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484
Π Π°Π·Π»ΠΈΡΠ½ΡΠ΅ ΠΈΡΡΠΎΡΠ½ΠΈΠΊΠΈ, Π²ΠΊΠ»ΡΡΠ°Ρ ΠΈΠ½ΡΠ΅ΡΠ²ΡΡ Ρ ΠΏΡΠ΅Π·ΠΈΠ΄Π΅Π½ΡΠΎΠΌ ConsumerLab Π’ΠΎΠ΄ΠΎΠΌ ΠΡΠΏΠ΅ΡΠΌΠ°Π½ΠΎΠΌ ΠΎΡ 25 ΡΠ½Π²Π°ΡΡ 2012 Π³ΠΎΠ΄Π°. ΠΡ ΡΠ°ΠΊΠΆΠ΅ ΠΌΠΎΠΆΠ΅ΡΠ΅ ΠΎΠ±ΡΠ°ΡΠΈΡΡΡΡ ΠΊ ΡΠ°ΠΉΡΡ ConsumerLab.com, ΡΡΠΎΠ±Ρ Π½Π°ΠΉΡΠΈ ΡΡΠΈ (ΠΈ Π΄ΡΡΠ³ΠΈΠ΅) ΡΠ΅ΡΠΌΠΈΠ½Ρ ΠΈ ΠΏΠΎΠ»ΡΡΠΈΡΡ ΠΈΠ½ΡΠΎΡΠΌΠ°ΡΠΈΡ ΠΎ ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²ΡΡΡΠΈΡ ΠΎΡΡΠ΅ΡΠ°Ρ .
485
Π Π°Π·Π»ΠΈΡΠ½ΡΠ΅ ΠΈΡΡΠΎΡΠ½ΠΈΠΊΠΈ, Π²ΠΊΠ»ΡΡΠ°Ρ ΠΈΠ½ΡΠ΅ΡΠ²ΡΡ Ρ ΠΏΡΠ΅Π·ΠΈΠ΄Π΅Π½ΡΠΎΠΌ ConsumerLab Π’ΠΎΠ΄ΠΎΠΌ ΠΡΠΏΠ΅ΡΠΌΠ°Π½ΠΎΠΌ ΠΎΡ 25 ΡΠ½Π²Π°ΡΡ 2012 Π³ΠΎΠ΄Π°. ΠΡ ΡΠ°ΠΊΠΆΠ΅ ΠΌΠΎΠΆΠ΅ΡΠ΅ ΠΎΠ±ΡΠ°ΡΠΈΡΡΡΡ ΠΊ ΡΠ°ΠΉΡΡ ConsumerLab.com, ΡΡΠΎΠ±Ρ Π½Π°ΠΉΡΠΈ ΡΡΠΈ (ΠΈ Π΄ΡΡΠ³ΠΈΠ΅) ΡΠ΅ΡΠΌΠΈΠ½Ρ ΠΈ ΠΏΠΎΠ»ΡΡΠΈΡΡ ΠΈΠ½ΡΠΎΡΠΌΠ°ΡΠΈΡ ΠΎ ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²ΡΡΡΠΈΡ ΠΎΡΡΠ΅ΡΠ°Ρ .
486
Offit, Do You Believe in Magic? P. 91.
487
Act of June 12, 2002, Pub. L. No. 107β88, 116 Stat. 594 (Public Health Security and Bioterrorism Preparedness and Response Act of 2002), Β§ 305 (Registration of Food Facilities). http://www.gpo.gov/fdsys/pkg/PLAW-107publ188/pdf/PLAW-107publ188.pdf.
488
Act of Jan. 4, 2011, Pub L. No. 111β353, 124 Stat. 3885 (FDA Food Safety Modernization Act). http://www.fda.gov/Food/GuidanceRegulation/FSMA/.
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490
Daniel, FDA Uses New Authorities to Get OxyElite Pro Off the Market.
491
Act of December 22, 2006, Pub. L. 109β462, 120 Stat. 3469 (Dietary Supplement and Nonprescription Drug Consumer Protection Act).
492
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Final Rule, 72 Fed. Reg. 34751 (June 25, 2007).
493
http://www.gpo.gov/fdsys/pkg/PLAW-109publ462/html/PLAW-109publ462.htm.
494
Dangerous Supplements: Still at Large, Consumer Reports; Hilts, Protecting Americaβs Health: 89; http://www.gpo.gov/dsys/pkg/FR-2007-10-15/html/07-5074.htm.
495
ΠΠ½ΡΠ΅ΡΠ²ΡΡ Ρ ΠΠ°Π½ΠΈΡΠ»ΠΎΠΌ Π€Π°Π±ΡΠΈΠΊΠ°Π½ΡΠΎΠΌ, 17 ΡΠ΅Π²ΡΠ°Π»Ρ 2012 Π³ΠΎΠ΄Π°; Roller, Sarah, and Megan Olsen, Kelley Drye & Warren LLP. Food Safety Modernization Act: Today and Tomorrow. Nutritional Outlook, January/February 2012: 42β44. http://www.kelleydrye.com/publications/articles/1547_res/id=Files/index=0/.
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Food and Drug Administration. Dietary Supplement Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts, June 22, 2007 (archived). http://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm110858.htm. ΠΡΠΎ Π±ΡΠ» ΠΏΠΎΡΡΠ°ΠΏΠ½ΡΠΉ ΡΡΠ΅Ρ ΡΠ°Π·ΠΎΠ²ΡΠΉ ΠΏΡΠΎΡΠ΅ΡΡ, ΠΊΠΎΡΠΎΡΡΠΉ Π½Π°ΡΠ°Π»ΠΈ Π² ΠΈΡΠ½Π΅ 2008 Π³ΠΎΠ΄Π° ΠΊΡΡΠΏΠ½ΡΠ΅ ΠΊΠΎΠΌΠΏΠ°Π½ΠΈΠΈ ΠΈ Π·Π°ΠΊΠΎΠ½ΡΠΈΠ»ΠΈ Π² ΠΈΡΠ½Π΅ 2010 Π³ΠΎΠ΄Π° ΠΊΠΎΠΌΠΏΠ°Π½ΠΈΠΈ Ρ ΠΌΠ΅Π½Π΅Π΅ ΡΠ΅ΠΌ Π΄Π΅ΡΡΡΡΡ ΡΠΎΡΡΡΠ΄Π½ΠΈΠΊΠ°ΠΌΠΈ.
497
Π’Π΅Π»Π΅ΡΠΎΠ½Π½ΡΠΉ ΡΠ°Π·Π³ΠΎΠ²ΠΎΡ Ρ ΠΠ°Π½ΠΈΡΠ»ΠΎΠΌ Π€Π°Π±ΡΠΈΠΊΠ°Π½ΡΠΎΠΌ, 17 ΡΠ΅Π²ΡΠ°Π»Ρ 2012 Π³ΠΎΠ΄Π°.
498
Angela Pope, Office of Dietary Supplements research practicum, June, 2014.
499
ΠΡΠΈ ΡΠΈΡΡΡ Π²Π·ΡΡΡ ΠΈΠ· ΠΈΠ½ΡΠ΅ΡΠ²ΡΡ ΠΎΡ 19 ΠΈΡΠ»Ρ 2014 Π³ΠΎΠ΄Π° Ρ Π¨Π°ΡΠ»ΠΎΡΡ ΠΡΠΈΡΡΠΈΠ½, ΠΈΡΠΏΠΎΠ»Π½ΠΈΡΠ΅Π»ΡΠ½ΡΠΌ Π΄ΠΈΡΠ΅ΠΊΡΠΎΡΠΎΠΌ ΠΎΡΠ΄Π΅Π»Π° FDA ΠΏΠΎ Π±ΠΈΠΎΠ»ΠΎΠ³ΠΈΡΠ΅ΡΠΊΠΈ Π°ΠΊΡΠΈΠ²Π½ΡΠΌ ΠΏΠΈΡΠ΅Π²ΡΠΌ Π΄ΠΎΠ±Π°Π²ΠΊΠ°ΠΌ. ΠΡΠΎΠΌΠ΅ ΡΠΎΠ³ΠΎ, FDA, Π²ΠΏΠΎΠ»Π½Π΅ Π²ΠΎΠ·ΠΌΠΎΠΆΠ½ΠΎ, Π½Π΅ Π²ΡΠ΅Π³Π΄Π° ΠΏΠΎΠ»ΡΡΠ°Π΅Ρ ΠΈΠ·Π²Π΅ΡΠ΅Π½ΠΈΠ΅, ΠΊΠΎΠ³Π΄Π° Π½ΠΎΠ²ΡΠΉ Π΄ΠΈΠ΅ΡΠΈΡΠ΅ΡΠΊΠΈΠΉ ΠΈΠ½Π³ΡΠ΅Π΄ΠΈΠ΅Π½Ρ ΠΏΠΎΠΏΠ°Π΄Π°Π΅Ρ Π½Π° ΡΡΠ½ΠΎΠΊ. Π‘ΠΎΠ³Π»Π°ΡΠ½ΠΎ ΡΡΠ°ΡΡΠ΅ Π² New England Journal of Medicine, FDA ΠΏΠΎΠ»ΡΡΠΈΠ»ΠΎ ΠΈΠ·Π²Π΅ΡΠ΅Π½ΠΈΡ Π²ΡΠ΅Π³ΠΎ ΠΎ 170 Π½ΠΎΠ²ΡΡ Π΄ΠΈΠ΅ΡΠΈΡΠ΅ΡΠΊΠΈΡ ΠΈΠ½Π³ΡΠ΅Π΄ΠΈΠ΅Π½ΡΠ°Ρ ΠΌΠ΅ΠΆΠ΄Ρ 1994 ΠΈ 2012 Π³ΠΎΠ΄Π°ΠΌΠΈ β Π³ΠΎΡΠ°Π·Π΄ΠΎ ΠΌΠ΅Π½ΡΡΠ΅, ΡΠ΅ΠΌ ΠΏΡΠ΅Π΄ΠΏΠΎΠ»ΠΎΠΆΠΈΡΠ΅Π»ΡΠ½ΠΎ ΠΏΠΎΠΏΠ°Π»ΠΎ Π½Π° ΡΡΠ½ΠΎΠΊ. Cohen, Pieter. Assessing Supplement Safety β The FDAβs Controversial Proposal. New England Journal of Medicine 366 (2012), p. 389β391. http://www.nejm.org/doi/full/10.1056/NEJMp1113325.
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Π§ΡΠΎΠ±Ρ ΠΏΡΠΎΡΡΠ½ΠΈΡΡ ΠΊΠΎΠ½ΡΠ΅ΠΊΡΡ, Π² 2004 Π³ΠΎΠ΄Ρ ΠΏΡΠΎΠ΄Π°ΠΆΠΈ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ² Π² ΠΠΌΠ΅ΡΠΈΠΊΠ΅ Π±ΡΠ»ΠΈ Π² 12 ΡΠ°Π· Π±ΠΎΠ»ΡΡΠ΅, ΡΠ΅ΠΌ ΠΏΡΠΎΠ΄Π°ΠΆΠΈ Π΄ΠΎΠ±Π°Π²ΠΎΠΊ, Π° Ρ FDA Π±ΡΠ»Π° ΠΏΡΠΈΠΌΠ΅ΡΠ½ΠΎ Π² 43 ΡΠ°Π·Π° Π±ΠΎΠ»ΡΡΠ°Ρ ΡΡΠΌΠΌΠ° Π΄Π»Ρ ΠΊΠΎΠ½ΡΡΠΎΠ»Ρ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ², ΡΠ΅ΠΌ Π΄Π»Ρ ΠΊΠΎΠ½ΡΡΠΎΠ»Ρ Π΄ΠΎΠ±Π°Π²ΠΎΠΊ, ΠΈ ΠΏΡΠΈΠΌΠ΅ΡΠ½ΠΎ Π² 48 ΡΠ°Π· Π±ΠΎΠ»ΡΡΠ΅ Π»ΡΠ΄Π΅ΠΉ. Dangerous Supplements Still at Large, Consumer Reports.
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Dietary Supplement Access and Awareness Act, H.R. 3156, 109th Cong., 1st Sess. (2005). http://thomas.loc.gov/cgi-bin/query/z?c109:H.R.3156.IH.
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US Government Accountability Office. Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding, p. 1.
503
ΠΡΠΈ ΡΡΠ²Π΅ΡΠΆΠ΄Π΅Π½ΠΈΡ Π‘ΡΠΈΠ²Π° ΠΠΈΡΡΠ΅ΡΠ° Π²Π·ΡΡΡ ΠΈΠ· ΡΠ΅Π»Π΅ΡΠΎΠ½Π½ΠΎΠ³ΠΎ ΡΠ°Π·Π³ΠΎΠ²ΠΎΡΠ° 7 ΠΌΠ°Ρ 2013 Π³ΠΎΠ΄Π°.
504
ΠΠ°ΠΏΡΠΈΠΌΠ΅Ρ, ΠΊΠΎΠ³Π΄Π° Π² 2005 Π³ΠΎΠ΄Ρ ΡΡΠ°Π³Π°Π½Ρ ΠΎΠ±ΡΡΡΠΈΠ»ΠΈΡΡ Π½Π° Π€Π»ΠΎΡΠΈΠ΄Ρ, Π·Π½Π°ΡΠΈΡΠ΅Π»ΡΠ½Π°Ρ ΡΠ°ΡΡΡ ΠΏΠ°Π»ΡΠΌΠ΅ΡΡΠΎ Π±ΡΠ»Π° ΡΠ½ΠΈΡΡΠΎΠΆΠ΅Π½Π°. Β«Π Π½ΠΈ Ρ ΡΠΎΠ³ΠΎ Π½ΠΈ Ρ ΡΠ΅Π³ΠΎ Π²ΡΡ ΡΡΠ° Π΄Π΅ΡΠ΅Π²Π°Ρ Π΄ΠΎΠ±Π°Π²ΠΊΠ° Π½Π°ΡΠΈΠ½Π°Π΅Ρ ΠΏΡΠΈΠ±ΡΠ²Π°ΡΡ ΠΈΠ· ΠΠΈΡΠ°Ρ, β ΡΠΊΠ°Π·Π°Π» ΠΠΈΠ»-ΠΠ°Π±Π΅Π±ΠΈΠΊ. β Π ΡΡΠΎΠΉ ΡΠΈΡΡΠ°ΡΠΈΠΈ Π½Π°ΠΏΡΡΠ³Π°ΡΡ Π΄Π²Π° ΠΌΠΎΠΌΠ΅Π½ΡΠ°: Π²ΠΎ-ΠΏΠ΅ΡΠ²ΡΡ , ΠΎΠ½Π° Π² Π΄Π΅ΡΠΈΡΠΈΡΠ΅ ΠΏΠΎ Π²ΡΠ΅ΠΌΡ ΠΌΠΈΡΡ, Π½ΠΎ ΡΠ΅ΠΏΠ΅ΡΡ ΠΊΠΎΠΌΠΏΠ°Π½ΠΈΠΈ ΠΏΡΠΎΠ΄Π°ΡΡ Π΅Π΅ ΠΏΠΎ Π±ΠΎΠ»Π΅Π΅ Π½ΠΈΠ·ΠΊΠΎΠΉ ΡΠ΅Π½Π΅. Π Π²ΠΎ-Π²ΡΠΎΡΡΡ , ΠΏΠ°Π»ΡΠΌΠ΅ΡΡΠΎ Π½Π΅ ΡΠ°ΡΡΠ΅Ρ Π² ΠΠΈΡΠ°Π΅. ΠΠ½Π° ΠΎΠ³ΡΠ°Π½ΠΈΡΠ΅Π½Π° ΡΠ³ΠΎ-Π²ΠΎΡΡΠΎΡΠ½ΡΠΌ ΡΠ΅Π³ΠΈΠΎΠ½ΠΎΠΌ Π‘Π¨Π. ΠΡΠΎ Π²ΡΠ΅ ΡΠ°Π²Π½ΠΎ ΡΡΠΎ Π²ΡΡΠ°ΡΠΈΠ²Π°ΡΡ ΠΊΠ°ΠΊΡΡΡΡ Π½Π° Π‘Π΅Π²Π΅ΡΠ½ΠΎΠΌ ΠΏΠΎΠ»ΡΡΠ΅Β». ΠΠ½ΡΠ΅ΡΠ²ΡΡ Ρ Ρ ΠΈΠΌΠΈΠΊΠΎΠΌ-Π°Π½Π°Π»ΠΈΡΠΈΠΊΠΎΠΌ ΠΠΆΠ΅ΠΉΠΌΡΠΎΠΌ ΠΠΈΠ»-ΠΠ°Π±Π΅Π±ΠΈΠΊΠΎΠΌ, ΡΠ½Π²Π°ΡΡ 2013 Π³ΠΎΠ΄Π°; Bogus Ingredients Put Consumersβ Health at Risk. NBCnews.com, June 14, 2007. http://www.nbcnews.com/id/19230748/#.Um_Gi3DBPD4.
505
Hurley, Natural Causes, p. 88β89.
506
Regulation of Dietary Supplements, p. 65 (Π²ΡΡΠΊΠ°Π·ΡΠ²Π°Π½ΠΈΡ ΠΡΠ²ΠΈΠ΄Π° ΠΠ΅ΡΡΠ»Π΅ΡΠ°).
507
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ΠΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΡ Π³ΠΈΠ½ΠΊΠ³ΠΎ Π±ΠΈΠ»ΠΎΠ±Π° ΠΏΠΎΠΊΠ°Π·Π°Π»ΠΈ, ΡΡΠΎ ΠΎΠ½ Β«Π½Π΅ΡΡΡΠ΅ΠΊΡΠΈΠ²Π΅Π½ Π΄Π»Ρ ΡΠ½ΠΈΠΆΠ΅Π½ΠΈΡ ΠΎΠ±ΡΠ΅ΠΉ Π·Π°Π±ΠΎΠ»Π΅Π²Π°Π΅ΠΌΠΎΡΡΠΈ Π΄Π΅ΠΌΠ΅Π½ΡΠΈΠ΅ΠΉ ΠΈ Π±ΠΎΠ»Π΅Π·Π½ΡΡ ΠΠ»ΡΡΠ³Π΅ΠΉΠΌΠ΅ΡΠ° Π² ΠΏΠΎΠΆΠΈΠ»ΠΎΠΌ Π²ΠΎΠ·ΡΠ°ΡΡΠ΅ ΠΈ Π΄Π»Ρ Π·Π°ΠΌΠ΅Π΄Π»Π΅Π½ΠΈΡ ΡΠ½ΠΈΠΆΠ΅Π½ΠΈΡ ΠΊΠΎΠ³Π½ΠΈΡΠΈΠ²Π½ΡΡ ΡΡΠ½ΠΊΡΠΈΠΉ, ΠΊΡΠΎΠ²ΡΠ½ΠΎΠ³ΠΎ Π΄Π°Π²Π»Π΅Π½ΠΈΡ ΠΈΠ»ΠΈ ΡΠΌΠ΅Π½ΡΡΠ΅Π½ΠΈΡ ΡΠ»ΡΡΠ°Π΅Π² Π³ΠΈΠΏΠ΅ΡΡΠΎΠ½ΠΈΠΈΒ». Π Π²ΠΎΡ ΡΡΠ΅Π΄ΠΈ Π΅Π³ΠΎ ΠΏΠΎΡΠ΅Π½ΡΠΈΠ°Π»ΡΠ½ΡΡ ΠΏΠΎΠ±ΠΎΡΠ½ΡΡ ΡΡΡΠ΅ΠΊΡΠΎΠ² β Π³ΠΎΠ»ΠΎΠ²Π½Π°Ρ Π±ΠΎΠ»Ρ, ΡΠΎΡΠ½ΠΎΡΠ°, ΡΠ°ΡΡΡΡΠΎΠΉΡΡΠ²ΠΎ ΠΆΠ΅Π»ΡΠ΄ΠΎΡΠ½ΠΎ-ΠΊΠΈΡΠ΅ΡΠ½ΠΎΠ³ΠΎ ΡΡΠ°ΠΊΡΠ°, Π΄ΠΈΠ°ΡΠ΅Ρ, Π³ΠΎΠ»ΠΎΠ²ΠΎΠΊΡΡΠΆΠ΅Π½ΠΈΠ΅, Π°Π»Π»Π΅ΡΠ³ΠΈΡΠ΅ΡΠΊΠΈΠ΅ ΡΠ΅Π°ΠΊΡΠΈΠΈ Π½Π° ΠΊΠΎΠΆΠ΅, Π°Π½ΠΎΠΌΠ°Π»ΡΠ½ΠΎΠ΅ ΠΊΡΠΎΠ²ΠΎΡΠ΅ΡΠ΅Π½ΠΈΠ΅ ΠΈ Π²Π·Π°ΠΈΠΌΠΎΠ΄Π΅ΠΉΡΡΠ²ΠΈΠ΅ Ρ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠ°ΠΌΠΈ-Π°Π½ΡΠΈΠΊΠΎΠ°Π³ΡΠ»ΡΠ½ΡΠ°ΠΌΠΈ. ΠΡΠΈΠ΅ΠΌ ΡΠΊΡΡΡΠ°ΠΊΡΠ° Π³ΠΈΠ½ΠΊΠ³ΠΎ Π² ΡΠ΅ΡΠ΅Π½ΠΈΠ΅ Π΄Π²ΡΡ Π»Π΅Ρ Π²ΡΠ·ΡΠ²Π°Π» ΠΎΠΏΡΡ ΠΎΠ»ΠΈ Ρ ΠΊΡΡΡ. http://nccam.nih.gov/health/ginkgo/ataglance.htm.
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Offit, Do You Believe in Magic? Π . 98.
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Blot, W. J., J. Y. Li, P. R. Taylor, W. Guo, S. Dawsey, G. Q. Wang, C. S. Yang, S. F. Zheng, M. Gail, J. Y. Li, et al. Nutrition Intervention Trials in Linxian, China: Supplementation with Specific Vitamin/Mineral Combinations, Cancer Incidence, and Disease β Specific Mortality in the General Population. Journal of the National Cancer Institute 85, no. 18 (September 15, 1993), p. 1483β1492. http://www.ncbi.nlm.nih.gov/pubmed/8360931.
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Π Π΅ΡΡ ΠΈΠ΄Π΅Ρ ΠΎΠ± ΠΎΡΠ½ΠΎΠ²Π½ΠΎΠΉ Π³ΡΡΠΏΠΏΠ΅ ΠΏΠ°ΡΠΈΠ΅Π½ΡΠΎΠ², ΠΏΡΠΈΠ½ΠΈΠΌΠ°Π²ΡΠΈΡ ΡΡΠ°ΡΡΠΈΠ΅ Π² ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΡΡ Π² ΠΠΈΠ½ΡΡΠ½Π΅ ΠΈ ΠΏΠΎΠ»ΡΡΠ°Π²ΡΠΈΡ 15 ΠΌΠ³ Π±Π΅ΡΠ°-ΠΊΠ°ΡΠΎΡΠΈΠ½Π°, 30 ΠΌΠ³ Π²ΠΈΡΠ°ΠΌΠΈΠ½Π° Π ΠΈ 50 ΠΌΠΊΠ³ ΡΠ΅Π»Π΅Π½Π° Π² Π΄Π΅Π½Ρ. Blot, W. J., J. Y. Li, P. R. Taylor, W. Guo, S. Dawsey, G. Q. Wang, C. S. Yang, S. F. Zheng, M. Gail, J. Y. Li, et al. Nutrition Intervention Trials in Linxian, China: Supplementation with Specific Vitamin/Mineral Combinations, Cancer Incidence, and Disease β Specific Mortality in the General Population. Journal of the National Cancer Institute 85, no. 18 (September 15, 1993), p. 1483β1492. http://www.ncbi.nlm.nih.gov/pubmed/8360931.