Crucial transition periods related to Canada’s Natural Health Products Regulation.
In 2013, Canada’s Natural Health Products (NHP) Regulation will see a number of significant transition periods end. First, December 31, 2012, marked a significant deadline in the transition of food-like NHPs by Health Canada. It was the date by which all NHP-related submissions-i.e., exemption numbers (EN) and natural product numbers (NPN)-of transitioned food-like NHP products were set to expire. Second, February 4, 2013, marked the end of the Unprocessed Product License Applications Regulations (UPLAR) developed by the Natural Health Products Directorate (NHPD) to address the backlog of NHP applications.
Health Canada defines an NHP-under the NHP Regulations-as “vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics, and other products like amino acids and essential fatty acids.” NHPs-which are non-prescription items-must apply for a product license and undergo premarket approval before entering Canada’s market. But, on April 17, 2012, Health Canada formally announced it would transition products that more appropriately fit the definition of a food away from the NHP Regulations. Health Canada’s reasoning was that certain products regulated as NHPs are packaged, perceived, represented-and thus, consumed by end users-as food. Such products include energy drinks, beverages, bars, and soups.
During the transition period from NHP to food, marketers of food-like NHPs were required to apply for Temporary Marketing Authorization (TMA) to permit their products’ continued sale in the market. TMAs allow eligible products to be temporarily marketed under specific conditions, while industry collects and provides to the Food Directorate specific required data to assist in regulatory amendment to the Food and Drug Regulations (FDR). These food-like NHPs will meet an entirely different set of regulations once they are classified as food. For instance, companies are not required to have site licenses for food products as they would if the products were NHPs, and they also may not have to provide such extensive efficacy information on ingredients for substantiation. A TMA food, however, faces stricter regulation on fortification levels or ingredients allowed in some food categories, and may have stricter controls on related health claims.
By December 31, 2012, all food-like NHPs-excluding any case-by-case exceptions-were required to have a final TMA letter authorizing their sale under the food regulatory sphere. December 31, 2012, also marked the expiry of any NHP-related submission numbers or authorizations that any food-like NHPs had received prior, such as ENs or NPNs. Health Canada continues to issue documentation-e.g., Notice of Refusals, NPN Revocation-noting cancellation of any associated NHP submissions or authorizations for these transitioned products.
To date, most products at the food-NHP interface have been transitioned via TMA letters. Some products, however, did not require TMAs because they: 1) were already compliant as food, 2) were not eligible for TMAs without first being reformulated, or 3) remained classified as NHPs but first needed to change their marketing and other representation so as not to be confused with a food product.
Going forward, Health Canada announced it will develop category-specific TMA guidance documents, which it anticipates finalizing by the middle of this year. These documents will outline requirements for marketing data reporting, incident reporting, and other pertinent information for TMA food products. The Food Directorate has signaled that there will be a reasonable transition period for companies to bring their food-like NHPs into compliance with the TMA requirements and expects enforcement to be minimal during this reasonable transition period.
For new food-like NHPs that have not previously been in the NHP queue, the passing of the transition deadline marks the opportunity for new product TMA submissions to be reviewed by the Food Directorate. As we entered 2013, the Food Directorate continued to accept and review submissions of new eligible TMA food products.
Another transition period that ended relates to UPLAR, the Unprocessed Product License Applications Regulations. The NHPD enacted UPLAR on August 4, 2010, to ensure NHPs backlogged in the queue for premarket review can, in the meantime, be legally sold. Products granted this temporary license status received a preliminary assessment for safety and efficacy and were assigned an EN while they awaited full review. UPLAR was created as a temporary solution, however, and expired on February 4, 2013. Thereafter, the legislation was repealed.
Once UPLAR expired, what happened to pre-UPLAR submissions that were still awaiting premarket review? The good news is that, at the time of this writing, NHPD appeared to be on track with clearing its backlog of pre-UPLAR NHP assessments by February 4. Of the 10,885 pre-UPLAR submissions-considered to be any new submission or amendment received by the NHPD prior to August 5, 2010-86% of them completed NHP review by October 2012. As a result, these products were either approved, refused, or withdrawn by the applicant.
As we approached the end of UPLAR, 1534 pre-UPLAR applications still awaited assessment. Although this number sounds quite large, the NHPD was working steadfastly to meet its goal of clearing the backlog, with 1593 pre- and post-UPLAR applications assessed in October 2012 alone. Furthermore, the NHPD was meeting its 180-day and 60-day review time performance targets (79% of the time for non-traditional, traditional, and homeopathic applications; and 100% of the time for compendial and labeling standards) for all new (post-UPLAR) applications. This efficiency was due to a number of NHPD initiatives, including the publication of 30 new monographs in 2012 and such strategies as “batching,” in which products and/or ingredients of the same type are assessed in batches to expedite review time and provide consistency in reviewer decisions.
After UPLAR’s expiry on February 4, no products should remain in the assessment queue with an EN; by this date, all NHP applications should have received a decision. Many in the industry questioned what to expect regarding compliance and enforcement once UPLAR expired. The NHPD has clearly indicated that it will maintain its compliance and enforcement risk-based approach and is quick to emphasize that the end of UPLAR does not signal a change in its approach to compliance and enforcement activities. Furthermore, NHPD recently met with stakeholders and reviewed industry feedback regarding appropriate transition timelines and a compliance promotion period for transitioning to full-fledged compliance and enforcement of non–market authorized products.
At this time, the NHPD plans to begin phasing out products without NHP market authorization starting on March 1, 2013. By December 1, 2013-nine months from the start of the transition-the NHPD expects that all manufacturers, packagers, and labelers will have completed stock turnover and should not be selling unlicensed products. Retailers and distributors will receive an additional nine months from this time-until September 1, 2014-to finish selling their stock of non–market authorized products. After this time, the Compliance and Enforcement Policy (POL-0044) will come into full effect, and products without market authorization should not be sold.
In the end, we believe full-scale enforcement of the NHP Regulation will be good for industry. For companies that have diligently worked with the NHPD process-as flawed as the process has been at times-at the end of the tunnel will be marketplace fairness. Those that comply with the regulations and produce high-quality NHPs for the public will be rewarded for their patience. In turn, Canadian consumers will receive products that they know to be safe and effective-a good image for our industry.