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David Cockram, Independent Consultant, EAS Consulting Group, LLC

We live in exciting times, with new discoveries being announced daily about the relationships between nutrition, diet, health, and disease. So much so that it’s often hard to keep track of whether this food or food component is currently something we should be eating more or less of at the moment (think eggs or caffeine). At the same time, these discoveries create opportunities for new nutritional products to help maintain health, optimize physical performance, avoid disease, slow progression of a chronic condition, or manage an existing condition. A food or food ingredient that prevents or treats a disease sounds like a great commercial opportunity, right? How about omega 3s, CLAs, plant proteins, probiotics, prebiotics, individual amino acids, tropical plants and their fruits and seeds, “pre-digested” fats and carbohydrates?

From a regulatory standpoint, however, food products making therapeutic claims are very challenging. While most countries allow foods to make claims about their value in maintaining normal nutritional status and function, opportunities to make claims about disease risk reduction generally are either prohibited or permitted only in the context of approved health claims (claims about the relationship between the potential reduction in the risk of developing a disease and nutrition). Going a step further and making claims about treating or preventing an existing disease or condition, even where the evidence is clear that the claim is truthful and not misleading, is permitted only under very limited circumstances for foods. For products where the intended use is for therapeutic purposes, medical foods are a very limited category of foods that can make claims for dietary management of a disease or condition (but not that they prevent, treat, or cure anything). Developing a product positioning, adequate substantiation, and claim language that is both compliant but also commercially compelling is challenging but not impossible.

What can be done to assure success from a regulatory standpoint? Some pieces of the puzzle are clear, such as assuring that the finished product is safe and effective for its intended use, all components are permissible food ingredients, and packaging materials are acceptable for use. Design a product using solid science to support the intended benefits. Where products are intended for a multinational launch, early consideration of all country’s regulatory requirements (permitted ingredients, claims, packaging, substantiation standards, data needed for approval of novel ingredients, and review timelines) is critical. Fortunately, the basic data package is pretty standard across countries; however, formatting, review timelines, and fine points of data submissions vary widely so regulatory considerations must be a high priority throughout the formulation and product development process.

Other parts of the compliance puzzle, particularly in the area of product claims tend to be grayer and potentially subject to different interpretations. What a marketer may view as an awesome claim about their new food product may to a regulator be a violative drug claim that garners enforcement action for the company. Product claims must be substantiated using soundly designed and statistically-powered studies that clearly support the express and implied product benefits and label claims. Such studies in humans can be challenging to conduct and interpret for a number of reasons (e.g., all humans need to eat so careful attention to trial design is needed to detect the incremental effect of a product or nutrient beyond the baseline diet, free will and other causes of non-adherence to study protocols, etc.). To overcome the challenges of studying humans, preclinical designs are frequently used as partial substantiation for claims. However, increasingly regulatory bodies are unwilling to accept preclinical data as a sole source for substantiation for benefit claims in humans. Sometimes a premarket consultation with regulatory agency staff such as that provided by EAS can provide helpful guidance…but it can also yield challenging feedback that can only be ignored at great risk.

An infrequently discussed issue is the risk tolerance of the company around product positioning and claims. Where on the spectrum of risk does your company fall? It can range from ‘get a warning letter from a regulatory agency and you are fired’ to ‘if we don’t get an occasional warning letter then you’re obviously not pushing the envelope enough’. Keep in mind that agency enforcement action is enormously time-consuming and disruptive to the company and can quickly derail any product development, marketing and launch effort. This knowledge, along with an understanding of Agency expectations and historical enforcement activities will go a long way to helping a product development and marketing professional appropriately calibrate product claims and claim substantiation.

In the end, careful planning and early discussion between product development, clinical science, labeling and marketing staff are needed to assure that the product meets all needs including regulatory, as cost- and time-efficiently as possible. An experienced regulatory professional must have a seat at the table throughout the process to help the organization balance commercial objectives and desires with Agency expectations and EAS Consulting Group with over 150 Independent Consultants under contract has expertise in all of these areas.

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