ABA Challenges FDA On Science, Practical Deficiencies In Proposed NFP Revisions

Speaking on behalf of the American Bakers Association (ABA), Lee Sanders, ABA Senior Vice President for Government Relations and Public Affairs, made the following statement during FDA's Public Meeting on proposed changes to the Nutrition Facts Panel Label and Serving Size. As one of the few organizations selected to make a brief statement, ABA focused on key baking industry priorities including the use of sound science, definition of fiber, opposition to added sugar and concerns regarding the implementation time.

Good afternoon, my name is Lee Sanders, and I am Senior Vice President for Government Relations and Public Affairs for the American Bakers Association.

ABA is the voice of the wholesale baking industry, advocating on behalf of more than 700 baking facilities and their suppliers. Providing healthful products, improving public health and food safety are top priorities for our members. ABA appreciates this opportunity to provide our industry’s perspective today on FDA’s proposal to revise the nutrition facts panel.

Use of Sound Science:

As required by Executive Order, all rules/policies of the Agency must be based on the best available science, which is the approach advocated by Commissioner Hamburg earlier this year on April 9 during National Public Health Week, in which she stated “As a science-based regulatory agency with a public health mission all of our activities must be guided by the best possible data and science. We must shape our programs, policies and decision-making on sound evidence, and we must continually re-evaluate scientific and regulatory strategies against real-world outcomes.”

ABA as an organization, and as a leader of the Nutrition Facts Panel Alliance, concurs with Commissioner Hamburg’s statement. ABA and the NFP Alliance strongly advocate that any NFP changes must be justified by verifiable, peer reviewed, published science that is accessible through an open and transparent process; and that will enhance consumer understanding.

Yet, most of the proposed revisions in the NFP proposal are not science-based decisions and are not based on “the best possible data and science.” To improve the proposed rules’ transparency, the Agency should seek and provide empirical support for each of the proposed changes.

Fiber:

FDA has taken an unprecedented approach in defining dietary fiber by its physiological effect rather than by its chemical structure.  FDA has refused to take this approach with other nutrients.  The proposed definition essentially would exclude all currently added fiber ingredients, even those supported by sound science demonstrating health benefits.

FDA’s list of dietary fibers should include those ingredients already determined by authorities to have a beneficial effect, including those identified by Health Canada, by the IOM, and in FDA’s GRAS notices database.  In addition, rather than use the arduous petition process in adding ingredients to FDA’s “approved” dietary fiber list, FDA should use a notification approach or a substantiation approach.  If FDA requires use of the petition process, it should include and commit to a specific timeframe in which it will review and respond to petitions.

Added Sugars:

ABA opposes the added sugars declaration. The proposed rule concedes that there is no chemical difference between naturally-occurring sugars or added sugars, and also, that there is no scientific evidence that added sugars are linked to obesity or other chronic diseases. Executive Order 13563 requires rules to be based on the best science available.  It would be difficult, if not impossible, to calculate added sugars or track added sugars through recordkeeping, especially for yeast-leavened bakery products in which the fermentation process results in overall sugar reduction. ABA continues to question the Agency’s legal authority to require records for this purpose.

Implementation Time:

If FDA goes forward with all the proposed changes, all sectors of the bakery industry will likely be unable to reach full compliance within FDA’s proposed two year implementation time, without incurring substantial costs. ABA’s survey of our membership shows that a minimum of three to five years would be needed to fully implement changes for all of their products.  

ABA notes that the report from the Mercatus Center of George Mason University shows that a two year compliance option would cost 2.3 billion dollars while providing 31.4 billion dollars in benefits. By contrast, a four year compliance option would cost $ .6 billion dollars while still providing 30.2 billion in benefits. Thus a four year compliance date could result in almost a four-fold reduction in cost while only marginally reducing benefits. This approach would also greatly assist small businesses that are most likely to be impacted.

Footnote:

If FDA obtains consumer data in support, ABA agrees that the footnote should explain the % DV and include reference to the 2000 calorie diet, but the size should stay the same or it could result in reformatting entire packages, rather than just labels, and consequently, substantially increase the cost to industry and ultimately to consumers.

Vitamins/Minerals:

ABA supports the proposed mandatory declarations of Vitamin D and Potassium.  ABA notes that FDA’s proposal to include quantitative declarations of vitamins/minerals are not based on consumer data and will likely be very confusing, especially if accompanied with the percent DV on the left side, which is also a change opposed by ABA.  If included, FDA should provide clarity on rounding rules and should not include the percent DV on the left side.

Trans Fat and PHO GRAS:

FDA requested comments on whether the trans fat declaration should remain on the label if FDA withdraws the GRAS status of all uses of PHOs. This action illustrates that FDA has confused the health effects of trans fats with PHOs. If FDA removes the trans fat declaration from the label, then consumers are likely to be very confused – thinking that all trans fats have been removed from foods, even though foods will still contain naturally-occurring sources of trans fat.

Sodium:

Any change to sodium daily value should be based on new peer reviewed, published science that clearly demonstrates the need for lower daily intakes – even a reduction from 2400 mg to 2300 mg. In May 2013, IOM noted the gap in science and did not recommend lower intake. We would question what current science supports this proposed change.

Closing:

As ABA develops its written comments, we intend to provide detailed comments on the issues raised today, as well as other critical topics impacting both large and small bakers. ABA looks forward to partnering with FDA as we move forward to develop policies that focus on improving public health and consumer understanding so that they can make better informed food choices. Thank you.

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About the American Bakers Association:

The American Bakers Association (ABA) is the Washington D.C.-based voice of the wholesale baking industry. Since 1897, ABA has represented the interests of bakers before the U.S. Congress, federal agencies, and international regulatory authorities. ABA advocates on behalf of more than 700 baking facilities and baking company suppliers. ABA members produce bread, rolls, crackers, bagels, sweet goods, tortillas and many other wholesome, nutritious, baked products for America’s families. The baking industry generates more than $102 billion in economic activity annually and employs more than 706,000 highly skilled people.

Source: American Bakers Association