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Dietary Supplements - Can Consumers Trust What’s on the Label and in the Package?

Posted: 2022-11-23
Dietary Supplements - Can Consumers Trust What’s on the Label and in the Package?

What’s happening?

Consumers purchase dietary supplements for a variety of reasons. Mitigating the risks of buying dietary supplements online is a priority in Australia (1), Canada (2) and the U.K. (3), coinciding with international efforts to disrupt the online sale of counterfeit and other illegal health products around the world (4). The PEN Team thought a deeper look into mislabelled dietary supplement products might be a topic of interest to practitioners whose clients are, or are considering, taking dietary supplements.  

What’s the issue?

The PEN Team reviewed recent studies and reports related to mislabelled dietary supplements sold to consumers:
  • A 2022 study explored the incidence of mislabelled supplements that target immune health (5). The study reported that out of 30 dietary supplement products with immune health claims bought from Amazon.com, 17 had incorrect labels, including 13 that had missing ingredients and nine that had extra components added that were not identified on the label. Additionally, some of the claims stated on the product labels did not fall under any of the classifications of claims defined by the U.S. Food and Drug Administration (FDA) regulations.
  • A 2021 study analyzed 17 brands of sports and weight loss supplements sold in the U.S. and detected nine prohibited stimulants within the products (6). Almost half of the brands tested included more than one prohibited stimulant.
  • In 2022, Health Canada recalled a medication containing calcium due to an error in the dosage (7). The ingredient amounts were higher than what was listed on the label.  
  • A 2019 global survey identified that 27% of DNA-tested herbal products (5,957 commercial herbal products) sold in 37 countries were adulterated based on the claimed label description (8). The adulteration included containing undeclared contaminant, substitute and filler species, or none of the labelled species.
  • Based on notifications within the European Union's Rapid Alert System for Food and Feed (RASFF) for poor quality control issues, incomplete, incorrect or absent labelling of foods, incorrect packaging and adulteration/fraud on packaged foods are increasing across the globe (9). 
 
Stricter regulation, quality control and monitoring is needed to ensure the quality and safety of dietary supplements (1,6-10). Consumers are being exposed to potential health and safety risks as products may not provide the stated health benefits or may cause adverse reactions ranging from mild to severe.

Where does regulation fit in? 

Dietary supplements, also known as natural health products (NHPs), complementary medicines or food supplements, are regulated differently in different countries (10). The use of different terminologies to describe dietary supplements as well as country-specific agencies setting and revising their standards and monitoring activities (including labelling, safety and marketing of products) poses regulatory challenges (10). Other challenges to enforcement include regulating supplements as a food versus a drug and a wide distribution of products through various stores and online (9,10).
 
Examples of country-specific agencies (not an exhaustive list):
AU
The Australian Government’s Department of Health and Aged Care - Therapeutic Goods Administration regulates complementary medicines. See: Overview of the Regulation of Listed Medicines and Registered Complementary Medicines.
 
Canada
Health Canada regulates natural health products (NHPs). See: About Natural Health Product Regulation in Canada.
 
NZ
New Zealand’s Ministry of Health regulates dietary supplements through Medsafe (New Zealand Medicines and Medical Devices Safety Authority). See: Medsafe - Regulation of Dietary Supplements.
 
UK
Information on the licensing and regulations of herbal medicines in the U.K. is available at the Medicines and Healthcare Products Regulatory Agency website. The Medicines and Healthcare products Regulatory Agency (MHRA) is an agency of the Department of Health in the UK.
 
USA
The Food and Drug Administration (FDA) regulates dietary supplements. See:  FDA - Dietary Supplements.

Now what?

Many consumers purchase dietary supplements that may include vitamins, minerals, herbs or other botanicals, amino acids, enzymes and other ingredients (11,12). To help clients reduce their health risks related to dietary supplements, dietetic practitioners can:
  • Assess if a supplement(s) is needed.
    • For individuals with health conditions that affect nutrient levels and during different life stages, dietary supplements may be needed. Some examples are:
      • folate to prevent neural tube defects before and during pregnancy (13)
      • iron for individuals with anemia (14)
      • following a medical procedure such as after stomach or intestinal surgery (15).
  • Determine if there may be potential interactions. Some supplements can interact with medications or affect medical conditions. For example, vitamin K supplements are not suggested in individuals taking the blood thinner Warfarin® due to interference with blood clotting (16).
  • Provide advice on how to take supplements safely, including (11,12,17):
    • Be cautious of what is in the news or on social media. Check in with a health professional before starting a new supplement to determine if it’s right for them.
    • Buy approved products from a reputable source (including online sources). Unlicensed or unregulated websites and some stores, particularly discount-type stores, may not be safe.
    • Look for authorization:
    • Read labels and follow the instructions and dose recommended, unless instructed otherwise. Taking too much might be harmful. 
    • Natural does not always mean safe. The links below provide more information on supplements that have been recalled or have an advisory.

Dietary Supplements Advisories, Alerts and Recalls

See Additional Content:

References

  1. Better Health Channel. Herbal medicine. 2021 Jul 27. Available from: https://www.betterhealth.vic.gov.au/health/conditionsandtreatments/herbal-medicine
  2. Health Canada. Risks of buying natural health products online. 2015 Jun 16. Available from: https://www.canada.ca/en/health-canada/services/natural-health-products/risks-buying-natural-health-products-online.html
  3. NHS. Herbal medicines. 2018 Nov 23. Available from: https://www.nhs.uk/conditions/herbal-medicines/
  4. Interpol. USD 11 million in illicit medicines seized in global INTERPOL operation. 2022 Jul. Available from: https://www.interpol.int/News-and-Events/News/2022/USD-11-million-in-illicit-medicines-seized-in-global-INTERPOL-operation 
  5. Crawford C, Avula B, Lindsey AT, Walter A, Katragunta K, Khan IA, et al. Analysis of select dietary supplement products marketed to support or boost the immune system. JAMA Netw Open. 2022;5(8):e2226040. Abstract available from: https://pubmed.ncbi.nlm.nih.gov/35947382/ 
  6. Aschwanden C. Prohibited, unlisted, even dangerous ingredients turn up in dietary supplements. The Washington Post. 2021 Jun 30. Available from: https://www.washingtonpost.com/health/contaminated-supplements-unexpected-ingredients/2021/06/25/5d2227ec-bd62-11eb-83e3-0ca705a96ba4_story.html 
  7. Health Canada. JAMP ATORVASTATIN CALCIUM: Affected lot may be labelled with the incorrect strength on the label. Recalls and Safety Alerts. 2022-08029. Available from: https://recalls-rappels.canada.ca/en/alert-recall/jamp-atorvastatin-calcium-affected-lot-may-be-labelled-incorrect-strength-label 
  8. Ichim MC. The DNA-based authentication of commercial herbal products reveals their globally widespread adulteration. Front Pharmacol. 2019;10:1227. Abstract available from: https://pubmed.ncbi.nlm.nih.gov/31708772/ 
  9. Pigłowski M. Food hazards on the European Union market: The data analysis of the Rapid Alert System for Food and Feed. Food Sci Nutr. 2020 Feb 11;8(3):1603-1627. doi: 10.1002/fsn3.1448. PMID: 32180969; PMCID: PMC7063371. Abstract available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7063371/ 
  10. Dwyer J, Coates PM, Smith MJ. Dietary supplements: regulatory challenges and research resources. Nutrients. 2018;10(1):41. Abstract available from: https://pubmed.ncbi.nlm.nih.gov/29300341/         
  11. National Institutes of Health. Dietary supplements: what you need to know. Consumer Fact Sheet. 2020 Sep 3. Available from:  https://ods.od.nih.gov/factsheets/WYNTK-Consumer/
  12. Health Canada. About Natural Health Products. 2016 Mar 14. Available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/regulation/about-products.html   
  13. Dietitians of Canada. What are the indications for the use of vitamin/mineral supplements during pregnancy? In Practice-based Evidence in Nutrition. 2021 Nov 30. Available from: https://www.pennutrition.com/KnowledgePathway.aspx?kpid=3043&pqcatid=146&pqid=724. Access only by subscription. Click Sign Up on PEN login page.
  14. Dietitians of Canada. How should iron-deficiency anemia in infants be managed? In Practice-based Evidence in Nutrition. 2018 Feb 26. Available from: https://www.pennutrition.com/KnowledgePathway.aspx?kpid=2764&pqcatid=146&pqid=2754. Access only by subscription. Click Sign Up on PEN login page.
  15. Dietitians of Canada. Which vitamin and mineral supplements should be prescribed to adults who have undergone bariatric surgery to prevent postoperative malnutrition, and do recommendations differ based on the type of surgery? In Practice-based Evidence in Nutrition. 2022 Aug 11. Available from: https://www.pennutrition.com/KnowledgePathway.aspx?kpid=15324&pqcatid=146&pqid=29374. Access only by subscription. Click Sign Up on PEN login page.
  16. Dietitians of Canada. What recommendations should be given to individuals who are prescribed warfarin regarding their vitamin K intake? In Practice-based Evidence in Nutrition. 2018 Sep 6. Available from: https://www.pennutrition.com/KnowledgePathway.aspx?kpid=11728&pqcatid=145&pqid=11785. Access only by subscription. Click Sign Up on PEN login page. 
  17. U.S. Food and Drug Administration. FDA 101: dietary supplements. Consumer Updates. 2022 Jun 2. Available from: https://www.fda.gov/consumers/consumer-updates/fda-101-dietary-supplements 
  18. Better Health Channel. Complementary therapies - safety and legal issues. Victoria State Government. 2014 Feb 14. Available from: https://www.betterhealth.vic.gov.au/health/conditionsandtreatments/complementary-therapies-safety-and-legal-issues#general-safety-suggestions-for-complementary-therapies 
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