Canadian Government Issues Guidance Document on Natural Health Products in Conventional Food Format
Editor’s Note: There are instances in the United States where herbal products marketed as “dietary supplements” have been sold in the form of conventional foods, e.g., beverages, meal replacement bars, teas, and other food formats. Sometimes herbal and other ingredients are sold in, or as, so-called “functional foods.” For products regulated as conventional foods, unlike dietary supplements, structure-function claims must derive from the nutritive value of ingredients and ingredients must be either Generally Recognized as Safe (GRAS) or authorized for use by a US Food and Drug Administration (FDA) food additive regulation. In the United States, both conventional foods and dietary supplements are allowed to make “health claims” under the Nutritional Labeling and Education Act of 1990, and subsequent amendments to federal law, only if such claim is pre-authorized by the FDA.
There is no designation in Canada for dietary supplements. Products with health claims are either sold as foods, Natural Health Products (NHPs), or drugs. In Canada, the fundamental question is: under what regulatory framework would the product fit? This question has become much more problematic with the passage of the Natural Health Product Regulations, and the relatively new category of NHPs. The essential question that has Health Canada stating a position only to see it change, is “whether NHPs, regulated as a category of drugs, can be marketed in a conventional food format.” NHPs can include vitamins, minerals, herbs, and homeopathic ingredients, and similar natural substances having a health function. Canadian food and drug attorney Joel B. Taller provides a report on Health Canada’s recent guidance on when a product in a food format may be classified as either a NHP or as a food.
While it is possible for a NHP to be sold in a (conventional) food format, Health Canada has struggled with how to classify and regulate these types of NHPs. A product is in “food format” if it is sold in a format and serving size consistent with food use. Examples include chewing gum, hard candies, candy bars, tea, juices, and other beverages. (This policy does not clearly address on what basis the numerous health products sold in food format, e.g., fruit juice (mineral supplement), chocolate-flavored chews, (mineral supplement), frozen treats (cough, cold treatment), and night-time warm beverages (cough, cold treatment), became drugs as opposed to foods).
For a brief period at the outset, NHPs in a food format were regulated as NHPs, and Product License Applications (PLAs) were reviewed as such. Shortly thereafter, all reviews of PLAs for NHPs in food format were frozen for over 2 years until Health Canada announced that NHPs in food format would remain regulated as NHPs but the substantial review would be conducted by the Food Directorate, not the Natural Health Products Directorate (NHPD, the governmental body created in 2004 to regulate NHPs).
The NHPD is on the same regulatory level as the Food Directorate and the Therapeutic Products Directorate. This resulted in a different set of review criteria being applied to NHPs in food format compared to the review criteria applied to all other NHPs. The difference was met with resistance from members of the Natural Health Products Industry.
On March 6, 2009, the NHPD released a new Guidance Document entitled, “Classification of Products at the Food-Natural Health Product Interface: Products in Food Format.”1
The Food-NHP Classification Committee (F-NCC) will adjudicate and classify products in food format on a case-by-case basis, based on 4 criteria.1 The Guidance document does not indicate which of these criteria have priority over the others or whether the ultimate classification as a food or NHP will be based on a majority of the 4 criteria favoring one classification over the other. In addition, the criteria below appear to be best directed to clear (or unambiguous) situations, which for the most part, seldom occur. Since decisions will continue to be resolved on a case-by-case basis, there continues to be little predictability.
These 4 criteria are as follows:
1. Product Composition. When a product or ingredient is present solely to provide nourishment, nutrition, hydration, or to satisfy hunger, thirst, or a desire for taste, texture or flavor (typical food attributes), then such criteria are indicative that the product or ingredient is a food. Conversely, a product that is or has an added ingredient that has no known food purpose, suggesting the ingredient has been added for its therapeutic use, then the ingredient or food is likely to be classified as an NHP.
2. Product Representation. A product that might, for composition or other reasons, be classified as a food may nonetheless be an NHP if it is represented or sold as a product having therapeutic uses. Claims that provide for a therapeutic use not based on the use of the product as a food suggest the product is an NHP.
3. Product Format. A product sold in a manner that lends itself to dosing, i.e., sold in single dose units for measured amounts, is an indication that the product is an NHP.
4. Public Perception and History of Use. If a product has a historical pattern of use as a food or if public perception is that the product is a food, then this perception is an indication that the product is to be classed as a food. This latter criterion appears to be a general catch-all, that, if desired, would allow the F-NCC to classify any product in a food format as a food.
Despite the release of the new policy and the government’s attempts to provide clarity to the situation, many in the Canadian NHP Industry are left with uncertainty as to whether a product in food format will be classed as a NHP or as a food. In order to avoid the time and expense of preparing a PLA, prudence would suggest that potential applicants should consult the NHPD to discuss the classification issue. An applicant that fails to do so could find out that the F-NCC has decided to classify the product as a food. This means the effort in preparing the PLA was wasted, and, depending on the nature of the claim and the active ingredient in the product, the product may not be capable of lawfully being sold as a food.
As of the date of publication, there have been suggestions by Health Canada that it is again looking at the regulation of products in a food format, which may lead to a change in the above and/or regulatory changes to allow for the sale of products that would not previously have been permitted to be sold as foods in Canada, where those products are classified as foods and not NHPs.