Don’t sit back and wait: Be proactive!
The comment period for FDA’s proposed regulations revising the “Nutrition Facts” label has closed. The comment period has also closed for FDA’s proposed rule that would lead to more than 30 new serving sizes for foods. This is a big deal because the nutrient content information that appears on the “Nutrition Facts” label must be listed for customarily consumed amounts determined by FDA. So, new serving sizes will effectively dictate the amount of each nutrient for particular foods that will appear on the label. Similarly, the Agency has proposed to redefine what a single serving package is, and to require that calories, fat, sodium, sugars and other nutrient amounts be listed for the entire package on the assumption that it will be consumed on a single eating occasion. In brief, larger serving sizes mean labels will list larger amounts of nutrients that some consumers may wish to avoid.
Hundreds of companies and trade associations have filed comments with the Agency; some believe that filing is the end of the public participation process. Nothing could be further from the truth. Filing a comment with FDA is the first, not the last, step in participating in the development of a final regulation.
The comments that have been filed are being analyzed by Agency staffers and summaries will be given to senior FDA policy makers in the Commissioner’s office. Under the Administrative Procedure Act, FDA is required to review and respond to the comments and provide a “reasoned explanation,” in a preamble to any final regulation, explaining why the Agency agrees or disagrees with the views that have been expressed.
That may sum up the textbook description of the rulemaking process but, in reality, numerous other factors will influence FDA’s final regulations. Concerned stakeholders should consider the following additional actions:
- Review the comment record: The comments already submitted to FDA on key provisions of the proposed regulations can provide a treasure trove of information. By reviewing the comment record, interested parties can discern who may share their viewpoint, who is opposing, and why. In some cases, stakeholders may be surprised at what they find.
- Meet with FDA officials: Agency officials will sometimes agree to meet and sometimes will not. But the importance of face-to-face discussions with Agency decision makers cannot be overemphasized. As in any business development situation, meeting personally with those in charge can be infinitely more valuable than communicating in writing. Unlike business situations, FDA officials will place a short memorandum on the public record indicating that a meeting took place, but that legal requirement should not deter stakeholders from making efforts to reach out to the Agency.
- Contact the White House Office of Information and Regulatory Affairs (OIRA): OIRA is a department within the White House Office of Management and Budget. OIRA plays a major role in reviewing regulations proposed by FDA and other agencies by conducting rigorous economic and public policy analyses before permitting proposed regulations to be finalized. Contrary to conventional wisdom, OIRA has assumed a particularly strong role under the Obama Administration. OIRA officials may agree to meet with stakeholders. Meetings may be difficult to obtain, but should remain a key objective of concerned parties because OIRA, not FDA, may make the final determination about what the Agency’s rules actually require.
- Urge OIRA to require FDA to follow proper procedures: OIRA signed off on a portion of FDA’s proposal requiring “added sugar” content to be disclosed on the “Nutrition Facts” label (total “sugars” are already required to be disclosed), but inexplicably failed to approve a research study the Agency wanted to conduct to determine how consumers would react to the new disclosure before the proposed regulation was published in the Federal Register. OIRA finally approved the research planned by the Agency after the proposed rule was published, but clearly FDA should not proceed any further with its proposed rulemaking until the results are in, put out for public comment, and analyzed. Despite the delay, OIRA retains authority to compel FDA to follow that sensible approach.
- Meet with key Members of Congress: To maximize the chances of seeing final FDA regulations that comport with the recommendations in a company’s written comment, stakeholders should meet with key Members of Congress (or their senior staffers) to inform Hill offices about the issues at stake, the tentative position of the FDA, and your company’s concerns. It is particularly effective to request meetings with Members of the House and Senate Committees that have jurisdiction over FDA’s annual appropriations, as well as leading Members from Congressional committees that have FDA oversight responsibilities. These Members of Congress have a particular interest in seeing that the Agency is on the right course and making decisions on the basis of sound public policy. Ultimately, concerned parties may request that Members of Congress write the FDA, hold oversight hearings, or consider restrictions in FDA’s annual appropriations bill that require the Agency to act in a particular manner.
These advocacy measures are well known within the Washington Beltway, but are often overlooked by stakeholders who believe there is little they can do to affect FDA policy once a written comment is submitted. Parties wishing to maximize their chances of achieving changes in FDA’s proposed rules before they are finalized should consider availing themselves of these additional steps that can, and almost certainly will, affect the final regulatory requirements they will have to comply with in the not so distant future.