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Product Quality Verification of Dietary Supplements
Update, September 2018
J. Boullata, M. Nicolo, K. Stratton

The continuing activity you are about to view was originally released in September of 2012. The content has been reviewed by the faculty (2015, 2018) and remains contemporary. Below are updates the faculty felt are important complements to the activity. Please make yourself aware of these updates PRIOR to viewing the remaining content. Thank you.

 

Marketplace

  • Dietary supplements represent over $37 billion in annual U.S. sales with over 85,000 distinct products; this includes $2.6 billion spent on muscle-building and another $2 billion on weight-loss products (1,2,3)
  • Adults
    • 49-52% of adults in the U.S. use dietary supplements mostly to maintain or improve health based on national survey data with <25% under the recommendation of a health care provider (4,5)
    • 43% of adults use multivitamin/mineral supplements which is associated with a decrease in micronutrient inadequacies in the U.S.; this includes increased use of vitamin D supplements ≥1000 IU (6,7,8)
    • 20% of adults use botanical/herbal supplements and 16% use sports-related dietary supplement products (6)
    • Adults in low-to-middle- income households were more likely than high-income households to use dietary supplements products for weight loss; while those who are food secure with high incomes use more multivitamin/mineral supplements (3,5)
  • Older Adults
    • 70-82% of older adults in the U.S. use at least one dietary supplement, with 29% using 4 or more products; women are twice as likely as men to use dietary supplements and those using prescription drugs also more likely to use dietary supplements (5,9)
  • Pediatrics
    • 31% of children in the US use dietary supplements mostly to maintain or improve health based on national survey data with <16% under the recommendation of a health care provider (10)
    • Use among children and adolescents has begun to increase following the decline between 2006 and 2014; vitamins, omega-3 fatty acids, immune-enhancing, and body-building supplement products predominate (11)
  • Other
    • Military service personnel obtain dietary supplements at military treatment facilities upon a physician’s prescription (12)
    • Surveys of athletes, including elite athletes, indicate that ~50-100% use dietary supplements on a routine basis for a variety of reasons including the chance of gaining a competitive edge despite potential risks (13)

Regulations

  • There is an FDA guidance (2014) for industry on distinguishing liquid dietary supplement products from food beverages (14)
  • The FDA issued a draft guidance (2016) for industry on new dietary ingredients (NDIs) which requires pre-market notification to the agency (14)
  • Following deaths associated with pure caffeine included in dietary supplement products, the FDA released a guidance (2018) for manufacturers, marketers, and distributors of dietary supplements that contain pure or highly-concentrated caffeine (14)
  • Industry insiders and outsiders are beginning to discuss the need for new regulations (i.e., revision of DSHEA) to address issues of premarket approval, label claims, cGMPs, and adverse event reporting to better inform and protect consumers (1,2)
  • Given wide interest in compounds isolated from plants (e.g., lutein) found in dietary supplement products for health benefits, establishing recommended intake levels will necessitate toxicological review to determine safety limits (15)

Third-Party Verification

  • A survey of pharmacists in the U.S. revealed that the USP verification mark was the most commonly recognized and recommended third-party verification program
  • Of 753 dietary supplement products dispensed by military treatment facilities <3.6% had been reviewed and verified by a third-party program (70% by USP) (12)
  • NSF International started a “NSF Certified for Sport®” program to screen for substances banned by athletic organizations as well as other undeclared ingredients (16)
  • Consumer Labs relayed to subscribers dietary supplement product warnings (e.g., Salmonella contamination of numerous kratom dietary supplement products) and poor product quality reports (e.g., nearly one-third of turmeric/curcumin-containing products failed testing criteria) (17)

Safety Alerts

  • 1560 dietary supplement-related regulatory alerts were issued between Jan 2005 and Dec 2013, 82.5% coming from Health Canada and only 17.5% through the FDA, with the US being the most common source of the dietary supplement products (18)
  • The FDA continues to issue Warning Letters to manufacturers for adulterated, misbranded, or dietary supplement products otherwise out of compliance; for example, the FDA identified several dietary supplement products containing ingredients that do not meet the statutory definition of dietary ingredients or are clearly new dietary ingredients (e.g., Acacia rigidula, BMPEA, DMAA, DMBA, methylsynephrine, picamilon) (14)
  • The State of New York Office of the Attorney General issued (2015) cease and desist notifications to four major retailers charging that DNA testing showed certain dietary supplement products tested were “either unrecognizable or a substance other than what they claimed to be and therefore constituted contaminated or substituted products” in violation of the law (19)
  • Melamine, a nitrogen-containing substance associated with adverse effects, was found as a contaminant in 47% of 138 dietary supplement products tested (20)
  • A review of four dietary supplement ingredients with the potential for abuse and misuse (i.e., garcinia, guarana, salvia, St John’s wort) among adolescents revealed 84 cases of single substance exposure reported to poison centers with minimal toxicity in 74% of cases (21)

References

  1. Anonymous. Supplement business report, 2015. Nutrition Business Journal. Available from www.nutritionbusinessjournal.com.
  2. Wallace TC. Twenty years of the Dietary Supplement Health and Education Act: how should dietary supplements be regulated? J Nutr. 2015;145:1683-1686.
  3. Austin SB, Yu K, Liu SH, Dong F, Tefft N. Household expenditures on dietary supplements sold for weight loss, muscle building, and sexual function: disproportionate burden by gender and income. Prev Med Rep. 2017;6:236-241.
  4. Bailey RL, Gahche JJ, Miller PE, Thomas PR, Dwyer JT. Why US adults use dietary supplements. JAMA Intern Med. 2013;173:355-361.
  5. Cowan AE, Jun S, Gahche JJ, et al. Dietary supplement use differs by socioeconomic and health-related characteristics among U.S. adults, NHANES 2011-214. Nutrients. 2018;10:1114.
  6. Brown AC. An overview of herb and dietary supplement efficacy, safety and government regulations in the United States with suggested improvements. Part 1 of 5 series. Food Chem Toxicol. 2017;107:449-471.
  7. Blumberg JB, Frei BB, Fulgoni VL, Weaver CM, Zeisel SH. Impact of frequency of multi-vitamin/multi-mineral supplement intake on nutritional adequacy and nutrient deficiencies in U.S. adults. Nutrients. 2017;9:E849.
  8. Rooney MR, Harnack K, Michos ED, et al. Trends in use of high-dose vitamin D supplements exceeding 1000 or 4000 international units daily, 1999-2014. JAMA. 2017;317:2448-2450.
  9. Gahche JJ, Bailey RL, Potischman N, Dwyer JT. Dietary supplement use was very high among older adults in the United States in 2011-2014. J Nutr. 2017;147:1968-1976.
  10. Bailey RL, Gahche JJ, Thomas PR, Dwyer JT. Why US children use dietary supplements. Ped Res. 2013;74:737-741.
  11. Qato DM, Alexander GC, Guadamuz JS, Lindau ST. Prevalence of dietary supplement use in U.S. children and adolescents, 2003-2014. JAMA Pediatr. 2018;172:780-782.
  12. Jones DR, Kasper KB, Deuster PA. Third-party evaluation: a review of dietary supplements dispensed by military treatment facilities from 2007 to 2011. Milit Med. 2015;180:737-741.
  13. Garthe I, Maughan RJ. Athletes and supplements: prevalence and perspectives. Int J Sport Nutr Exer Metab. 2018;28:126-138.
  14. U.S. Food and Drug Administration. Dietary supplements. Available from: http://ww w.fda.gov/Food/DietarySupplements/default.htm.
  15. Yates AA, Erdman JW, Shao A, Dolan LC, Griffiths JC. Bioactive nutrients: time for tolerable upper intake levels to address safety. Reg Toxicol Pharmacol. 2017;84:94-101.
  16. NSF International. Dietary, nutritional and sports supplements certification. Available from: http://www.nsf.org/consumer-resources/what-is-nsfcertification/dietary-sports-supplements-certification.
  17. Consumer Lab.com, LLC. Available from: https://www.consumerlab.com/.
  18. Abe AM, Hein DJ, Gregory PJ. Regulatory alerts for dietary supplements in Canada and the United States, 2005-13. Am J Health-Syst Pharm. 2015;72:996-971.
  19. Schneiderman ET. Mislabeled consumer products pose unacceptable health hazards. Feb 2015. Available from: http://www.ag.ny.gov/press-release/agschneiderman-asks-major-retailers-halt-sales-certain-herbal-supplements-dna-tests.
  20. Gabriels G, Lambert M, Smith P, Wiesner L, Hiss D. Melamine contamination in nutritional supplements: is it an alarm bell for the general consumer, athletes, and ‘weekend warriors’? Nutr J. 2015;14:69 (7 pages).
  21. Biggs JM, Morgan JA, Lardieri AB, Kishk OA, Klein-Schwartz W. Abuse and misuse of selected dietary supplements among adolescents: a look at poison center data. J Pediatr Pharmacol Ther. 2017;22:385-393.

 

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