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Regulatory News – December 3, 2002
Check Your Labels!
Changes to the Food and Drug Regulations are expected to be in force by the end of this year. The main changes that all companies must prepare for are: (1) mandatory nutrition labeling for most prepackaged foods (currently, nutrition labeling is largely voluntary in Canada); (2) new rules for nutrient content claims (eg. “low cholesterol”); and (3) new generic health claims for certain foods. One of the main issues of debate has been the length of time that food manufacturers will have to comply with the amendments. The draft regulations published in June 2001 would require most manufacturers to comply within two years from the effective date of the regulations. Small businesses (having a gross annual revenues of less than one million dollars) were given a three year transitional period. Some stakeholders have lobbied for an additional year but Health Canada has not said whether it will allow the additional time or any of the other changes requested by stakeholders.
Canada Stands its Ground on Voluntary GMO Labeling
The federal government recently reaffirmed its position on genetically modified organism (GMO) labeling in its comments following a report issued by the Standing Committee on Agriculture. Labeling of biotechnology-derived foods and biotechnology-free foods will be on a voluntary basis.
No legislation is pending on GMO labeling. Instead, guidance will be provided through a government Canadian General Standards Board voluntary labeling standard. The standard, currently in draft form, will be limited to foods produced through the use of recombinant DNA (genetic engineering) and related techniques. The approval and publication of the final standard will likely occur sometime in 2003.
Having Your Say on Natural Health Product Approvals and Claims
The Office of Natural Health Products (ONHP) has published draft guidelines on the amount and type of evidence required for natural health product approvals and health claims1.
Public comments on the guidelines are due by December 13, 2002.
All NHPs will soon need to have a product license. Prior to receiving a license, applicants will have to provide evidence about efficacy, safety and conditions of use. The amount and type of evidence will vary with the product. In order to ease the evidential burden for known and low-risk products, the ONHP is developing a Compendium of Monographs of product information to which applicants can refer. Other products will need to submit a safety summary report including information about safety issues identified in scientific literature or traditional references. The amount of evidence for traditional products will be less than for new products. Traditional products will have to provide toxicological studies, or where none are available, two independent references documenting the traditional use of the product and showing a long history of use with no safety problems. Non-traditional products with prior marketing experience must be accompanied by a literature review for their safety summary report. Totally new products are subjected to a toxicity testing requirement, and may be required to undergo limited clinical trials. Where safety issues are identified, applicants may be able to resolve them through appropriate labeling.
The Compendium of Monographs will include a list of allowed health claims for some NHPs. Other NHP claims will have to be substantiated by the applicant with evidence. Possible claims will include maintaining or promoting good health, reducing risk of a disease and treatment of disease.
Health Canada is Making it Easier to Take Your Vitamins: Food Fortification
On November 1, 2002, Health Canada released updated proposals for changing its food fortification policy2. Public comments on the food fortification policy are due by December 15, 2002. “Fortification” refers to the addition of vitamins and minerals to food to restore nutrients lost during processing or to remedy inadequate intake of specific nutrients. Currently, fortification is strictly controlled under the Food and Drug Regulations. The Regulations list the foods to which nutrients may be added, the nutrients that may be added, and the exact amounts of nutrients that may be added. The current Regulations have been in place since 1964 and are considered to be too restrictive.
Health Canada is proposing to allow a wider range of fortified food products to provide more sources of nutrients. Under the new system, manufacturers will have more discretion to decide what nutrients will be added and in what amount.
Some foods will be excluded from discretionary food fortification. Excluded foods are primarily those that contain more than a specified amount of saturated and trans fat, sodium or alcohol and foods that are high in added sugars. Health Canada also intends to exclude white and whole wheat flours, breads, pasta, rice, milk, margarine and calorie free beverages including bottled water.
1Natural Health Products Directorate. Standards of Evidence for Evaluating Safety and Claims of Natural Health Products. October 2002. www.hc-sc.gc.ca/hpb/onhp/proposed_soe_e.html
For more information about the new food and drug regulations, please feel free to contact a member of our regulatory, advertising & marketing practice group.
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