Hordenine - Unapproved Dietary Ingredient

 

C. Muralikrishna Goud*, G. N. Pramodini, Raja Rajeshwari Kamisetti

Shadan College of Pharmacy, Peerancheru, Himayatsagar Road, Hyderabad, Telangana, India, 500091.

 

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.

 

 

INTRODUCTION:

Dietary supplements include such ingredients as vitamins, minerals, herbs, amino acids, and enzymes, and are typically marketed in forms such as tablets, capsules, softgels, gelcaps, powders, and liquids. Two types of ingredients may be used in dietary supplements – “dietary ingredients” and “other ingredients.”

 

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any dietary ingredient from the preceding categories.

 

Dietary supplements may also include other ingredients, such as fillers, binders, excipients, preservatives, sweeteners, and flavorings. These “other ingredients” are listed separately from dietary ingredients on the Supplement Facts label.

 

DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994 (DSHEA)²::

FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):

·       Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of the Federal Food, Drug, and Cosmetic Act as amended by DSHEA and FDA regulations.

·       FDA has the authority to take action against any adulterated or misbranded dietary supplement product after it reaches the market.

·       If there is no evidence of a dietary ingredient being marketed before October 1994, then a “new dietary ingredient” (NDI) notification must be filed to FDA.

·       A dietary ingredient (i.e. vitamins, minerals, herbs, botanicals, amino acids, enzymes) may only be used in dietary supplements unless the ingredient also has GRAS status.

·       "GRAS" is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive³.

 

HORDENINE⁴:

Hordenine is a naturally occurring substance found in several plants, including barley (from which its name originates: Hordeum vulgare), seaweeds, Aconitum tanguticum (Maxim.) Stapf, Senecio scandens, Coryphantha ramillosa, and Citrus aurantium (bitter orange). Hordenine also can be made in a laboratory (that is, as a synthetic chemical). Both natural and synthetic hordenine might promote stimulant effects.

 

Products containing hordenine are considered “adulterated,” and the safety of hordenine is unknown. Hordenine is on the DoD Prohibited Dietary Supplement Ingredients list.

 

The U.S. Food & 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.” Therefore, any product containing hordenine is considered “adulterated.”

 

OTHER NAMES OF HORDININE⁵:

One should be aware of other names of hordenine used so can avoid adulterated hordenine products. Some names that might appear on a product label instead of “hordenine” include:

·       Hordenine hcl

·       Hordenine hydrochloride

·       Hordenine sulfate

·       Anhaline

·       Eremursine

·       N,N-dimethyltyramine

·       Peyocactine

·       Peyocactin

·       Peyocatine

·       P-hydroxy-N,N-dimethylphenethylamine

·       P-hydroxy-N,N-dimethyphenethylamine

·       4-[2-(dimethylamino)ethyl]phenol

·       2-(4-hydroxyphenyl)N,Ndimethyl-ethylamine

·       Cactine

·       Ordenina

·       Ordenine

·       N,N-dimethyl-4-hydroxy-beta-phenethylamine.

·       L-hordenine

 

Hordenine is on the DoD Prohibited Dietary Supplement Ingredients list and the National Collegiate Athletic Association’s (NCAA) list of banned substances. In addition, hordenine might register on an initial urine screening test for amphetamines or opioids, but it will not cause a positive result on a confirmation drug test.

 

SIDE EFFECTS OF HORDININE ⁶:

·       Rapid heart rate

·       High blood pressure

·       Jitteriness

·       Nervousness

·       Nausea

·       Vomiting or insomnia. 

 

These adverse events are more likely to occur in sensitive sub-populations of people such as pregnant women and consumers with cardiovascular disease.  Currently, hordenine is not an approved dietary ingredient in dietary supplements because it is a new dietary ingredient that hasn’t been submitted to FDA to establish its safety.

 

PRODUCTS CONTAINING HORDININE ^7-12:

Hordenine is included in many dietary supplements used for athletic performance and weight loss. List of products containing hodinine given in table no 1.

 

Table no 1. List of products containing hodinine

 

CONCLUSION:

Hordenine a dietary ingredient is possibly unsafe when taken by mouth and might cause stimulant side effects such as rapid heart rate and high blood pressure. Most studies showing these effects were done with animals, and limited human studies are available to date. Products containing hordenine are prohibited for use by FDA and considered “adulterated” because it is a new dietary ingredient that hasn’t been submitted to FDA to establish its safety. It is unknown how they might affect your readiness or health. 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.

 

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

10.   WARNING LETTER Max Muscle MARCS-CMS 622401 — MAY 04, 2022. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/max-muscle-622401-05042022

11.   WARNING LETTER Nutritional Sales and Customer Service, LLC MARCS-CMS 622403 — MAY 04, 2022. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nutritional-sales-and-customer-service-llc-622403-05042022

12.   WARNING LETTER Steel Supplements Inc MARCS-CMS 622405 — MAY 04, 2022. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/steel-supplements-inc-622405-05042022

 

 

Received on 29.04.2023           Modified on 20.06.2023

Accepted on 12.07.2023   ©Asian Pharma Press All Right Reserved