According to Sarah Schmidt, Health Canada has sent a letter this past week to the food industry stating that it will no longer accept NHP applications for products that are “represented, packaged and sold as foods” and that by the end of December, the department expects to complete the transition of over 1,000 products to the food regulatory framework.
Health Canada apparently hopes that this will solve what its own experts flagged more than three years ago as “consequential” problems around safety and consumer confusion of permitting companies to market fortified foods and drinks as natural health products.
These changes, if followed up on, are important for consumers in Canada, especially those who are attempting to live a healthy lifestyle and care about what they are ingesting into their bodies. When I was in law school at Queen’s University I wrote a paper on the problems that the NHP regulations cause for Canadian consumers for a health law class with Professor Patricia Peppin in the spring of 2011.
In the paper, entitled “Mass Confusion: The Canadian Regulatory System for Natural Health Products and Consumer Confusion” (paper available upon requests made to firstname.lastname@example.org), I reviewed recent surveys and studies and found that 71% of Canadians regularly take vitamins, minerals, herbal supplements, or homeopathic medicines. I found that the high use of NHP’s in Canada was a common trend around the globe as the global sales in the NHP industry are expected to reach $187 billion by the end of 2010, an increase from $20 billion in 2006. It is estimated that there are 40,000 products available in the Canadian market that are NHPs and that these products are sold at least 10,000 retail establishments. Health Canada’s decision to “crack down” on the trend of food companies classifying traditional food and drinks as NHP’s to get around health regulations is a definite benefit for consumers, at the expense of a very large and powerful industry and is just the latest attempt to regulate products that fall on the edge of drugs and food.
The below are excerpts from my 2011 paper which demonstrate the importance of Health Canada’s decision to prevent the licensing of foods as NHPs. Ultimately, the decision means that Health Canada will be able to prevent food manufacturers from using the flexible NHP regulations to make misleading and exaggerated health claims that are currently available for NHPs but are expressly prohibited by the Food and Drugs Act for food products.
History of NHP Regulation
In 1997, Canada’s Minister of Health ordered a study of the regulation of NHPs. This study resulted in the Standing Committee on Health, chaired by Joseph Volpe, which released a report in November 1998 entitled “Natural Health Products: A New Vision.” This report identified numerous shortcomings in Canada’s regulatory approach of NHP’s and called for, among other things, updated legislation. The end result of the process was the enactment of the Natural Health Products Regulations which came into force on January 1, 2004. These regulations created a new category of products that are regulated under the Food and Drugs Act. The purpose of these regulations was to “provide Canadians with ready access to natural health products which are safe, effective, and of high quality, while respecting freedom of choice and philosophical and cultural diversity.” This Regulation creates a structure different from that which covers food or drug regulation and, therefore, unless the NHP regulations expressly indicate otherwise, the Food and Drug Regulations no longer apply.
The NHP Regulations apply to manufacturers, distributors, importers, packagers and labellers of NHPs. The regulations do not, in any way, impact retailers.
i) Pre-Market Approval
The most important, and potentially the most significant, section of the NHP Regulations are those which outline the requirements for product licenses. The regulations clearly state that “no person shall sell a natural health product unless a product license is issued in respect of the natural health product.” Part 1 of the NHP Regulation outlines the steps required to submit a license. The most important information that has to be submitted and approved, for the purposes of this paper, is information that supports the safety and efficacy of the natural health product. When applying for a license the manufacturer also has to submit the text of each label that will be used to sell the NHP.
It is at this stage that Health Canada has decided that food products will no longer be accepted for consideration into the NHP licensing process and, therefore, the food products will have to comply with Canada’s food regulations.
Part 5 of the Regulations outline the stringent labelling requirements that NHPs are supposed to follow once a licence is received. The NHP Regulations state that “no person shall sell a natural health product unless it is labelled and packaged in accordance with these regulations” unless the sale of the product is to a manufacturer or distributor (ie. not to a consumer). The product label must contain several components, including; the ingredients list, both medical and non-medical; the recommended use (also known as the approved use) of the product; the recommended dosage; the storage conditions, and; its risk information, including any cautions, warnings, contra-indications or known adverse reactions associated with its use. The NHP must also display display their license number preceded by either DIN-HM (in the case of a homeopathic medicine) or NPN (in the case of any other product).
The 2010 Regulation: Exempting Unlicensed NHPs
In 2005 when the Natural Health Products Regulations came into force, there were an estimated 40,000 unlicensed products on the market. The regulations prohibited the sale of unlicensed NHPs but instead of requiring the market withdrawl of all unlicensed NHPs, Health Canada implemented a compliance policy which enforcement was focused on NHPs that posed a health risk and on NHPs that had not yet submitted an application for approval. This interim policy was only supposed to last until the end of 2009. By late 2009 Health Canada officials were notifying individuals in the NHP industries that compliance actions will be pushed until 2011.
In May of 2010, in order to address problems associated with a continued backlog of NHPs the government published the Natural Health Products (Unprocessed Product License Application ) Regulations. These regulations are to provide a temporary solution to provide Canadians with access to NHPs waiting for regulatory approval, while implementing some safety and monitoring checks.
On August 3, 2010 the Natural Health Products (Unprocessed Product License Applications) Regulations, SOR/2010-171 (Unprocessed Product Licence Applications) Regulations (the “New Regulations”) came into force. These regulations make it legal to sell unlicenced NHPs on a temporary basis provided that certain conditions are met. The Minister of Health can grant an exemption to a manufacturer of an unlicenced NHP if a product license is pending. Once a product is given an exemption number they have 60 days to consent to their information being posted on Health Canada’s website and to make declaration about the product regarding its safety. Once the exemption number is posted on the Health Canada website, the product licence applicant is deemed to hold a product licence to satisfy the Regulations. This regulation will assist Health Canada with removing NHPs without pending licenses from stores. This had previously been a priority, but before this regulation Health Canada inspectors had a hard time differentiating between NHPs that had submitted applications and those that have not.
Although the New Regulations enabled Health Canada inspectors to differentiate between NHPs that have pending licenses and those who have never filed an application, there are other concerns about the New Regulations. The most obvious of which is the fact that the 10,000 products, that were pending a license application, were legally on the market in Canada. Health Canada also published a policy relating to the advertising of these exempted products. This policy allows for advertising of these products will be pre-screened by an advertising preclearance agency based on the claims included on the product license application. Generally, when the product is licensed the claims are based on the terms of the product license, which have undergone at least a minimal scientific or historical use check by Health Canada. The impact of this policy is that exempted products can now advertise basically any claims they want as long as these claims are the same ones that exist on their product license application. The advertising preclearance agency will simply make sure that the advertising campaign does not go beyond what has been mentioned on the product license application.
Food producers were quick to have food products classified as NHPs because of certain labelling and advertising exemptions that apply to NHPs. For example, on June 1, 2008, a regulatory amendment to the Natural Health Products Regulation came into force to remove the prohibition on labelling and advertising of Schedule A preventative health claims. This gives NHPs a limited exemption from section 3(1) of the Food and Drugs Act which prohibits the advertising to the general public for the treatment, prevention or cure of the diseases, disorders or abnormal physical states listed in Schedule A of the act, and section 3(2) that prohibits the same products that are labelled for the treatment, prevention or cure of the same diseases. NHPs are still prohibited from advertising or labelling that they treat or cure the ailments but can now state that they prevent these conditions.
NHPs are essentially able to market themselves based on their license, or if the product is on the waiting list, the contents of their license application. On these applications or licenses you have to identify the health claims that your product is designed to do, along with varying amounts of evidence that demonstrates that the drug is a) safe and b) effective.
The evidence required to substantiate health claims to Health Canada varies depending on whether or not the product is brought forward as a traditional remedy or not. Traditional remedies only require evidence that it was “traditionally used” for a purpose, even if it cannot be scientifically proven to achieve that purpose, and even if the scientific evidence actually says the opposite. David Schardt, a nutritionist that is against Health Canada’s regulatory policy in this area, has been particularly outspoken about the impact that this regulatory framework has had on consumer confusion. He has identified several products that have been approved through Health Canada for seemingly ridiculous purposes. One example that he cites is the use of echinacea to prevent colds. Numerous studies have proven that Echinacea doe not prevent colds, and yet the product is still allowed to state that the herb is “traditionally used to fight off colds, flus and infections.” Perhaps more ludicrously, horehound has an approved use as being both “traditionally used as a sedative” and “traditionally used as a stimulant.” Clearly, the traditionally use avenue allows for plenty of creative marketing campaigns if the manufacturer is able to get it approved. Furthermore, since 2008, manufacturers can also make claims that they prevent serious diseases. Therefore, there is a great incentive to get a new product classified as a NHP rather than as a drug or as a food.
The trend of having a food product classified as an NFP is not a new development and, in fact, is one that Health Canada has been struggling with for the past few years. Health Canada issued an information bulletin to address the problems caused by products that are at the food-NHP Interface. It is appealing for some food and drink manufacturers that add vitamins or minerals to their products to have their products classified as an NHP so that they can market specific health claims without worrying about the more restrictive food health claims regulations, or in the case of unlicensed products, to market unapproved claims.
As of December 2009, there were nearly 500 juice and water products, 150 energy drinks and 25 candy products currently awaiting approval as NHPs. In fact, some very popular products are currently classified as NHPS when they would have traditionally been viewed, and are likely viewed by the public, as a food product. Red Bull Energy Drink and its related products are classified as NHPs. There are also 21 juices registered as NHPs, many of them by the same manufacturer. The company Isagenix Canada, which makes various nutritional and dietary supplements, was even able to get the products “Isagenix Snacks Vanilla” and “Isagenix Snacks Chocolate” licensed as a NHP even though they are clearly traditionally considered food products and the “dosage” is listed in the form of a waffer. Isogenix was also able to get, as an approved recommended use, that the product is “a factor in the maintenance of good health and also helps the body metabolize carbohydrates and fats.” On its website, it is marketed as “an important component of the Isagenix Cleansing and Fat Burning System.” The manufacturer has decided to package the wafers in a medicine bottle, rather than packaging traditionally used for foods, presumably in an attempt to have the product classified as an NHP. Isagenix is not the only company that has convinced Health Canada that a wafer is a suitable dosage for a NHP as there are currently 10 other products licensed as an NHP in wafer form.
Manufacturers of chewing gum have also benefited from being classified as an NHP. In the case of Wrigley Canada v. Canada, 2000 CanLii 15485 (F.C.A.) Evans J.A. wrote for the Federal Court of Appeal on whether or not the health claim on gum products that stated that it “prevents cavities” brings the gum under the definition of a drug for the purposes of the Food and Drugs Act. This decision was rendered in the year 2000 before the NHP Regulations were enacted. Wrigley Canada had brought a declaration stating that its product, EXTRA Sugarfree Gum, was not a drug despite the fact that it makes the claim that the gum prevents tooth decay and cavities. Wrigley Canada had applied to Health Canada, twice, to have the product classified as a drug and failed both times as the gum had no active ingredient. The first application was rejected in 1987 and a second application was rejected in 1993. With the creation of the NHP Regulations various gum manufacturers are now able to make the exact same health claims that they were previously prevented from making as they have been licensed as NHPs.
As of 2010 there were no reported cases of Canadian NHPs being prosecuted by Health Canada for misleading advertising under the Food and Drugs Act.
Manufacturers of foods, beverages and chewing gums were clearly taking advantage of the NHP regulations as a means to market their products that would be illegal if the product was considered to be a food. The relaxed labelling and marketing rules regarding NHPs has created a system in which products can get approval for a “recommended use” based on a low standard of evidence. Furthermore, due to the backlog in the licensing system, products can begin marketing these products without even getting approved by Health Canada, and can, essentially, make any claims that they wish to make until their license is processed.