2017 report on compliance monitoring: Good manufacturing practices for natural health products

We visited the facilities of 23 natural health product companies across Canada in 2017 to check how they followed good manufacturing practices. Learn about how we conducted our review, what we found and what actions we took.

Why did we do this review?

Companies must hold a site licence to manufacture, package, label or import natural health products (NHPs) in Canada. We grant site licences to companies based on our review of the documents in their applications. Companies must follow good manufacturing practices (GMP) requirements in the Natural Health Product Regulations (the Regulations) when carrying out their activities. These requirements are specific for NHPs ("NHP GMPs"). They have been in place since 2004 to help ensure the safety and quality standards are in place for these products.

Currently, we take a risk based and complaint driven approach to post-market activities for NHPs. The Health Canada report Evaluation of the Natural Health Products Program 2010-2011 to 2014-2015 was published in 2016. It recommends the use of proactive tools such as inspections to balance the current paper-based licensing process. This was the first time we performed a series of planned visits of NHP facilities. We have sampled and tested products on the market before but this was a different way of checking the safety and quality of products in Canada. We saw how different companies followed NHP GMPs. Many companies used our visits as a chance to clarify the requirements in order to follow them better. Our findings will help us improve the safety of NHPs in Canada.

What did we focus on?

We focussed on two types of companies that conduct higher risk activities:

Manfacturers:: Companies who manufacture NHPs have the most direct impact on product safety and quality when it comes to NHP GMPs. For example, NHPs need to be made using clean equipment by properly trained staff. Companies need to test their products to make sure what is on the label is what ends up in the bottle. They need to keep good records of their supply chain and a process in place for product recalls.
Importers:: Many products are made outside of Canada. Importers need to make sure that the products they bring into the country are made in facilities that follow NHP GMPs. For example, importers need to give us proof that each foreign site they import from has NHP GMPs in place. They need to make sure the products they import have been tested for safety and quality. They also need a process in place for product recalls.

Some companies also manufacture and package sterile NHPs. They must meet further requirements on sterility. We paid particular attention to those companies who hold a licence to manufacture sterile NHPs. This is because improper sterility can have a negative impact on the health of Canadians.

We selected facilities randomly beyond these criteria. This allowed us to visit different types of facilities.

What did we do?

Inspectors visited the facilities of 23 companies between February and April 2017. This was about 3% of all companies with NHP site licences in Canada at the time. We visited the facilities of:

12 companies that import NHPs (4% of total importers)
4 companies that manufacture, package and label sterile NHPs (100% of total sterile manufacturers)
7 companies that manufacture, package and label non-sterile NHPs (4% of total non-sterile manufacturers).

Over 90% of all companies with site licences are located in Ontario, Quebec or British Columbia.

We did not review all NHP GMP requirements in the Regulations at all facilities. We focussed on key aspects. Inspectors checked for example:

Are the premises clean?
Are there records showing that staff are trained on how to carry out their tasks?
Are procedures kept up to date and followed?
Are there processes in place to prevent product contamination?
Is the quality of products being reviewed before they are made available on the market?
Do companies have a process in place to receive and investigate complaints and recall products?

Inspectors spent 1 to 4 days at each facility depending on its type and complexity.

Companies must have test results for all NHPs they manufacture or import. We tested products at our own laboratories during the review if we believed there might be a problem with the company's processes or test results. The type of tests conducted was based on the inspector's findings and specific quality or safety concerns. For example, we tested a sterile product to check that it was in fact sterile. We tested 10 products in total and obtained results that were not satisfactory for 6 of them. We noted when further actions were taken based on the results in Table 2 and Table 3 below.

After each visit, the inspectors provided a summary of findings to the company.

What did we find?

During our 23 visits, we found areas where companies need to improve their practices to meet NHP GMPs. We found that some companies held site licences but had not recently conducted activities for NHPs. This is mainly because there is currently no fee associated with applying for, renewing or maintaining a site licence.

Compliance issues ranging in severity were found at all facilities. We, however, look at the whole picture of what we see during a visit to assess general compliance with NHP GMPs. We classify each issue according to the potential risk it poses to the health and safety of Canadians. Examples of risk classifications are outlined in the Good Manufacturing Practices Guidance Document for NHPs.

Table 1: Examples of findings at manufacturers and importers
Section of Regulations	What we found^{table 1 note a}	Why this matters
Premises (section 45)	Raw material (ingredients), packaging material and finished products were not being stored under conditions that would maintain their quality and safety. This could include not having clearly marked areas to quarantine materials that have or have not been approved for use.	The building must be designed and constructed in a manner that permits cleanliness and orderliness and prevents contamination. Regular upkeep is required to prevent deterioration of the premises. The goal is that products do not become contaminated because of unsanitary conditions.
Personnel (section 47)	There were issues with the role of the quality assurance person at the facility. This could include that a person had not been assigned to the role or they did not have adequate training, experience and technical knowledge to perform their duties.	People are the most important element in performing any licensed activity. Personnel with sufficient training are necessary to maintain the high quality of NHPs. It is essential that qualified personnel supervise all activities involving NHPs. The operations involved in the handling of NHPs require constant monitoring, attention to details and a high degree of competence on the part of employees. Inadequate qualification or training of personnel may lead to an NHP not meeting its specifications and its quality standards.
Sanitation Program and Equipment (sections 48 and 46)	The sanitation program of the facility was not adequate. For example: The premise did not appear clean, organized or well maintained. Personnel did not follow health and hygiene requirements. There were no clear written cleaning procedures for the facility. Cleaning logs were not used or were missing important information such as the date and name of person who cleaned the area.	Sanitation of a building and employee hygiene affects the quality of NHPs. The NHP GMPs require that activities be performed in areas that are free from environmental contamination and free from contamination by another product. A written sanitation program informs employees of the expectation as well as the necessary steps to maintain sanitation. It also gives some assurance that cleanliness in the building is looked after. The purpose of requirements related to equipment is to prevent the contamination of NHPs by other products, dust, cleaning agents and foreign materials such as rust, lubricant and particles coming from the equipment. Contamination problems may arise from inadequate cleaning practices, poor maintenance, the misuse of equipment or the use of worn-out equipment. Equipment arranged in an orderly manner permits effective cleaning and limits interference with other operations. It also reduces the circulation of personnel and optimizes the flow of materials.
Operations (sections 49 and 50)	There were issues with the tracking records for raw materials or with the quality/technical agreements between contractors who conduct activities on behalf of the site licence holder.	The Regulations require that measures be in place to maintain the integrity of an NHP from when the raw materials enter the building to the time the finished product is released and distributed for sale. This means that companies must ensure that practices and procedures are in place for material control, process control, the inspection program for contractors, and product recall, where applicable.
Quality Assurance (section 51)	Finished products were not being assessed against their specifications or the finished product specifications were missing important information.	Quality assurance is the area concerned with sampling, specifications, testing, including documentation and release procedures. The quality assurance person must ensure that each product is suitable for sale. This regulation ensures that the necessary and relevant tests are carried out and that products are not released for sale until their quality has been determined to be adequate by confirming that product specifications are met. There are two important aspects to ensuring that a product meets its specifications. The first is that product specifications are established. The second is that the manufacturer has a quality system in place to make sure the product consistently meets the established specifications. Testing on finished products complements the controls employed during the manufacturing and importing processes. Each manufacturer and importer must have accurate specifications, adequate quality systems in place, and appropriate test methods. Where test methods exist (such as a pharmacopeia method), companies must not rely on quantification by input. Quantification by input is acceptable only if there is no appropriate test method to accurately determine the quantity of a medicinal ingredient in the finished product. You can find more information on quantification by input in the Quality of Natural Health Products Guide.
Stability (section 52)	There was no data, scientific rationale or program available to establish a product's shelf life (expiry date).	The purpose of a stability program is to determine how long the NHP can be expected to remain within its specifications under recommended storage conditions. Without data or a scientific rationale to demonstrate that an NHP meets its label claims at the expiry date, companies cannot reasonably ensure that the NHP is safe, of acceptable quality and effective until it expires.
Recall Reporting (section 62)	Written procedures for recalls did not specify that the information in section 62 must be given to the Minister within three days of the recall start date.	The requirements for a recall system and recall reporting ensure that a licence holder can recall a product successfully, with all the pertinent information available. It also ensures that all products on the market are disposed of correctly.
Site Licences (sections 26-42)	Importers had not demonstrated that imported products were compliant with NHP GMPs.	Importers need to prove that the foreign companies manufacture, package and label the products they import follow Canadian NHP GMPs. This can be done by adding foreign sites to the importer's site licence once we receive appropriate supporting evidence. When companies have not notified us about foreign sites from which they are importing, we may not have reviewed whether the foreign site, and by extension any products that come from that site, meet Canadian NHP GMPs.
Table 1 Notes Table 1 Note a Note: This is not a complete list. Return to table 1 note a referrer

What enforcement actions did we take?

We considered the nature and extent of all issues noted at the 23 facilities and took the necessary actions to protect the health and safety of Canadians. This included asking for stop sales and recalls of certain products. Half (11 out of the 23) of site visits identified issues significant enough for us to notify the company through a regulatory letter that we were considering suspending, and in some cases suspended, the company's site and/or product licence. As a result of our visits, some companies and products no longer hold valid licences. We removed companies no longer holding a site licence from our online List of site licence holders.

Companies need to put measures in place to ensure that they meet the regulatory requirements and are responsible for taking action to fix problems when they occur. They were given the opportunity to correct issues during the visits, where possible.

Details on the issues identified and actions that we have taken for each visit as of the date of this report are listed below. After following up with four companies at the time of initial publishing of this report, all companies have now addressed the issues to our satisfaction.

We will also assess that all site licence holders continue to meet their obligations at the time of the renewal of their site licence.

Table 2: Findings and enforcement actions at manufacturers (also licensed to package and label)
Establishment name	Province	Where we identified issues^{table 2 note b}	Actions
Agri-Food Discovery Place	Alberta	Sanitation Program Equipment Quality Assurance Operations Stability Recall Reporting	After the site visit, we asked the company for more information about the issues we noted. We reviewed their response and found it to be adequate. No further follow-up is required at this time.
Aqua Rems Inc.	Ontario	Premises Personnel Sanitation Program Equipment Operations Quality Assurance Stability	As part of the site visit, upon our request, the company stopped selling products that did not have a valid product licence. We also asked the company to remove health claims from the labels of any cosmetic products. After the site visit, we sent the company regulatory letters about the issues we noted and the likely impact on their product licences and site licence if the issues were not addressed. We reviewed their response and found that it was not adequate. We suspended their product licences and site licence on October 3, 2017. The company has since asked to discontinue their site licence. Their product licences may be reinstated if the company provides acceptable information that addresses all of the issues we noted. Update (2018-04-27): The company gave us information about the issues with its suspended product licences. We reviewed their response and found it to be adequate, thus reinstated their product licence. No further follow-up is required at this time.
David Jones Services (sterile)	Quebec	Premises Personnel Sanitation Program Equipment Operations Quality Assurance Stability We were not able to assess sterility as the company was found to be in the process of setting up to conduct these activities.	As part of the site visit, upon our request, the product licence holder for non-sterile products made by David Jones Services stopped selling products that had insufficient testing. After the site visit, we sent the company a regulatory letter about the issues we noted and the likely impact on their site licence. We reviewed their response and found it to be adequate. No further follow-up is required at this time.
Flora Beverages Co., Ltd.	Alberta	Premises Personnel Sanitation Program Equipment Operations Quality Assurance Stability Recall Reporting	As part of the site visit, upon our request, the company stopped selling the product Bitterswede. They also recalled 4 lots of Bitterswede on March 27, 2017. After the site visit, we sent the company regulatory letters about the issues we noted and the likely impact on their product licences and site licence if the issues were not addressed. The company asked to discontinue their site and product licences.
International Nutrition Ltd.	Ontario	Equipment Operations Quality Assurance Stability Recall Reporting	After the site visit, we sent the company a regulatory letter about the issues we noted and the likely impact on their site licence if the issues were not addressed. We reviewed their response and found it was not adequate. We continue to work with the company to address these issues. Update (2018-03-15): The company gave us information about the issues impacting their site licence. We reviewed their response and found it to be adequate. No further follow-up is required at this time.
Laboratoires Medelys International Inc.	Quebec	Premises Personnel Equipment Operations Quality Assurance Stability Recall Reporting	After the site visit, we asked the company for more information about the issues we noted. We reviewed their response and found it to be adequate. No further follow-up is required at this time.
Lernapharm (Loris) Inc. (sterile)	Quebec	Premises Personnel Operations Equipment Quality Assurance Stability Recall Reporting Sterility	After the site visit, we sent the company regulatory letters about the issues we noted and the likely impact on their product licences and site licence if the issues were not addressed. We reviewed their response and found it to be adequate. No further follow-up is required at this time.
Les Eaux Saint Léger / Waters Inc. (sterile)	Quebec	Premises Personnel Sanitation Program Equipment Operations Quality Assurance Stability Recall Reporting Sterility	As part of the site visit, upon our request, the company stopped selling products for which there were sterility concerns. They were allowed to sell products again once those concerns were addressed to our satisfaction. We also tested samples of products Salin.O and Stéril.O and found they were contaminated. The company recalled one lot of Salin.O (lot 16090) and one lot of Stéril.O (lot 17017) on April 4, 2017 as a result. After the site visit, we sent the company a regulatory letter about the issues we noted which informed them of the immediate suspension of their site licence. We reviewed their response and found it to be adequate. Their licence was reinstated but the activity of manufacturing sterile products was removed from their site licence. No further follow-up is required at this time.
Les Enterprises Gérard Doucet Ltée (Bleu & Boreal)	Quebec	Sanitation Program Operations Quality Assurance Stability	As part of the site visit, upon our request, the company stopped selling products that had not been adequately tested. The company was no longer conducting licensable activities so their site licence was not renewed. They no longer hold a site licence.
Naturo Aid Pharmaceuticals Inc.	BC	Premises Sanitation Program Operations Quality Assurance Stability Recall Reporting	After the site visit, we sent the company regulatory letters about the issues we noted and the likely impact on their product licences and site licence if the issues were not addressed. We reviewed their response and found it to be adequate. No further follow-up is required at this time.
Niagara Pharmaceuticals Inc. (sterile)	Ontario	Quality Assurance	We informed the company of the issues we noted. We will assess that they have addressed them at the time of their next site licence renewal. The nature of these issues did not require other regulatory action at this time.
Table 2 Notes Table 2 Note b See "What did we find?" section for examples of compliance issues Return to table 2 note b referrer

Table 3: Findings and enforcement actions at importers
Establishment name	Province	Where we identified issues^{table 3 note c}	Actions
1852884 Ontario Inc. (Nutrition Club Canada)	Ontario	Operations Quality Assurance Stability Recall Reporting	As part of the site visit, upon our request, the company stopped importing and selling products that did not meet requirements. They are allowed to sell the products again once the appropriate documents are provided to us. After the site visit, we sent the company regulatory letters about the issues we noted and the likely impact on their product licences and site licence if the issues were not addressed. We reviewed their response. We found it to be adequate for the site licence. We continue to work with the company to address issues with their product licences. Update (2018-05-02): The company gave us information about issues impacting their product licences. We reviewed their response and found it to be adequate. No further follow-up is required at this time.
3239497 Canada Inc.	Quebec	Premises Operations Quality Assurance Stability Recall Reporting	As part of the site visit, upon our request, the company stopped importing and selling products from foreign sites that had not demonstrated meeting NHP GMPs. We tested a sample of a product they import, Aminolast. We found it did not meet its specifications. We confirmed the company no longer sells this product. After the site visit, we sent the company a regulatory letter about the issues we noted and the likely impact on their site licence if the issues were not addressed. We continue to work with the company to address these issues. Update (2018-08-02): The company gave us information about issues impacting their site licence. We reviewed their response and found it to be adequate. No further follow-up is required at this time.
Abundance Marketing Ltd.	Ontario	Operations Quality Assurance Stability Recall Reporting	As part of the site visit, upon our request, the company stopped importing and selling products from foreign sites that had not demonstrated meeting NHP GMPs. They were allowed to sell the products again once the appropriate documents were provided to us. After the site visit, we sent the company regulatory letters about the issues we noted and the likely impact on their product licences and site licence if the issues were not addressed. We reviewed their response and found it to be adequate. No further follow-up is required at this time.
Andrews & George Limited	BC	Quality Assurance Stability Recall Reporting	We sent the company a regulatory letter about the issues we noted and the likely impact on their site licence if the issues were not addressed. We reviewed their response and found it to be adequate. No further follow-up is required at this time.
Bell Lifestyle Products Inc.	Ontario	Operations Quality Assurance Stability	As part of the site visit, upon our request, the company stopped importing and selling products from foreign sites that had not demonstrated meeting NHP GMPs. We also asked that the company stop conducting activities not listed on their licence. They were allowed to sell the products and conduct the activities once the appropriate documents were provided to us. We also informed the company of the other issues we noted. We will assess that they have addressed them at the time of their next site licence renewal. The nature of these other issues did not require other regulatory action at this time.
Canada RNA Biochemical Inc.	BC	Premises Quality Assurance Stability Recall Reporting	We informed the company of the issues we noted. We will assess that they have addressed them at the time of their next site licence renewal.
DGA Fulfillment Services Inc.	Ontario	Operations Quality Assurance Stability Recall Reporting	We informed the company of the issues we noted. They no longer hold a site licence (expired in July 2017).
Distripharm Inc.	Quebec	Premises Operations Quality Assurance Stability	We informed the company of the issues we noted. We will assess that they have addressed them at the time of their next site licence renewal. The nature of these issues did not require other regulatory action at this time.
Morinda Canada Co. (Tahitian Noni International)	Ontario	Operations Quality Assurance Recall Reporting	We informed the company of the issues we noted. We will assess that they have addressed them at the time of their next site licence renewal. The nature of these issues did not require other regulatory action at this time.
New Chapter Canada	Ontario	Operations Quality Assurance Stability	We informed the company of the issues we noted. We worked with the company to address them as part of their site licence renewal. No further follow-up is required at this time.
Richwin Toronto Corporation	Ontario	Operations Quality Assurance Stability	We informed the company of the issues we noted. We will assess that they have addressed them at the time of their next site licence renewal. The nature of these issues did not require other regulatory action at this time.
The Clorox Company (Burt's Bees Canada / Renew Life Canada Inc. / Advanced Naturals)	Ontario	Quality Assurance Recall Reporting	We informed the company of the issues we noted. We will assess that they have addressed them at the time of their next site licence renewal. The nature of these issues did not require other regulatory action at this time.
Table 3 Notes Table 3 Note c See "What did we find?" section for examples of compliance issues Return to table 3 note c referrer

Who is responsible for the safety of NHPs?

Companies that manufacture, package, label or import NHPs must follow the Natural Health Product Regulations. This includes having a valid site licence before conducting these activities. You can find the List of site licence holders posted on the Health Canada website.

A person has to apply for and receive a product licence before an NHP can be legally sold in Canada. They then become a product licence holder. They must make sure that the product meets Canadian requirements.

Retailers should make sure the NHPs they sell have a valid 8-digit product licence number (NPN or DIN-HM).

Consumers should only buy NHPs that have an 8-digit NPN or DIN-HM number on the label. You can check to see if your NHP has a valid licence by looking it up in the Licensed Natural Health Products Database. If you have questions about health products, speak with your health care provider. This will help you avoid taking something that may interact with medications or other products you're already taking.

This planned review is an example of how Health Canada fulfills its responsibility to regulate the safety, effectiveness and quality of health products such as NHPs. We take action when a company or product does not comply with the Food and Drugs Act and its regulations. Actions are based on the risk posed to Canadians.

Have a complaint about an NHP or an NHP facility?

We want to hear from you if you have a complaint about an NHP, an NHP facility or any other health product. Report your complaint using the health product complaint form.

Examples of complaints can include label errors, foul odour, potential contamination or facility issues.

We also receive many questions every year about health products in Canada. For general questions related to the safety of health products, contact toll-free 1-800-267-9675 or by e-mail at info@hc-sc.gc.ca.

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Date modified:: 2021-08-06

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