The regulation of natural health products (NHPs) in Canada: myths and facts

Myth: Since the Natural Health Products Regulations (NHPR) fall under the Food and Drugs Act (Act), NHPs are subject to the same level of scrutiny as prescription drugs.

Fact:

• The NHPR is a newer and distinct regulatory framework under the Act, which reflects the unique nature of NHPs. The NHPR is separate from the regulations which govern prescription drugs.
• The NHPR outlines the requirements for the sale, manufacturing, packaging, labelling, importation for sale, and distribution of NHPs in Canada.

Myth: The evidence required to obtain an NHP licence is unreasonable.

Fact:

• A wide range of evidence is accepted to support the safety and efficacy of NHPs and their associated health claims because of the diverse nature of the Canadian NHP market and the range of health claims. (A health claim is the recommended use or purpose for the product.)
• The accepted evidence includes references to published studies, journals, pharmacopoeias (books describing medicinal preparations issued by governments and recognized authorities, such as the Pharmacopoeia of the People's Republic of China) as well as traditional resources (e.g., references in support of Traditional Chinese Medicine) and clinical trial data.
• The more serious the claim, the higher the evidence requirements. The level of evidence required for a claim to treat a disease (e.g., for the treatment of mild and transitory depressive disorders) is higher than for a claim of health maintenance (helps to maintain joint health).

Myth: Since the Natural Health Products Regulations (NHPR) came into effect, Canadians have had access to fewer NHPs.

Fact:

• Since the introduction of the NHPR, the number of NHPs available to Canadians has grown steadily.
• Today, Canadians have access to over 55 000 authorized NHPs and the number continues to grow.
• According to a July 2010 survey sponsored by Consumer Health Products Canada "most Canadians (76%) say that the selection of NHPs available to them has increased (54% of respondents) or remained the same (22% of respondents) over the past two years. By contrast, only 2% said the selection had declined."

Myth: Health Canada is refusing a large number of products, thereby reducing access.

Fact:

• To date, Health Canada has authorized for sale over 55 000 NHPs.
• As the chart below illustrates, since 2007 the rate of products licensed has remained significantly higher than the number of products refused.
• The number of product licence applications completed per month has increased from 793 in October 2011 to 1 291 in July 2012, a 63% increase.
• As well, the product licensing rate has increased from 57% (455/793) in October 2011 to 81% (1 045/1 291) in July 2012.
• Since 2008, the majority of refusals were due to failure to meet basic application requirements (47%) and not responding to Health Canada requests for further information (29%).
• Refusal rates for applications failing to meet basic application requirements decreased from 20% in October 2011 to 1% in July 2012.
• Refusal rates for applications meeting pre-cleared information have decreased from 24% in October 2011 to <1% in July 2012. Pre-cleared information is any form of information supporting the safety, efficacy or quality of a medicinal ingredient or NHP that the Natural Health Products Directorate has reviewed and determined to be acceptable.

Product licences issued vs. refused per year

Myth: Health Canada inspectors persecute NHP producers/retailers.

Fact:

• When a compliance issue is identified, Health Canada works with the affected company to ensure that the risks to health and safety are mitigated through voluntary actions.
• NHP post-market activities are focused on situations that pose risks to the health and safety of Canadians, e.g., poorly manufactured NHPs, health claims not supported by evidence. Any action taken is guided by sound risk analysis and proportional to the assessed level of risk based on science.
• Health Canada responds to complaints from consumers, practitioners or industry, and prioritizes those complaints based on the level of risk to the health and safety of Canadians.

Myth: Health Canada is not accountable for how it manages and reviews applications and makes decisions.

Fact:

• Application management policy-it's available on the website and includes details on how to file an application and the application review process.
• Reconsideration of decision-a product licence applicant can request a reconsideration of a decision on an application.
• Performance targets-proposed targets are published for the various types of product licence applications and there are plans to shorten targets.
• Pre-submission meetings-Health Canada offers product licence applicants the opportunity to have a meeting prior to submitting an application to discuss evidence and other requirements in support of the application.
• Evidence requirements for applications-revised guidance documents specifying what is required to support an application were published for a 90-day consultation ending August 21, 2012. These documents equip stakeholders with the straightforward information and tools they need to bring products to market, and provide innovative pathways for licensing products.
• Pre-cleared information-Health Canada publishes on its website approved pre-cleared information (e.g., previous licensing decisions) which product licence applicants can cite in support of their application.

Myth: Health Canada's process is confusing for NHP product licence applicants and loaded with red tape.

Fact:

• Health Canada has developed a new approach to NHPs that focuses on getting the level of oversight for these products right. This means eliminating unnecessary red tape for companies trying to bring products to market while continuing to protect consumer safety.
• Review times for applications will be based on how much we know about a product's benefits and risks, relying on a library of information amassed from the authorization of over 55 000 NHPs.
• This means that products about which we know the most will be reviewed in a shorter period of time than those for which we have less certainty. Our evaluation efforts will be focused on the latter group.
• A new three-class system will enable us to determine how much review time a product needs, starting with Class I products that will move through the system the most quickly up to the more complex class III products, which will require more review before approval.  See chart below.

Natural Health Products Directorate product licence applications: level of certainty* and level of pre-market review required (* how much is known about product - pre-cleared information)

More pre-cleared information developed = less review required

Myth: The new approach to NHPs will compromise the safety of NHPs.

Fact:

• The new approach to NHPs will achieve a balance that ensures safety and consumer access while enabling industry innovation and growth.
• Shortened review time does not change the measures in place to protect consumer safety. The level of evidence required to demonstrate safety remains the same, and products will continue to be labelled with required cautionary statements.
• Health Canada will continue to focus its post-market activities for NHPs on situations that pose risks to the health and safety of Canadians, e.g., poor manufacturing, adulteration (e.g., addition of prescription and non-prescription drugs to NHPs), or products making claims not substantiated by evidence.
• The regulatory requirement for a company to submit reports of serious adverse reactions will not change, and we will also continue to collect, track, and analyze adverse reactions to NHPs through the Canada Vigilance Program. When analysis of this adverse reaction information shows that there is a need to take action to protect the health and safety of Canadians, Health Canada can take a range of steps such as changes to product labelling, distribution of information to consumers and health professionals, and, in more serious cases, removal of a product from the market.