Holistic Study of Natural and dietary Supplements under law in Virginia

Natural and dietary Supplements

Dietary supplements are included under the health functional foods (HFF) category in Korea, regulated by the Ministry of Food and Drug Safety (MFDS) according to the HFF Law for the purpose of ensuring safety. Dietary supplements–and their sometimes questionable claims about health effects are regulated differently from regular foods or medicines by the Food and Drug Administration (FDA).

In the US, supplement safety is regulated by the FDA, however, legal restrictions have prevented FDA from effectively regulating supplements (e.g. This has increased risks to public health, which has led to many calls for reform. Dietary supplements, which include vitamins, minerals, plant and animal extracts, hormones, and amino acids ingested orally, are used extensively in the US, with four out of five adults reporting having taken one. The market for these products has grown exponentially in the past 25 years from a $4 billion industry with 4,000 products in 1994 to one of over $40 billion today, with up to 8,00 products but consumer protection regulations have failed to keep up.

In Australia, most dietary supplements are regulated within a complementary medicines category, including vitamins, minerals, herbs, aromatherapy, and homeopathic products, though some products can be considered foods for specific purposes and regulated by food authorities. These only apply to supplements that contain vitamins and/or minerals, in those cases in which those products are regulated as foods, and address supplement composition, including its safety, purity, and bioavailability.

In addition, manufacturers are not required to submit product safety data to FDA before marketing dietary supplements, except when supplements contain a novel dietary ingredient (a dietary ingredient not sold in this country before Oct. 15, 1994) that has not been presented in the food supply as a food-use article in a form where 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 The underlying framework of DSHEA allows any products marketed as food additives at the time of enactment of DSHEA, except for products in the context of new ingredients this is what is known as a grandfathered) that they are safe. Manufacturers are required to inform FDA prior to marketing of any new ingredients. Under DSHEA, supplement manufacturers are not required to prove safety or effectiveness; Rather, DSHEA deliberately minimizes the supervision by U.S. Food and Drug Administration, and emphasizes the industrys value to the U.S. economy.

The authors found no impact of presence or absence of a disclaimer on consumers beliefs about whether the product will have the effects claimed, or on their beliefs about whether FDA has evaluated a manufacturers claims about effectiveness despite the fact that the DSHEA disclaimer explicitly states that the FDA does not evaluate claims. The authors concluded that disclaimers, which are common on supplements, did little to decrease consumers misconceptions about the FDAs role in approving supplements. Despite near-universal knowledge of the FDAs disclaimers, many participants believed supplement claims were subject to FDA review and were skeptical about the ability of FDA to effectively regulate health products.

Under the Dietary Supplement Health and Education Act (DSHEA) the 1994 legislation that established the current regulatory framework for dietary supplements the FDA does not typically perform premarket reviews of supplements, nor are manufacturers required to submit essential information about their products, including names or ingredients, to the agency prior to marketing. This leaves the agency without clear visibility into what is on the market at any given moment. Dietary and herbal supplement companies are responsible for evaluating their products for safety and labeling purposes on their own before marketing, in order to make sure that they are compliant with all requirements of the DSHEA. As the standards-setting organization committed to public health, the U.S. Pharmacopeia supports the manufacturers of dietary supplements in continuing their efforts to produce quality products to meet the needs of consumers.

Despite the dietary supplement industrys development into a multibillion-dollar business, now costing more than $30 billion in the U.S., regulatory agencies and researchers who study health care are still learning little about the effects of dietary supplement labeling, or how it influences consumers health behaviors. It is generally challenging to examine the use of supplements for the purposes of disease prevention and health promotion in epidemiologic studies, since the use of supplements cannot be separated from other health-seeking behaviors. Previous studies have also shown that supplement users consume more vitamins and minerals than nonusers through food choices alone. Thus, disentanglement of effects from healthful dietary choices and lifestyle choices from supplement use is often challenging in epidemiologic studies. Randomized controlled trials are ideal for studying supplement use and health outcomes, but often yield inconsistent results. Previous research also suggests the supplement users have higher intakes of most vitamins and minerals from their food choices alone than nonusers. Thus, it is often difficult to disentangle the effects of healthy food and lifestyle choices from the use of dietary supplements in epidemiologic research. Randomized controlled trials are ideal to examine supplement use and health outcomes, but they often have conflicting results. Data from national surveys indicate most herbal supplement users fail to disclose such use to their healthcare provider. This is perhaps concerning as certain herbal supplements have a potential to adversely interact with prescribed medications. While it is true that the law has succeeded in releasing many safe and beneficial supplements from needless regulation, it is also true that the law appears to have provided sanctuary to substances many experts consider to have potential serious health risks. To legally be sold in China, each food additive must receive the Certificate of Health Food Approval from the CFDA, suggesting Chinas current emphasis is on the products safety and scientific evidence of function.


Related Posts