Len Monheit07.01.06
A multi-year consultative development process led to Canada's Natural Health Products regulations, a system that most agreed would bear watching as a possible model for other regions where the distinctive characteristics of natural health products could be recognized and the products treated as neither foods nor drugs, but as an entirely separate class of products. We're now two-and-a-half years into the new regulatory environment. Apparently what began as good regulation in theory has come up against serious challenge and criticism. Most agree, though, that when fully implemented and enforced, these regulations have the potential to create a unique environment where consumers have access both to a broad range of natural health products, and access to information in the form of substantiated health claims. But there is still a long way to go.
In January of 2000, Phil Waddington was appointed Director General of the Natural Health Products Directorate (NHPD) of Health Canada. The Directorate was tasked with the responsibility of framing and implementing regulations and guidelines for natural health products, based on 53 recommendations of the Standing Committee on Health, and after a thorough consultative process with stakeholder groups across the country. The objective of the regulations was and remains "to ensure that Canadians have ready access to natural health products that are safe, effective and of high quality while respecting freedom of choice and philosophical and cultural diversity."
Canada's Natural Health Products (NHP) regulations came into effect on January 1, 2004, covering vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines (i.e., traditional Chinese medicines), probiotics, and other products like amino acids and essential fatty acids.
The regulations apply to companies involved in manufacturing, packaging, labeling or importing natural health products. As these regulations were phased in, a risk oriented enforcement strategy was developed by NHPD to transition existing available products on the market to make the change to the Natural Health Products environment.
The NHP regulations outline Good Manufacturing Practice (GMP) standards, which must be followed by those involved in manufacturing, packaging, labeling or importing of products or ingredients. This requires that facilities involved in these operations obtain a Site Manufacturing License from NHPD. As of January 1, 2006, all facilities were required to have this license and NHPD enforcement action was initiated in this area.
Applicants must submit evidence to support a claim they wish to make associated with the product, with NHPD allowing therapeutic claims, risk reduction claims and structure-function claims, in addition to non-specific claims. Claims are sub-divided into either traditional or non-traditional use. NHPD has established criteria for the evaluation of the evidence to support the conditions of use of the product, including totality of evidence.
All natural health products offered for sale are required to have product licenses by the time the regulations are completely phased in on January 1, 2008. Any products with an identified health risk are an immediate priority for NHPD enforcement activity. As far as enforcement for non-compliant products is concerned, NHPD has divided products into six categories based on risk, and as of today, deadline dates have passed for three of the categories, including products on Health Canada's listing of New Drugs, isolates, amino acids, fatty acids, concentrated volatile oils and extracts other than those prepared by traditional methods and algal, bacterial, probiotic, fungal and non-human animal materials. Deadline dates for the other categories have recently been revised (see Table 1).
The process of acquiring an NPN involves submitting a product license application to NHPD along with safety and efficacy information to support the claim. Companies making submissions receive an acknowledgement letter (and number) when the file is logged by NHPD, informing them that the product is in the queue. Health Canada is currently focusing its compliance efforts against NHPs that have not been issued submission numbers by Health Canada, acknowledgement of receipt of a complete Product License Application including all required information.
NHPD has posted numerous monographs, so if a company wishes to make a simple monograph claim, they need only refer to the monograph and a shorter turnaround time theoretically applies. This compares to a lengthy, some would claim impractical turnaround time for more complicated submissions.
It quickly became apparent under the new regulations that the NHPD would be unable to deliver the quick turnaround times it originally predicted and that a backlog of product submissions would evolve. In its most recent communications, NHPD has identified steps it is taking to reduce the backlog of over 10,000 product license applications pending, stating it "can no longer afford to accept poor quality applications-all incomplete submissions are being returned." The immediate impact of this measure was a reduction of 500 in the number of product submissions backlogged.
Another development post-January 2004 was the ability of ingredient suppliers to provide ingredient master files to NHPD. Finished product manufacturers would then reference these ingredient master files in their product license applications. One challenge to this system is that the ingredient files are not reviewed for completion by NHPD until they are actually referenced in an NPN submission. Conceivably, this means that a deficient ingredient master file might not trigger any action until months or even years after it was created by the ingredient company, if no finished product references it. Only then would the NPN applicant and presumably master file creator be notified of a deficiency.
As of December 31, 2005, all companies involved in the manufacturing, packaging, labeling, and importing of Natural health Products must carry a Site License. According to the regulations, a company must have standards and practices regarding product manufacture, storage, handling and distribution in order to obtain a site license. This process involves a company self-assessment and submission of an application.
In an April presentation to industry, NHPD admitted that because of the current backlog in product approvals, a system redesign would be required for a long-term solution. NHPD performance to date was communicated including 13,200 product and site license applications received since 2004, 1,570 product licenses issued, 290 site licenses issued, and a current rate of 28 applications received per day compared to an output of eight licenses per day. As of April, the backlog stood at 11,340 applications. NHPD has increased evaluation staff to 126 people, and established an objective of processing 72 licenses per day by 2007. Another objective expressed by NHPD was its desire to expand the list of monographs from the current 86 to over 300 by December 2006.
On the positive side, NHPD has eliminated its backlog in logging and analysis of submissions, allowing it to focus on evaluation. The NHPD also communicated its objective to post application forms online by June, publish new guidance documents by summer 2006, and allow online submissions by the end of 2006. As it reviews the regulations, it expects to eventually establish a cost recovery system once performance standards are being met. NHPD has also eliminated its backlog of Clinical Trials approvals, intending to keep this backlog clear in the future.
Other recent communications from NHPD involve marketing and enforcement strategies. In April, NHPD advised that using the term "NPN Pending" on labels was formally prohibited, a transition strategy many in the industry had been using to enable new product introduction due to lack of movement on the backlog.
Two-and-a-half years into the current regulatory environment has left everyone frustrated at the promise of the new regulations not being met.
According to Robert Ross-Fichtner, director of compliance consultants Focal Point Research, "The new regulations allow products to legally make health claims that were either difficult or impossible to make prior to 2004. The optimism of these new regulations has been dampened by the difficulty in getting applications for new products approved in a timely way." In fact, Ross-Fichtner continues, "Some companies that strictly adhere to compliance with regulations have walked away from the Canadian market, or are postponing plans until lead times to approval become more certain."
Alicia Wojewnik of Dicentra, Inc. commented, "One of the biggest frustrations is inconsistency of reviewers, as frequently each requests different items. We've experienced cases where new requirements for quality are suddenly introduced, such as effectiveness tests for preservatives, or an animal tissue form of vitamin D is required. And when you use the information line set up by NHPD, a response is rare. It seems as though they're confused and disorganized and the answers, instead of being thorough, are only partially relevant."
On the positive side, Ross-Fichtner pointed out the hiring of more front line personnel. Further, Ms. Wojewnik highlighted the monthly and quarterly communications issued by NHPD as providing excellent general information about the status of NHPD, as well as compliance and enforcement.
The most critical aspect of the NHP regulations from an industry perspective, is ability to get products through the system in a compliant, cost effective and time efficient manner. Here NHPD is facing its biggest challenge and industry's biggest frustration. According to Mr. Ross-Fichtner, "The length of time to get a Product License into the system, and then approved is the issue.NHPD is more than aware of this and are announcing improvements to the process."
The backlog and measures taken to address it are also challenging. Ms. Wojewnik confirmed, "NHPD automatically rejects all incomplete submissions. For example, applications with lots of references are being rejected if two full-text copies of each essential reference are not provided. This requires reams of paper, and CDs containing the referenced attached are not permitted and are not reviewed. Even if the reference comes from the NHPD itself, it is still required as two full text hard copies with the application."
The Canadian regulations are clearly an example of where theory and practice have yet to become aligned. There is optimism that the model is viable, but the devil is in the details. A clear example of this issue is the strategy regarding food and beverage products containing natural ingredients. Early on in the approval process, NHPD granted an NPN to Red Bull energy drink, a move that was of interest to food and beverage companies who hoped that the new environment might enable them to make health-related claims. Currently, though, NHPD and its sister Directorate (Foods) are engaged in branch level review to determine what the evaluation process for such products will ultimately be, in the meantime freezing all pending product applications, including drinks, bars, spreads and juices.
To its credit, NHPD continues its open, consultative approach with industry and with consumers. It has been honest in stating its challenges and from leadership on down appears committed to providing the access to products outlined in its mission. In the future, the resources NHPD is allocated and the level of its ongoing dialogue with industry will be key factors in determining the success of this particular regulatory model.NW
About the author: Len Monheit is the president and CEO of NPI Center, Mississauga, Ontario, Canada, a major online resource for the dietary supplement, personal care and functional food industries. He can be reached at 877-463-0110; E-mail: len@npicenter.com; Website: www.npicenter.com.
The History of Natural Product Regulation
In January of 2000, Phil Waddington was appointed Director General of the Natural Health Products Directorate (NHPD) of Health Canada. The Directorate was tasked with the responsibility of framing and implementing regulations and guidelines for natural health products, based on 53 recommendations of the Standing Committee on Health, and after a thorough consultative process with stakeholder groups across the country. The objective of the regulations was and remains "to ensure that Canadians have ready access to natural health products that are safe, effective and of high quality while respecting freedom of choice and philosophical and cultural diversity."
Canada's Natural Health Products (NHP) regulations came into effect on January 1, 2004, covering vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines (i.e., traditional Chinese medicines), probiotics, and other products like amino acids and essential fatty acids.
The regulations apply to companies involved in manufacturing, packaging, labeling or importing natural health products. As these regulations were phased in, a risk oriented enforcement strategy was developed by NHPD to transition existing available products on the market to make the change to the Natural Health Products environment.
Critical Aspects of the Regulations
The NHP regulations outline Good Manufacturing Practice (GMP) standards, which must be followed by those involved in manufacturing, packaging, labeling or importing of products or ingredients. This requires that facilities involved in these operations obtain a Site Manufacturing License from NHPD. As of January 1, 2006, all facilities were required to have this license and NHPD enforcement action was initiated in this area.
Requirement for a Claim
Applicants must submit evidence to support a claim they wish to make associated with the product, with NHPD allowing therapeutic claims, risk reduction claims and structure-function claims, in addition to non-specific claims. Claims are sub-divided into either traditional or non-traditional use. NHPD has established criteria for the evaluation of the evidence to support the conditions of use of the product, including totality of evidence.
Natural Product Numbers (NPNs)
All natural health products offered for sale are required to have product licenses by the time the regulations are completely phased in on January 1, 2008. Any products with an identified health risk are an immediate priority for NHPD enforcement activity. As far as enforcement for non-compliant products is concerned, NHPD has divided products into six categories based on risk, and as of today, deadline dates have passed for three of the categories, including products on Health Canada's listing of New Drugs, isolates, amino acids, fatty acids, concentrated volatile oils and extracts other than those prepared by traditional methods and algal, bacterial, probiotic, fungal and non-human animal materials. Deadline dates for the other categories have recently been revised (see Table 1).
The process of acquiring an NPN involves submitting a product license application to NHPD along with safety and efficacy information to support the claim. Companies making submissions receive an acknowledgement letter (and number) when the file is logged by NHPD, informing them that the product is in the queue. Health Canada is currently focusing its compliance efforts against NHPs that have not been issued submission numbers by Health Canada, acknowledgement of receipt of a complete Product License Application including all required information.
NHPD has posted numerous monographs, so if a company wishes to make a simple monograph claim, they need only refer to the monograph and a shorter turnaround time theoretically applies. This compares to a lengthy, some would claim impractical turnaround time for more complicated submissions.
It quickly became apparent under the new regulations that the NHPD would be unable to deliver the quick turnaround times it originally predicted and that a backlog of product submissions would evolve. In its most recent communications, NHPD has identified steps it is taking to reduce the backlog of over 10,000 product license applications pending, stating it "can no longer afford to accept poor quality applications-all incomplete submissions are being returned." The immediate impact of this measure was a reduction of 500 in the number of product submissions backlogged.
Another development post-January 2004 was the ability of ingredient suppliers to provide ingredient master files to NHPD. Finished product manufacturers would then reference these ingredient master files in their product license applications. One challenge to this system is that the ingredient files are not reviewed for completion by NHPD until they are actually referenced in an NPN submission. Conceivably, this means that a deficient ingredient master file might not trigger any action until months or even years after it was created by the ingredient company, if no finished product references it. Only then would the NPN applicant and presumably master file creator be notified of a deficiency.
Site Licenses Mandatory
As of December 31, 2005, all companies involved in the manufacturing, packaging, labeling, and importing of Natural health Products must carry a Site License. According to the regulations, a company must have standards and practices regarding product manufacture, storage, handling and distribution in order to obtain a site license. This process involves a company self-assessment and submission of an application.
Other Recent Developments and Observations
In an April presentation to industry, NHPD admitted that because of the current backlog in product approvals, a system redesign would be required for a long-term solution. NHPD performance to date was communicated including 13,200 product and site license applications received since 2004, 1,570 product licenses issued, 290 site licenses issued, and a current rate of 28 applications received per day compared to an output of eight licenses per day. As of April, the backlog stood at 11,340 applications. NHPD has increased evaluation staff to 126 people, and established an objective of processing 72 licenses per day by 2007. Another objective expressed by NHPD was its desire to expand the list of monographs from the current 86 to over 300 by December 2006.
On the positive side, NHPD has eliminated its backlog in logging and analysis of submissions, allowing it to focus on evaluation. The NHPD also communicated its objective to post application forms online by June, publish new guidance documents by summer 2006, and allow online submissions by the end of 2006. As it reviews the regulations, it expects to eventually establish a cost recovery system once performance standards are being met. NHPD has also eliminated its backlog of Clinical Trials approvals, intending to keep this backlog clear in the future.
Other recent communications from NHPD involve marketing and enforcement strategies. In April, NHPD advised that using the term "NPN Pending" on labels was formally prohibited, a transition strategy many in the industry had been using to enable new product introduction due to lack of movement on the backlog.
Two-and-a-half years into the current regulatory environment has left everyone frustrated at the promise of the new regulations not being met.
According to Robert Ross-Fichtner, director of compliance consultants Focal Point Research, "The new regulations allow products to legally make health claims that were either difficult or impossible to make prior to 2004. The optimism of these new regulations has been dampened by the difficulty in getting applications for new products approved in a timely way." In fact, Ross-Fichtner continues, "Some companies that strictly adhere to compliance with regulations have walked away from the Canadian market, or are postponing plans until lead times to approval become more certain."
Alicia Wojewnik of Dicentra, Inc. commented, "One of the biggest frustrations is inconsistency of reviewers, as frequently each requests different items. We've experienced cases where new requirements for quality are suddenly introduced, such as effectiveness tests for preservatives, or an animal tissue form of vitamin D is required. And when you use the information line set up by NHPD, a response is rare. It seems as though they're confused and disorganized and the answers, instead of being thorough, are only partially relevant."
On the positive side, Ross-Fichtner pointed out the hiring of more front line personnel. Further, Ms. Wojewnik highlighted the monthly and quarterly communications issued by NHPD as providing excellent general information about the status of NHPD, as well as compliance and enforcement.
The most critical aspect of the NHP regulations from an industry perspective, is ability to get products through the system in a compliant, cost effective and time efficient manner. Here NHPD is facing its biggest challenge and industry's biggest frustration. According to Mr. Ross-Fichtner, "The length of time to get a Product License into the system, and then approved is the issue.NHPD is more than aware of this and are announcing improvements to the process."
The backlog and measures taken to address it are also challenging. Ms. Wojewnik confirmed, "NHPD automatically rejects all incomplete submissions. For example, applications with lots of references are being rejected if two full-text copies of each essential reference are not provided. This requires reams of paper, and CDs containing the referenced attached are not permitted and are not reviewed. Even if the reference comes from the NHPD itself, it is still required as two full text hard copies with the application."
In the End
The Canadian regulations are clearly an example of where theory and practice have yet to become aligned. There is optimism that the model is viable, but the devil is in the details. A clear example of this issue is the strategy regarding food and beverage products containing natural ingredients. Early on in the approval process, NHPD granted an NPN to Red Bull energy drink, a move that was of interest to food and beverage companies who hoped that the new environment might enable them to make health-related claims. Currently, though, NHPD and its sister Directorate (Foods) are engaged in branch level review to determine what the evaluation process for such products will ultimately be, in the meantime freezing all pending product applications, including drinks, bars, spreads and juices.
To its credit, NHPD continues its open, consultative approach with industry and with consumers. It has been honest in stating its challenges and from leadership on down appears committed to providing the access to products outlined in its mission. In the future, the resources NHPD is allocated and the level of its ongoing dialogue with industry will be key factors in determining the success of this particular regulatory model.NW
About the author: Len Monheit is the president and CEO of NPI Center, Mississauga, Ontario, Canada, a major online resource for the dietary supplement, personal care and functional food industries. He can be reached at 877-463-0110; E-mail: len@npicenter.com; Website: www.npicenter.com.
