Dietary supplement

A dietary supplement, also known as food supplement or nutritional supplement, is a preparation intended to supplement the diet and provide nutrients, such as vitamins, minerals, fiber, fatty acids, or amino acids, that may be missing or may not be consumed in sufficient quantities in a person's diet. Some countries define dietary supplements as foods, while in others they are defined as drugs or natural health products.

Supplements containing vitamins or dietary minerals are included as a category of food in the Codex Alimentarius, a collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to foods, food production and food safety. These texts are drawn up by the Codex Alimentarius Commission, an organization that is sponsored by theFood and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO).

In the United States, a dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994 (DSHEA) as a product that is intended to supplement the diet and contains any of the following dietary ingredients:

• a vitamin
• a mineral
• an herb or other botanical (excluding tobacco)
• an amino acid
• a concentrate, metabolite, constituent, extract, or combination of any of the above
• a substance historically used by man to supplement the diet

Furthermore, it must also conform to the following criteria:

• intended for ingestion in pill, capsule, tablet, powder or liquid form
• not represented for use as a conventional food or as the sole item of a meal or diet
• labeled as a "dietary supplement"

  Regulation

  The Food and Drug Administration (FDA) regulates dietary supplements as a category of foods, and not as drugs. While pharmaceutical companies are required to obtain FDA approval, which involves assessing the risks and benefits prior to their entry into the market, dietary supplements do not need to be pre-approved by FDA before they can enter the market. Instead, manufacturers and distributors who wish to market dietary supplements that contain a "new dietary ingredient" (defined as "a vitamin; a mineral; a herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients" not marketed before October 15, 1994) must notify the FDA beforehand. The notification requires information indicating the ingredient is safe, and the ingredient can not be marketed (sold or delivered for sale) for seventy-five days following filing the information. During this time, the agency reviews the information for adequacy and safety concerns; fifteen days after this period (ninety days after the information was filed), the FDA posts nonproprietary information on their website. Listing the information means the ingredient can be marketed, but does not mean it is necessarily safe. On September 24, 2007 the FDA has implemented a "current good manufacturing practices" (GMP) policy to ensure dietary supplements "are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled" and covers the manufacturing, packaging, labelling, and storing of supplements, with requirements for quality control, design and construction of manufacturing plants, testing of ingredients and final products, record keeping, and complaints processes. And, in that same year, FDA implemented the “Dietary Supplement and Nonprescription Drug Consumer Protection Act” passed by Congress in 2006. This law established requirements for manufacturers to submit to the FDA reports of serious adverse events involving their products. These laws establishing requirements for GMP’s and adverse event reporting increased FDA’s oversight of dietary supplements.

  However, in an April 25, 2012 presentation to the Natural Products Association (NPA), Dan Fabricant, Director of the FDA’s Dietary Supplements Program, called the level of non-compliance with cGMP’s “astonishing”. Based on audits completed by the FDA’s compliance division in 2011 and 2012, it was estimated that nearly 70% of dietary supplement manufacturers are currently not compliant with cGMP. Fabricant also indicated that FDA had concerns regarding under-reporting of adverse events. Despite concerns over under-reporting of serious AE’s the vast majority of adverse events documented by SafetyCall International on behalf of hundreds of supplement companies have typically included non-serious adverse effects with mild, self-limiting effects that require no need for any specific treatment. SafetyCall acknowledged that there are supplement companies that are not fully compliant with best practices for adverse event documenting and reporting, but like FDA, SafetyCall believes more and more companies are critically evaluating their capabilities and coming into full compliance.

  The DSHEA, passed in 1994, was the subject of lobbying efforts by the manufacturers of dietary supplements and restricted the ability of the FDA to exert authority over supplements as long as manufacturers made no claims about their products treating, preventing, or curing diseases. According to Consumer Reports, "The law has left consumers without the protections surrounding the manufacture and marketing of over-the-counter or prescription medications" and it became the FDA's responsibility to prove that a supplement is not safe. While pharmaceutical manufacturers must demonstrate their products are effective as well as being safe, supplement manufacturers are not required to demonstrate efficacy. The FDA has ever found only one dietary supplement to be unsafe, the weight loss/energy supplement ephedra. Discussing the legislation, Time referred to the DSHEA as "ill-conceived and reprehensible", that "gives the industry virtually free reign  to market products defined as dietary supplements, while severely limiting the FDA's ability to regulate them". The DSHEA was heavily lobbied for by the supplement industry, and was criticized for exposing the public to worthless compounds that bilked consumers out of money to no benefit. Because of the requirements put into place by the DSHEA, the FDA must demonstrate that individual supplements are unsafe using their adverse events reporting system, which is estimated to capture only 1 to 10 percent of all adverse events linked to supplements. The FDA has also lacked the funding to undertake the rigorous tests to meet the standards for a supplement to be considered "hazardous" and, thus, removed from the market; in the one situation where this standard was reached (ephedra), the agency faced significant opposition from the supplement industry and the United States Congress, instead limiting themselves to making announcements about problematic supplement safety records on their website.

  A 2001 study, published in Archives of Internal Medicine, found broad public support for greater governmental regulation of dietary supplements than was currently permitted by DSHEA. The researchers found that a majority of Americans support pre-marketing approval by the FDA, increased oversight of harmful supplements, and greater scrutiny of the truthfulness of supplement label claims.