Industry Secrets - To Regulate or Not To Regulate?

Hello fellow climbers, today I wanted to share with you some industry secrets behind government regulations to help you decipher what to look for and what to stay away from when choosing a supplement. This post will explain the importance of understanding manufacturing regulations to ensure that you do not buy products that could harm you. By the end you will have learned industry secrets that will help you choose a product that is right for you.

*Disclaimer*

*This post is not created to compare countries. By no means am I saying one country is better than another. The sole purpose is to help you, the consumer, make an informed decision when choosing a brand or product. With this post I hope to help you recognize the products that are manufactured with harmful or useless ingredients.*


What is the difference between government regulated products and non-government regulated products?

Certain countries like Canada, have government regulations in place to ensure the accuracy and quality of supplements. These countries require: in depth applications filled out by the distributor, manufacturing done by an approved manufacturer, and specific testing to ensure quality of product. These regulations are in place to prevent any heavy metals, dangerous bacteria, or other potentially dangerous contents to be ingested by the consumer. Other countries (like the United States of America (US)), do not have any of these regulatory bodies in place. This means that you, the consumer, are putting all your faith in the company you are buying from to ensure that what you are consuming, is actually what they say it is and is free of any harmful ingredients.


The US is a prime example of a country who does not regulate their dietary supplements. The Food and Drug Association (FDA) “...is not authorized to review dietary supplement products for safety and effectiveness before they are marketed...” [3] Furthermore, in order for a product to be removed from the market it must be deemed unsafe. [1] This means that you and I could be consuming potentially dangerous product for a long time before it is removed and deemed unsafe? WTF!?


Without a regulating body, the claims made on the label do not have to be supported by any accurate scientific studies. This means that the manufacturer can say it does “XYZ” and have no accurate scientific evidence backing it. You and I just have to trust the manufacture isn’t pulling the wool over our eyes.


“Structure/function claims are not pre-approved by FDA, but any label that contains such a claim must also contain a “disclaimer” that FDA has not evaluated the structure/function claim, and that the dietary supplement is not intended to “diagnose, treat, cure, mitigate or prevent any disease” (the basic tenants of a drug).” [1]


As long as the label states the claim below, the company can pretty much say whatever the hell they want? They can say it increases strength or they can say it will help you grow wings and fly, but both of these claims hold no merit.

*Above is an example of the statement commonly found at the bottom of non-regulated US supplements

 

If you see the above statement on any supplement label, be very very skeptical! This means they have no evidence to support their claims and the FDA does not support or review their claims.


This is an example of a system that is not designed to benefit the consumer. It is a system designed to make it easier for companies to create and sell supplements. No one is held accountable until someone gets sick or worse...?


Where should I get my supplements from then?

There are many countries that have regulations put in place by their governments for the manufacturing and distribution of supplements. Japan, China, and Europe are examples of countries that have regulations in place. Another country with an amazing regulatory system which is also the closest to the US is Canada. Yes Canada, the land of hockey and beavers.


Canada’s Natural Health Product Regulation

In Canada there is a system in place for the manufacturing and distribution of all supplements. The system is the Natural Health Product Regulations which is monitored by the Natural and Non-prescription Health Products Directorate (NNHPD).

“The Regulations help give Canadians access to a wide range of natural health products that are safe, effective and of high quality.” [2]

The regulations are a way of ensuring the products that make it to market are of high quality and do not contain any harmful substances. Any product sold in Canada must undergo a series of regulatory requirements.


“To be legally sold in Canada, all natural health products must have a product licence, and the Canadian sites that manufacture, package, label and import these products must have site licences.
To get product and site licences, specific labelling and packaging requirements must be met, good manufacturing practices must be followed, and proper safety and efficacy evidence must be provided.” [2]

What does a company have to do to sell a supplement in Canada and why is this important to me?

In order to get a product license a company must follow the guidelines laid out by Health Canada which are designed to ensure the quality of the finished product. Once these guidelines are met, Health Canada will issue a NPN number. This number helps the consumer identify which products have been reviewed and approved by Health Canada. [2]


“To get a licence, applicants must give detailed information about the product to Health Canada, including: medicinal ingredients, source, dose, potency, non-medicinal ingredients and recommended use(s)." [2]

 

*Above is an example of an NPN number on an approved Natural Health Product.


All this information that must be approved by Health Canada will ensure that the product you are purchasing and consuming is 100% transparent.


What evidence does Health Canada need in order to approve the claims made?

Health Canada requires accurate scientific evidence to support the claims being made by the company on the label. This evidence must be provided in the application form before any license is issued to the company. [2] Unlike the US and the FDA, Health Canada supports the claims made by the company and reviews them before the product is sold to the public. This ensures the supplement does exactly what it says it does, no bullshit.


“Evidence may include clinical trial data or references to published studies, journals, pharmacopoeias and traditional resources. The type and amount of supporting evidence required depends on the proposed health claim of the product and its overall risks.” [2]


What are the label requirements of Natural Health Products sold in Canada?

On top of all the information needed for the licensing, companies must meet specific labelling requirements. This helps you and I make safe and informed choices about the supplements, or Natural Health Products, we use.


“Information required on NHP labels includes:
  • product name
  • product licence number
  • quantity of product in the bottle
  • complete list of medicinal and non-medicinal ingredients
  • recommended use (including purpose or health claim, route of administration and dose)
  • any cautionary statements, warnings, contra-indications and possible adverse reactions associated with the product
  • any special storage instructions [2]

  • What are the specific regulations that a manufacturer must follow?

    We have talked a lot about the requirements of a company distributing a supplement, what about the manufacturer who creates it? They also have regulations they must follow.


    “Good Manufacturing Practices make sure proper standards and practices for the testing, manufacture, storage, handling and distribution of natural health products are met. Good Manufacturing Practices for NHPs cover:

  • product specifications
  • premises
  • equipment
  • personnel
  • sanitation program
  • operations
  • quality assurance
  • stability
  • records
  • sterile products
  • lot or batch samples
  • recall reporting” [2]

  • Manufacturers must also test all products for allergens and harmful contaminants, such as; heavy metals and harmful bacteria. [2] The Good Manufacturing Practices ensures that there is little to no possibility for cross contamination. This alone is huge for consumers. Giving you the piece of mind knowing the product you are consuming is meticulously manufactured and tested.


    I’m a climber, what products should I take?

    NutriClimb only creates products that meet or exceed the regulations laid out by Health Canada. On top of meeting the regulations we also include specific testing for gluten allergens and all our products are made in a peanut free facility. Unfortunately, at the moment NutriClimb only sells a Pre-workout. If you were looking for another type of supplement, a protein or BCAA, this will help you filter through the many products on the market.

    When choosing a supplement keep in mind what you want to get out of it. Do you want more power, more muscle, reduced pump, reduced inflammation, recovery, less weight, more weight, joint health, endurance, etc? Once you know what you want then you can decide on a product that works for you.

    Research

    The best way to know if a product is good for you is to research it! Look at the reviews, read papers on the ingredients, look at the non-medicinals (is it all natural or is there artificial ingredients in it), ask a buddy, ask a nutritionist, or try it. Whatever you have to do to ensure this product is right for you, do it. The only way you will know if a product is right for you is to try it for yourself.

    Some ingredients to stay away from, especially as a climber, include testosterone boosters, artificial colours and flavours, high doses of citrulline malate and agmatine sulfate (which increases “pump”), large amounts of caffeine (which can cause heart problems and the “jitters), Talc or magnesium silicate (used by some manufacturers as an anti-caking agent which can cause stomach cancer). There are other ingredients to watch out for but these are some of the most common, so make sure you do your research!

    Final thoughts

    When choosing a product for yourself, make sure it is a product that is approved by a governing body. This is the only way you can ensure the claims are supported and the quality is held to a higher standard. If you are a Canadian looking for a supplement, I recommend sticking to something in the Canadian market, we have regulations for a reason so take advantage of them.

    If you are an American looking for a supplement, my recommendation is look at the Canadian market. With the regulations and accountability, you are less likely to buy a low quality/dangerous product. A lot of companies will ship to the US, some even provide a discounted shipping rate.

    Whoa. That was a big post with tons of information. This post was created to help you differentiate between different supplements that are on the market and to give you some behind the scenes information on what goes on in the manufacturing and distribution part of the industry. I hope this will help you make some informed decisions on which supplements to consider and which ones to stay the hell away from.

    If you want to take the guess work out of choosing the right supplement you can learn more and get your own Climber Pre-Workout+ by clicking the hyper link. Use the code "NUTRICLIMBER" for 10% off your purchase. The only supplement on the market made specifically for climbers and athletes alike! 

    If you have any questions or comments you can leave them below. Thank you for reading and happy sending!

     

     

     

     

    “NutriClimb is dedicated to helping climbers be the best they can be and perform their best every time. Through information, motivation, and high quality great tasting products. Join us on a journey to better performance!”

     

    Sources

    [1] http://burdockgroup.com/dietary-supplements-in-the-u-s-and-abroad-similarities-and-differences/

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

    [3]

    https://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/default.htm


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