Natural Health Products Move to Food Directorate

On Thursday morning April 19th, I was at a four and a half hour open session with the Canadian Health Food Association (CHFA), with both the heads of the NHPD and the Food directorate. It was very informative, but more importantly, it was in an open forum, so I can talk about it. Most of the work I have been doing with the NHPD, as a PAC member, is under a confidentiality agreement and thus is not for public knowledge.

I spoke first and shared some of the industry’s and my own personal ideas about how hard it has been for researchers to be heard about the efficacy of their products. The next speaker was Scott Sawler, Director General of NHPD. I liked his presentation. I have got to admit I like this guy. He is a no-nonsense guy, with a keen mind, and a good sense of humor.  He gave us a refreshing look at what is coming up and what has been accomplished to date. He did say the rulebook (a.k.a. Standards of Evidence, SOE) would be published by June. This is really important, as the industry has been summiting tens of thousands of applications for over 6 years now, with no user manual or rulebook. Now we will have a rulebook that both industry and government can refer to.  Don’t you think that should have been created six years ago? Oh well I guess that is water under the bridge now. Well it will be in June anyway, I hope.

The next speaker was Dr. Samuel Godfrey, Director General, Food Directorate. He spent the first part of his talk, reviewing how the government is laid out when it comes to consumer products for health. To make it really simple (something it never is with government), in Canada a substance is either a Food or a Drug. NHPs are regulated under the drug category. Yes, I know they should have their own directorate of Natural Food Products instead of drugs, but that is not going to happen with all of the budget cuts. This means that all foods that wanted to have claims, like ‘oatmeal can reduce cholesterol,’ or energy drinks like Red Bull, had to be classified as NHPs and get Natural Product Numbers (NPNs) over the last several years.

The new push is to get most of these things that were once considered NHPs to move over to the food category. The idea is “that if it looks like a duck, walks like a duck and quacks like a duck and is sold beside chicken in the super market; it is probably a food.” I was not sure that this statement was politically correct, in a room full of people who in the past where considered a bunch of quacks, but you get the point.

Many of the caffeinated energy drinks have already made the transition to the food category over the last several months. I for one have a hard time considering all those energy drinks lined up at the truck stops as natural products in the first place. Of course I cannot really consider them foods either. Is it just me? I don’t really know what to consider them, but obviously they are quite popular among Canadians, as they seem to be making big sales.

The whole point here is that they can now be considered foods, with claims. Depending on how significant the claims are reflects if it needs a preclearance or not. There is about a two-year transition time for labeling to be compliant. In the past if a person wanted to make a claim that something gave them energy, it would be considered a drug. Now it can have that claim and be a food. This could be really good for the Super Food category that I have Blogged about in the past.   This means Super Foods can have claims like: increases energy, antioxidant, etc. It is up to the manufactures to have the critical information on file. If the claim goes over the boundaries of Schedule A, e.g. ‘this product works on Diabetics’, then it would need to be pre-cleared with solid scientific information.  I am sure we are going to find many grey areas over the next few years.

One of the areas in the grey zone is teas, as they are both foods and medicines. When I asked Dr. Godfrey about this, he asked, ‘what would you like it to be?’. Oh I wish the world was that simple! This goes back to the old argument of, ‘what is the substance used for and what is its format?’. Those boundaries are getting even foggier, as we can now make claims for foods. Is garlic a food or a drug? If I put it in my sauce for dinner, it is a food. If I take it in a capsule, it is a drug. Both of them lower cholesterol to the same degree, so it is confusing on the surface.

We will be hearing and I will most likely be blogging more about this in the future. For now I have included the BEEP on this so you can read it.

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Transition of Products at the Food-Natural Health Products Interface to the Food Regulatory Framework

The purpose of this message is to provide you with an overview of the transition of products at the food-natural health products interface to the food regulatory framework.

Background 

Some products with added vitamins, minerals or amino acids, that appear to be foods, as well as foods making certain health claims, have previously been able to gain market access as natural health products (NHPs) under the Natural Health Products Regulations (NHPR). Examples of products that are currently marketed as NHPs include waters and juices with added vitamins and minerals, and yogurts and bars with specific health claims. These products represent a very small portion (2%) of the approximately 50,000 NHPs on the market.

Health Canada has determined, based on consumption patterns, history of use, representation to consumers, and in accordance with its guidance document on “Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats”, that most of these products fit the definition of a food. The Department, therefore, intends to classify and transition most of these products to the food regulatory framework.  This is consistent with the policy intent of the NHPR, as outlined in the regulatory impact analysis statement, as well as the outcomes of the Natural Health Product Regulatory Review conducted in 2007, which reiterated that foods are excluded from the scope of the NHPR.

A phased transition is underway by Health Canada, beginning with the transition of caffeinated energy drinks.  Additional categories of products now marketed as NHPs, which have been classified as foods, will begin to transition in April 2012.  The transition process is expected to be complete by December 2012 in order to coincide with the repealing of the  Natural Health Products (Unprocessed Product Licence Application) Regulations scheduled for February 4, 2013. The end goal is that products that look like foods and are consumed as foods are regulated as foods.

Food-Natural Health Product Transition

As of April 17, 2012, the Natural Health Products Directorate will no longer accept NHP applications for products that are represented, packaged and sold as foods.

Health Canada now has a process to transition products already on the market as NHPs to reduce market disruption, as long as the products are safe to be consumed as foods.  Products that are captured under the transition are those where a Product Licence Application has been received by the Natural Health Products Directorate and have been issued either a Natural Product Number, an Exemption Number or are considered “application in progress”.

There are three main principles that underlie this transition:

·       A risk-based approach to protect the health and safety of Canadians

·         Procedural fairness and transparency; and

·        Minimal disruption to the stream of commerce.

These three principles will be respected and applied throughout this transition.

To facilitate the transition, products deemed to present no immediate safety concerns, but found to be in contravention with the Food and Drug Regulations, will be transitioned through the issuance of Temporary Marketing Authorization Letters (TMALs). TMALs will allow eligible products to be marketed subject to specific conditions, while industry collects and provides data that are required to finalize regulatory requirements for these products (Section B.01.054 of the Food and Drug Regulations).

Products identified as unsuitable to be sold and consumed as foods or products that do not meet the conditions for a TMAL will be provided with the opportunity to reformulate, change the representation of the product so that it can no longer be similar to an equivalent food product.  These products will be identified early to permit the maximum possible window for reformulation.

It is anticipated that most products will need to be transitioned using TMALs as a tool, except for  a small number of products that are currently compliant with the Food and Drug Regulations as it relates to their composition. While most health claims used on food labels are not subject to pre-market clearance by Health Canada’s Food Directorate, the Directorate is open to work with interested companies to ensure that claims used on their food labels are compliant with the Food and Drugs Act and Regulations.

In July 2012, Health Canada, in consultation with stakeholders, will develop  and share performance standards for TMA submissions, explaining the commitment and timelines with respect to the processing of new submissions.  TMA submissions are only needed for new products for which there is a regulatory impediment to the legal marketing of a safe food in Canada.  New compliant foods are not subject to pre-market scrutiny and do not require TMAs.

Next Steps

Companies will be receiving correspondence from Health Canada in the coming days with the details of the transition plan and the various options for their products.

Health Canada will provide regular updates, and continues to work with affected stakeholders throughout this process. We encourage you to visit the newly developed Food-Natural Health Products webpages for more information on the transition of products at the food-natural health products interface. We also encourage you to contact the Food Directorate at SMIU-UGDI@hc-sc.gc.ca should you have any questions.

Natural Health Products Directorate
Health Canada

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Transition des produits situés à la frontière entre les aliments et les produits de santé naturels au cadre réglementaire des aliments

L’objectif de ce message consiste à vous communiquer une vue d’ensemble de la transition des produits situés à la frontière entre les produits de santé naturels (PSN) et les aliments au cadre réglementaire des aliments. 

Contexte 

Certains produits auxquels des vitamines, des minéraux ou des acides aminés sont ajoutés tout en s’apparentant à des aliments, de même que des aliments faisant l’objet de certaines allégations santé ont pu accéder au marché à titre de produits de santé naturels en vertu du Règlement sur les produits de santé naturels (RPSN). Les eaux et les jus contenant des vitamines et des minéraux ajoutés, les yogourts et les barres faisant l’objet d’allégations santé particulières en sont des exemples. Ces produits ne représentent qu’une faible part (2 %) des quelque 50 000 PSN offerts sur le marché.

Santé Canada a déterminé qu’en vertu des habitudes de consommation, des antécédents d’utilisation, de la présentation des produits aux consommateurs et de son document d’orientation Classification des produits situés à la frontière entre les aliments et les produits de santé naturels : Produits sous forme d’aliments, la plupart de ces produits correspondent à la définition d’un aliment. Par conséquent, le Ministère entend classifier la plupart de ces produits comme aliments et faire en sorte qu’ils soient régis en vertu du cadre réglementaire des aliments. Ces dispositions respectent l’esprit du RPSN comme exposé dans le résumé de l’étude d’impact de la réglementation, de même que dans les résultats de l’examen de la réglementation des produits de santé naturels réalisé en 2007, lesquels ont confirmé que les aliments sont exclus de sa portée.

Santé Canada a entrepris une transition par étapes en commençant par celle des boissons énergisantes contenant de la caféine. La transition d’autres catégories de produits actuellement vendus comme PSN, lesquels ont été classifiés comme aliments, sera entreprise en avril 2012. Le processus de transition devrait être terminé en décembre 2012 afin de coïncider avec l’abrogation du Règlement sur les produits de santé naturels (demandes de licence de mise en marché non traitées) qui doit avoir lieu le 4 février 2013. L’objectif ultime consiste à faire en sorte que les produits semblables aux aliments et consommés comme tels soient réglementés à ce titre.

Transition des produits situés à la frontière entre les aliments et les produits de santé naturels

À compter du 17 avril 2012, la Direction des produits de santé naturels n’acceptera plus les demandes visant la mise en marché à titre de PSN de produits qui sont présentés, emballés et vendus comme aliments.

À présent, dans le but d’atténuer la perturbation des activités commerciales, Santé Canada s’est doté d’un processus de transition des produits déjà mis en marché en tant que PSN et ne suscitant pas de préoccupations immédiates en matière d’innocuité à titre d’aliments. Les produits visés par la transition sont ceux qui font l’objet d’une demande de licence de mise en marché auprès de la Direction des produits de santé naturels et auxquels un numéro de produit naturel ou un numéro d’exemption a été attribué ou encore au sujet desquels la demande est en traitement.

Cette transition s’appuie sur les trois principaux principes suivants : 

·        Une approche fondée sur les risques visant à protéger la santé et la sécurité de la population canadienne; 
·        L’équité en matière de procédures et la transparence; et 
·        La perturbation minimale des activités commerciales. 

Ces trois principes seront respectés et appliqués tout au long de la transition.

Afin d’appuyer la transition, les produits ne suscitant pas de préoccupations immédiates en matière d’innocuité, mais non conformes au Règlement sur les aliments et drogues, seront transférés au cadre réglementaire des aliments au moyen de la délivrance de lettres d’autorisation de mise en marché temporaire (LAMT). Pendant que l’industrie recueillera et communiquera les données requises pour mettre la dernière main aux exigences réglementaires relatives aux produits admissibles (article B.01.054 du Règlement sur les aliments et drogues), les LAMT autoriseront, sous réserve de conditions particulières, la mise en marché de ces produits.

Les fabricants des produits jugés inadéquats pour la vente et la consommation en tant qu’aliments et des produits qui ne satisfont pas les conditions leur permettant de faire l’objet d’une LAMT auront la possibilité d’en modifier la composition ou d’en changer la présentation de façon à ce qu’ils ne soient plus assimilables à des produits alimentaires équivalents. Les fabricants des produits concernés en seront informés rapidement de sorte qu’ils disposeront du plus de temps possible pour en modifier la composition.

On prévoit que la plupart des produits nécessiteront la délivrance d’une LAMT, sauf quelques exceptions qui sont conformes au Règlement sur les aliments et drogues sur le plan de leur composition. Bien que les fabricants ne soient pas tenus d’obtenir, de la Direction des aliments de Santé Canada, une autorisation préalable à la mise en marché visant la plupart des allégations santé, la Direction consent à collaborer avec les entreprises concernées pour veiller à ce que celles qui figurent sur l’étiquette de leurs produits alimentaires soient conformes à la Loi sur les aliments et les drogues et du  Règlement sur les aliments et les drogues.

En juillet 2012, Santé Canada, en consultation avec les intervenants,  élaborera et partagera des normes de services applicables aux demandes de LAMT tout en faisant état de son engagement et des échéances relatives à la gestion des nouvelles demandes.  Une demande de LAMT est requise pour les nouveaux produits faisant l’objet d’obstacle réglementaire à leur commercialisation au Canada.  Les nouveaux produits qui sont conformes au Règlement sur les aliments et les drogues ne doivent pas faire l’objet d’une autorisation préalable à la mise en marché, ni d’une demande de LAMT.

Prochaines étapes

Au cours des jours à venir, les entreprises seront informées par Santé Canada des détails du plan de transition et des diverses options qui leur sont proposées à l’égard de leurs produits.

Santé Canada communiquera des mises à jour régulières et poursuivra sa collaboration avec les intervenants concernés tout au long de ce processus. Pour obtenir plus de renseignements sur la transition des produits situés à la frontière entre les produits de santé naturels et les aliments, nous vous invitons à visiter les pages Web réiscemment mes en ligne à ce sujet. Si vous avez des questions, nous vous invitons aussi à communiquer avec la Direction des aliments en écrivant à SMIU-UGDI@hc-sc.gc.ca.

Direction des produits de santé naturels
Santé Canada

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