Dr. Scott Gottlieb, recently submitted written responses to questions posed by members of the Senate Health, Education, Labor and Pensions Committee as a follow up to his hearing on April 5. As a follow up to our April 13 post, below are selected Q&A exchanges based on questions submitted by Senators Elizabeth Warren (D-MA) and Patty Murray (D-WA).

Food Safety Funding and Implementation

Q (Murray): Are you committed to requesting the funds in your budget necessary to support FDAs implementation of FSMA to ensure that consumers remain confident in our food supply?

A: The Food Safety Modernization Act (FSMA) provides FDA with important tools and authorities to support its responsibility to ensure the safety of our nation’s food supply. If confirmed, I will work to ensure the agency has the appropriate policies, processes, and resources in place to implement FSMA, as intended by Congress. FDA should implement FSMA in a way that protects and promotes public health by enhancing food safety, while also collaborating with the U.S. Department of Agriculture, state officials, and other government agencies to conduct regulatory activities in a manner that takes into account the unique challenges faced by small farmers and small businesses.

Guidance on Sodium Reduction

Q (Murray): Last June, FDA proposed draft voluntary guidance to industry to reduce sodium in processed and restaurant foods and has received comments from industry, public health groups and consumers. Will you commit to the Agency’s finalizing this voluntary guidance in 2017?

A: We need to ensure that everything FDA does is science based and try to encourage science based, voluntary action to reduce sodium levels in foods. I know some companies have already taken voluntary steps to reduce sodium levels, and I support these public health goals. In some cases sodium plays an important food safety role, but many companies are already reducing sodium levels, and we want to find ways to continue to encourage those actions in a risk-based and science-based manner. If confirmed, I will review the comments received from stakeholders and the scientific evidence related to salt intake as well as consult agency staff before proceeding on this issue. I am committed to taking science-based steps, within the scope of FDA’s authority and mandate, to reduce the burden of heart disease.

Menu/Nutrition Labeling

Q (Murray): Researchers have concluded that menu labeling could prevent up to 41,000 cases of childhood obesity and save over $4.6 billion in healthcare costs over ten years.[1] […] If confirmed, how will you ensure that the FDA implements menu labeling beginning May 5, 2017, as planned, and does not penalize food establishments that have followed the law and prepared to meet the compliance date over food establishments that have not? How will you ensure that all Americans have access to basic nutrition information to allow them to make up their own minds about what to eat?

A: While I am broadly aware of the menu labeling issue, this is not a matter on which I am familiar with the specific technical details. As a general matter, I support providing clear, accurate, and understandable information to American consumers to help inform healthy dietary choices. And I believe information about caloric content can be a useful tool. However, I am mindful of the unique challenges that developing and communicating such information can pose, particularly on small, independent businesses. If confirmed, I will commit to working with FDA’s professional staff to quickly get up to speed on the regulatory history related to menu labeling, as well as FDA’s latest thinking and actions. I would welcome the opportunity to work with Congress and stakeholders to ensure any regulatory requirements would promote public health by providing helpful information to consumers, while not placing excessive compliance burden on businesses, particularly small, independent ones.

Q (Murray): Will you commit to prioritizing giving industry the guidance they need to move forward with updated packages and maintaining a compliance date no later than July of 2019 for the revised Nutrition Facts label, which would be a one year delay from the current compliance date? Other countries, like the United Kingdom, France, and Chile, have implemented front-of-package labeling where a consumer doesn’t “need a calculator” as you so aptly put it, and major international companies with strong market presence in the U.S. – Mars, Nestlé, Mondelez, Coca-Cola, Unilever, and Pepsi — have already taken major strides towards uniform labeling across Europe. As commissioner, would you move ahead with a uniform and useful version of front-of-pack labels?

A: I agree that providing industry sufficient information to comply with this rule, as with any rule, is imperative. I also agree that FDA should be open to considering and evaluating additional approaches, especially those that could promote better consumer awareness and understanding of nutritional information about the foods they eat.

Seafood Consumption and Pregnant and Nursing Women

Q (Murray): If confirmed, will you consider revisions to this document [guidance concerning seafood consumption by pregnant and nursing women] to ensure it is in line with the latest science and provides clear advice to consumers?

A: If confirmed, I will ensure FDA’s advice concerning seafood consumption by pregnant and nursing women is based on the most current and relevant nutritional science and appropriately takes into account both the nutritional benefits, and any toxicological risks associated with seafood consumption. I will also work to ensure effective collaboration between FDA and the U.S. Environmental Protection Agency (EPA) on this issue, and a range of other public health matters over which both agencies share regulatory authority.

Q (Warren): As a doctor, do you agree that pregnant women should have access to the latest science-based nutrition advice so that they can make healthy nutrition decisions before and after pregnancy? If confirmed Commissioner, what additional steps will you take to ensure that this final advice is consistent with the latest nutritional science?

If this advice is confirmed to be consistent with the latest nutritional science, what steps will you take to work with appropriate stakeholders to ensure that this final advice is clearly communicated to pregnant women?

A: As a doctor, I do agree that pregnant women should have access to the latest science-based nutrition advice so that they can make healthy nutrition decisions before and after pregnancy. If confirmed, I will ensure FDA’s advice concerning seafood consumption by pregnant and nursing women is based on the most current and relevant nutritional science and appropriately takes into account both the nutritional benefits, and any toxicological risks associated with seafood consumption. I will also work to ensure effective collaboration between FDA and the U.S. Environmental Protection Agency (EPA) on this issue, and a range of other public health matters over which both agencies share regulatory authority.