Semester 4, Week 7, Day 3: Gentian Regulation

Today I will work on the discussion post for toxicology then get to work on my book entry and the herbariums.  Lots to do!  So far, the kids are happy and just fed.  I do need to empty the drier at some point.  I have dishes done already...  We had to use kits forks for our last meal because yesterday was so hectic.  I bought them cheddar bacon burgers for dinner last night.  I took a taste to see if the kids would eat it and I got it wrong.  My daughter ate her burger and left her carrots, my son the opposite.  So I swapped out their plates!  My daughter isn't normally a meat eater but she inhaled these.  I thought there would be too much pepper in there.  My boy is the pepper eater.  Other than that, not much gong on, just plugging away at my school work as much as the kids will allow me to.  Hoping today will continue to be a good day to get something accomplished! Love and Light!

On to the discussion post!

Select one of the herbs in the module and research and discuss the current regulatory status of the botanical in the United States, Canada, UK and Australia, as well as any regulatory actions or issue. 
 
 
I wanted to discuss an herb that was in my kit and also in the lesson this week.  I looked up the herb gentian Gentiana lutea , which I had never heard of prior to this class in Mills and Bone (2010) and there is a table on page 419 on the regulation status in 4 countries.  It reads as follows:
            “Australia: Gentian is not included in Part 4 of Schedule 4 of the Therapeutic Goods Regulation.
            UK and Germany: Gentian is included on the General Sale List. It is covered by a positive Commission E monograph. Gentian root is official in the European Pharmacopeia 4.3.
            US: Gentian does not have generally regarded as safe (GRAS) status. However it is freely available as a “dietary supplement” in the US under DSHEA legislation (Dietary Supplement Health and Education Act of 1994).”

This made me curious because comfrey is stricter in these other countries than ours yet gentian is not on the GRAS list. To me, if Germany and the United Kingdom support it as well as they do, I’d expect a similar status here. Since I have no clue what Schedule 4 is, I had to dig more for Australia. This schedule is called “Therapeutic goods required to be included in the part of the Register for listed goods”. Mills and Bone (2010) said it wasn’t part 4 but part 5 is also about homeopathic preparations.  Maybe I should have chosen an easier herb…  LOL  I actually chose this herb before I even read the prompt here for my lab for the week for my Herbarium so…  LOL Looking at part 4 and part 5, part 4 would be considered safer. It includes a line about none of the ingredients being considered poisonous where part 5 doesn’t have that line. I then wondered how you could find where the herb was listed in Australia so I could have a proper comparison. I found Sharma’s article on PubMed which states Australia lists approved medications as being in the Australian Register for Therapeutic goods (ARTG). I searched the ARTG and gentian products but there was no listing about ONLY gentian, like for a tea. I guess they do things differently down under which makes comparison a tad more difficult.  I looked for Canada and I got a lot of results for other gentian plants, just didn’t see anything for G. lutea. The Canadian plants were endangered so I’d assume they have something in place to preserve the wild versions making only cultivated plants authorized for use. I also didn’t see any pending regulation but I will remind you this plant is on the “to watch” list for united plant savers.

This was a great exercise in how to find regulatory information. What I found is nothing is straight forward, no matter the nation you are looking at.  I guess that’s why they say everyone commits at least 3 crimes a day. Write things vague intentionally and you can nab anyone.
Mindy
 
References
Commonwealth Consolidated Regulations Retrieved from http://www5.austlii.edu.au/au/legis/cth/consol_reg/tgr1990300/sch4.html

Mills, S. & Bone, K. (2010).  The Essential Guide to Herbal Safety. Elsevier Limited. P 419.
Australian Regulatory Guidelines for Complimentary Medicine Part IV Retrieved from https://www.tga.gov.au/sites/default/files/cm-argcm-p4.pdf
Australian Register of Therapeutic Goods Retrieved from https://www.tga.gov.au/artg

Sharma, S. (2015). Current status of herbal product: Regulatory overview. Journal of Pharmacy and BioAllied Sciences 7(4): 293–296. doi: 10.4103/0975-7406.168030 Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4678984/

Have a Great day!