Natural Health Products – Big Changes Coming Fall 2010

Regulating the over 30,000 natural health products (NHPs) available for sale in Canada has been a difficult task. Although required by law since 2004 to be licensed prior to sale, many products remain unlicensed. Thousands of applications have been stuck in queue for years at the Natural Health Products Directorate (NHPD) waiting for review. In part in response to pressure from retailers and manufacturers, the NHPD has put in place a new three part plan to address the backlog of applications and the sale of products without licences. These include the introduction of new regulations and policies expected to come into effect this fall.

Proposed NHP-UPLAR Regulations

Although the law requires that all NHPs be licensed prior to sale, it was recognized that enforcing this requirement outright would have had the effect of destroying the NHP market in Canada. To lessen this risk, the NHPD and the HPFBI adopted the policy of focusing enforcement actions only against those NHPs that were of the highest risk to the public, including products for use by children, pregnant or lactating women, and products which caused serious adverse reactions. Products with pending product licence applications were considered to be of lower risk. The importation and sale of thousands of unlicensed NHPs continued under this policy until earlier this year, when the National Association of Pharmacy Regulatory Authorities (NAPRA) advised its pharmacy members to stop the sale of unlicensed NHPs. The NAPRA position had Canadian pharmacies removing almost all of the NHPs from their shelves. The NHP community struck out at the NAPRA position and Health Canada was put in the middle of the dispute. In response, the Natural Health Product – Unprocessed Product Licence Application Regulations (NHP-UPLAR) were created. The proposed regulations codify the existing non-enforcement policy. Low risk products with applications pending for at least 180 days with the NHPD would be eligible for an exemption from the prohibition against sale without a product licence. An exemption number (EN) is considered to be marketing authorization, allowing sale and advertising of a product, until a final decision is made as to the product’s application. If passed, the regulations will address NAPRA’s concerns, along with those of the NHP community. They are expected to come into force August 1, 2010.

Only for 30 Months

The proposed regulations would only continue for a period of 30 months. They are only intended to be in force long enough for the NHPD to work through the backlog of pending applications, which is assumed will take only 30 months.

Low Risk and 180 days

Low risk products with applications pending for at least 180 days will be eligible for an EN. Eligible applicants must sign a waiver indicating that the product is not for use by children, pregnant or lactating women, and agree to the inclusion of certain information in an online database. Although typically considered low risk, products such as children’s vitamins are not eligible for an EN. The NHPD claims that these products will be subject to priority review to move applications along faster, but this is not yet guaranteed by legislation or even a written policy. It is possible that these products will be a casualty of the new regulations.

EN Database

The NHPD will create an online public database of all products with an EN. It is proposed that the database will include the applicant’s name, exemption number, product brand name and dosage form, and the status of the exemption number (Valid, Invalid or Product Licensed). The NHPD has indicated that information will remain in the database indefinitely. It is expected that some applicants will refuse the EN due to concerns of premature release of confidential product information. Concern has also been raised about the exemption number status included in the database. Applications that have been withdrawn will be shown as “Invalid”, which could leave a negative impression in the eyes of the public with respect to the applicant.

Status of the Proposed Regulations

The regulations were published in the Canada Gazette, Part I on May 8th, 2010. They have been subject to a short 30 day consultation period, and are expected to be published in the Canada Gazette, Part II this summer, coming into force on August 1, 2010. Health Canada is in the process of conducting a series of information/consultation sessions with stakeholders across Canada regarding the proposed regulations.

NHPD Application Management Policy

The huge backlog of pending applications is a major problem facing the NHPD. Many applications have been pending for years. While the Natural Health Product Regulations requires a 60 day turn around for compendial (monograph) applications, there are no targets for non-compendial applications. The NHPD is attempting to change this with the introduction of a new Application Management Policy, expected to come into force either with UPLAR or later this summer. It is believed that the processing of applications will be sped up by the implementation of the following four points:

1. Pre-clearance of ingredients will be required;
2. New performance targets will be set;
3. Application templates will be made available; and
4. NHPD reviewers will provide more assistance.

Ingredients Preclearance

Reducing the number of problem applications is the first step the NHPD is taking to speed up application processing. Under the new policy, an application will no longer receive a submission number until it has passed an initial assessment for supporting evidence and ingredients “pre-clearance”. In order for an ingredient to be “cleared”, it must be included in the NHPD Ingredient Database. If an ingredient is not included in the database, further data must be submitted for Health Canada scientists to determine whether the substance is or can be used in a NHP. Review is expected to take 2 weeks for a non-medicinal ingredient, and 4 weeks for a medicinal ingredient. If the ingredient is cleared, it will be added to the database. If use restrictions are found, these will be included in the database.

Performance Targets

The NHPD has set performance targets of 40 days for initial assessment (required before submission number is granted) and full assessment within 90 days after submission number is granted.

Application Templates

To further streamline the review process, the NHPD is creating new application templates to both help applicants understand what information is required for an application and to organize the applications for easier review. It is expected that the following templates will be available soon:

• Finished Product Specifications Form Template;
• Evidence Assessment Template; and
• Electronic “Submission Builder” for use with compendial applications.

More Assistance

One of the most labour intensive portions of the application process has been the review of safety and efficacy evidence. To help speed up the processing of applications, the NHPD is creating a database of pre-cleared information of common ingredient safety information, creating an issue management database and is working with experts to resolve long standing issues such as soy and enzymes. In addition, instead of just rejecting a claim, reviewers will begin offering acceptable claim wording suggestions based on their review of the evidence submitted.

New HPFBI Enforcement Policy

The Health Products and Food Branch Inspectorate is responsible for the enforcement of the NHPR. To date, the HPFBI has followed a policy of taking enforcement action against high risk products. Typically, product classification was the source of risk classification. The new policy, expected to come into force this summer, continues to focus enforcement action on high risk products, but sets out new factors taken in consideration when determining the risk of a product. The sale or importation of unlicensed products, an unlicensed site conducting activities, the advertising or labelling for Schedule A diseases, and products out of specification or adulterated are all considered to make a product a high risk. In deciding what action should be taken, risk will also be considered in conjunction with factors such as compliance history and cooperation, likelihood of reoccurrence, public confidence, intent, priority and resources. In addition to the traditional triggers for an enforcement action, the HPFBI will also be looking health hazard evaluation, new information about safety of ingredient or even a foreign product alert as factors in risk evaluation.

Conclusion

Although it is not yet known if the proposed NHP-UPLAR will become law, we can be certain that there will be changes to the NHP application and review process will be coming this fall. It remains to be seen, however, whether the changes will have the intended effect of helping the NHPD work through the backlog of NHP applications and process new applications within the new targets. Article by: Sue Diaz.