Save Our Supplements!

Have you ever used supplements to:

• Help you sleep?

• Get your kids pooping?

• Navigate PMS symptoms?

• Accelerate healing after illness or surgery?

• Manage the unpleasant symptoms of GERD?

• Improve athletic performance?

If supplements have helped you improve your overall health or supported your specific health concerns, then keep reading…

71% of Canadians use Natural Health Products (NHPs) like vitamins and supplements toothpaste, sunscreen, deodorant, probiotics, and infant/children’s products as part of their proactive health and well-being.[1] As Canadians take a more active role in their health, the sector continues to grow - across the country, NHPs are available at pharmacies, naturopathic clinics, health food stores, grocery stores, and independent retailers, employing 54,000 Canadians in the sector.[2]

Health Canada is making significant regulatory changes to natural health products, leading to increased costs and fewer products in store shelves. These unnecessary changes will treat natural health products like pharmaceutical drugs. This over-regulation will negatively impact how these brands can do business in Canada and will ultimately have a negative effect on you, the consumer.

What happened:

Health Canada announced a public consultation regarding new fees which would raise the price of NHPs - this was to be open for 90 days, beginning on May 12, 2023.[3] However, on June 22, 2023 the government passed Bill C-47 - and the sections pertaining to NHPs (500-504) were well-hidden inside a lengthy budget bill.[4] This bill was passed much earlier than anticipated, was not reviewed by the Standing Committee on Health (since it was labelled as a budget bill), and Canadians were not made aware.

What should have happened:

Health Canada should have introduced a standalone bill to amend the Food and Drugs Act. The bill would have ended up at the Standing Committee on Health - a committee comprised of experts on the regulation of health products.[5] Public consultation should not have been cut short - brands, retailers, and consumers did not get a fair say. Ideally, discussion of proposed fees should have been pushed back until completion of the Self-Care Framework by the NNHPD (Natural and Non-Prescription Products Directorate).

For historical context - Health Canada first attempted to pass these regulations in 2008 with Bill C-51, but the pushback was so strong that the bill did not pass.[6]

Potential impact:

• 1 out 5 NHP brands say they are seriously considering leaving the Canadian market due to Health Canada’s new rules.[7] This could have serious consequences to our patient treatment plans and care - many small to medium-sized businesses will be forced to shut down Canadian operations. Prices will increase and product availability will suffer.

• Health Canada is adding additional fees for NHP developers, manufacturers, and distributors - all of whom will likely increase their individual prices before they even reach the customer.

• Healthcare practitioners will have limited ability to help their patients assess which NHPs are best suited to their particular needs. There will be less access to new and innovative products that offer a better clinical benefit than their dated versions.

• There will be an increased influx of unregulated products from international markets. As a clinic that recognizes the importance of high-quality products for our patients, this is a problematic, and potentially dangerous development.

• Strict labelling regulations will cause packaging sizes to double but for the same amount of product. This creates a dramatic increase in the use of plastic, fuel, glue, wood and water and will have serious implications on our environmental footprint.

TO BE CLEAR - as health care professionals, we are all for good regulation on NHPs to ensure accessibility to high-quality products. The regulatory changes outlined in Bill C-47 seem to be a BIG overreach in NHP regulation without proper consideration of the negative impact these changes will have.

We believe it is essential to have access to high-quality supplements at an affordable price.

We need your help in this advocacy effort if we are to succeed in getting Health Canada to reconsider its proposal.

1. Please reach out to your MP by clicking HERE and tell them to Save Our Supplements.

2. Please sign Petition e-4474 and request Health Canada suspend the proposed fees discussion until the Self-Care Framework has been completed and the NNHPD has cleared its current backlog.

3. Please print off this letter template and send a paper copy to your MPs office. Traditional letters get more attention and have more impact - letters let elected officials know the impact of their decisions.
   

[1] https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/regulation/about-products.html

[2] Deloitte LLP. (May 2023). Economic Contribution Study of Canada’s Natural Health Product Sector.

[3] https://www.canada.ca/en/health-canada/programs/consultation-proposed-fees-natural-health-products/consultation-process.html

[4] https://www.parl.ca/DocumentViewer/en/44-1/bill/C-47/royal-assent

[5] https://www.ourcommons.ca/Committees/en/HESA/About

[6] https://www.cbc.ca/news/science/criticism-of-natural-health-products-bill-c-51-mounts-1.719529

[7] https://www.saveoursupplements.ca/changing-regulations

Is Melatonin Safe for Long-Term Use?

Does it prevent our body from making melatonin on its own? Are there withdrawal effects when you stop taking it? These are all great questions we are asked often. To answer them, let’s review what melatonin is, what it is used for, and what the research is saying.

What is melatonin?

Melatonin is a hormone that is produced in response to darkness by the pineal gland. It was once thought that its sole purpose was to regulate our internal circadian rhythm (our internal 24 hour clock) and aid in sleep[1]. However, we are now discovering it has roles far beyond this. We now know melatonin has anti-oxidant, anti-ageing, immunomodulating and anticancer properties as well[2]. Research suggests that melatonin may also play roles in our levels of human growth hormone[3] [4], eye health [5] [6], Gastroesophageal reflux disease (heartburn) treatment [7] [8] [9], anxiety prevention[10] [11], and the treatment (adjunctive) and prevention of cancers such as breast cancer[12] [13].

Here's what the research says:

To date, researchers appear to agree that supplementing melatonin (including doses up to 100mg/day) is well tolerated and is not typically associated with any serious adverse affects[14] [15]. The mild adverse effects that have been reported include drowsiness, headaches and dizziness and nausea[16]. Of these mild adverse effects, research suggests they either resolve spontaneously within a few days with no adjustment in melatonin, or immediately upon withdrawal of treatment[17]. Melatonin has not been found to be addictive in nature nor cause hangover symptoms[18], which is why it has been considered as a possible alternative to many sleep medications. In addition to this, research also suggests that the supplementation of melatonin does not interfere with the bodies internal production of melatonin once treatment has ceased[19] [20]. This makes sense when we consider that the half life (the time it takes for half of a drug to be cleared) of melatonin is only 1-2 hours depending on the formulation. This means that in 1-2 hours 50% of the melatonin will be removed from the body. Therefore, in 5 hours the amount of melatonin in the body is negligible and the body knows start producing a “new batch” of melatonin in the pineal gland as soon as you are exposed to light in the morning. Given that melatonin has a short half life, melatonin only targets sleep onset and not maintenance. Because of the short half life, we see so many prolonged release formulations of melatonin to slow down the absorption into the bloodstream to ensure the levels of melatonin are maintained in blood stream for a longer period to extend its sleep benefits. Prolonged release formulas allow you to maintain higher active levels of melatonin throughout the night if your goal with supplementing melatonin is to prevent nighttime waking.

But what about our more vulnerable populations such as children or elderly people?

In children, research suggests adverse effects of melatonin supplementation were few and mild[21]. Of these adverse effects, fatigue and somnolence were mentioned and were found to resolve with dose reduction. In addition, studies on pediatric populations looking at the long term effects of melatonin supplementation (two, three and four years on average) in doses of 2mg-10mg/day, found no notable long term effects on vitals signs or measures of child growth[22] [23]. In a two year long study assessing sleep, growth and puberty in children taking melatonin, a two week placebo period was implemented after treatment to assess withdrawal effects to which there were no apparent signs of withdrawals (mallow).

A 2022 review article discussing the safety of melatonin use in the elderly found that adverse effects were similar to those found in adult populations such as dizziness, nausea and headaches[24].However, there may be an increased risk of hypothermia if melatonin levels reach above normal physiologic levels as well as fractures in those who are at risk of falling due to the possibility of daytime sedation [25]. In regards to discontinuation, research suggests there is no evidence of withdrawal effects in populations 55 years and older[26].

It is important to note that the above research does not include individuals on medications or health concerns/diagnoses outside the parameters of each individual study. Therefore, it is important to discuss melatonin supplementation with your healthcare provider before taking.

In summary, it is SAFE to say melatonin is SAFE for those who are taking melatonin long term as recommended by their health care provider for one of the many clinical benefits we see with melatonin supplementation. 

[1] Ferracioli-Oda E, Qawasmi A, Bloch MH. Meta-analysis: melatonin for the treatment of primary sleep disorders. PLoS One. 2013 May 17;8(5):e63773. doi: 10.1371/journal.pone.0063773. PMID: 23691095; PMCID: PMC3656905.

[2] Bhattacharya S, Patel KK, Dehari D, Agrawal AK, Singh S. Melatonin and its ubiquitous anticancer effects. Mol Cell Biochem. 2019 Dec;462(1-2):133-155. doi: 10.1007/s11010-019-03617-5. Epub 2019 Aug 26. PMID: 31451998.

[3] Forsling ML, Wheeler MJ, Williams AJ. The effect of melatonin administration on pituitary hormone secretion in man. Clin Endocrinol (Oxf). 1999 Nov;51(5):637-42. doi: 10.1046/j.1365-2265.1999.00820.x. PMID: 10594526.

[4] Valcavi R, Zini M, Maestroni GJ, Conti A, Portioli I. Melatonin stimulates growth hormone secretion through pathways other than the growth hormone-releasing hormone. Clin Endocrinol (Oxf). 1993 Aug;39(2):193-9. doi: 10.1111/j.1365-2265.1993.tb01773.x. PMID: 8370132.

[5] Lundmark PO, Pandi-Perumal SR, Srinivasan V, Cardinali DP. Role of melatonin in the eye and ocular dysfunctions. Vis Neurosci. 2006 Nov-Dec;23(6):853-62. doi: 10.1017/S0952523806230189. PMID: 17266777.

[6] Yi C, Pan X, Yan H, Guo M, Pierpaoli W. Effects of melatonin in age-related macular degeneration. Ann N Y Acad Sci. 2005 Dec;1057:384-92. doi: 10.1196/annals.1356.029. PMID: 16399908.

[7] Pereira Rde S. Regression of gastroesophageal reflux disease symptoms using dietary supplementation with melatonin, vitamins and aminoacids: comparison with omeprazole. J Pineal Res. 2006 Oct;41(3):195-200. doi: 10.1111/j.1600-079X.2006.00359.x. PMID: 16948779.

[8] Kandil TS, Mousa AA, El-Gendy AA, Abbas AM. The potential therapeutic effect of melatonin in Gastro-Esophageal Reflux Disease. BMC Gastroenterol. 2010 Jan 18;10:7. doi: 10.1186/1471-230X-10-7. PMID: 20082715; PMCID: PMC2821302.

[9] Pereira Rde S. Regression of gastroesophageal reflux disease symptoms using dietary supplementation with melatonin, vitamins and aminoacids: comparison with omeprazole. J Pineal Res. 2006 Oct;41(3):195-200. doi: 10.1111/j.1600-079X.2006.00359.x. PMID: 16948779.

[10] Khare A, Thada B, Jain N, Singh D, Singh M, Sethi SK. Comparison of Effects of Oral Melatonin with Oral Alprazolam used as a Premedicant in Adult Patients Undergoing Various Surgical Procedures under General Anesthesia: A Prospective Randomized Placebo-Controlled Study. Anesth Essays Res. 2018 Jul-Sep;12(3):657-662. doi: 10.4103/aer.AER_90_18. PMID: 30283171; PMCID: PMC6157235.

[11] Ghaeli P, Solduzian M, Vejdani S, Talasaz AH. Comparison of the Effects of Melatonin and Oxazepam on Anxiety Levels and Sleep Quality in Patients With ST-Segment-Elevation Myocardial Infarction Following Primary Percutaneous Coronary Intervention: A Randomized Clinical Trial. Ann Pharmacother. 2018 Oct;52(10):949-955. doi: 10.1177/1060028018776608. Epub 2018 May 11. PMID: 29749262.

[12] Li Y, Li S, Zhou Y, Meng X, Zhang JJ, Xu DP, Li HB. Melatonin for the prevention and treatment of cancer. Oncotarget. 2017 Jun 13;8(24):39896-39921. doi: 10.18632/oncotarget.16379. PMID: 28415828; PMCID: PMC5503661.

[13] Yang A, Peng F, Zhu L, Li X, Ou S, Huang Z, Wu S, Peng C, Liu P, Kong Y. Melatonin inhibits triple-negative breast cancer progression through the Lnc049808-FUNDC1 pathway. Cell Death Dis. 2021 Jul 16;12(8):712. doi: 10.1038/s41419-021-04006-x. PMID: 34272359; PMCID: PMC8285388.

[14] Menczel Schrire Z, Phillips CL, Chapman JL, Duffy SL, Wong G, D'Rozario AL, Comas M, Raisin I, Saini B, Gordon CJ, McKinnon AC, Naismith SL, Marshall NS, Grunstein RR, Hoyos CM. Safety of higher doses of melatonin in adults: A systematic review and meta-analysis. J Pineal Res. 2022 Mar;72(2):e12782. doi: 10.1111/jpi.12782. Epub 2021 Dec 30. PMID: 34923676.

[15] Andersen LP, Gögenur I, Rosenberg J, Reiter RJ. The Safety of Melatonin in Humans. Clin Drug Investig. 2016 Mar;36(3):169-75. doi: 10.1007/s40261-015-0368-5. PMID: 26692007.

[16] Savage RA, Zafar N, Yohannan S, et al. Melatonin. [Updated 2021 Aug 15]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK534823/

[17] Besag FMC, Vasey MJ, Lao KSJ, Wong ICK. Adverse Events Associated with Melatonin for the Treatment of Primary or Secondary Sleep Disorders: A Systematic Review. CNS Drugs. 2019 Dec;33(12):1167-1186. doi: 10.1007/s40263-019-00680-w. PMID: 31722088.

[18] Cardinali DP, Srinivasan V, Brzezinski A, Brown GM. Melatonin and its analogs in insomnia and depression. J Pineal Res. 2012 May;52(4):365-75. doi: 10.1111/j.1600-079X.2011.00962.x. Epub 2011 Sep 23. PMID: 21951153.

[19] Matsumoto M, Sack RL, Blood ML, Lewy AJ. The amplitude of endogenous melatonin production is not affected by melatonin treatment in humans. J Pineal Res. 1997 Jan;22(1):42-4. doi: 10.1111/j.1600-079x.1997.tb00301.x. PMID: 9062869.

[20] Hack LM, Lockley SW, Arendt J, Skene DJ. The effects of low-dose 0.5-mg melatonin on the free-running circadian rhythms of blind subjects. J Biol Rhythms. 2003 Oct;18(5):420-9. doi: 10.1177/0748730403256796. PMID: 14582858.

[21] Maras A, Schroder CM, Malow BA, Findling RL, Breddy J, Nir T, Shahmoon S, Zisapel N, Gringras P. Long-Term Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insomnia in Children with Autism Spectrum Disorder. J Child Adolesc Psychopharmacol. 2018 Dec;28(10):699-710. doi: 10.1089/cap.2018.0020. Epub 2018 Oct 11. PMID: 30132686; PMCID: PMC6306655.

[22] Malow BA, Findling RL, Schroder CM, Maras A, Breddy J, Nir T, Zisapel N, Gringras P. Sleep, Growth, and Puberty After 2 Years of Prolonged-Release Melatonin in Children With Autism Spectrum Disorder. J Am Acad Child Adolesc Psychiatry. 2021 Feb;60(2):252-261.e3. doi: 10.1016/j.jaac.2019.12.007. Epub 2020 Jan 23. PMID: 31982581; PMCID: PMC8084705.

[23] Kennaway, D.J. (2015), Melatonin use in paediatrics. J Paediatr Child Health, 51: 584-589. https://doi.org/10.1111/jpc.12840

[24] Zhdanova IV, Wurtman RJ, Regan MM, Taylor JA, Shi JP, Leclair OU. Melatonin treatment for age-related insomnia. J Clin Endocrinol Metab. 2001 Oct;86(10):4727-30. doi: 10.1210/jcem.86.10.7901. PMID: 11600532.

[25] Should Melatonin Be Used as a Sleeping Aid for Elderly People? Can J Hosp Pharm. 2019 Jul-Aug;72(4):327-329. Epub 2018 Aug 31. PMID: 31452545; PMCID: PMC6699865.

[26] Lemoine P, Nir T, Laudon M, Zisapel N. Prolonged-release melatonin improves sleep quality and morning alertness in insomnia patients aged 55 years and older and has no withdrawal effects. J Sleep Res. 2007 Dec;16(4):372-80. doi: 10.1111/j.1365-2869.2007.00613.x. PMID: 18036082.

Lower Blood Sugar and Cholesterol and Improve Heart Health with Berberine!

BERBERINE AND CARDIOMETABOLIC HEALTH

Berberis Vulgaris (Barberry)

Berberine is a bright yellow-coloured alkaloid compound found in many plants, some of the more common ones including Hydrastis canadensis (goldenseal), Berberis vulgaris (barberry), Coptis chinensis (Chinese goldthread), and Berberis aquifolium (Oregon grape). Berberine has been used traditionally to combat inflammatory disorders, infectious diseases, diabetes, digestive disorders and many others, and has demonstrated benefits on blood sugar metabolism, cardiovascular effects, cholesterol and atherosclerosis.

Berberine appears to exert its cardiovascular effects through various mechanisms that play a role in protecting the blood vessels, decreasing inflammation and modulating levels of cholesterol and blood sugar. Berberine has been shown to affect the modulation of an enzyme called adenosine monophosphate-activated protein kinase (AMPK). AMPK is responsible for maintaining healthy blood vessels through a variety of different mechanisms, including the regulation of another enzyme, called endothelial nitric oxide synthase (eNOS), which is responsible for producing nitric oxide in the cell layer lining our blood vessels. Nitric oxide is important in regulating how our blood vessels dilate (which plays a role in our blood pressure), platelet and white blood cell activation and adhesion (which plays a role in the development of arterial plaques), and antioxidant functions (which is important for preventing damage from free radicals like glycated blood sugar, which is prevalent in diabetes). In simpler terms, AMPK and eNOS are important for maintaining a healthy cardiovascular system. When eNOS is not functioning properly, it can contribute to the development of high blood pressure, diabetes and high cholesterol. Berberine has been found to increase the production of nitric oxide through enhancing activity of eNOS [1, 2, 6, 7].

Current research on berberine has been focused on its metabolic and cardiovascular properties. A research study suggested that berberine was shown to decrease levels of total cholesterol, triglycerides and LDL cholesterol levels, while increasing HDL-cholesterol (which is thought to be protective, or the “good” cholesterol). A meta-analysis demonstrated that the addition of berberine to simvastatin, a cholesterol-lowering drug, resulted in a greater reduction of triglycerides and total cholesterol, and a reduction in the number of side effects, compared to the use of simvastatin on its own [5].

Berberine also benefits blood sugar levels and reduces body fat mass. A research study on diabetic patients showed that those who were given berberine had a reduction in blood sugar levels and cholesterol levels, and those with metabolic syndrome also experienced a decrease in their body mass index (BMI) and waist circumference [3]. A study on women with polycystic ovary syndrome (PCOS), a disorder characterized by insulin-insensitivity, obesity and high cholesterol, found that berberine decreased waist circumference and waist-to-hip ratio, insulin sensitivity and blood sugars and cholesterol levels comparable and/or superior to that of metformin [4].

Berberine is generally well-tolerated, and side effects of usage are usually mild in nature, such as abdominal discomfort, diarrhea, constipation, decreased appetite, and dermatological rashes. Berberine may interfere with certain medications and may not be suitable for everyone. As always, with any natural health product it is important to consult with your naturopathic doctor to see if berberine is safe for you.

References:

[1] Neag M, Mocan A, Echeverria J, et al. Berberine: Botanical Occurrence, Traditional Uses, Extraction Methods, and Relevance in Cardiovascular , Metabolic, Hepatic, and Renal Disorders. Front Pharmacol. 2018; 9:557. https://pubmed.ncbi.nlm.nih.gov/30186157/

[2] Hoffmann D. (2003). Medical Herbalism: The Science and Practice of Herbal Medicine. Healing Arts Press.

[3] Pirillo A, Catapano AL. Berberine, a plant alkaloid with lipid- and glucose-lowering properties: from in vitro evidence to clinical studies. Atherosclerosis. 2015; 243(2): 449-61. https://pubmed.ncbi.nlm.nih.gov/26520899/

[4] Wei W, Zhao H, Wang A, et al. A clinical study on the short-term effect of berberine in comparison to metformin on the metabolic characteristics of women with polycystic ovary syndrome. Eur J Endocrinol. 2012; 166(1):99-105. https://pubmed.ncbi.nlm.nih.gov/22019891/

[5] Zhang LS, Zhang JH, Feng R, et al. Efficacy and safety of berberine alone or combined with statins for the treatment of hyperlipidemia: a systematic review and meta-analysis of randomized controlled trials. Am J Chin Med. 2019; 47(4):751-767. https://pubmed.ncbi.nlm.nih.gov/31094214/

[6] Affuso F, Mercurio V, Fazio V, et al. Cardiovascular and metabolic effects of berberine. World J Cardiol. 2010; 2(4):71-7. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2999047/

[7] Bagade A, Tumbigeremutt V, Pallavi G. Cardiovascular Effects of Berberine: A Review of the Literature. Journal of Restorative Medicine. 2017; 6: 37-45.