Supplements - Herstasis® Health Foundation

Supplements advertised to help manage hundreds of different health conditions are widely available. Many target specific issues (like menopause or weight loss), while others are promoted for broad health benefits.

The growth in this market has led to ever increasing numbers of supplements on the market, some of which are untested, may contain unknown or unidentifiable medicinal or non-medicinal ingredients, have no manufacturer listed, may have no effect, or, in the worst cases, may cause dangerous or even fatal side effects.

What Are Supplements?

Supplements, known in Canada as natural health products (NHPs) include vitamins and minerals, but they also include herbal and botanical products, collagen, probiotics, Ayurvedic medicines, Traditional Chinese Medicines, amino acids, fatty acids (such as omega 3, 6 and 9), and some personal care products such as antiperspirants, medicated shampoos and mouthwashes. [1]

They can come in the form of pills, capsules, gels, creams, or powders. They may be products recommended by evidence-based medical research or they may contain untested combinations of ingredients that could cause worse health issues than the original symptoms.

Commonly, supplements may just pass right through the body, giving you “expensive pee”.

Types of Supplements

Single Ingredient to Prevent or Treat a Nutritional Deficiency

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Single Ingredient to Prevent or Treat a Nutritional Deficiency

These are vitamins and minerals used to make up a nutritional shortfall. One common example is vitamin B12 supplements for vegans and vegetarians, as B12 is only found in animal products. Vitamin D is another example for people living in northern countries who are not exposed to enough sunlight throughout the year.

These are recommended by health care professionals and medical associations for people who need to add specific nutrients so they can meet their nutritional needs. [2]

Single Ingredient Supplements for Specific Reasons

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Single Ingredient Supplements for Specific Reasons

This category contains a broad range of products for a variety of issues such as melatonin for sleep. Some of these products, like d-mannose for prevention of urinary tract infections (UTIs), have strong scientific evidence supporting their safety and effectiveness. Others do not. This means that each individual product and the claims made about it need to be further evaluated by the consumer. [2]

Multi-ingredient Supplements with Claims about Medical Benefits

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Multi-ingredient Supplements with Claims about Medical Benefits

Supplements in this category are ‘buyer-beware’. This category of supplements means that no medical claims can be made because the testing and rigorous safety and medical processes that are required for regulated health products are not in place. These products have not been subjected to scientific studies, they are hard to evaluate, and it is difficult to determine if they actually work. This means that each individual ingredient and the claims made about it would need to be further evaluated by the consumer. However, the interactions between and among ingredients cannot be assessed without further studies that should (but aren’t required to be) done by the in order to be considered Safe. [2]

Regulations & Safety Concerns

Supplements are categorized as Natural Health Products (NHPs) in Canada. NHPs are considered to be lower-risk products than prescription medications, so the process to approve them is not overly stringent. Essentially, manufacturers or sellers must apply for a product license, a site license and follow good manufacturing practices. To get a product license, the applicant must list all the medicinal and non-medicinal ingredients, indicate what they are to be used for, and supply some information on the label demonstrating the safety and efficacy of the NHP. [3]

Supplements are not required to prove that their product is safe. Rather, supplements are assumed to be safe, and the ingredients listed on the label are assumed to be both correct and present in the stated levels. It is only when adverse reactions are reported that further investigation and testing for safety occurs.

One of the major safety concerns with supplements is their impact on liver health.

RISK: Liver Failure

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RISK: Liver Failure

One study looked at changes in the number of waitlisted patients for liver transplants caused by drug-induced acute liver failure over three time periods: 1995-2003, 2004-2012, and 2013-2022. [3] Liver failure resulting in the need for a liver transplant attributed to herbal or dietary supplements (HDSs) showed a significant increase from 2.9% in the 1995-2003 period to 24.1% in the 2013-2022 period. This is an 8-times increase. [4] Other estimates suggest supplements may cause up to 43% of drug-induced liver injury in the United States and 19% of drug-induced acute liver failure. [3]

In the US, supplements are regulated as if they were foods, so they are assumed to be safe unless the Food and Drug Administration (FDA) can demonstrate that they pose a significant risk to the consumer. The fact that they are considered ‘food’ but are used to enhance health, and that many supplements have been used medicinally by other cultures for centuries makes it difficult to make policies and regulations that focus on their safety. This is true even though there is general agreement that consumers would benefit if there was a safety approval process before being sold. To date there is no such process in place. [5]

The FDA has an ‘adverse event surveillance system’ in place that monitors negative effects. In addition if there is other supporting scientific evidence, this allows the FDA to take action after the damage has been done. This surveillance system requires companies to report any serious adverse events – defined as death; life-threatening experience; inpatient hospitalization; persistent or significant disability or incapacity; or a congenital anomaly or birth defect – but is voluntary on the part of consumers. [5] [6]

There are also established minimum current good manufacturing practices (cGMPs) that relate to the manufacturing, packaging, labelling, and storing of dietary supplements to ensure their quality, but not the safety or efficacy of that product. [5] [6]

Canadian and US Drug vs Supplement Regulatory Processes

The risks associated with putting a substance into your body cannot be overstated. The human body is incredibly complex and sensitive, so introducing any foreign material (including supplements) can possibly cause damage, including severe life-threatening impacts.

Regulated drugs (not supplements) are required by law to prove (i) that they are safe and (ii) that they do what they say they are going to do (“efficacy”). Regulated drugs include both over-the-counter medications like acetaminophen, and prescription medications that are only available through a properly licensed and certified healthcare providers’ prescription and must be purchased at a regulated and licensed pharmacy. [7]

Drugs are approved and authorized for sale in Canada once they have successfully gone through the drug review process, where an application is reviewed by scientists at Health Canada, to assess the safety, efficacy and quality of a drug. [7] Natural Health Products are also regulated, but the level of scrutiny is significantly less than for regulated drugs [8]

In 2021, Health Canada’s NHP program was audited and the following recommendations were made:

increased oversight of the quality of NHPs
greater monitoring of labels and advertising
improved product labelling
a risk-based inspection program
strengthened tools for compliance and enforcement [11]

Previous to the audit, NHP labels were required to show:

In 2022 the following changes were added to the above labelling requirements:

These changes will come into effect by June 2028 for NHPs authorized by Health Canada before June 2025. [12]

In the US, the drug approval process is very similar and requires the same long, high-risk process from basic research, preclinical development tests, clinical trials with humans, and regulatory approval by the Food and Drug Administration (FDA).

After 10 to 15 years and hundreds of millions of dollars, the new drug may be approved for marketing. The complexity and cost of drug discovery and development is one of the most financially risky ventures in science. [13]

Safety: How Do I Know If a Supplement Is Safe?

In short, you don’t, but you can at least look for a few markers:

Canada: 8-Digit NPN or DIN-HM

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In Canada, look for the eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) on the label. This indicates it has been authorized for sale after being designated safe and effective by Health Canada. However, a Natural Health Number from Health Canada means the description of the supplement sounds safe but there is no actual testing. [7]

US: Stamp of Independent Verification

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In the US, look for the stamp of independent verification. For example, a USP-verified (United States Pharmacopeia) supplement has been tested and found to contain what it claims it contains and is free of certain contaminants. The USP website also has a list of verified supplements [13](https://store.usp.org/dietary-supplements-and-herbal-medicines)

National Sanitation Foundation (NSF) Label

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Another independent verification label comes from the National Sanitation Foundation (NSF), a globally recognized public health standards company. Consumer Reports also posts information about testing. [14]

DoD Supplement Checker

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The US Department of Defense has an easy-to use supplement checker, found at https://www.opss.org/opss-scorecard-check-your-dietary-supplement

Finally, consider the source: Menopause Supplements are earning millions for their manufacturers and sellers. In addition to safety checks on the individual ingredients, consider the following questions about the supplement seller:

Supplement Seller Evaluation

▢ Are they staying within their training and their credentials?
▢ Are they allowed to prescribe medications?
▢ Is their expertise related to medicine?
▢ Do they recommend compounded medications?
▢ Do they use meaningless terms such as adrenal fatigue? [15]
▢ Do they recommend scientifically unsupported tests that require out of pocket payment, such as salivary hormone testing or the DUTCH test?
▢ Do the recommendations on the supplement label match the recommendations from relevant expert guidelines?
▢ How do they profit, for example, is it a multi-level marketing (MLM) model?
▢ Is the messaging fear-based?
▢ Was there a recommendation to see your healthcare provider before using?
▢ Are medicinal (active) and non-medicinal (stabilizer) ingredients listed?

Efficacy: How Do I Know If a Supplement Is Effective?

Finding out if your supplement is safe is only one step. The next is to find out if the supplement actually works! This can be very difficult for a number of reasons:

Combinations of ingredients may impact how effective each individual ingredient actually is, and there is rarely testing of supplements with mixed ingredients to see how well they will work in combination. The assumption is that if each ingredient works (which is also very uncertain, given the rarity of scientific studies on supplement ingredients) then the combination of ingredients will work.
There is no guarantee the listed ingredients are actually the ingredients contained in the supplement or that they are present in the listed amounts.
There can be other ingredients present, even contaminants like bacteria or fungi introduced during the manufacturing process of the supplement that are not on the label. [1]

Supplement Table (Evidence-Based)

It is important to tell your Healthcare Provider about the supplements you are taking before being given a new drug prescription as they may cause unintended side-effects, or make the medication useless.

Ingredient	Uses / Indications	Scientific evidence supporting use	Side Effects	Dangers
Black cohosh	symptoms of menopause	no, but sufficient evidence for further study	stomach and bowel problems, rashes, headaches, dizziness, and nausea	potential for liver damage
Red clover	symptoms of menopause weak and brittle bones, breast pain, male-pattern baldness	no	might cause muscle aches, nausea, vaginal bleeding (spotting)	Conditions that might be made worse with estrogen may be made worse with red clover. If estrogen is being taken separately, red clover may decrease the effectiveness of estrogen
Wild yam, Mexican yam or wild yam root	symptoms of menopause, infertility, menstrual problems. promoted to create estrogen from its ingredient DHEA. But the body can’t make estrogen from DHEA in edible yams (must be done in a lab)	no	Taking large amounts might cause vomiting, upset stomach, headache	Wild yam is possibly safe when used for up to 12 weeks
Dong quai	menopausal symptoms menstrual cramps migraine	no	burping gas high blood pressure	Dong quai is possibly safe when taken for up to 6 months. It’s been safely used in combination with other ingredients in doses up to 150 mg daily.
Evening primrose	premenstrual syndrome (PMS) menopause symptoms arthritis high cholesterol acne	no	upset stomach nausea diarrhea headache	Evening primrose oil is likely safe for most people when taken in doses up to 6 grams daily for up to 1 year.
Flaxseed	constipation diabetes high cholesterol high blood pressure breast pain obesity	no	bloating gas stomachache nausea	Likely safe for most adults. May decrease the effectiveness of estrogen-containing medications
Ginseng [16]	to improve well-being stimulate immune function anxiety depression hot flashes	no	insomnia menstrual problems breast pain increased heart rate high or low blood pressure headache loss of appetite digestive problems	May be unsafe when taken orally during pregnancy. May interact with certain medications, such as calcium channel blockers and other high blood pressure medications, as well as statin medications and some antidepressants
Hops	anxiety sleep disorders restlessness symptoms of menopause	no	dizziness sleepiness	Possibly safe when used short-term
Maca	male infertility health problems after menopause increasing sexual desire in healthy people	no	unknown	Likely safe for most people when eaten in foods

The Science

Supplements come in the form of pills, capsules, gummies, powders, gels, or creams all of which must enter into the bloodstream to be distributed to target areas in the body.

Oral pathway for pills, capsules or powdered supplements:

1. Mouth

A pill, capsule or powdered supplement enters through the mouth, where digestion begins as enzymes in the saliva and the act of chewing (if the supplement is taken with food) begin to break it down.

2. Stomach

The supplement moves down the esophagus and into the stomach, where gastric juices (stomach acid) continue to break it down into smaller and smaller parts.

3. Small Intestine

The broken-down supplement then passes into the small intestine, where the supplements are broken down into the smallest possible pieces – the basic molecules contained in the ingredients.

4. Villi & Capillaries

These molecules are absorbed by structures called villi, which are tiny finger-like structures that line the end portion of the small intestine. Villi connect to networks of capillaries, which are the smallest type of blood vessel.

5. Bloodstream

From the capillaries, the molecules move into the bloodstream and are carried around the body to the locations where they will act. [19]

6. Liver

All circulating blood leaving the stomach and small intestine pass through the liver, which acts as a filter, removing impurities and toxins from the blood. [20] If supplements contain ingredients that the body considers to be toxic, these can poison the liver and damage it to the point of failure, where it needs to be replaced with a transplanted organ.

Dermal pathway for patches and creams:

Patches and creams do not enter the bloodstream directly, because the top layers of skin have no blood vessels. Instead, the skin gets its nutrients and other substances by diffusion (the passive movement of a substance from an area of high concentration to an area of low concentration) from the middle layer of skin, called the dermis.

The problem with patches and creams is that the skin is designed to keep any outside material out. Skin forms a protective layer over your whole body with the purpose of protecting your insides from the outside environment. Creams and patches can release ingredients into the top layer of skin (the epidermis), which is how moisturizers and other cosmetic creams work, but they may not penetrate all layers of skin to enter the bloodstream. [21][22]

When products applied to the skin enter the bloodstream, it is because they are able to diffuse from the outer skin layer, the epidermis, into the capillaries in the dermis and then transported out into the bloodstream. The skin is known as a lipophilic barrier, meaning it can absorb (and allow diffusion of) substances that are soluble in fat (like vitamin D) compared to low absorption for substances soluble in water (like vitamin C). So it is possible to deliver supplement ingredients through the skin if they are fat soluble. [23]

Myths & Mysteries

No. Both are made in labs and both contain synthesized ingredients. Hormone replacement therapy has undergone stringent testing to meet regulations and ensure the HRT is safe for use on humans. This is not the case for supplements, as most have never been tested for safety. As well, no supplements are as effective as HRT (based on scientific studies).

False. Supplements may or may not be safe, but it’s unrelated to whether the ingredients are natural. In fact, natural ingredients are not inherently safe. Lead is natural, but is definitely not safe, as are millions of other natural ingredients. Don’t be fooled into believing that you are protecting yourself by relying on natural ingredients. Most multi-ingredient supplements contain medicinal and non-medicinal ingredients that are made in labs in large quantities.

Possibly, depending on what the ingredients are. For example, 20% of Ayurvedic medicines contain high levels of lead, which build up in the body and can cause lead poisoning. [18] Typically, however, ingredients in supplements are filtered out by the liver where they then become waste products that leave the body. The liver can be so impacted by these toxins that liver damage, or even complete liver failure is a growing problem.

No. Absolutely not. Your liver functions as your body’s detoxifier, removing waste and toxins from the bloodstream. If you want to detox your liver, reduce the amount of alcohol, fast foods, and ultra-processed foods that you take into your body.

Maybe. Supplements can provide nutrients that may be lacking from a person’s diet, however, there is broad agreement across the medical establishment that the preference is to get all nutrients from food in the diet. If that isn’t possible, for example in the case of vegetarians and vegans who may need supplementation because they don’t eat meat (so can’t get those nutrients in their diet), then supplements are recommended. Always talk to your healthcare provider before taking supplements.

Maybe. There is no way to guarantee that a supplement will work because there is no guarantee that the supplement contains what it says it contains in the amounts that are specified on the label. As well, there is no guarantee that there are no extra ingredients or contaminants in the supplement. It is highly recommended that you do your own research on the ingredients, the manufacturer and the brand name.

Maybe. There is no way to guarantee that the ingredients in a supplement are safe unless it has been certified by a third party verifier like NSF or USP, both of which have stamps that are easily visible on packaging. If no verification is obvious, there is no guarantee that the supplement contains what it says it contains in the amounts that are specified on the label.

Supplements may have a Natural Health Number from Health Canada, but that means the description of the supplement sounds safe but there is no actual testing. As well, there is no guarantee that there are no extra ingredients or contaminants in the supplement. It is highly recommended that you do your own research on the ingredients, the manufacturer and the brand name.

Another issue with supplements is the potential for interactions with other medications or supplements you might be taking. It is very important to always tell your healthcare provider if you are taking or planning on taking supplements so you can have confidence there will be no drug interactions.