingredients.

Code SS 82.08.0293 gives the food and food ingredients exemption, and also which items are included as food and food ingredients. As of July 1, 2014, West Virginia has a sales tax exemption on food and food ingredients intended for human consumption. Wyoming issued the sales tax waiver on food, 4/24/2006, clarifying the exemption.

It should be noted that food additives were exempt before 2005 when South Dakota eliminated the exemption. In Texas, vitamins or dietary supplements are exempted from sales tax, not as foods, but as medical supplies. Florida – Food substitutes, including herbal supplements, are exempt.

Additionally, unlike the regulatory structure of drugs, all dietary supplements are given the opportunity to conform to the U.S. Pharmacopeias (USP-NF) Open Standard, with labeling including instructions about a products effects on the bodys structure or function, claims about general health, or claims about benefits related to a category of nutrient deficiencies. Dietary supplements also must contain a disclaimer that states the claims have not been evaluated by FDA, and the products are not intended to diagnose, treat, or prevent any illness. They may include general health claims, claims about the content of nutrients, or statements about the structures-functionality. Some scientific evidence needs only be submitted to FDA regarding health claims, that show a direct relationship between use of dietary supplements and a reduction in the risk of illness. Some dietary supplements may include claims about nutrient composition, and claims about structure-functionality. Some dietary supplements may include claims about health effects, or nutrient composition, and may include claims about structure-functionality. Some scientific evidence needs to contain general health claims, claims about the nutrient composition, or structure-functionality. Some scientific evidence needs to be submitted to FDA only for health claims, that show a direct relationship between use of the supplement and reduced risk for a direct association of use with nutrients. Some science needs to establish a direct association of use with nutrients. Identifying food additives for recalls by The Food and Drug Administration (FDA) can occur via multiple mechanisms, including random sampling of manufacturers, recommendations for potentially adulterated products by retailers, consumer and medical reports of adverse events, and many others.

Given that the FDA does not regulate supplements as rigorously as it does medications, the rise of products and consumer use highlights the importance of physicians being knowledgeable about the potential for quality problems with dietary supplement products. FDA and the Federal Trade Commission have jointly issued warning letters to seven manufacturers of dietary supplements for marketing products that make claims about disease prevention, affirming that dietary supplements cannot make claims about disease prevention or treatment.

Consumers wanted reassurance they could have access to safe, helpful products that promoted better health, and DSHEA provides this assurance. As the U.S. Food and Drug Administration (FDA) has recently reiterated, DSHEA is a product of the complex balancing act between providing access and protecting public safety. As a result, there is a broad spectrum of products that are now part of a broad spectrum that are rightful inheritors of wisdom from centuries of traditional medicine, folk remedies, nutrition practices, and self-care. For an agency charged with oversight of both food and drugs (with the dietary supplement category created by DSHEA falling somewhere in between the two), the Food and Drug Administration unquestionably has a role in regulating these products to protect consumers from unsafe products but the extent of that oversight remains at the heart of the controversy with us today. Critics of DSHEA have routinely smeared the 1994 law by inaccurately claiming that it defanged [ed] the FDA by prohibiting the agency from requiring even rudimentary premarket screening for the safety or efficacy of these products, leaving the dietary supplement industry free of any meaningful regulation. For an agency charged with oversight of both food and drugs (with the DSHEA-created category of dietary supplements fitting somewhere between the two ), Food and Drug Administration undeniably has a role in regulating these products to protect consumers from unsafe products but the extent of that oversight remains at the core of a controversy with us today.Critics of DSHEA have routinely slandered the 1994 law by inaccurately claiming it defang [ed] FDA by prohibiting the agency from requiring even rudimentary premarket screening for the safety or efficacy of these products, leaving the dietary supplement industry free of any meaningful regulation. This hostility, as well as the absence of clear regulatory structures has been made plain before passage of this bill.

The ephedra supplement story makes it very clear that it is very hard for the FDA to protect consumers from unsafe food products, and this is precisely why Representatives Susan Davis, Representative John Dingell introduced H.R.3156, The Food Additives Access, Awareness, and Awareness Act. The popularity of safe food additives, and concern about regulating them, is what led to passage of Act It in 1994, the bill Senator Harkin and I were proud to co-author along with Bill Richardson, the current governor of New Mexico. The law allows FDA to protect the publics health from dangerous or fraudulent products, while at the same time assuring more than 150 million Americans have access to vitamins, minerals, and other nutritional supplements, which have a major role in preventing disease.

Federal guidelines, such as the U.S. Department of Agricultures and U.S. Department of Health and Human Servicess 2010 Dietary Guidelines for Americans, recommend meeting nutrition needs primarily through dietary intake, while restricting use of vitamins and supplements. There are significant public health reasons to take some supplements, including folate and iodine, when pregnant. In certain cases, excess vitamin and mineral intake can be harmful or produce undesirable side effects; thus, maximal levels are needed to assure safe supplementation with foods. Previous studies have also shown that supplement users consume higher amounts of most vitamins and minerals through food choices alone compared with nonusers. Thus, disentangling effects of healthful food and lifestyle choices from use of food supplements is generally challenging in epidemiologic studies. Randomized controlled trials are ideal for investigating the use of supplements and health outcomes, but often they yield inconsistent results. Less than one-quarter of supplements used by adults are recommended by a doctor or healthcare professional. Results The most frequently reported rationale was toimprove (45%) or tomaintain (33%) general well-being. Multivitamin-mineral products remain the most frequently reported type of supplements, mainly used for either improving or maintaining health. The European Food Safety Agency (EFSA) added, Consults can be used to remedy a nutrient deficiency or maintain adequate levels of specific nutrients.