DuPont, these new challenge are “really not an issue,” Craig said, “but for the industry in general, this is going to be quite a change.” With respect to the draft guidance on NDI notifications, Craig expects there to be considerable dialogue between the food industry and FDA in the coming years.

The global trend in health claims around food is toward higher safety and efficacy standards. As Craig put it, there is a “higher bar.” At the same time, there is also uncertainty around how to scientifically substantiate claims. Craig emphasized the significance of having clear rules and guidance. Gray areas of regulation that are open to interpretation are challenging for everyone involved. Typical questions of regulatory affairs staff include the following: What claims can I make based on this study? Can you make a list of suggested claims we can send to customers? Is this one study enough? If not, why not? If I do another study, will that be enough? Can I study the reduction of XXX and claim the maintenance of YYY or ZZZ? Is this GRAS? Should we notify? Do I need to file an NDI notification?

The EFSA health claim evaluations have drawn on many of DuPont’s resources over the past couple of years. Craig noted the high level of EFSA rejections industry-wide, a lack of dialogue, and misunderstanding about what is required of health claims for food products. The challenge has been especially difficult for probiotic and prebiotic claims. While some products have seen success, the overall effect on industry investment has been “chilling.” Moreover, the effect is spilling over into other countries.

The “higher bar” for safety and efficacy is difficult for the food industry for two main reasons. First is return on investment. Human clinical studies are expensive, sometimes costing more than $1 million. The food industry model does not compare to the pharmaceutical industry model; with shorter time lines and lower profit margins, protection of research investment in the food industry is lacking. Second, it is more difficult to demonstrate health maintenance than disease intervention. Using the “cholesterol reduction” claim as an example, Craig wondered how a study on cholesterol maintenance would even be designed. Normal subjects should not have elevated cholesterol; they should have normal cholesterol levels, he observed. How does one design a study aimed at evaluating whether a product helps to maintain those normal levels over time? Health maintenance studies need to be longer and involve larger numbers.

Inside DuPont Regulatory and Scientific Affairs

When conducting its own internal scientific substantiation of claims, DuPont tries to use existing tools, such as the Health Canada Claims Substantiation Template, which includes a list of eight items that are scored; the



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