Comparison between the American and the European Systems of Monitoring Adverse Effects of Dietary Supplements and Their Usefulness on the Polish Market
Abstract
:1. Introduction
- (1)
- to determine the needs for creating, in the future, a national register of adverse effects caused by dietary supplements by determining the degree of the presence of borderline-type supplements on the Polish market, including their potential for causing adverse effects;
- (2)
- to prepare a general concept of a register of adverse effects for Poland, considering the various conclusions drawn from European and American experiences in the area of the functioning of such registers.
2. Materials and Methods
2.1. The French Register
2.2. Recognising Selected Ingredients as Borderline
2.3. Borderline Products in the American Register
2.4. Assessment of Dietary Supplements Containing Borderline Ingredients
2.5. Data Comparison
3. Results
4. Discussion
Limitations
5. Conclusions
- Considering the system of notification of dietary supplements newly placed on the market in force in Poland and its current flaws and imperfections, it is reasonable to undertake work on creating a register of adverse effects caused by dietary supplements.
- The studied ingredients are commonly present in dietary supplements placed on the Polish market and may be simultaneously available as OTC medicines or plant-based medicines. The number of notifications recorded in Poland’s national register indicates a real risk of producing the adverse effects identified in the CAERS register.
- Non-professional entities generate more general-type notifications, whose scientific and substantive value is lower, but which may nonetheless identify certain trends and needs for further, more in-depth studies.
- Owing to the multidrug approach of patients who also consume dietary supplements, as well as the role that dietary supplements play in causing adverse effects, the concept of a national register should include the possibility to report other concurrently used medicinal preparations and functional food products.
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Date of Issue | Title of Document | Ingredients or Other Factors That Constitute a Probable Cause of the Adverse Effect |
---|---|---|
14 December 2007 | Opinion of the French Food Safety Agency on the use of botanical food supplements which have been the subject of drug safety monitoring reports | Hoodia Gordoni Cimcifuga racemosa + Desmodium Viola tricolor Viola arvensis Echinacea angustifolia + Echincea pallida + Echinacea purpurea + Polygonum multiflorum |
7 June 2010 | Opinion of the French Food Safety Agency on the safety of use of a plant (Galega officinalis) in food supplements | Galega officinalis |
22 November 2010 | Opinion of the French Agency for Food, Environmental and Occupational Health and Safety regarding the safety of yam (Dioscorea) alcohol extracts in food supplements | Dioscorea |
25 February 2011 | Opinion of the French Agency for Food, Environmental and Occupational Health and Safety regarding the risk of drug eruption following the consumption of lutein and zeaxanthin in food supplements | Lutein Zeaxanthin |
7 August 2012 | ANSES OPINION regarding the safety of consumption of powdered green tea in food supplements | Green tea + |
14 February 2014 | OPINION of the French Agency for Food, Environmental and Occupational Health and Safety on the risks associated with the presence of “red yeast rice” in food supplements | Red yeast rice |
14 March 2014 | OPINION of the French Agency for Food, Environmental and Occupational Health and Safety on the risks associated with the presence in food supplements of p-synephrine or ingredients obtained from Citrus spp. fruits containing this substance | p-synephrine |
31 October 2014 | ANSES OPINION on allergy to a food supplement containing spirulina | Spirulina |
27 March 2015 | ANSES OPINION on a case of hepatitis following the consumption of a food supplement for joint conditions | Glucosamine + Chondroitin + |
n/a | ANSES OPINION AND REPORT on the risks associated with the consumption of food supplements for sportsmen whose purpose is muscle building or adipose tissue reduction | n/a |
19 April 2017 | ANSES OPINION regarding photo-induced drug eruption following the consumption of a Bio-butter food supplement | Butyric acid |
4 August 2017 | ANSES OPINION on the risks associated with the consumption of food supplements containing spirulina | Spirulina |
23 February 2018 | ANSES OPINION on the risks associated with the consumption of food supplements containing melatonin | Melatonin + |
23 May 2018 | ANSES OPINION on allergy to the food supplement Nutrilin® | Linseed extract |
23 May 2018 | ANSES OPINION on three cases of allergy to food supplements containing pollen or hive products | Hive |
16 January 2019 | ANSES OPINION on a case of severe hypokalaemia following misuse of the food supplement Rhubarbe® containing liquorice | Liquorice + Rhubarb |
1 August 2019 | ANSES OPINION on the “safety of use of berberine-containing plants in the composition of food supplements” | Berberine |
16 October 2019 | ANSES OPINION on a case of severe hypokalaemia following misuse of an oral food supplement | Consumer’s error |
24 December 2019 | ANSES OPINION regarding anaphylaxis associated with consumption of a food supplement containing passiflora | Passiflora |
1 April 2020 | ANSES OPINION on a case of fatal fulminant hepatitis associated with consumption of the food supplement Slim Metabol® | Garcinia cambogia |
19 June 2020 | ANSES OPINION on two cases of severe acute life-threatening hepatitis associated with consumption of the food supplement Chewable Hair Vitamins® | Ingredient not determined |
26 January 2021 | ANSES OPINION regarding oesophageal perforation associated with the consumption of the food supplement Préservion 3 capsules | Large capsule |
28 July 2021 | ANSES OPINION regarding vitamin D poisoning in infants following misuse of food supplements | Vitamin D |
4 October 2021 | ANSES OPINION regarding epileptic seizures associated with consumption of the food supplement Novanuit® Triple Action | Melatonin + |
US | UE | PL | |
---|---|---|---|
KEY WORD | Melatonin | Melatonin | Melatonin * |
NUMBER OF REGISTERED DS | 1696 | 786 | |
NUMBER OF CASES | 463 | 2658 | |
AGE GROUP | |||
Not Specified | 13.6% | 22.2% | |
0–1 Month | 0.3% | ||
2 Months–2 Years | 0.4% | 0.6% | |
3–11 Years | 4.1% | 10.5% | |
12–17 Years | 2.4% | 9.2% | |
18–64 Years | 51.2% | 37.7% | |
65–85 Years | 25.9% | 16.3% | |
More than 85 Years | 2.4% | 3.2% | |
SEX | |||
Female | 67.6% | 57.8% | |
Male | 28.5% | 38.3% | |
Not Specified | 3.9% | 3.8% | |
REPORTER GROUP | |||
Healthcare Professional | 65.2% | ||
Non-Healthcare Professional | 34.7% | ||
Not Specified | 100% | 0.1% |
Key Word | US Liquorice | UE Glycyrrhiza Glabra L. Radix | PL Lukrecj * |
---|---|---|---|
NUMBER OF REGISTERED DS | 3091 | 1191 | |
NUMBER OF CASES | 27 | 234 | |
AGE GROUP | |||
Not Specified | 22.2% | 2.1% | |
0–1 Month | |||
2 Months–2 Years | 0.9% | ||
3–11 Years | 3.7% | 1.7% | |
12–17 Years | 1.3% | ||
18–64 Years | 44.4% | 55.1% | |
65–85 Years | 29.6% | 32.9% | |
More than 85 Years | 6.0% | ||
SEX | |||
Female | 70.4% | 56.4% | |
Male | 25.9% | 42.7% | |
Not Specified | 3.7% | 0.9% | |
REPORTER GROUP | |||
Healthcare Professional | 93.6% | ||
Non-Healthcare Professional | 5.6% | ||
Not Specified | 100% | 0.9% |
US | UE | PL | |
---|---|---|---|
Key Word | Green Tea | Camellia Sinensis * | Zielon * + Herbat * |
NUMBER OF REGISTERED DS | 6259 | 3595 | |
NUMBER OF CASES | 223 | 171 | |
AGE GROUP | |||
Not Specified | 24.7% | 21.6% | |
0–1 Month | |||
2 Months–2 Years | 1.9% | ||
3–11 Years | |||
12–17 Years | 0.9% | 0.6% | |
18–64 Years | 55.6% | 70.2% | |
65–85 Years | 18.4% | 7.6% | |
More than 85 Years | 0.4% | ||
SEX | |||
Female | 65.9% | 60.8% | |
Male | 31.8% | 35.7% | |
Not Specified | 2.2% | 3.5% | |
REPORTER GROUP | |||
Healthcare Professional | 69.6% | ||
Non-Healthcare Professional | 29.8% | ||
Not Specified | 100% | 0.6% |
US | UE | PL | |
---|---|---|---|
Key Word | Glucosamine * | Glucosamine * | Glukozamin * |
NUMBER OF REGISTERED DS | 3221 | 1408 | |
NUMBER OF CASES | 673 | 1543 | |
AGE GROUP | |||
Not Specified | 14.7% | 16.3% | |
0–1 Month | 0.1% | ||
2 Months–2 Years | 0.4% | ||
3–11 Years | 0.6% | ||
12–17 Years | 0.6% | ||
18–64 Years | 33.9% | 33.1% | |
65–85 Years | 44.9% | 45.4% | |
More than 85 Years | 6.5% | 3.5% | |
SEX | |||
Female | 64.2% | 70.8% | |
Male | 34.2% | 26.9% | |
Not Specified | 1.6% | 2.3% | |
REPORTER GROUP | |||
Healthcare Professional | 72.10% | ||
Non-Healthcare Professional | 27.50% | ||
Not Specified | 100% | 0.40% |
US | UE | PL | |
---|---|---|---|
Key Word | Echinacea * | Echinacea * | Jeżówk * |
NUMBER OF REGISTERED DS | 2901 | 498 | |
NUMBER OF CASES | 82 | 347 | |
AGE GROUP | |||
Not Specified | 15.9% | 15.9% | |
0–1 Month | 0.3% | ||
2 Months–2 Years | 1.2% | 3.7% | |
3–11 Years | 3.7% | 4.9% | |
12–17 Years | 2.0% | ||
18–64 Years | 43.9% | 57.6% | |
65–85 Years | 32.9% | 14.7% | |
More than 85 Years | 2.4% | 0.9% | |
SEX | |||
Female | 65.9% | 70.0% | |
Male | 34.1% | 27.4% | |
Not Specified | 2.6% | ||
REPORTER GROUP | |||
Healthcare Professional | 68.6% | ||
Non-Healthcare Professional | 29.1% | ||
Not Specified | 100% | 2.3% |
US | UE | PL | |
---|---|---|---|
Key Word | Chondroitin | Chondroitin * | Chondroityn * |
NUMBER OF REGISTERED DS | 1713 | 1120 | |
NUMBER OF CASES | 362 | 758 | |
AGE GROUP | |||
Not Specified | 14.4% | 20.1% | |
0–1 Month | |||
2 Months–2 Years | 0.4% | ||
3–11 Years | 0.4% | ||
12–17 Years | 0.7% | ||
18–64 Years | 32.0% | 35.4% | |
65–85 Years | 46.1% | 39.1% | |
More than 85 Years | 7.5% | 4.1% | |
SEX | |||
Female | 68.8% | 66.6% | |
Male | 37.6% | 27.6% | |
Not Specified | 1.7% | 5.8% | |
REPORTER GROUP | |||
Healthcare Professional | 62.3% | ||
Non-Healthcare Professional | 36.8% | ||
Not Specified | 100% | 0.9% |
US | UE | PL | |
---|---|---|---|
Key Word | Black Cohosh | Cimicifuga * | Pluskwic * |
NUMBER OF REGISTERED DS | 947 | 96 | |
NUMBER OF CASES | 85 | 558 | |
AGE GROUP | |||
Not Specified | 20.0% | 13.6% | |
0–1 Month | 0.2% | ||
2 Months–2 Years | |||
3–11 Years | |||
12–17 Years | 0.4% | ||
18–64 Years | 67.1% | 79.4% | |
65–85 Years | 12.9% | 6.3% | |
More than 85 Years | 0.2% | ||
SEX | |||
Female | 95.3% | 96.8% | |
Male | 1.8% | ||
Not Specified | 4.7% | 1.4% | |
REPORTER GROUP | |||
Healthcare Professional | 66.7% | ||
Non-Healthcare Professional | 32.4% | ||
Not Specified | 100% | 0.9% |
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Wróbel, K.; Zastawna, B.; Milewska, A.J.; Marczak, M.; Kozłowski, R. Comparison between the American and the European Systems of Monitoring Adverse Effects of Dietary Supplements and Their Usefulness on the Polish Market. Int. J. Environ. Res. Public Health 2023, 20, 902. https://doi.org/10.3390/ijerph20020902
Wróbel K, Zastawna B, Milewska AJ, Marczak M, Kozłowski R. Comparison between the American and the European Systems of Monitoring Adverse Effects of Dietary Supplements and Their Usefulness on the Polish Market. International Journal of Environmental Research and Public Health. 2023; 20(2):902. https://doi.org/10.3390/ijerph20020902
Chicago/Turabian StyleWróbel, Kacper, Beata Zastawna, Anna Justyna Milewska, Michał Marczak, and Remigiusz Kozłowski. 2023. "Comparison between the American and the European Systems of Monitoring Adverse Effects of Dietary Supplements and Their Usefulness on the Polish Market" International Journal of Environmental Research and Public Health 20, no. 2: 902. https://doi.org/10.3390/ijerph20020902