Author(s): C. Muralikrishna Goud, G. N. Pramodini, Raja Rajeshwari Kamisetti

Email(s): muralikrishna1789@gmail.com

DOI: 10.52711/2231-5659.2023.00038   

Address: C. Muralikrishna Goud*, G. N. Pramodini, Raja Rajeshwari Kamisetti
Shadan College of Pharmacy, Peerancheru, Himayatsagar Road, Hyderabad, Telangana, India, 500091.
*Corresponding Author

Published In:   Volume - 13,      Issue - 3,     Year - 2023


ABSTRACT:
The present work focuses on providing awareness to the users of dietary supplement containing hordenine an unapproved dietary ingredient causing severe side effects. Hordenine is a new dietary ingredient that hasn’t been submitted to FDA to establish its safety. Hordinine is an ingredient without GRAS status. The U.S. Food and Drug Administration (FDA) recently determined hordenine to be a “new dietary ingredient (NDI) for which an NDI notification is required and has not yet been submitted” and not an approved dietary ingredient under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Therefore, any product containing hordenine is considered “adulterated”. Rapid heart rates and high blood pressure are the side effects of hordenine that are more likely to occur in sensitive sub-populations of people such as pregnant women and consumers with cardiovascular disease. Usage of hordenine should be avoided during surgeries because of its side effects i.e rapid heart rates and high blood pressure. Dietary supplement products containing hordinine are not safe for weight loss and improving athletic performances and should be avoided for consuming.


Cite this article:
C. Muralikrishna Goud, G. N. Pramodini, Raja Rajeshwari Kamisetti. Hordenine - Unapproved Dietary Ingredient. Asian Journal of Research in Pharmaceutical Sciences. 2023; 13(3):218-0. doi: 10.52711/2231-5659.2023.00038

Cite(Electronic):
C. Muralikrishna Goud, G. N. Pramodini, Raja Rajeshwari Kamisetti. Hordenine - Unapproved Dietary Ingredient. Asian Journal of Research in Pharmaceutical Sciences. 2023; 13(3):218-0. doi: 10.52711/2231-5659.2023.00038   Available on: https://ajpsonline.com/AbstractView.aspx?PID=2023-13-3-6


REFERENCES:
1.    Dietary Supplement Ingredient Directory. https://www.fda.gov/food/dietary-supplements/dietary-supplement-ingredient-directory
2.    Dietary Supplements. https://www.fda.gov/food/dietary-supplements
3.    Generally Recognized as Safe (GRAS). https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras  
4.    Hordenine in dietary supplements: why avoid it? https://www.opss.org/article/hordenine-dietary-supplements-why-avoid-it
5.    DOD Prohibited Dietary Supplement Ingredients. https://www.opss.org/dod-prohibited-dietary-supplement-ingredients
6.    TruVision Health Recalls Dietary Supplement Products Because of Possible Health Risk. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/truvision-health-recalls-dietary-supplement-products-because-possible-health-risk?utm_medium=email&utm_source=govdelivery
7.    WARNING LETTER Advanced Nutritional Supplements LLC MARCS-CMS 622055 — MAY 04, 2022. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/advanced-nutritional-supplements-llc-622055-05042022
8.    WARNING LETTER Assault Labs MARCS-CMS 622050 — MAY 04, 2022. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/assault-labs-622050-05042022
9.    WARNING LETTER Ironmag Labs MARCS-CMS 622504 — MAY 04, 2022. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ironmag-labs-622504-05042022
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