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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 quantity 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 the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO).


[edit] European Union

The Food Supplements Directive of 2002 requires that supplements be demonstrated to be safe, both in quantity and quality.[1] By definition, vitamins and minerals are essential, i.e. the body cannot make them, so they must be obtained exogenously or from the diet, but excessive intakes can be harmful, notably Vitamin A. Consequently, only those supplements that have been proven to be safe may be sold without prescription. As a category of food, food supplements cannot be labeled with drug claims in the bloc but can bear health claims and nutrition claims.[2]

The dietary supplements industry in the UK, one of the 27 countries in the European Union, strongly opposed the Directive. In addition, a large number of consumers throughout Europe, including over one million in the UK, and many doctors and scientists, had signed petitions by 2005 against what are viewed by the petitioners as unjustified restrictions of consumer choice.[3] In 2004, along with two British trade associations, the Alliance for Natural Health had a legal challenge to the European Union's Food Supplements Directive[4] referred to the European Court of Justice by the High Court in London.[5] Although the European Court of Justice's Advocate General subsequently said that the EU's plan to tighten rules on the sale of vitamins and food supplements should be scrapped,[6] he was eventually overruled by the European Court, which decided that the measures in question were necessary and appropriate for the purpose of protecting public health. ANH, however, interpreted the ban as applying only to synthetically produced supplements'and not to vitamins and minerals normally found in or consumed as part of the diet.[7] Nevertheless, the European judges did acknowledge the Advocate General's concerns, stating that there must be clear procedures to allow substances to be added to the permitted list based on scientific evidence. They also said that any refusal to add a product to the list must be open to challenge in the courts.[8]

A survey conducted in Ireland in 2001, of adults aged 18'64 years, suggested that with the possible exception of niacin (flushing) and vitamin B6 (neuropathy), there appears to be little risk of the occurrence of adverse effects due to excessive consumption of vitamins in this population, based on current dietary practices.[9]

[edit] Russia

Russian legislation, Ministry of Health's order number 1898 dated as of 15 April 1997, under the title "Concerning the procedure for the examination and health certification of Active Dietary Supplements", provides the usage of the following terminology:

As a rule, BADSs are foodstuffs with clinically proven effectiveness. BADSs are recommended not only for prophylactics, but can be included into a complex therapy for the prevention of pharmaceutical therapy's side effects and for the achievement of complete remission.

The development of BADSs and their applications has been very fast moving. They were originally considered as dietary supplements for people who had heightened requirements for some normal dietary components (for example, sportsmen). Later, they were employed as preventive medicines against chronic diseases.

[edit] China

In China, prior to market entry, manufacturers must register dietary supplements with SFDA. The process requires investments of both time and money. After market entry, the registration is valid for five years and then must be renewed.

SFDA has a list of 27 approved functional claims that manufacturers of dietary supplements are allowed to make when register a product. The process involves a strict testing protocol, including animal and human studies. In a large degree it is similar to the approval of pharmaceuticals.

[edit] United States

In the United States, a dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994[10] (DSHEA) as a product that is intended to supplement the diet and contains any of the following dietary ingredients:

  • a concentrate, metabolite, constituent, extract, or combination of any of the above

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"

The hormones DHEA (a steroid), pregnenolone (also a steroid) and the pineal hormone melatonin are marketed as dietary supplements in the US.[11][12]

[edit] 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.[13] Instead, manufacturers and distributors who wish to market dietary supplements that contain a "new dietary ingredient" (defined as "a vitamin; a mineral; an 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 agency reviews the information for adequacy and safety concerns; fifteen days after the 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.[14] On September 24, 2007 the FDA has implemented a "current good manufacturing practices" 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.[15]

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 so long as manufacturers made no claims about their products treating, preventing or curing diseases. Accordign 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 wasn't 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 only ever found one dietary supplement to be unsafe, the weight loss/energy supplement ephedra.[16] Discussing the legislation, Time referred to the DSHEA as "ill-conceived and reprehensible", that "gives the industry virtually free reign [sic] to market products defined as dietary supplements, while severely limiting the FDA's ability to regulate them".[17] 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.[16][17] 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 it is estimated captures only 1% of all adverse events linked to supplements.[citation needed] 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.[18]

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 supported pre-marketing approval by the FDA, increased oversight of harmful supplements, and greater scrutiny of the truthfulness of supplement label claims.[19]

[edit] Quality

Under the FDA's final rule on good manufacturing practices, quality is defined as meaning "that the dietary supplement consistently meets the established specifications for identity, purity, strength, and composition and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the Federal Food, Drug, and Cosmetic Act".[20] The new regulations allow FDA inspectors to look at a company's records upon request.[21] However, enforcement could be difficult given the number of supplement manufacturers and the 16% decline in FDA investigators from 2003 to 2006.[22] Much of the contamination is due to poor raw ingredients. Suppliers provide certificates of analysis stating that they have tested the material.[22] Under the 2003 proposed rule, manufacturers would have been required to retest the supplied ingredients. Under the final rule, testing for identity is always required. Other retesting is not required if the manufacturer has verified the reliability of the ingredient supplier.[21]

In the U.S., contamination and false labeling are "not uncommon".[23] Independent certification programs exist, but these may have problems as well. United States Pharmacopeia 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,[24] and it is the only certification program which conducts random off-the-shelf testing.[23] The USP program will not certify products which contain ingredients that the USP's Dietary Supplement Information Expert Committee determines have a safety risk.[25] ConsumerLab.com randomly tests some dietary supplements and makes the results available to subscribers. It has reported that 25% of the supplements it tests have problems, and for multivitamins about half had problems.[22] In 2008 ConsumerLab criticized the USP for proposing a 10 microgram perdaily serving limit on lead in dietary supplements and drugs. It noted that under the FDA's 2006 guidance on lead in candy, only 0.2 micrograms of lead per serving are allowed.[26] NSF International,[27] HFL Sport Science,[28] and the Natural Products Association[29] also have a dietary supplement certification programs.

[edit] Permissible claims

If a dietary supplement claims to cure, mitigate, or treat a disease, it would be considered an unauthorized new drug and in violation of the applicable regulations and statutes. As the FDA states, in a response to this question, in a FAQ:

Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?
No, a product sold as a dietary supplement and promoted on its label or in labeling* as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved--and thus illegal--drug. To maintain the product's status as a dietary supplement, the label and labeling must be consistent with the provisions in the Dietary Supplement Health and Education Act (DSHEA) of 1994.
*Labeling refers to the label as well as accompanying material that is used by a manufacturer to promote and market a specific product.

Dietary supplements are permitted to make structure/function claims. These are broad claims that the product can support the structure or function of the body (e.g., "glucosamine helps support healthy joints", "the hormone melatonin helps establish normal sleep patterns"). The FDA must be notified of these claims within 30 days of their first use, and there is a requirement that these claims be substantiated. In reality, misleading claims about supplements are common, particularly on poorly regulated commercial websites.[30][31] For example, the compound hydrazine sulfate is sold as a dietary supplement in the USA and promoted as a treatment for cancer, despite little evidence that it is either safe or effective.[32][33]

Other claims that required approval from FDA include health claims and qualified health claims. Health claims are permitted to be made if they meet the requirements for the claims found in the applicable regulations. Qualified health claims can be made through a petition process, including scientific information, if FDA has not approved a prior petition.

[edit] See also

[edit] References

  1. ^ Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements
  2. ^ European Commission website: Food Safety - Labelling & Nutrition - Health & Nutrition Claims
  3. ^ "Controversial EU vitamins ban to go ahead" (the Times, July 12 2005)
  4. ^ EU Food Supplements Directive
  5. ^ 'Court victory for vitamin firms' BBC News Published 30 January 2004. Accessed 29 April 2007.
  6. ^ 'EU health foods crackdown 'wrong BBC News. Published 5 April 2005. Accessed 29 April 2007.
  7. ^ 'Vitamin controls backed by Europe' BBC News. Published 12 July 2005. Accessed 29 April 2007.
  8. ^ 'EU court backs health supplements ban' The Guardian Published 12 July 2005. Accessed 6 October 2007.
  9. ^ O'Brien MM, Kiely M, Harrington KE, Robson PJ, Strain JJ, Flynn A (October 2001). "The North/South Ireland Food Consumption Survey: vitamin intakes in 18-64-year-old adults". Public Health Nutrition 4 (5A): 1069'79. PMID 11820920. 
  10. ^ US Dietary Supplement Health and Education Act of 1994
  11. ^ "Over-the-counter DHEA hormonal therapy may be an effective treatment for depression". News-Medical.net. 7 February 2005. http://www.news-medical.net/?id=7657. Retrieved 2008-06-25. "DHEA (dehydroepiandrosterone), an adrenal androgen and neurosteroid is available as a supplement in the U.S." 
  12. ^ "Sleep Aids And Stimulants". MedicineNet.com. http://www.medicinenet.com/sleep_aids_and_stimulants/page3.htm. Retrieved 2008-06-25. "Melatonin is the only hormone available OTC for insomnia.... Melatonin is sold as a dietary supplement and is, therefore, not regulated by the FDA." 
  13. ^ Goldman, P (2001). "Herbal medicines today and the roots of modern pharmacology". Annals of internal medicine 135 (8 Pt 1): 594'600. PMID 11601931.  edit
  14. ^ "New Dietary Ingredients in Dietary Supplements - Background for Industry". FDA. 2009-06-18. http://www.fda.gov/Food/DietarySupplements/ucm109764.htm. Retrieved 2010-07-28. 
  15. ^ "FDA Issues Dietary Supplements Final Rule". FDA. 2007-06-22. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108938.htm. Retrieved 2010-07-28. 
  16. ^ a b "Nutritional Supplements: Your Questions Answered". Consumer Reports. 2006-06-14. http://www.consumerreports.org/mg/free-highlights/manage-your-health/supplements_questions.htm?AFFID=HNARSIC5. Retrieved 2010-07-28. 
  17. ^ a b Jaroff, L (2004-02-10). "Beyond Ephedra". Time. http://www.time.com/time/printout/0,8816,589533,00.html. Retrieved 2010-07-28. 
  18. ^ "Dangerous supplements: still at large". Consumer Reports. 2004-05-01. http://www.accessmylibrary.com/article-1G1-115405678/dangerous-supplements-still-large.html. Retrieved 2010-07-28. 
  19. ^ Blendon RJ, DesRoches CM, Benson JM, Brodie M, Altman DE (March 2001). "Americans' views on the use and regulation of dietary supplements". Archives of Internal Medicine 161 (6): 805'10. doi:10.1001/archinte.161.6.805. PMID 11268222. 
  20. ^ FDA. (2007). Final Rules: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Federal Register.
  21. ^ a b Dickinson A, Shao A. (2007). The Evolution of Dietary Supplement GMPs. Natural Products Insider.
  22. ^ a b c O'Connell J. (2007). The untold dietary-supplement scandal. Men's Health.
  23. ^ a b Larimore WL, O'MathĂșna DP (June 2003). "Quality assessment programs for dietary supplements". The Annals of Pharmacotherapy 37 (6): 893'8. doi:10.1345/aph.1D031. PMID 12773081. 
  24. ^ USP. USP Verified Dietary Supplements.
  25. ^ USP. Frequently Asked Questions about USP Verification Program for Dietary Supplements.
  26. ^ ConsumerLab.com. (2008). ConsumerLab.com Asks USP to Adopt Safer Lead Limits for Drugs and Supplements.
  27. ^ NSF International. The Importance of Certification.
  28. ^ Mathews AW. (2009-9-03). What's Really in Supplements? . Wall Street Journal.
  29. ^ NPA. Quality Assurance Programs.
  30. ^ 'Miracle' Health Claims: Add a Dose of Skepticism Federal Trade Commission
  31. ^ Bonakdar RA (2002). "Herbal cancer cures on the Web: noncompliance with The Dietary Supplement Health and Education Act". Fam Med 34 (7): 522'7. PMID 12144007. 
  32. ^ Questions and answers about hydrazine sulfate. National Cancer Institute. March 12, 2009. http://www.cancer.gov/cancertopics/pdq/cam/hydrazinesulfate/Patient/page2. 
  33. ^ Black M, Hussain H (December 2000). "Hydrazine, cancer, the Internet, isoniazid, and the liver". Annals of Internal Medicine 133 (11): 911'3. PMID 11103062. http://www.annals.org/cgi/pmidlookup?view=long&pmid=11103062. 

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