CHFA Expo East Regulatory Recap: NHPs and Food – Communicating the Changes & Challenges

CHFA Expo East Regulatory Recap: NHPs and Food – Communicating the Changes & Challenges

September 20, 2018 By

Last weekend’s CHFA East 2018 started with two days of conferences with conversations surrounding dozens of regulatory, scientific and business topics related to Canada’s natural products industry. dicentra was proud to sponsor Thursday’s full day regulatory session entitled NHPs and Food – Communicating the Changes & Challenges.

The new self-care framework pertaining to natural health products (NHPs) was a prime theme of the morning portion of the Thursday session. Here’s a recap of the day’s talking points about NHPs and food.

 

Morning Session: Natural Health Products (NHPs)

The reason behind the new self-care framework approach was once again presented as a need to align with the oversight of risk assessment and cost recovery for equivalent product categories.

In February, Health Canada announced a three-phased approach to updating self-care product regulations with a goal of improved labeling in the first phase that starts this fall. Many manufacturers supplying NHP commodities are unsure of how to adopt the upcoming Products Facts Table for NHPs and what the challenges are.

The panel included upper management members of the Consumer Health Product Modernization unit at the Natural and Non-prescription Health Products Directorate (NNHPD), Policy & Regulatory Affairs at Consumer Health Products Canada, and the CEO of Concentrics Research. Their high-level overview for the Product Facts Table was that the Plain Language Labeling (PLL) on the pharma side will help to model tactics needed during this time, and that the cost recovery and implementation time line would most likely be proposed at the third phase, intended for early 2020. Changes will apply to sections 86 through 94 (Part 5) of the Natural Health Products Regulation. Mock-ups for review may even be required in some cases.

 

How has PLL Affected Industry So Far?

Most of the panel gave feedback to the industry based on their own experiences of the process. Reconfiguring packages takes many months. Delays occur when determining format and language, which all together jeopardize the ability to make retail deadlines. Space accommodation becomes problematic and with the PLL project, flexibilities had to be introduced overtime. Information was being moved around on the table based on consumer risk, and packaging styles had to be innovated to include additional panels and even URL webpages.

Concerns were raised from industry members over NHPs being treated like pharma products, and if the environmental impact for more packaging material was worth the time and money. Matt Bown, the Senior Policy Advisor of the Consumer Health Product Modernization unit at the NNHPD, provided reassurance that NHPs would be treated fairly given the low risk profile and the cost recovery challenges that would be faced over time, as it will be a learning phase for even the government.

The US Drug Facts Table was the start of this evolution in labeling, and Canada had its own unique challenges such as bilingual requirements that had to change the prescriptive guidance initially provided for the PLL* project. The overall message was this need for guidance flexibility will also be embraced as needed for NHPs during implementation.

The panel’s presentation covered educational background, such as the research conducted by Concentrics Research on label comprehension. Their findings show that consumers can make correct decisions about whether a product is appropriate for them to use, based on labeling styles. Consumers perceive different labeling formats and styles for safety and attraction as well. All tied back to why consumer safety is the ultimate reason behind why the Product Facts Table conversation is being had with the Drug Facts Table.

*See below for dicentra’s Life Sciences services related to Plain Language Labeling

Afternoon Session: Food Products

Dr. William Yan, Director at Health Canada’s Food Directorate, and Rosella Suppa, National Operational Specialist at the Canadian Food Inspection Agency (CFIA), provided regulatory updates on the food product side of things and the recently finalized Safe Food for Canadians Regulations (SFCR), respectively.

Product labeling for foods are facing changes. The front-of-package (FOP) labeling will require displaying symbols for foods high in saturated fat, sodium and sugars. The intention is to get manufacturers to consider reformulating their products. The next step is to publish final regulations in Canada Gazette, Part II in Fall 2018, to allow sufficient time for industry to implement by 2022.

The use of partial hydrogenation of oils (PHOs) is prohibited in foods and has taken effect on September 15, 2018. They are added to Part 1 of the List of Contaminants and Other Adulterating Substances in Foods, and as the Notice of Modification was published in September 2017 had informed. Trans fats can be naturally-occurring or industrially produced, mainly through PHOs, which increases risk of coronary heart disease.

 

Safe Food for Canadians Regulations

The Safe Food for Canadians Regulations (SFCR) was discussed and the main advice to the industry was to take time to review the regulations and guidance, and to be prepared to meet the new requirements well in advance. One of the main challenges voiced from both the industry and the panel is that navigating through the regulations, to understand your business requirements, is very difficult. Some requirements such as licensing will have to be met soon, by January 15, 2019, while other requirements will be phased in over a period of 12- 30 months based on food commodity, type of activity, and business size.

The day was capped off with a fascinating presentation by Dylan Jones, CEO of Coast Protein, discussed this emerging protein source in North America that can currently be found in big food chains such as Whole Foods, and Longos. CFIA currently considers this a safe ingredient, which also acquired GRAS status in the US (Generally Recognized As Safe).

 

Questions on any of the above developments in Canadian regulations, or interested in entering the Canadian market? Contact dicentra at 1-866-647-3279 or info@dicentra.com.

 

dicentra’s Food Safety & Quality Consulting services for SFCR requirements:

 

dicentra’s Life Sciences services related to Plain Language Labeling

 

dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces.