Intertek is in the unique position to offer comprehensive scientific and regulatory solutions for medical foods, flavourings, packaged foods, cannabis, and other product categories in major and minor jurisdictions around the world.
Medical Foods
Medical foods are a product class that meets particular dietary needs resulting from a physical, physiological, pathological, or other condition, including diseases, convalescence, pregnancy, lactation, allergic hypersensitivity to food, and being under- or overweight. In the U.S., medical foods were previously regulated as drugs due to their role in mitigating serious diseases; however, in 1972, the U.S. Food and Drug Administration (FDA) reclassified medical foods as Foods for Special Dietary Use. Medical foods are now defined as foods which are:
“…formulated to be consumed or administered enterally under the supervision of a physician, intended for the specific dietary management of a disease or condition, for which distinctive nutritional requirements, based on recognized scientific principles, have been established by medical evaluation.”
Medical foods must meet the statutory definition of a medical food and be safe and effective in the intended population group. It is insufficient to demonstrate that a dietary substance is effective in treating a disease or condition; the substance must also fulfil a nutritional requirement that arises because of the disease. Substances that are marketed to treat, cure, or mitigate symptoms of a disease are considered drugs. In addition to specific guidance for regulation of medical foods, other applicable requirements for foods must be met, and health claims must not be false or misleading.
Flavourings
Food flavour(ing)s are added to food to impart flavour and give food a specific taste and/or smell. Depending on the jurisdiction, flavourings are not always considered a sub-category of food additives. Flavourings consist of one or more individual flavouring ingredients (referred to as “flavouring substances” or “flavouring agents,” depending on jurisdiction), which can be natural or synthetically derived, and may contain non-flavouring ingredients (flavour adjuvants) and related compounds (e.g., flavour enhancers or modifiers). Although the exact quantities of flavouring substances present in food are elusive, due to the volatile nature of most flavouring substances, use levels are generally self-limiting due to the adverse effect that high levels often have on taste.
The regulatory framework for flavouring substances varies by jurisdiction, but specialized procedures have been developed specifically for flavouring substances. These procedures are generally based on the threshold of toxicological concern (TTC) approach for assigning exposure thresholds, based on chemical structure, below which exposure is assumed to have no significant risk. Such procedures have been adopted by some regulatory and scientific advisory bodies for safety evaluations of flavours added to food, and they provide a scientifically sound approach for the evaluation and use-authorization of this unique group of substances.
Cannabis
Although illegal in many jurisdictions, cannabis-containing foods are legal for medical and/or recreational use in some countries (e.g., Canada). Cannabis constituents such as cannabidiols (CBD), moreover, have garnered interest for their use in foods and supplements. However, regulatory agencies have differing levels of certainty regarding the distinction between CBD-containing foods and supplements as medicine/drugs versus dietary supplements.
In Canada, dietary supplements, or "natural health products" (NHPs), are regulated as a subset of drugs under the Food and Drugs Act. No changes to the NHP regulations have yet been made with respect to allowing cannabis or concentrated-CBD products into NHPs, and currently these products are not permitted. However, the Natural and Non-prescription Health Products Directorate (NNHPD) has indicated that concentrated CBD may possibly be permitted in NHPs in the future.
In the U.S., the FDA has stated that it is not apparent how CBD-containing products could meet current standards for dietary supplements or food additives. However, due to the growing public interest in cannabis and cannabis-derived products, including CBD, the FDA plans to develop a new regulatory pathway for CBD-containing products that balances the public’s desire for access to CBD products with the regulatory oversight needed to manage risks.
In the EU and the UK, the Commission and Member States have confirmed that CBD products are novel foods (if they are presented as foods). However, after reviewing many applications for authorization of CBD-containing products as novel foods, the European Food Safety Authority (EFSA) published a statement on the safety of CBD as a novel food in which they outlined several major limitations related to the safety of CBD from the public literature. These limitations must be addressed before risk assessment for these products can continue. Whether you are considering submitting a novel food application for CBD in the EU, or looking to navigate the regulatory framework for CBD-containing products in light of EFSA’s statement on the safety of CBD as a novel food, our experts are here to support you.
The regulatory landscape is often in flux—that’s why Intertek's Food and Nutrition Assurance experts specialize in developing and implementing global regulatory strategies and scientific submissions. We can help you navigate compliance issues to gain proper and efficient access to global markets. We can also support the full range of nutrition, risk assessment, and food safety compliance requirements in the following jurisdictions:
United States, Canada, European Union, United Kingdom, China, Japan, Australia/New Zealand, South Korea, Thailand, Brazil, and others
Intertek’s expert staff have extensive experience navigating regulatory requirements, identifying data gaps, and providing scientific consultation for approvals across the globe.
Intertek’s knowledgeable and well-connected global team can help at all stages of product development—from conception, to stewardship with authorities, to final approval.
Related Services
