Roberta Wagner
Danielle Quist
Roberta Wagner is senior vice president, regulatory and scientific affairs and Danielle Quist is vice president, regulatory affairs and counsel, IDFA

The U.S. Food and Drug Administration (FDA) regulates food and color additives and food contact materials, but non-governmental organizations (NGOs) are pressuring state legislatures to ban some of these substances previously approved by the FDA for specific conditions of use without the level of science needed to support such action. 

Last year, California became the first state to ban the food additives and colors brominated vegetable oil (BVO), potassium bromate, propylparaben, and Red Dye No. 3, respectively. Now, legislators in Illinois, New York and Washington are considering bans on the same and several additional additives, including titanium dioxide. Most of these substances are under review by FDA, and notably the agency issued a proposed rule to ban BVO and is reviewing Red Dye No. 3 under the Delaney clause, a law requiring FDA to ban additives found to cause or induce cancer in humans or animals as indicated by testing. New York is also considering reporting requirements for substances Generally Reported as Safe (GRAS), and NGOs are signaling that this is only the beginning of a massive push to use state legislatures as the arbiters of the safety of food and color additives and GRAS substances. 

Concurrent to these state activities, the FDA finds itself at a crossroads. A recent expert panel report described an FDA culture of “inaction, risk aversion and a glacial pace of decision making.” Add to that FDA’s past inability to leverage academic and private sector expertise, robustly engage with diverse stakeholders, and operate transparently, and you have an organization whose mission is being challenged by a host of state legislative and regulatory bodies responding in a haphazard fashion to demands from NGOs.  

In the past decade, the FDA prioritized preventing foodborne illnesses and enhancing outbreak response to fulfill its public health mission and protect consumers. Furthermore, recent efforts have focused on nutrition policy due to the prevalence of diet-related chronic diseases. However, this focus — and some might say limited resources — have led to the lack of proactive agenda for post-market activities, including safety reassessments of approved additives and colors, at times despite scientific backing, and a lack of oversight for GRAS substances. Additionally, the FDA has been slow in addressing environmental contaminants in foods and packaging, including those affecting infants and young children.

Against this backdrop, the FDA human foods program is also undergoing major transformation and modernization to become more action-oriented, which would allow for innovation and growth in the food industry. 

IDFA understands NGO criticisms of FDA. We share many of them. In fact, IDFA is a member of several coalitions including the FDA Foods Coalition and Alliance for a Stronger FDA, where we work alongside NGOs, academia and industry to reform the agency. This work has gotten the FDA’s attention and changes are being made to address concerns expressed by industry and NGOs. 

Rather than legislating food safety through a patchwork of state laws, we strongly encourage NGOs and state legislators to work with industry in a coordinated fashion. Creating a patchwork of state laws weakens FDA, harms businesses, and undermines science and interstate commerce.

At its worst, this patchwork strategy could turn states into powerful regulatory fiefdoms able to crush business. That is why we urge the food industry to prevent this splintering at the hands of NGOs and states. When your company learns of an effort by an NGO or state legislative body to weaken FDA’s authority by advancing conflicting or redundant policy, we urge you to advocate strenuously against it or to contact IDFA or your trade association to create a plan of action.  

Our goal should be to collaborate with FDA on prioritizing reassessments by the agency and better position the food industry for success. Questions such as what criteria should be used to create a priority list, who should conduct the reassessments, and how should the reassessments be conducted, require collaboration rather than legislation. The new deputy commissioner for FDA’s human foods program, for example, has repeatedly sought stakeholder engagement and recognized the need for regulatory certainty and transparency, signaling that it’s a new day at the FDA. 

We are optimistic that under this new leadership, FDA’s culture will change, and its human foods program will be trusted and respected once again.