its claims, Rusk said, but FTC concluded that the claims went beyond the evidence.

Rusk mentioned recent concern that FTC is raising its substantiation standard. She assured the workshop audience that this is not the case. Rather, the commission is trying to be more specific when it enters into an order with a company it has investigated. In some cases, FTC requires that future claims about specific products go through the FDA approval process. In other cases, it says that claims should be supported by two additional studies conducted by independent researchers. However, these requirements do not reflect a changing standard. Rather, the intention is to be concrete and transparent so that a company under order knows exactly what to expect in terms of compliance.

REGULATORY FRAMEWORKS: THE INDUSTRY EXPERIENCE14

Looking through the lens of DuPont, Stuart Craig explored how the changing regulatory landscape is affecting the food industry. DuPont has been a key player in the lactic acid bacteria industry for more than 100 years and works with regulatory agencies worldwide on new legislation and emerging guidelines and requirements related to probiotic safety and efficacy. Indeed, collaborating with regulators to find better ways to ensure food safety and security is a key component of DuPont’s focus on food.

As an example of the “paradigm we are in,” Craig mentioned the Cheerios labeling controversy. Even though data showed cholesterol reduction, the claim “cholesterol reduction” is a health claim that falls outside the purview of food. In addition to FDA warning letters stating that studies with disease end points support drug claims, not nutrition claims, FDA has made other recent moves that represent significant change for the food industry. Recent FDA actions include the agency’s new strategic plan for regulatory science (FDA, 2011a), the Food Safety Modernization Act of 2011,15 and draft guidance on NDI notifications (FDA, 2011b). FDA’s new strategic plan for regulatory science reflects the agency’s overall changing priorities: an emphasis on toxicology, personalized medicine, manufacturing and quality, emerging technologies, information sciences, prevention-focused food safety, medical countermeasures, and social and behavioral science. The FSMA legislation is focused on improving the capacity to prevent food safety problems and to detect and respond to food safety problems and on improving the safety of imported food. For a large company such as

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14 This section summarizes the presentation of Stuart Craig.

15 FDA Food Safety Modernization Act of 2011, Public Law 111-353, 111th Cong. (Jan. 4, 2011).



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