By Ron Tanner
Following a 15-year hiatus, the Food & Drug Administration is moving toward modernizing the food standards of identity.
In 2005, the FDA and the USDA Food Safety and Inspection Service proposed a rule to modernize these standards, many of which were more than 60 years old, long before ingredient listings and the nutrition labels were required on food products. The standards were originally established to protect the public from food adulteration because some manufacturers were adding extenders and other non-nutritive additives to food yet still calling products by common names. Also, some standards appeared to be supportive of the major manufacturers that dominated the food industry in the 1950s and 1960s. For instance, ketchup could only be comprised of tomatoes. And some of the standards, for products such as Chicken Kiev and Frozen Cherry Pie, were decidedly outdated. There are currently more than 270 FDA standards of identity and over 80 FSIS standards of identity.
According to FDA, modernizing food standards would:
- Better promote honesty and fair dealing in the interest of consumers and protect the public
- Allow for technological advances in food production
- Be consistent with international food standards to the extent feasible; and
- Be clear, simple, and easy to use for both manufacturers and the governmental agencies
USDA and FDA did not finalize the proposed rule in 2005 “due to resource constraints and competing priorities.”
Comment Period Reopens
FDA signaled that it would revisit modernizing the standards of identity last summer as part of its Nutrition Innovation Strategy. A public hearing was held on September 27, 2019, during which approximately 80 organizations and individuals presented their viewpoints, including the Specialty Food Association.
At the hearing, Ron Tanner, SFA’s vice president of education, government, and industry relations, said, “SFA members produce and market many foods within the broad categories for which there are mandatory standards. Consequently, revising or modernizing food standards will have significant business consequences for the specialty food industry and for consumer perceptions about the quality of specialty foods.
“Human creativity is inspiring foods that taste better and are often more healthy. Technology is contributing as some typical ingredients in products such as mayonnaise are being replaced by vegetable-based alternatives. At the same time, the Association recognizes and appreciates the traditions represented by centuries-old foods. Both respond to consumer interests and demand. Modernized food standards must do the same.”
SFA also filed written comments reflecting its viewpoint that the standards as written can stymie innovation.
After receiving and reviewing 72 comments by its November 2019 deadline, including comments that the agency should re-open the comment period on the 2005 FDA and USDA FSIS proposed rule, the FDA reopened the proposed rule docket in February 2020 with a deadline for comments of April 21. (This has since been extended to July 20.)
Principles for Modernizing Food Standards
FDA has asked the industry and public to comment on 13 principles (see sidebar) for modernizing food standards. These proposed standards provide a framework for FDA to assess a citizen petition to eliminate, revise, or propose a new Standard of Identity. FDA would consider eliminating a Standard of Identity if it were inconsistent with the first four principles. Any revised or newly proposed standards should meet all 13 principles.
13 Principles for Modernizing Food Standards
FDA is seeking comment on the following principles for modernizing food standards.
- Promote honesty and fair dealing in the interest of consumers.
- Describe 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.
- Reflect the essential characteristics of the food—or those that define or distinguish a food and describe the distinctive properties of a food that may contribute to achieving the food’s basic nature or may reflect the relevant consumer expectations of a food product.
- Ensure the food does not appear to be of better or greater value than it is. May be used as a vehicle to improve the overall nutritional quality of the food supply.
- Contain clear and easily understood requirements to facilitate compliance by food manufacturers.
- Permit 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.
- Harmonize with international food standards to the extent feasible.
- Be simple, easy to use, and consistent among all food standards. Includes only those elements necessary to define the basic nature and essential characteristics of the food, without unnecessary details.
- Allow for variations in the physical attributes of the food. Where necessary to provide for specific variations in the physical attributes of a food within a standard, variations are consolidated into a single standard.
- Incorporate general requirements that pertain to multiple food standards of a commodity group into general regulatory provisions that address the commodity group whenever possible.
- Consider 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. Provide 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, and, when appropriate incorporate current scientific nomenclature.
SFA Response to Modernized Standards
SFA welcomed FDA’s reopening of the docket and the opportunity to expand upon its November comments and the effectiveness of the proposed framework for modernizing the standards of identity. The response advocated that:
- Failure to modernize the SOI negatively impacts SFA members.
- FDA should not finalize the rule as written because the framework is legally and practically problematic.
- Objective, science-driven approaches provide a path forward for reforming the SOI.
- The general principles require significant revision to meet the statutory mandate, provide certainty to petitioners, and to facilitate an effective process for modernizing the SOI.
- Adopting objective, science-driven evaluation criteria for an SOI petition meets statutory requirements and provides predictability to petitioners seeking to modernize the SOI.
Failure to Modernize SOI Hurts SFA Members
Innovative specialty food manufacturers succeed by experimenting with new ingredients and new methods of producing foods. Such experimentation meets consumer demand for products that are healthier, free from major allergens, and use more sustainable production methods. However, when their experimentation confronts a strict Standard of Identity, food manufacturers must choose between innovation or producing non-compliant food.
The most pressing concern for SFA members with the absence of meaningful progress to modernize SOI is that SOI non-compliance and ambiguity has resulted in increased private litigation, deterring manufacturers from innovating and producing healthier foods.
FDA’s Framework Is Legally and Practically Problematic
The proposed regulation raises both legal concerns, in principle, and practical problems in its application.
The Association believes that the proposed rule exceeds FDA’s statutory mandate to promulgate food standards regulations that will “promote honesty and fair dealing in the interest of consumers.” Moreover, while the regulation does not directly impose punitive criminal or civil consequences implicating the “void for vagueness” doctrine, the fundamental premise should be observed. The proposed principles are not sufficiently objective to provide appropriate benchmarks to those submitting a petition to revoke, revise, or propose a standard of identity.
Science-Driven Approaches Will Reform SOIs Consistent with the Nutrition Innovation Strategy
SFA supports the Nutrition Innovation Strategy objectives to modernize the SOI in a manner to (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 healthier foods. However, we also believe that efforts to modernize the SOI should account for evolution in the requirements of and reflect modern approaches to food regulation.
Part of the function of an SOI became obsolete 30 years ago with the passage of the Nutrition Labeling and Education Act of 1990, which required every food product to list its ingredients, regardless of whether the product was a standardized food. The NLEA also required the listing of nutrition facts on packaged foods. Today, many other items on a food label are much more important in evaluating the healthfulness of a product than the name specified by a SOI, and the restrictiveness of current SOIs can make producing healthier options unlawful. The approach to modernizing standards of identity should be science-driven, employing scientific experts and consumer data and to establish objective criteria that support innovation in production practices while preventing economic adulteration by reflecting consumer perceptions.
General Principles Require Significant Revision
SFA recommends that Principles 1, 4, 5, 6, 8 and 12 be eliminated. Suggested changes in the following principles include, but are not limited to:
- Principle 2: Require that the name of a food subject to an SOI must be based on existing, documented uses of the name (or similar names) among a majority of consumers purchasing the food or, for a new food, be based on a reasonable consumer’s likely understanding of the name as established through consumer studies.
- Principle 3: Require that an existing, revised or proposed food standard only specify ingredients or describe a manufacturing or cultivation process when they are necessary to produce the food’s characteristics as recognized by a majority of consumers.
- Principle 7: Require that revised or proposed SOI align with CODEX when a CODEX standard exists. Permit a petition to remove an SOI if a standard does not align with CODEX.
- Principle 10: Define “commodity area” and also make sure that small and very small businesses are protected from definitions determined by commodity groups.
- Principle 13: Simplify to require that food standards incorporate existing regulations by reference and allow demonstrated conflict to serve as grounds to eliminate an existing standard.
Science-Driven Evaluation Criteria for an SOI Petition Should Be Predictable
Food standards should be straightforward, protect consumers from economic adulteration (and honest manufacturers from unfair competition), meet their expectations, and allow manufacturers to innovate and improve foods. The SFA believes this can be accomplished by adopting fewer, but mandatory, criteria against which both new and existing food standards should be measured.
Food standards should be based on objective data and reflect what consumers expect from and understand of the defined foods. The standards should be as simple as possible and flexible in how they allow manufacturers to achieve the expected results. When innovation demonstrates that other ingredients or processing techniques can achieve the same results, then the standard can be modified based on expert consensus.
Finally, the criteria should rely on existing regulations and require international harmonization so that food standards are predictable and universal. Objective, predictable outcomes help both consumers and manufacturers and provide a path forward to modernize food standards consistent with the Nutrition Innovation Strategy.
SFA would like to thank Jeni Lamb Rogers, J.D., M.S. of the PSL Law Group in Boulder, Colorado for her contributions to this article and the SFA comments to FDA.
Ron Tanner is vice president of education, government, and industry relations for the Specialty Food Association.