Supplemented foods and natural health products (NHPs) can sometimes pose challenges when trying to determine the correct regulatory pathway to gain market access in Canada. Supplemented foods are broadly defined by Health Canada as pre-packaged products that are manufactured, sold or represented as foods, which contain added vitamins, minerals, amino acids, herbal or bioactive ingredients. While NHPs, which are sold in discrete dosage units, often contain these same ingredients, the 2 types of products are regulated through different pathways.
In order to determine the correct regulatory pathway for these types of products, Health Canada implements a risk-based approach in considering the composition of the product, how the product is marketed, the format of the product, public perception of the product & the history of use of the product.
Of these factors to consider, the main contributing factor is often product format. If a product looks like a food and is consumed as a food, it will likely be classified as a food regardless of the composition of the product. Products of this nature typically include fortified ready-to-drink beverages, bars and other conventional food formats. Alternatively, a product can be in a typical food format, such as a ready-to drink liquid, and still be classified as an NHP. This could be the case for a product which was marketed for its health benefits and sold in individual units of 90 mL (or less) or if the same product was sold with a measuring cup.
As indicated in the previous example, product representation is also a main factor in determining the classification of a product at the food-NHP interface. If the product is being marketed as a food (i.e. as a source of nutrition, hydration or for its delicious flavour) and/or being sold at the grocery store with other foods, the product is likely to be considered a food. It is important to note that inclusion of health claims on the label is not sufficient to classify the product as an NHP. If the product is deemed to be a food and the claim is found to be unacceptable, the product may be deemed a non-compliant food. In these cases, it is imperative to confirm product classification before going to market.
Product ingredients, perception and history of use are also considered when determining the classification of a food-like product. Inclusion of certain ingredients which are known to be used primarily for their health benefits and are not commonly found in foods will likely render the product an NHP. However, inclusion of an ingredient with medicinal properties is not enough to classify the product as an NHP on its own. In cases like these, Health Canada will also look at how the product will be perceived by the public and how similar product types have been historically used in addition to the format of the product and how it is being marketed.
In summary, Health Canada uses several factors when determining whether a product is a supplemented food or NHP. Special consideration should be given when trying to classify products in the following formats: ready-to-consume drinks, conventional food formats (including confectionary) and powders. If you are looking to bring one of these types of products to the Canadian market, Quality Smart Solutions has a team of experts who can assist you in determining the correct regulatory pathway for your innovative product. Contact us today to discuss how we can be your solution!
Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 11 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Canna, Medical Devices and OTC drugs. Ask us for details or visit our website at www.qualitysmartsolutions.com.
Summertime has finally arrived and with it comes hot temperatures and intense ultraviolet rays. Exposure to ultraviolet light is known to be associated with early skin aging and skin cancer. While the best protection from the sun is to avoid exposure altogether there are times when this is not possible. Using an appropriately regulated sunscreen can offer protection from the sun’s harmful rays.
If you are looking to market sunscreen in Canada or the United States, there are a few things to consider.
Canadian Sunscreen Requirements
In Canada, sunscreens can be classified as either Natural Health Products (NHPs) or non-prescription drugs, depending on the ingredients they contain. Commonly used natural ingredients include titanium dioxide, zinc oxide, and p-aminobenzoic acid. Marketing a product containing these ingredients would require a Natural Product Number (NPN) unless the product also contains ingredients that are not naturally derived, such as avobenzone, oxybenzone, octinoxate, or other recognized drug ingredients as outlined in the Natural and Non-Prescription Health Products Directorate’s (NNHPD’s) sunscreen monograph. For products that contain drug ingredients, a Drug Identification Number (DIN) would be required.
It is important to note that all Canadian sunscreen products must include a statement to the effect of “helps prevent sunburn” and display the appropriate Sun Protection Factor (SPF) value on the label. Companies are also permitted to market their sunscreen products with a ‘Broad Spectrum SPF’ value provided that test results demonstrate a critical wavelength of? 370 nm for the product.
There are however a few labeling statements that are not permitted by Health Canada. Statements that suggest the product completely blocks the penetration of the sun’s rays (e.g. sunblock) are not acceptable. Those that suggest the product helps to prevent cancer or photo-aging are also not permitted and the product cannot claim to filter out other UV rays apart from UVA/UVB. These are not the only non-permitted statements but rather are those which are most commonly misused.
In summary, if you are looking to market a sunscreen in Canada, you need to determine whether it will be classified as a drug or an NHP, prepare the appropriate application, and label your product according to the criteria as set out in the NNHPD sunscreen monograph and the appropriate set of governing regulations.
key requirements you should be aware of before bringing your sunscreen product to the Canadian market:
Product Classification and Registration:
In Canada, sunscreens are classified as natural health products (NHPs) or non-prescription drugs, depending on their active ingredients and intended use. Check the classification of your product to determine the applicable regulatory pathway.
If your sunscreen is classified as an NHP, you need to apply for product registration with the Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada.
If your sunscreen is classified as a non-prescription drug, you must follow the regulatory requirements outlined by Health Canada’s Health Products and Food Branch (HPFB).
Labeling and Packaging Requirements:
Sunscreen product labels must be bilingual (English and French) and meet specific format and content requirements outlined in the Food and Drugs Act and Regulations.
Ensure accurate SPF (Sun Protection Factor) labeling and UV protection claims.
Sunscreens must also include usage instructions, precautions, and any required warnings.
Sun Protection Factor (SPF) Testing:
SPF testing is essential to determine the effectiveness of your sunscreen product. Testing should be conducted by Health Canada’s guidelines.
Ensure that your product provides the level of sun protection claimed on the label.
Safety and Efficacy Data:
Provide data on the safety and efficacy of your sunscreen product, including information on the active ingredients, formulation, and potential side effects.
Ensure that your product is safe for use on the skin and does not cause adverse reactions.
Stability Testing:
Conduct stability testing to assess the product’s shelf life and ensure that it maintains its effectiveness and safety over time.
Data from stability studies should be submitted to Health Canada as part of the regulatory requirements.
Comply with GMP standards to ensure the quality, safety, and consistency of your sunscreen product.
Facilities involved in the production of sunscreen should adhere to GMP guidelines.
Notification and Reporting:
Report any adverse reactions or safety issues associated with your sunscreen product to Health Canada promptly.
Maintain records of complaints and adverse events and provide these to Health Canada as needed.
Packaging and Dosage Forms:
Ensure that your sunscreen product’s packaging and dosage forms meet Health Canada’s requirements and guidelines.
Different dosage forms, such as creams, lotions, sprays, and sticks, may have specific regulatory considerations.
Health Canada Notifications and Submissions:
Prepare and submit all required documentation, including product labeling, safety and efficacy data, stability testing results, and any other relevant information, to Health Canada.
Comply with Health Canada’s notification and submission procedures and timelines.
Compliance with International Standards:
Familiarize yourself with international sunscreen standards, such as those from the International Organization for Standardization (ISO), and align your product with these standards for broader market acceptance.
Market Surveillance and Compliance Reporting:
Implement a system for market surveillance to monitor the safety and compliance of your sunscreen product after it is on the market.
Report any updates or changes to the product, labeling, or formulation to Health Canada as required.
It is essential to work closely with regulatory experts or consultants familiar with Canadian sunscreen regulations to navigate the complex requirements effectively. Failing to meet these regulatory obligations can result in delays in product approval or market withdrawal, potentially harming your business’s reputation. Compliance with Canadian sunscreen regulations ensures that your product is safe and effective for consumers in the Canadian market.
U.S. Sunscreen Requirements
Sunscreens in the United States are regulated as drugs through 2 pathways:
The Over-the-Counter (OTC) monograph process outlined in 21 CFR part 330 and accordance with the Sunscreen Innovation Act (SIA), or
The new drug approval process is outlined in 21 CFR part 314.
The United States Food and Drug Administration (FDA) has categorized sunscreen products by type and published several final rules. If you are looking to market a sunscreen product in the U.S., it is advisable to consult the FDA’s published final rules to verify if your product meets the indicated conditions. If the conditions as set out by the FDA are met and the product also complies with the FDA’s general regulations for OTC drugs then the FDA considers the sunscreen to be Generally Recognized as Safe and Effective (GRASE) and not misbranded.
Regulation through the OTC monographs was once the only option for sunscreen products, but in 2014, the FDA published the Sunscreen Innovation Act (SIA) to allow for an expedited review process for new sunscreen ingredients. The SIA functions to supplement the Time and Extent Application (TEA) regulation, as outlined in 21 CFR part 330.14(c), which together allows anyone (not only sponsors) to request that an active sunscreen ingredient be recognized as GRASE and not misbranded when used by the criteria set out in a final sunscreen order. This collaborative framework has allowed for a new process by which OTC active sunscreen ingredients or combinations of ingredients can be deemed GRASE and not misbranded when used according to the conditions set out in an administrative order.
To gain GRASE status for a new sunscreen ingredient, initial eligibility of the ingredient is determined by the FDA. If the ingredient is deemed eligible for review, data supporting the safety and efficacy of the ingredient is to be submitted by either the sponsor or the public. If the provided evidence is deemed acceptable, a final GRASE determination in the form of an administrative order is made by the FDA within 60 days of data submission.
In summary, if you are looking to market a sunscreen product in the U.S., it is advisable to first check the OTC final rules for sunscreens and if your ingredient(s) is/are not present, then look into preparing a GRASE data submission.
If you are looking to expand your business into the U.S. or Canadian sunscreen market, we can assist you in confirming which regulatory framework best suits your innovative sunscreen product. Contact us today to discuss how we can be your solution!
Quality Smart Solutions is an end-to-end compliance solutions expert who has been assisting clients for 10 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices, and OTC drugs.
Resources
Non-prescription Sunscreen Drug Products – Format and Content of Data Submissions. Guidance for Industry. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Nov 2006.
The Safe Food for Canadians Act (SFCA) and the Safe Food for Canadians Regulations (SFCR) are set to come into effect on January 15, 2019. Under the new legislation and corresponding regulations, certain companies involved in the manufacturing, distribution, handling and sale of food will be required to implement regulatory changes to improve food safety in Canada.
Regulatory changes which are being implemented under the SFCA and corresponding SFCR focus on 5 core areas: licensing, preventative controls, traceability, labelling & standards of identity/grade and organic certification. The focus of this article is to highlight the main changes associated with these new requirements.
Licensing
Certain food businesses will need to be licensed. Food businesses involved in any of the following activities will be required to have a licence by January 15, 2019 in order to maintain food production/handling activities:
Importation of food
Manufacturing, processing, storing, packaging, or labelling food to be exported or sent across provincial or territorial borders
Exportation of food that requires an export certificate
Slaughtering of food animals for export or shipment across provincial or territorial borders
Handling and storage of imported meat products in their imported condition for inspection by the Canadian Food Inspection Agency (CFIA).
Preventative Controls
Preventative control measures will need to be implemented by most businesses by the coming of force of the SFCR. The preventative control measures are to be documented in a Preventive Control Plan (PCP) as outlined in Part 4, Division 6 of the SFCR. However, certain businesses will be exempt from this regulation, including businesses with $100,000 or less in gross annual food sales and exporters of non-meat and non-fish products.
Traceability
Requirements to assist with the traceability of food through the market will come into effect with SFCR. These requirements will affect your business if you are involved in any of the following food-related activities:
Importation
Exportation
Distribution across provincial or territorial borders
Manufacturing, processing, storing, packaging or labelling food to be exported or sent across provincial or territorial borders
Growing/harvesting fresh fruits or vegetables which are to be shipped internationally or across provincial or territorial borders
Slaughtering of food animals for export or shipment across provincial or territorial borders
Handling and storage of an imported meat product in its imported condition for inspection by the CFIA
Selling food to consumers at the retail level
As a note, restaurants and other similar businesses are not subject to the traceability requirements.
Labelling, Standards of Identity and Grades
Food labelling requirements, standards of identity and grades requirements from the former Consumer Packaging and Labelling Act, Canada Agricultural Products Act, Meat Inspection Act, Fish Inspection Act, and their respective regulations and been consolidated into the SFCA and SFCR. Furthermore, the CFIA has published documents outlining specific requirements on standards of identity and grades for certain types of foods.
Organic Products
As per section 13 of the SFCR, organic products must be certified organic according to the Canadian Organic Standards. More specifically, compliance with section 13 of the SFCR is required for imported or nationally distributed products which are making an organic claim or products which bear the Canada Organic Logo, regardless of shipping destination.
Most companies have until January 15, 2019 to bring their business practises in line with the SFCR for most food-related practises. Quality Smart Solutions has a team of regulatory specialists who can assist with the assessment of your food-related activities. Contact us today to discuss how we can be your solution for your Canada food safety and label compliance needs!
Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for over 10 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Canna, Medical Devices and OTC drugs. Ask us for details or visit our website at www.qualitysmartsolutions.com.
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