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Increased Regulations for Natural Health Products, but Soft Drinks Get a Free Pass?

In a world where government regulations purportedly aim to ensure our "safety", one might wonder if the logic behind these decisions is, well, logical. Recently, the Canadian government has set its sights on natural health products under the banner of "safety." But let's take a moment to unpack this and see if it holds any water. Bill C-47.


Here we go again folks

For Your Safety

What are We Talking About?

On June 22, 2023, Bill C-47 officially became law, marked by receiving Royal Assent. This bill brought forth notable amendments to the Food and Drugs Act (FDA), specifically addressing Natural Health Products (NHPs).


These changes amplify Health Canada's authority, intended to bolster public health protection. Effective immediately, here are the pivotal amendments:


Recall Authority Health Canada now possesses the authority to mandate the recall of NHPs when they pose a serious or imminent threat to human health.


Labelling and Packaging Modifications In cases where Health Canada perceives that an NHP product poses a significant risk to human health, they can now require label modifications or changes to the packaging.


Increased Fines and Penalties To discourage non-compliance with NHP regulations, Health Canada now wields the power to impose more substantial fines and penalties.


Information Disclosure Health Canada has the ability to demand information from individuals or entities to assess whether an NHP product might pose a severe risk to human health.


Confidential Business Information This provision grants Health Canada the authority to disclose confidential business information when they believe that an NHP product could entail a significant health or injury risk or when it's necessary for safeguarding and promoting human health.


Incorporation by Reference This provision empowers Health Canada to seamlessly integrate external documents, standards, or guidelines into their regulatory processes, aligning them with established best practices.


Prohibition of False or Misleading Statements The bill explicitly outlaws false or misleading statements and providing inaccurate information to the Minister.


What Does Bill C-47 Mean for the Industry?

Bill C-47 revises the definition of therapeutic products within the Food and Drugs Act (FDA). This change eliminates the existing exemption for Natural Health Products from Vanessa's Law within the Natural Health Products Regulations (NHPR). Consequently, the provisions outlined above, drawn from the FDA, now extend to natural health products. The extent to which Health Canada will enforce these provisions hinges on the safety risk posed by the product. Generally, these powers will come into play when a serious health and/or safety risk is identified. It's crucial to highlight that these amendments include penalties of up to $5,000,000.00 CAD for non-compliance.


According to the NHPPA.org , the key issues here are:


Health Canada is implementing stricter regulations that will significantly impact consumer choice and restrict access to health products and supplements.


Health Canada is introducing new fees on natural health products, which will place a considerable financial strain on NHP businesses. This will lead to significant price hikes for consumers or even force many small to medium-sized companies out of business.


Increased Health Canada censorship will prevent truthful advertising by both manufacturers and natural health stores.


Huge new fines will cripple and destroy the natural health community. Prior to June 22, 2023, the maximum fine you faced for violating the laws on NHPs (such as selling a product with improper labelling) was $5,000. Now it is $5,000,000 a day.


 

Are Natural Health Products an Emergency or is there Something Else Here?


Vaccines vs. Natural Health Products The government's concern for safety is questionable. However, the same government has been pushing COVID-19 vaccines, which have unfortunately resulted in adverse reactions for millions individuals, including deaths. It's ironic that natural health products, which have a track record of supporting well-being for centuries, are suddenly deemed unsafe.


According to Dr. Denis Rancourt, the vaccines in Canada and the mandates resulted in approximately 35,000 deaths up to September 2023, and the genocide is continuing today.


Prior to the implementation of the COVID-19 vaccines, how many of you recall Health Canada saying "Doctors are Baffled"?


I wonder what else could be going on here?


Hmmm, how much money does big pharma pay into the government and lobby groups and the mainstream media. "This program brought to you by the good people at Phizer" ever heard that before?


The Soft Drink Dilemma Now, let's talk about soft drinks, the elephant in the room. These sugary beverages have wreaked havoc on the health of Canadians for decades. From contributing to obesity and diabetes to being linked to cancer, soft drinks are like silent assassins lurking in our refrigerators. Yet, where is the government's concern for safety here?


The Soda Statistics According to Health Canada, soft drinks are among the leading sources of added sugars in our diet. We're talking about teaspoons upon teaspoons of sugar in a single can of soda. And don't even get us started on diet sodas with their questionable artificial sweeteners.


The consumption of soft drinks has been associated with various health issues, and while it's difficult to pinpoint the exact number of deaths attributed to soft drink consumption worldwide, studies and data suggest that these beverages can contribute to significant health problems.

One of the most significant health concerns associated with excessive soft drink consumption is the risk of developing chronic conditions like obesity, type 2 diabetes, heart disease, and dental problems. These conditions can increase the risk of premature death.


Photo Credit: NBC News


Here are some key points related to the impact of soft drinks on health:

  1. Obesity: Soft drinks are often high in added sugars, which can contribute to weight gain and obesity when consumed in excess. Obesity is a major risk factor for numerous health problems and can lead to premature death.

  2. Type 2 Diabetes: High sugar intake, especially from sugary beverages like soft drinks, has been linked to an increased risk of developing type 2 diabetes. Poorly managed diabetes can lead to complications and a shortened lifespan.

  3. Heart Disease: Excessive consumption of sugary drinks has been associated with an increased risk of heart disease. Heart disease is one of the leading causes of death globally.

  4. Dental Problems: Soft drinks are acidic and can erode tooth enamel, leading to cavities and dental decay. Severe dental issues can impact overall health.

  5. Other Health Concerns: Soft drinks may contribute to other health problems, such as kidney disease, fatty liver disease, and certain types of cancer, although the links are more complex and require further research.


Now I am not calling for a ban on your favourite POP, but how is it that we are working to ban or restrict natural health products when soft drinks are available everywhere including schools?


Hmmm, how much money does big soft drink companies pay into the government and lobby groups and the mainstream media. "This program brought to you by the good people at Coke"


Natural Health Products: The Misunderstood Heroes On the other hand, natural health products often include vitamins, minerals, and herbal remedies. These products have been used by countless individuals worldwide to support their health naturally. While regulation is essential, it's perplexing that they are now perceived as dangerous.


A Call for Balanced Regulation The issue here is not about soft drinks being banned; it's about ensuring balanced regulation. Natural health products can indeed pose risks if misused, and they should be held to appropriate safety standards. But if we're talking about safety, let's address the most immediate and widespread threats first.


Conclusion While the government's intention to ensure our safety is commendable, it's essential to maintain a sense of proportion. Natural health products have played a crucial role in many people's well-being, along with diet and exercise. However, let's not forget the dangers lurking in our soda cans.


It's time for a more nuanced approach to regulation, one that addresses the most pressing health concerns Canadians face daily. Until then, it seems like soft drinks are getting a free pass while natural health products are left scratching their heads in disbelief.


 

The Dollars and Sense of Health Industries:

To truly grasp the disparity between Big Pharma, soft drinks, and the Natural Health Products industry, we need to delve into the financial figures.


Big Pharma:

The pharmaceutical industry is a colossal global entity. In 2020, the worldwide pharmaceutical market was estimated to be worth around $1.27 trillion USD. This mammoth figure is driven by research, development, manufacturing, and marketing of prescription drugs.


Soft Drinks:

The soft drink industry also racks up some significant numbers. In 2020, the global soft drink market was estimated at approximately $337 billion USD. This encompasses everything from carbonated sodas to fruit juices, sports drinks, and energy drinks.


Natural Health Products:

Now, let's shift our focus to the Natural Health Products industry. This is a bit more challenging to quantify, as it encompasses a wide range of products from vitamins and minerals to herbal supplements. However, estimates place the global dietary supplements market at around $150 billion USD in 2020.


The Balance Sheet:

When you compare these figures, it becomes evident that Big Pharma towers over the other two industries combined. Its financial might surpasses that of soft drinks and Natural Health Products put together. This isn't surprising given the high costs associated with pharmaceutical research and development.


Although the figures for big pharma from 2023 were not available, we can only imagine that the numbers have increased .


Yet, here's the catch: the soft drink industry, despite its adverse health effects, continues to thrive and expand. This is a testament to its marketing prowess and ubiquitous presence in our daily lives.


On the other hand, the Natural Health Products industry, while substantial, often struggles against stringent regulations and a lack of marketing muscle compared to Big Pharma and soft drink giants. The irony lies in the fact that it's the sector more focused on health and well-being that faces tougher scrutiny.


Conclusion:

The financial landscape of these industries offers a compelling narrative. It emphasizes the importance of balanced regulation and public awareness. While Big Pharma reigns supreme in terms of dollars, soft drinks have been alarmingly influential in our lives. Natural Health Products, with their potential to promote well-being, often face uphill battles.


As consumers, understanding the economics behind these industries can empower us to make informed choices for our health. It's a reminder that our health choices aren't merely personal but are deeply intertwined with the interests of these mammoth industries.


 

What Does the Government of Canada Say?


As of June 22, 2023, the powers conferred by the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) apply to natural health products (NHPs). This is because the definition of "therapeutic product" has been revised in the Food and Drugs Act to include natural health products.


The key authorities in the Food and Drugs Act that come into force immediately for natural health products are:

  • order a recall of NHPs that present a serious or imminent risk of injury to human health

  • require a label change or package modification, if necessary, to prevent serious injury to health

  • impose higher fines and penalties for non-compliance

  • order a person to provide information to determine if a product presents a serious risk of injury to human health

  • disclose confidential business information in circumstances where the product may present a serious risk of injury to human health or for the protection or promotion of human health or the safety of the public

  • incorporate by reference, and

  • prohibit false or misleading statements or information made to the Minister


The remaining authorities would come into force by an Order in Council later when supporting regulations are published. Supporting regulations would be subject to consultation.

The Act includes the following changes:


Definition of a therapeutic product

A therapeutic product is defined as a drug, a medical device or a combination thereof but does not include a Natural Health Product. These will continue to be regulated under the Natural Health Products Regulations.


Reporting of serious adverse drug reactions and medical device incidents by healthcare institutions

Certain healthcare institutions will be required to report serious adverse drug reactions and medical device incidents to the Minister of Health.


While most drugs are prescribed and used by patients outside of healthcare institutions, patients who experience serious reactions to drugs generally require hospitalization. Healthcare institutions, such as hospitals, are therefore in a unique position to identify and report serious adverse reactions.


New federal regulations setting out which information, how it is to be reported, and which healthcare institutions will be required to report, will be developed in consultation with provincial and territorial counterparts.


New powers for the Minister to compel information, gather more information, require new tests or studies, monitor experience, and conduct product assessments

Over the course of a therapeutic product's lifecycle, new information may raise questions about the product's effect on health and safety.


The Minister of Health will now have the authority to gather more information about the product. This can be done either by compelling persons to provide information for the purpose of assessing serious risks to health, or by requiring a therapeutic product authorization holder to compile information, conduct new tests or studies, or monitor experience. The Minister of Health may also direct a therapeutic product authorization holder to assess the benefits, harms and uncertainties of a product.


New ability for the Minister to disclose confidential business information related to therapeutic product safety

The Minister of Health will now have the authority to disclose confidential business information about a therapeutic product if the Minister believes it is necessary to determine whether a therapeutic product presents a serious risk of injury to human health.


As well, the Minister may now disclose confidential business information about a therapeutic product to a government, a person from whom the Minister seeks advice, or, a person who carries out functions relating to the protection or promotion of human health or the safety of the public if the purpose of the disclosure is related to the protection or promotion of human health or the safety of the public.


New power for the Minister to require companies to modify or replace drug or medical device labels or packaging

In certain situations, the potential harm from the use of the therapeutic product may not be adequately reflected on the approved label. In addition, similar looking or sounding brand names or similar looking packaging may pose a risk to health and lead to prescribing and dispensing errors.


When a determination is made that it is necessary to make revisions to prevent injury to health, the Minister of Health will now be able to direct an authorization holder to revise the label of a therapeutic product to include new harm information or to change the brand name or packaging.


New power for the Minister to recall unsafe therapeutic products

The Minister of Health will now be able to order the removal of a therapeutic product from the marketplace when a product presents an imminent or serious risk to health.


Obligation on therapeutic product authorization holders to make information about clinical trials publicly available

This new section places an obligation on therapeutic product authorization holders to ensure that prescribed information concerning any clinical trial is made public in a time and manner that will be set out in regulations. This could be accomplished by requiring mandatory registration of those trials on publicly accessible, well-established clinical trial registries.


Tougher measures for those who do not comply

Fines and penalties for those who do not comply with the Act will be increased, to a maximum penalty of $5,000,000 or 2 years in prison, to better reflect the serious nature of the offence. Additionally, a person who knowingly makes a false or misleading statement to the Minister of Health or who knowingly or recklessly causes a serious risk of injury in contravening the Act or its regulations could face a higher fine or up to five years in jail, at the discretion of the court. An injunction power will also be added such that, upon application of the Minister of Health, a court will be able to order a person to refrain from performing an act related to the commission of an offence under the Act.


Improving the Minister of Health’s ability to enforce the provisions of the Act allows the federal government to take more effective action against those who jeopardize the safety of Canadians. The increase in the level of fines is consistent with fines under other Canadian legislation, such as the Canadian Consumer Product Safety Act and the Safe Food for Canadians Act.


New ability to incorporate by reference

This enables the incorporation by reference of technical and non-technical documents relating to therapeutic products into the Food and Drug Regulations.


Currently, these types of documents can be included within the regulations by regulatory amendment. Incorporation by reference is a simpler and less time-consuming process that does not require regulatory amendment. The process of incorporation by reference will continue to involve appropriate scientific oversight and public accessibility. This approach will reduce red tape and allow the department to focus resources where they will have the greatest impact on the health and safety of Canadians.


An obligation on the Minister to make orders publicly available

The Minister of Health must make any orders issued under these new powers publicly available.


New authorities for the Governor in Council to make supporting regulations

These provisions set out new regulation-making authorities for the Governor in Council (GIC) that enable the implementation of the new amendments to the Act. Among other things, these authorities allow the GIC to make regulations authorizing the Minister to impose and amend terms and conditions on an authorization or licence; to require holders of clinical trial or investigational testing authorization to report safety information after the conclusion or discontinuation of the trial; to require an authorization or licence holder to report information concerning the safety of a therapeutic product issued by a foreign regulator; and to require an authorization or licence holder to conduct further test and studies. Regulation-making authorities also allow the GIC to prescribe how healthcare institution reporting requirements and recall provisions will function.


A new regulation-making authority, introduced by the House of Commons Standing Committee on Health, permits the GIC to make regulations that will require the Minister to ensure that certain decisions, and the reasons for those decisions, are made publicly available. These decisions relate to the issuance, amendment, suspension and revocation of an authorization, and the imposition or amendment of terms and conditions on a licence.



 

Additional Comments and Background


For those of you who may not be aware of how "Vanessa's Law" came about. It was predicated on the death of 15 year old Vanessa Young of Oakville Ontario, who died from heart arrhythmia caused by a common prescription acid reflux drug. That dug was later taken off the market.


Partially because of this case "The Protecting Canadians from Unsafe Drugs Act" was passed by the Canadian Parliament. This law is often referred to as "Vanessa's Law".



This law was passed on November 6, 2014.


"The law was intended to increase drug and medical device safety in Canada through various measures, including strengthening Health Canada’s ability to better monitor the safety of products being used by Canadians by requiring hospitals to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs).


Vanessa’s Law also empowers Health Canada to order recalls, impose tougher penalties for unsafe products and compel drug companies to review labels or do further testing on products."


I wonder how this law was applied to the COVID-19 SHOTS?


According to this law, it is mandatory for all hospitals to report serious Adverse Drug Reactions (ADR's)


I guess that did not apply to COVID-19 shots! Where doctors were fired for reporting adverse reactions.


So one has to ask the question, who are the actual people who died as a result of the Natural Food Products in Canada. Where is the Natural Food Products Vanessa?


According to Health Canada over 488 patients, in Canada, died from taking the COVID-19 vaccines. How are these medications still. on the market?


Why now?


Why now when Canada has gone through the worst case of prescription drug adverse reactions, including death due to a mandatory PRESCRIPTION COVID-19 injections. BTW those injections were never evaluated under the traditional Food and Drug regulations, and still to this day are exempt from those regulations to prove objective safety and efficacy.


My understanding that following the COVID-19 fiasco, more and more Canadians were looking toward natural health alternatives.


So my question is why?


Follow the money!


 

Let us know what you think, comment below!


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