SUPPLEMENTARY INFORMATION:

I. Background on the Proposed Rule

In the Federal Register of May 20, 2005 (70 FR 29214), FDA and USDA jointly issued a proposed rule entitled “Food Standards; General Principles and Food Standards Modernization,” as a first step in instituting a process to modernize FDA definitions and standards of identity (and standards of quality and fill of container) consistent with section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341), and USDA's definitions and standards of identity or composition under the Federal Meat Inspection Act and the Poultry Products Inspection Act (21 U.S.C. 607(c) and 457(b)) (and standards of fill of container). The proposed rule, if finalized, would establish general principles that FDA and USDA would consider when determining whether to establish, revise, or eliminate a food standard.

Although the general principles were mostly consistent between FDA and USDA, a few principles were not identical. Because FDA and USDA regulate different products under different statutory authorities, some principles were developed to reflect specific FDA or USDA regulatory needs and perspectives. FDA and USDA stated that adherence to principles identified in the proposed rule would result in standards that would (1) better promote honesty and fair dealing in the interest of consumers and protect the public; (2) allow for technological advances in food production; (3) be consistent with international food standards to the extent feasible; and (4) be clear, simple, and easy to use for both manufacturers and the agencies that enforce compliance with the standards.

The Preliminary Regulatory Impact Analysis (PRIA) of the proposed rule anticipated that the associated social costs of finalizing both FDA and USDA principles would be small, however would likely yield substantial benefits. The PRIA noted that:

Standards that contain unnecessary elements or that fail to provide flexibility in terms of allowable food technology, may generate unnecessary production costs, and impede technological innovation in the food industry. Such standards may also serve as effective barriers to competition, thereby raising product prices and transferring resources from consumers to producers. Finally, some standards may be inconsistent with international standards, which may impede international trade. Impeding international trade may also restrict competition and lead to higher product prices.

The PRIA stated that applying the principles set forth in the proposed rule could help address these issues and that the benefits of establishing the proposed principles outweighed the costs.

Interested persons were originally given until August 18, 2005, to comment on these proposed general principles and to provide additional information as described in the Request for Comments section of the proposed rule. While comments received were generally supportive, FDA and USDA did not finalize the proposed rule due ( printed page 10109) to resource constraints and competing priorities.

II. FDA Principles in the Proposed Rule

In the proposed rule, FDA proposed a set of 13 general principles we would consider when establishing, revising, or eliminating a food standard (see 70 FR 29214 at 29234 to 29235 (proposed 21 CFR 130.5(b)). The first four general principles stated the purpose or function of a food standard and were the most fundamental principles addressing consumer economic protection. Therefore, if a food standard is inconsistent with any one of these four principles, we would consider eliminating it. The proposed rule also would revise or establish a new food standard if it was consistent with the full set of 13 principles:

1. Promotes honesty and fair dealing in the interest of consumers.

2. Describes the basic nature of the food to ensure that consumers are not misled by the name of the food and to meet consumers' expectations of product characteristics and uniformity.

3. Reflects the essential characteristics of the food—or those that define or distinguish a food or describe the distinctive properties of a food and that may contribute to achieving the food's basic nature or may reflect relevant consumer expectations of a food product.

4. Ensures food does not appear to be better or of a greater value than it is. May be used as a vehicle to improve the overall nutritional quality of the food supply.

5. Contains clear and easily understood requirements to facilitate compliance by food manufacturers.

6. Permits maximum flexibility in the technology used to prepare the food provided the technology does not alter the basic nature or essential characteristics, or adversely affect the nutritional quality or safety, of the food. Provides for any suitable, alternative manufacturing process that accomplishes the desired effect, and describes ingredients as broadly and generically as feasible.

7. Harmonizes with international food standards to the extent feasible.

8. Is simple, easy to use, and consistent among all food standards. Includes only those elements that are necessary to define the basic nature and essential characteristics of a particular food, without unnecessary details.

9. Allows for variations in the physical attributes of the food. Where necessary to provide for specific variations in the physical attributes of a food within the standard, variations are consolidated into a single food standard.

10. Incorporates general requirements that pertain to multiple food standards of a commodity group into general regulatory provisions that address the commodity group whenever possible.

11. Considers other relevant regulations. Any specific requirements for foods intended for further manufacturing are incorporated within the reference standard rather than provided as a separate standard.

12. Provides terms that can be used to name a food and allows terms to be used in any order that is not misleading to consumers.

13. Names of ingredients and functional use categories in a food standard should be consistent with other food standards and relevant regulations in this chapter, and, when appropriate, incorporate current scientific nomenclature.

III. FDA's Current Food Standards Modernization Efforts

Since publication of the proposed rule, FDA announced our Nutrition Innovation Strategy (NIS) with the goal of helping to reduce preventable death and disease related to poor nutrition. The NIS focuses on, among other things, providing incentives for food manufacturers to produce products that have more healthful attributes. Under the NIS, FDA is seeking to modernize food standards in a manner that will achieve three primary goals: (1) Protect consumers against economic adulteration; (2) maintain the basic nature, essential characteristics, and nutritional integrity of food; and (3) promote industry innovation and provide flexibility to encourage manufacturers to produce more healthful foods.

In July 2018, FDA held a public meeting on the NIS.^[1] At the meeting, we led a breakout session to discuss our food standards modernization goals and, among other things, to learn from stakeholders what FDA should be aware of when reviewing our food standard regulations and exploring how to modernize. At this public meeting, and in comments submitted to the public meeting docket, stakeholders expressed general support for FDA continuing its work with USDA to finalize the proposed rule. However, stakeholders also shared that, given the time that has passed since its publication, we should reopen the comment period to allow the public the opportunity to provide data and information on changes that have occurred in manufacturing, food technology, market trends, and nutrition science that FDA should consider when determining next steps for the proposed rule.

While FDA intends to work with USDA if we pursue finalization of the proposed rule, for purposes of this notice we are only interested in comments, data, and information on FDA-specific aspects of the proposed rule, including the 13 general principles listed above.

IV. Additional Issues for Consideration

In response to stakeholder comments and to inform our decision regarding whether to proceed with finalizing the proposed rule, we seek new information and public comment on how we could create general principles for establishing new food standards and for revising or eliminating existing food standards. While FDA and USDA jointly issued the proposed rule, we are only seeking comments on the FDA-specific aspects of the proposal. We encourage comments to be as specific as possible and, when possible, to provide data and information for FDA to consider.

While the public may comment on any FDA aspects of the proposed rule, we are particularly interested in comments on the following questions:

1. Should FDA finalize the proposed rule? Why or why not?

2. Are there general FDA principles that should be added, eliminated, revised, or retained?

a. What is the specific principle?

b. Why should the principle be added, eliminated, revised, or retained?

c. Are there specific product examples that illustrate why a principle should be added, eliminated, revised, or retained?

3. What specific revisions should FDA make to the proposed rule's principles or framework to better reflect our modernization goals of:

a. Protecting consumers against economic adulteration?

b. Ensuring standardized foods continue to meet consumer expectations?

c. Maintaining the basic nature, essential characteristics, and nutritional integrity of food?

d. Promoting industry innovation?

e. Providing flexibility to produce more healthful foods?

f. Facilitating additional flexibility across all or broad categories of standardized foods?

4. How should FDA weigh the general principles?

a. The proposed rule stated that the first four principles were the most fundamental to addressing consumer ( printed page 10110) economic protection and therefore, FDA would consider eliminating a food standard if it is inconsistent with any of these four principles.

i. Please explain whether you agree with this framework.

ii. If you do not agree, what principles should FDA consider when deciding whether to eliminate a food standard?

b. The proposed rule explained that FDA would consider revising or establishing a new food standard only if it was consistent with all 13 principles.

i. Please explain whether you agree with this framework.

ii. If you do not agree, what principles should FDA consider when deciding whether to revise or establish a new food standard?

5. What explanation is needed to provide more clarity, certainty, or context regarding:

a. The rationale for the principles?

b. How FDA will consider the principles when evaluating whether to eliminate, revise, or establish a new food standard?

c. How stakeholders should use the principles to inform the preparation of petitions requesting that FDA eliminate, revise, or establish a new food standard?

6. What additional information should FDA consider when evaluating the costs, benefits, and estimates of the annual reporting burden of the proposed rule?

85 FR 10107