Dietary Supplements

Wikipedia, September 25, 2012

Edited by Andy Ross

A dietary supplement or nutritional supplement is a preparation intended to 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. The Codex Alimentarius Commission is sponsored by the UN Food and Agriculture Organization (FAO) and the World Health Organization (WHO).

European Union

The EU Food Supplements Directive of 2002 requires that supplements be demonstrated to be safe, both in dosages and in purity. Only those supplements that have been proven to be safe may be sold in the bloc without prescription. As a category of food, food supplements cannot be labeled with drug claims but can bear health claims and nutrition claims.

The dietary supplements industry in the UK opposed the directive. A large number of consumers throughout Europe and various doctors and scientists signed petitions against what they saw as an unjustified restriction of consumer choice.

The European Court decided that the measures in question were necessary and appropriate. But they acknowledged the concerns, stating that there must be clear procedures to allow substances to be added to the permitted list based on scientific evidence. They also allowed that any refusal to add a product to the list is open to challenge in the courts.

United States

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; an amino acid; a concentrate, metabolite, constituent, extract, or combination of them; or a substance used historically to supplement the human diet.

According to the act, a dietary supplement must be 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; and labeled as a dietary supplement.

The Food and Drug Administration (FDA) regulates dietary supplements as a category of foods and does not need to approve them before they can enter the market. But manufacturers and distributors who wish to market dietary supplements that contain a new dietary ingredient must notify the FDA in advance with information indicating the ingredient is safe for the agency to review.

The FDA has implemented a current good manufacturing practices (cGMP) policy to ensure dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled. Based on audits completed in 2011 and 2012, the FDA estimated that nearly 70% of dietary supplement manufacturers are currently not compliant with cGMP.

 The Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 established requirements for manufacturers to submit to the FDA reports of serious adverse events involving their products.

The DSHEA 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 protection and assigns to the FDA the burden of proof that a supplement is unsafe. While pharmaceutical manufacturers must demonstrate their products are effective as well as being safe, supplement manufacturers are not required to demonstrate efficacy.

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. The FDA has also lacked the funding to undertake the rigorous tests to meet the standards for a supplement to be considered hazardous.

The FDA defines a quality dietary supplement as one that consistently meets the established specifications for identity, purity, strength, and composition and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration. But enforcement is difficult.

Contamination and false labeling are common. Much of the contamination is due to poor raw ingredients. Suppliers provide certificates of analysis stating that they have tested the material. Retesting is not required if the manufacturer has verified the reliability of the ingredient supplier.

United States Pharmacopeia (USP) manages the Dietary Supplement Verification Program (DSVP). Its USP Verified Mark seal indicates that the product has been tested for integrity, purity, dissolution, and safe manufacturing. The USP program conducts random off-the-shelf testing and will not certify products that contain ingredients that it determines have a safety risk. randomly tests dietary supplements and reports that a quarter of those it tests have problems. NSF International, HFL Sport Science, and the Natural Products Association (NPA) also have dietary supplement certification programs.

A dietary supplement claiming to cure or treat a disease would be considered an unauthorized new drug and in violation of the applicable regulations and statutes. Companies that market dietary supplements are permitted to make broad claims in the marketing material that the product can support the structure or function of the body. The FDA must be notified and the claims must be substantiated. Health claims require approval from FDA.