FDA is scheduled to issue regulations finalizing its proposed Nutrition Facts label soon according to the US Regulatory Agenda. Many food companies and trade associations are eagerly awaiting the final rules to see how the agency will handle the most controversial provisions. One part of the proposed rules would require the disclosure of added sugars, both the amount per serving and the percent Daily Value (%DV) based on a Daily Reference Value (DRV) of 50 grams. That battle is not over yet, there is discussion of possible litigation challenging the final rules. But regardless of how the agency handles the added sugars issue, the final rule updating the Nutrition Facts label will not mark the end of food labeling reforms.
The food industry should brace itself for more regulations to come that will align FDA’s nutrient content claims and health claims regulations with the new Nutrition Facts label, particularly if the Democrats retain control of the White House. Some companies may demand action by FDA regardless of which political party is in power. The reason would be to establish a level, competitive playing field and force the agency to make sense out of what is soon to become a convoluted scheme where Nutrition Facts regulations are unaligned with FDA nutrition and health claim regulations. Most food companies want a regulatory framework that makes sense and upon which marketing claims can be based.
Further, some FDA regulations governing nutrient content claims are not aligned with the Dietary Guidelines for Americans. This matter was already raised by Dr. Stephen Ostroff, then Acting Commissioner of FDA, at a February 24, 2016, House Appropriations Subcommittee hearing on FDA’s FY ’17 budget. California Representative David Valadao (R) asked whether FDA would be updating the rules for nutrient content claims in light of the new Dietary Guidelines for Americans. The Congressman stated that, for example, some pastries can be labeled “healthy” while salmon, nuts, and avocados cannot.
This is because FDA’s current regulations governing the use of the term “healthy” require foods to be low in saturated and total fat, but do not adequately distinguish between other types of fats found in foods like salmon and nuts which newer evidence finds may be healthful.
Further, FDA’s definition of “healthy” does not take into account either total or added sugars content. That would likely change if the agency moves forward with a regulation setting a DRV for added sugars. If there is an established DRV for added sugars, FDA might also define new nutrient content claims about added sugars content, such as “low in added sugars.”
The 2015-2020 Dietary Guidelines also raise questions about FDA existing regulations for “low cholesterol” and “low fat” claims. The new Dietary Guidelines deemphasize the role of dietary cholesterol and put into question whether a “low cholesterol” claim would help consumers maintain healthy dietary practices. The new Dietary Guidelines also recognize that not all fats are the same – some can be part of a healthful dietary pattern. Accordingly, FDA should review whether an across the board “low fat” claim is still helpful to consumers. FDA criteria for “lite” and “lean” claims may also be affected.
Changes to nutrition claims like “low sodium” may also follow if FDA, as proposed, reduces the current DRV for sodium from 2400 mg to 2300 mg per day (although the agency has previously set special rules for “low sodium” claims given the difficulty food companies face in reducing sodium content).
In addition, a domino effect of changes in disclosure requirements (like “see back panel for nutrition information about _____”) that at times must accompany nutrition claims such as “High Calcium,” would occur as serving sizes for foods like ice cream change.
Further, the new Dietary Guidelines may lead the agency to review its authorized health claim for total fat and cancer. In addition, disqualifying levels of total fat for all health claims may be reconsidered in light of the Dietary Guidelines findings about certain fats and dietary patterns. Kind LLC, the manufacturer of Kind bars, has already filed a petition raising such issues.
Early in the Obama Administration, FDA considered FOP and shelf marker labeling a top priority. The IOM issued two reports on the matter in 2010-2011; and the food industry responded in part with its own FOP labeling programs including the Grocery Manufacturers Association and Food Marketing Institute program “Facts-Up-Front,” the American Beverage Association’s “Clear on Calories” program, and the National Confectioners Association’s “Treat Right” program. Then, FDA shifted gears. The agency decided to fast-track proposed rules to revise its Nutrition Facts label and postponed deciding how a FOP labeling program could be developed to reinforce what will already be required to be disclosed on the Nutrition Facts label. However, it has been FDA’s intention all along to evaluate the industry systems now in use. It may take a few years, but we can expect FDA eventually to return to FOP labels.
In short, after finalizing changes regulating nutrition information on the backs of food packages, FDA will turn its attention to the fronts of the food package where the stakes on what the agency decides will be higher; it is well accepted that nutrition information on the front of a food package attracts more consumer attention than information on the back. Expect FDA’s treatment of nutrition claims and FOP nutrition labeling schemes to be just as or more controversial as the proposed changes to the Nutrition Facts label.
Stay tuned, or better yet, plan ahead! Contact FDA now before the agency has formulated its plans.