Specifically, the HHS's proposed rule would establish sunset (expiration) dates for effectively all of the Department’s regulations. As such, it extends to regulations issued by the Centers for Medicare and Medicaid Services (CMS) and all FDA regulations (including foods, pharmaceuticals, medical devices, and tobacco products) with very limited exceptions. The proposal would require the FDA to conduct detailed reviews and assessments of all such regulations under the Regulatory Flexibility Act within a two year period to prevent their automatic expiration.
On 16 November 2020, the HHS published a notice of a public meeting for interested stakeholders to provide input on this proposed rule.2 The public meeting is to be held virtually this coming Monday, 23 November 2020, and requests for participation must be submitted by tomorrow, Thursday, 19 November 2020.
The proposed rule raises issues that fall into three categories.
- Process: It is unprecedented for a government proposal of this magnitude to be published with only 30 days for public comment, especially given the ongoing pandemic and approaching Thanksgiving holiday break. This short comment period is surprising for a long-term activity of such broad scope, especially when there was no advance public notice of this action. The short time frame calls into question the fundamental fairness principles underlying the Administrative Procedure Act, assuring a reasonable opportunity to review and comment on new government actions. Indeed, the notice itself calls for comments on 16 different topics, each one of which warrants careful review and scrutiny.
At a minimum, there should be additional time in which to comment, commensurate with the breadth, scope, and impact of the proposed rule. Such an extension should be at least an additional 150 days (for a total of 180 days).
- Content: The proposed rule would require the FDA to analyze and justify, as warranted, its entire scope of substantive regulations that have been promulgated over the past 80+ years. In addition to the other product categories the agency regulates, for the food industry this would include virtually all regulations pertaining to:
- Food Safety (e.g., the Food Safety Modernization Act (FSMA), Good Manufacturing Practices (GMPs), LACF/AF, HACCP, Dietary Supplement GMPs, Import/Export, and Infant Formula, among others);
- Nutrition and Food Labeling (e.g., nutrition labeling, claims, and ingredient labeling, menu labeling, among others);
- Food Ingredients (e.g., food and color additive regulations, Generally Recognized as Safe (GRAS) regulations, and procedural regulations governing the agency’s premarket review functions, among others); and;
- Food Standards of Identify and Quality (e.g., dairy standards, bottled water, cacao products, and a host of other food categories).
These regulations have been in place for many years, some for many decades, and have become the standard for assuring the safety and labeling for all food products regulated by the FDA. They are in many cases necessary for industry to ensure compliance with statutory obligations and they help maintain consumer confidence in the food supply and ensure a level playing field.
- Unintended Consequences: If the proposed rule is finalized, the retrospective reviews required of the agency would become FDA’s top regulatory priority, and the agency’s attention to this would prevent it from considering actions more pressing and important to the industries it regulates and to American consumers. The agency’s focus on conducting reviews to ensure the continued effectiveness of existing regulations could prevent it from conducting meaningful reviews to eliminate, change, or modernize existing regulations, or even other agency policies and guidance. This rule also could thwart the issuance of new regulations, such as approval of new color additives.
Accordingly, the following actions should be considered:
- Identify person(s) to speak at the 23 November 2020 virtual public meeting (with requests to speak due tomorrow, 19 November)— our team will be working with the food trade associations to identify individuals that should ask to speak;
- File a written request for an extension of time of 150 days (for a total of 180 days) to consider the proposed rule and submit written comments; and
- Be ready to submit written comments on 4 December 2020, or at such future date to be established.
Our team is working with various food trade associations and the Food and Beverage Issue Alliance (FBIA) and will be drafting a sample written comments for consideration. We encourage individual trade associations and companies to file comments as well to ensure the administrative record reflects the industry’s thoughts.
If you have any questions on this or any other matter, please do not hesitate to contact us.
1 85 Fed. Reg. 70096 (4 November, 2020),
2 85 Fed. Reg. 73007 (16 November, 2020),
Authored by Martin Hahn, Joseph Levitt, and Elizabeth Fawell.