FDA Reopens Comment Period on General Principles for Food Standards Modernization

Today, the Food and Drug Administration (FDA) announced in the Federal Register that it is reopening the comment period for its 2005 proposed rule regarding the modernization of its food standards of identity. FDA’s standards of identity establish detailed requirements regarding the composition and manufacturing of food products. The Agency promulgated most of its current standards of identity in the mid-20th century. As a result, many of these standards do not reflect the innovation in food and technology that has taken place in recent decades. FDA recognized the need to modernize these standards as early as 1995. The Agency issued its 2005 proposed rule in an attempt to begin the process of modernizing these standards, but it never finalized the proposal.

As part of its Nutrition Innovation Strategy, FDA has renewed its efforts to modernize its food standards of identity in recent years. In July 2018, FDA held a public meeting on its Nutrition Innovation Strategy during which the Agency solicited stakeholder input on its efforts to finalize its 2005 proposed rule. FDA held another public meeting in September 2019 to specifically discuss horizontal changes to its food standards of identity. At both of these meetings, stakeholders expressed support for FDA’s efforts to finalize its 2005 proposed rule, but urged FDA to reopen the comment period so the Agency could gather information regarding recent changes in food technology, nutrition science, manufacturing, and market trends.

FDA has now reopened the comment period for its 2005 proposed rule and outlined three goals that will guide the Agency’s renewed efforts to modernize its food standards of identity:

(1) Protect consumers against economic adulteration.

(2) Maintain the basic nature, essential characteristics, and nutritional integrity of food.

(3) Promote industry innovation and provide flexibility to encourage manufacturers to produce more healthful foods.

FDA’s 2005 Proposed Rule

FDA’s proposed rule identifies thirteen “general principles” the Agency would use to evaluate whether it should establish, revise, or eliminate a food standard of identity. Under the proposal, FDA would consider eliminating standards that are inconsistent with any of the first four of these general principles. The Agency would consider revising or adding new standards only if they are consistent with all thirteen general principles. These general principles would require FDA to consider whether a given standard of identity:

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.

Next Steps

While interested stakeholders can provide general comments on the proposed rule, FDA is particularly interested in receiving comments on the following topics:

1. Whether the Agency should finalize its proposed rule.
2. Whether FDA should add, eliminate, revise, or retain any of the rule’s thirteen general principles.
3. Whether FDA should make any specific revisions to the rule to better reflect the three goals underlying its efforts to modernize its food standards of identity.
4. How FDA should weigh the rule’s thirteen general principles when determining whether to eliminate, revise, or add standards.
5. Whether there is any additional information FDA can provide to clarify the rationale for its general principles, how it will use the general principles to evaluate standards, and how stakeholders should use the general principles to prepare petitions to the Agency.
6. Whether there is any additional information FDA should consider when evaluating the costs, benefits, and annual reporting burden of the rule.

Interested stakeholders can submit comments during a 60-day comment period ending on April 21, 2020.

While it remains uncertain when—or whether—FDA will finalize its proposed rule, these developments suggest that the Nutrition Innovation Strategy, which was initiated by former Commissioner Scott Gottlieb, continues to be a priority under Commissioner Stephen Hahn. Additional information is available on FDA’s website.

If you have any questions concerning the material discussed in this client alert, please contact the following members of our Food, Beverage, and Dietary Supplements practice.