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Commentary

Adulteration and Counterfeiting of Online Nutraceutical Formulations in the United States: Time for Intervention?

, BPharm, MPSc, PhD, , PharmD Candidate, , BPharm, MPSc & , PharmD Candidate

References

  • Amazon Inc. 2017. Amazon online retail store. Amazon Inc [accessed May 2017]. www.amazon.com.
  • Andlauer W, Fürst P. 2002. Nutraceuticals: a piece of history, present status and outlook. Food Res Int. 35:171–176.
  • Attaran A, Barry D, Basheer S, Bate R, Benton D, Chauvin J, et al. 2012. How to achieve international action on falsified and substandard medicines. BMJ. 345:e7381.
  • Baert B, De Spiegeleer B. 2010. Quality analytics of Internet pharmaceuticals. Analyt Bioanalyt Chem. 398:125–136.
  • Bailey DG, Arnold JM, Bend JR, Tran LT, Spence JD. 1995. Grapefruit juice-felodipine interaction: reproducibility and characterization with the extended release drug formulation. Br J Clin Pharmacol. 40:135–140.
  • Balian JD, Rahman A. 1997. Metabolic drug-drug interactions: perspective from FDA medical and clinical pharmacology reviewers. Adv Pharmacol. 43:231–238.
  • Barone GW, Gurley BJ, Ketel BL, Abul-Ezz SR. 2001. Herbal supplements: a potential for drug interactions in transplant recipients. Transplantation. 71:239–241.
  • Barone GW, Gurley BJ, Ketel BL, Lightfoot ML, Abul-Ezz SR. 2000. Drug interaction between St. John's wort and cyclosporine. Ann Pharmacother. 34:1013–1016.
  • Bass S. 2011. Dietary supplement regulation: a comprehensive guide. 1st ed. Washington, DC, USA: Food and Drug Law Institute (FDLI).
  • Bauer S, Stormer E, Johne A, Kruger H, Budde K, Neumayer HH, et al. 2003. Alterations in cyclosporin A pharmacokinetics and metabolism during treatment with St John's wort in renal transplant patients. Br J Clin Pharmacol. 55:203–211.
  • Breidenbach T, Hoffmann MW, Becker T, Schlitt H, Klempnauer J. 2000. Drug interaction of St John's wort with cyclosporin. Lancet. 355:1912.
  • Breidenbach T, Kliem V, Burg M, Radermacher J, Hoffmann MW, Klempnauer J. 2000. Profound drop of cyclosporin A whole blood trough levels caused by St. John's wort (Hypericum perforatum). Transplantation. 69:2229–2230.
  • Brower V. 1998. Nutraceuticals: poised for a healthy slice of the healthcare market? Nat Biotechnol. 16:728–731.
  • Buckley GJ, Gostin LO. 2013. The effects of falsified and substandard drugs. In: Buckley GJ, Gostin LO, editors. Countering the problem of falsified and substandard drugs. Washington (DC): The National Academies Press.
  • Cockburn R, Newton PN, Agyarko EK, Akunyili D, White NJ. 2005. The global threat of counterfeit drugs: why industry and governments must communicate the dangers. PLoS Medicine. 2:e100.
  • Crawford SY. 2003. Internet pharmacy: issues of access, quality, costs, and regulation. J Med Syst. 27:57–65.
  • Curry M, Hazard-Daniel A, Daniel HJ. 1999. Nutraceuticals. Science. 286:1854–1855.
  • CVS.com. 2017. Online Pharmacy Digital-Rx [accessed May 2017]. https://www.cvs.com/content/pharmacy-account.
  • DeFelice SL. 1995. The nutraceutical revolution, its impact on food industry research and development. Trends Food Sci Technol. 6:59–61.
  • DeFelice SL. 2002. FIM rationale and proposed guidelines for the Nutraceutical Research & Education Act – NREA. FIM's 10th Nutraceutical Conference, November 10–11, 2002, The Waldorf-Astoria, New York City.
  • Dickinson A. 2011. History and overview of DSHEA. Fitoterapia. 82:5–10.
  • Dresser GK, Bailey DG, Leake BF, et al. 2002. Fruit juices inhibit organic anion transporting polypeptide-mediated drug uptake to decrease the oral availability of fexofenadine. Clin Pharmacol Ther. 71:11–20.
  • Droney D. 2016. Networking health: multi-level marketing of health products in Ghana. Anthropol Med. 23:1–13.
  • Dzanis DA. 1998. Regulatory aspects of diets, supplements, and nutraceuticals. Clin Tech Small Anim Pract. 13:193–196.
  • eBay Inc. 2017. eBay onlnie retail store [accesseed May 2017]. www.ebay.com
  • Edgar B, Bailey D, Bergstrand R, Johnsson G, Regardh CG. 1992. Acute effects of drinking grapefruit juice on the pharmacokinetics and dynamics of felodipine—and its potential clinical relevance. Eur J Clin Pharmacol. 42:313–317.
  • Edwards DJ, Fitzsimmons ME, Schuetz EG, Yasuda K, Ducharme MP, Warbasse LH, et al. 1999. 6',7'-Dihydroxybergamottin in grapefruit juice and Seville orange juice: effects on cyclosporine disposition, enterocyte CYP3A4, and P-glycoprotein. Clin Pharmacol Ther. 65:237–244.
  • Ekor M. 2014. The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety. Frontiers Pharmacol. 4:177.
  • ElAgouri G, ElAmrawy F, ElYazbi A, Eshra A, Nounou MI. 2015. Male enhancement nutraceuticals in the Middle East market: claim, pharmaceutical quality and safety assessments. Int J Pharm. 492:109–119.
  • ElAmrawy F, ElAgouri G, Elnoweam O, Aboelazayem S, Farouk E, Nounou MI. 2016. Adulterated and counterfeit male enhancement nutraceuticals and dietary supplements pose a real threat to the management of erectile dysfunction: a global perspective. J Diet Suppl. 13:660–693.
  • [FDA] US Food and Drug Administration. 2012 April 20. Public notification: “Instant Hard Rod” contains undeclared drug ingredient. Silver Springs (MD): US Food and Drug Administration [accessed 2017 Sept 1]. https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm301190.htm.
  • [FDA] US Food and Drug Administration. 2013a July 15. Enhance Nutraceutical. Silver Springs (MD): US Food and Drug Administration [accessed May 2017]. https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm529601.htm.
  • [FDA] US Food and Drug Administration. 2013b Nov 12. FDA warns consumers about counterfeit ExtenZe dietary supplements. Silver Springs (MD): US Food and Drug Administration [accessed 2017 Sept 1]. https://www.fda.gov/drugs/drugsafety/ucm374507.htm.
  • [FDA] US Food and Drug Adminstraton. 2013c June 11. Recall: Bethel Nutritional Consulting, Inc. issues a voluntary recall of weight loss pills “Bethel 30” found to contain an undeclared drug ingredient. Silver Springs (MD): US Food and Drug Administration [accessed 2017 Sept 1]. http://wayback.archive-it.org/7993/20170112142306/http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2013/ucm356233.htm.
  • [FDA] US Food and Drug Administration. 2016a Aug 12. Counterfeit medicine. Silver Springs (MD): US Food and Drug Administration [accessed 2017 Sept 1]. https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/counterfeitmedicine/.
  • [FDA] US Food and Drug Administration. 2016b April 11. Label claims for conventional foods and dietary supplements. Silver Springs (MD): US Food and Drug Administration [accessed 2017 Sept 1]. https://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm111447.htm.
  • [FDA/CFSAN] US Food and Drug Administration, Center for Food Safety and Applied Nutrition. 1994. Dietary Supplement Health and Education Act of 1994, Public Law 103–417, 103rd Congress. Bethesda, MD. [accessed May 2017, Approved 1994 October 25]. https://ods.od.nih.gov/About/DSHEA_Wording.aspx.
  • Fighting fake drugs: the role of WHO and pharma. 2011. Lancet. 377:1626.
  • Fittler A, Bosze G, Botz L. 2013. Evaluating aspects of online medication safety in long-term follow-up of 136 Internet pharmacies: illegal rogue online pharmacies flourish and are long-lived. J Med Internet Res. 15:e199.
  • Fung CH, Woo HE, Asch SM. 2004. Controversies and legal issues of prescribing and dispensing medications using the Internet. Mayo Clinic Proc. 79:188–194.
  • Gallagher JC, Colaizzi JL. 2000. Issues in Internet pharmacy practice. Annals Pharmacother. 34:1483–1485.
  • Ghodse H. 2010. Watching Internet pharmacies. Br J Psychiatry. 196:169–170.
  • Gulati OP, Berry Ottaway P. 2006. Legislation relating to nutraceuticals in the European Union with a particular focus on botanical-sourced products. Toxicology. 221:75–87.
  • Haller C, Kearney T, Bent S, Ko R, Benowitz N, Olson K. 2008. Dietary supplement adverse events: report of a one-year poison center surveillance project. J Med Toxicol. 4:84–92.
  • Hardy G, Hardy I, Ball PA. 2003. Nutraceuticals—a pharmaceutical viewpoint: part II. Curr Opin Clin Nutr Metab Care. 6:661–671.
  • Hardy G, Hardy I, McElroy B. 2002. Nutraceuticals: a pharmaceutical viewpoint: I. Curr Opin Clin Nutr Metab Care. 5:671–677.
  • Harris RZ, Jang GR, Tsunoda S. 2003. Dietary effects on drug metabolism and transport. Clinical Pharmacokinet. 42:1071–1088.
  • Health Canada. 2012. Recalls and safety alerts: Instant Hard Rod, RigiRx Plus, ZenMaxx. Ottawa, Ontario (Canada). [accessed May 2017]. Available from: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hcsc/2012/15022aeng.php.
  • Henderson TR. 1995. Comments about vitamins, nutraceuticals, and dietary enzymes. J Am Vet Med Assoc. 207:31.
  • Hendset M, Lunder N, Refsum H, Island TK. 2005. [Dietary supplements—surprise pills?]. Tidsskr Nor Laegeforen. 125:750–751.
  • Henkel J. 2000. It's convenient and private, but beware of “rogue sites.” FDA Consumer. 34:24–29.
  • Heyland DK. 2001. In search of the magic nutraceutical: problems with current approaches. J Nutr. 131:2591S–2595S.
  • Ho YF, Huang DK, Hsueh WC, Lai MY, Yu HY, Tsai TH. 2009. Effects of St. John's wort extract on indinavir pharmacokinetics in rats: differentiation of intestinal and hepatic impacts. Life Sci. 85:296–302.
  • Hodgson J. 2002. Nutraceuticals tread business tightrope in Europe. Nat Biotechnol. 20:322–323.
  • Izzo AA, Ernst E. 2001. Interactions between herbal medicines and prescribed drugs: a systematic review. Drugs. 61:2163–2175.
  • Izzo AA, Ernst E. 2009. Interactions between herbal medicines and prescribed drugs: an updated systematic review. Drugs. 69:1777–1798.
  • Johne A, Brockmoller J, Bauer S, Maurer A, Langheinrich M, Roots I. 1999. Pharmacokinetic interaction of digoxin with an herbal extract from St John's wort (Hypericum perforatum). Clin Pharmacol Ther. 66:338–345.
  • Johnson WA, Landry GL. 1998. Nutritional supplements: fact vs. fiction. Adolesc Med. 9:501–513, vi.
  • Kalra EK. 2003. Nutraceutical—definition and introduction. AAPS PharmSci. 5:E25.
  • Karliova M, Treichel U, Malago M, Frilling A, Gerken G, Broelsch CE. 2000. Interaction of Hypericum perforatum (St. John's wort) with cyclosporin A metabolism in a patient after liver transplantation. J Hepatol. 33:853–855.
  • Kennedy DA, Seely D. 2010. Clinically based evidence of drug-herb interactions: a systematic review. Expert Opin Drug Saf. 9:79–124.
  • Kligman AM. 1993. Why cosmeceuticals? Cosmet Toilet. 108:37–38.
  • Kligman D. 2000. Cosmeceuticals. Dermatol Clin. 18:609–615.
  • Ku YM, Min DI, Flanigan M. 1998. Effect of grapefruit juice on the pharmacokinetics of microemulsion cyclosporine and its metabolite in healthy volunteers: does the formulation difference matter? J Clin Pharmacol. 38:959–965.
  • Leucuta SE, Vlase L. 2006. Pharmacokinetics and metabolic drug interactions. Curr Clin Pharmacol. 1:5–20.
  • Levy RH. 2000. Metabolic drug interactions. Philadelphia, PA: Lippincott Williams & Wilkins.
  • Liang BA, Mackey T. 2009. Searching for safety: addressing search engine, website, and provider accountability for illicit online drug sales. Am J Law Med. 35:12–184.
  • LTS Nutraceuticals Inc. 2012. LTS Nutraceuticals, Inc. reinvents the network marketing model with its inline marketing (TM) program. Fort Lauderdale, FL. [accessed May 2017]. Available from: http://www.businesswire.com/news/home/20120117005478/en/LTS-Nutraceuticals-Reinvents-Network-Marketing-Model-Inline.
  • Mackey TK, Nayyar G. 2016. Digital danger: a review of the global public health, patient safety and cybersecurity threats posed by illicit online pharmacies. Br Med Bull. 118:110–126.
  • Malhotra S, Bailey DG, Paine MF, Watkins PB. 2001. Seville orange juice-felodipine interaction: comparison with dilute grapefruit juice and involvement of furocoumarins. Clin Pharmacol Ther. 69:14–23.
  • Mandelker L. 2004. Nutraceuticals and other biologic therapies. Preface. Vet Clin North Am Small Anim Pract. 34:xi–xii.
  • Martin A. 2000. [Nutraceuticals: marketing concept of new science]. Rev Prat. 50:817–818.
  • Miller JL. 2005. Interaction between indinavir and St. John's wort reported. Am J Health Syst Pharm. 57:625–626.
  • Millikan LE. 2001. Cosmetology, cosmetics, cosmeceuticals: definitions and regulations. Clin Dermatol. 19:371–374.
  • Min DI, Ku YM, Perry PJ, Ukah FO, Ashton K, Martin MF, et al. 1996. Effect of grapefruit juice on cyclosporine pharmacokinetics in renal transplant patients. Transplantation. 62:123–125.
  • Nekvindova J, Anzenbacher P. 2007.cInteractions of food and dietary supplements with drug metabolising cytochrome P450 enzymes. Ceska a Slovenska farmacie: casopis Ceske farmaceuticke spolecnosti a Slovenske farmaceuticke spolecnosti. 56:165–173.
  • Nicoletti M. 2012. Nutraceuticals and botanicals: overview and perspectives. Int J Food Sci Nutr. 63(Suppl 1):2–6.
  • Nutraceuticals, the milky way. 1998. Nat Biotechnol. 16:8.
  • Orizio G, Merla A, Schulz PJ, Gelatti U. 2011. Quality of online pharmacies and websites selling prescription drugs: a systematic review. J Med Internet Res. 13:e74.
  • Peterson AM. 2001. A survey of selected Internet pharmacies in the United States. J Am Pharm Assoc. 41:205–212.
  • Petroczi A, Taylor G, Naughton DP. 2011. Mission impossible? Regulatory and enforcement issues to ensure safety of dietary supplements. Food Chem Toxicol. 49:393–402.
  • Piscitelli SC, Burstein AH, Chaitt D, Alfaro RM, Falloon J. 2000. Indinavir concentrations and St John's wort. Lancet. 355:547–548.
  • Proppe DG, Hoch OD, McLean AJ, Visser KE. 1995. Influence of chronic ingestion of grapefruit juice on steady-state blood concentrations of cyclosporine A in renal transplant patients with stable graft function. Br J Clin Pharmacol. 39:337–338.
  • Rapaka RS. 2006. Nutraceuticals, herbals and related products. Life Sci. 78:2025.
  • Schrag ML, Wienkers LC. 2001. Covalent alteration of the CYP3A4 active site: evidence for multiple substrate binding domains. Arch Biochem Biophys. 391:49–55.
  • Shou M, Lin Y, Lu P, Tang C, Mei Q, Cui D, et al. 2001. Enzyme kinetics of cytochrome P450-mediated reactions. Curr Drug Metab. 2:17–36.
  • Stratio Inc. 2017. Broadband, handheld and affordable spectrometer (Linksquare) for fast and reliable drug identification. San Jose (CA): Stratio, Inc.
  • Tang W, Stearns RA. 2001. Heterotropic cooperativity of cytochrome P450 3A4 and potential drug-drug interactions. Curr Drug Metab. 2:185–198.
  • Toxicity. St. John's wort—interactions with indinavir and other drugs. 2000. TreatmentUpdate. 12:9–11.
  • Trefis Team. 2015 Oct 9. A comparative look at the valuation of Amazon, Alibaba and eBay. Forbes.
  • Tribby MD. 1995. Vitamins, nutraceuticals, and dietary enzymes. J Am Vet Med Assoc. 206:1113–1114.
  • van Breemen RB, Fong HH, Farnsworth NR. 2007. The role of quality assurance and standardization in the safety of botanical dietary supplements. Chem Res Toxicol. 20:577–582.
  • Vermeer BJ, Gilchrest BA. 1996. Cosmeceuticals. A proposal for rational definition, evaluation, and regulation. Arch Dermatol. 132:337–340.
  • Walgreens Inc. 2017. Walgreens Online Pharmacy and Drugstore. Walgreens [accessed May 2017]. https://www.walgreens.com/pharmacy/.
  • [WHO] World Health Organization. 2011. Safety and security on the Internet: challenges and advances in member states. Geneva (Switzerland): World Health Organization [accessed 2017 Sept 1]. http://www.who.int/goe/publications/goe_security_web.pdf.
  • [WHO] World Health Organization. 2016. Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products. World Health Organization [accessed 2017 Sept 1]. http://www.who.int/mediacentre/factsheets/fs275/en/.
  • Zeisel SH. 1999. Regulation of “Nutraceuticals.” Science. 1999;285:185–186, 1853–1855.

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