USDA, FDA Renew Efforts to Regulate Label Claims
Claims on foods are ubiquitous, with almost every food now bearing at least one claim on its front packaging. Given the continued growth in the use of label claims, food regulatory agencies are revisiting the circumstances under which certain label claims can be used. FDA and USDA both recently announced efforts to review label claims, with the goal of increasing consumer trust in and reliance on label claims.
FRONT-OF-PACK NUTRITION INFORMATION
FDA is currently conducting a consumer study on the impact of front-of-pack nutrition labeling, with the goal of creating a standard front-of-pack labeling scheme for foods. Front-of-pack labeling is intended to provide consumers with high-level nutrient information to allow consumers to make quick decisions about which foods to purchase and consume. FDA’s study will evaluate the effectiveness and usefulness of several proposed schemes. The study, and the anticipated future labeling scheme, are part of FDA’s efforts to increase healthy eating, as directed by the White House.
Front-of-pack labeling schemes that currently exist on the market are not enforced by FDA, nor are these schemes expressly permitted by FDA regulations. Instead, FDA determined that the agency would exercise enforcement discretion as to companies that use certain industry standard front-of-pack labeling schemes. The Facts-up-Front Nutritional Panel is a good example.
Studies of consumer perception of food labels demonstrate that the vast majority of Americans are aware of front-of-pack nutrition labeling, and more than half of study participants stated that they do consider front-of-pack nutrition labeling when making purchase decisions.
FDA DIETARY GUIDANCE CLAIMS
Dietary guidance statements are statements that state or imply a food may contribute to a particular diet pattern. FDA released a draft guidance detailing the agency’s current thoughts on these types of statements. Though not binding, the guidance details the agency’s considerations when determining whether a label is misleading. In the guidance, FDA states that dietary guidance statements are not nutrient content claims (and are therefore not subject to the regulations applicable to nutrient content claims). These statements, however, must focus on the food or food group’s contribution to or maintenance of a nutritious dietary pattern and cannot include references to or implications of disease risk reduction or treatment. Claims that a food or food group may serve to treat or prevent a disease would be considered impermissible health claims and would be subject to FDA’s regulations and scrutiny.
Dietary guidance statements, however, should be based on consensus reporting endorsed by a group of experts that reflects the current thinking of the scientific community with regard to particular diet patterns. Companies can also rely on the dietary guidelines published by FDA and USDA as a consensus report to support a dietary guidance statement. Dietary guidance statements should reflect the key or principal recommendations provided in the consensus report. In addition, foods that bear a dietary guidance statement should meet nutrient limits identified by FDA.
“PRODUCT OF THE U.S.A.” CLAIMS
USDA FSIS current policies permit the use of “Made in the U.S.A.” and “Product of the U.S.A.” on meat and poultry products that are processed in the United States, regardless of where the animal was born, raised, or slaughtered. However, following petitions and studies to assess consumer understanding of these claims, FSIS has determined that this policy is misleading to consumers and does not align with consumer expectations. Therefore, FSIS has developed a proposed rule that would redefine the requirements for the use of these voluntary claims. Under the proposed rule, these claims could only be used on FSIS products where all FSIS-regulated components of the product are born, raised, slaughtered, and processed in the U.S., and any non-FSIS-regulated components (other than spices and flavors) are of U.S. origin. The proposed rule does not impact any required country-of-origin labeling.
In addition, qualified claims, such as “sliced and packaged in the United States from imported pork,” would be permitted when truthful and not misleading. A description of the processing steps that occurred in the United States must be included in the qualified claim.
ANIMAL RAISING CLAIMS
FSIS recently began an effort to evaluate and strengthen the approval and substantiation of animal raising claims. Animal raising claims include claims that state or imply that an animal was “humanely raised” or was antibiotic or hormone free. A 2019 labeling guidance issued by FSIS details the substantiation required to make animal raising claims; however, some advocacy organizations allege that FSIS does not consistently follow and enforce those requirements.
FSIS intends to issue an updated labeling guidance following the agency’s evaluation. In addition, to specifically address “no antibiotics” claims, FSIS will conduct sampling to determine whether antibiotic residues are present in products bearing the claim. Currently, FSIS is requiring in-plant inspectors at establishments that slaughter cattle with “raised without antibiotics” claims to complete a questionnaire. The results from the questionnaire are then used to determine the appropriate sampling plan. In turn, the results from such sampling will dictate how FSIS moves forward in its efforts to reevaluate animal raising claims.
SAFE HANDLING INSTRUCTIONS REQUIREMENTS
FSIS regulations require that all raw and partially cooked meat and poultry products include federally mandated safe handling instructions on the product label. The specific text and formatting of the safe handling instructions are also defined by regulation, prohibiting companies from modifying the text or formatting of the instructions (9 CFR 381.125(b) and 9 CFR 317.2(l)).
Though these instructions have been required since 1994, FSIS conducted a study on the efficacy of the label in 2013. Following this study, the agency determined that FSIS should conduct consumer research and make changes to the required safe handling instructions. Since then, FSIS has conducted a number of consumer studies to evaluate possible revisions. Now, the agency has announced that it will be conducting consumer focus groups to evaluate safe handling label designs created in response to the learnings of the previous studies.
Consumer groups and other stakeholders have advocated consistently for updated safe handling labeling to ensure labeling requirements provide consumers with education and direction that reflects the changes in food safety science and best practices since the instructions were first adopted in 1994.
ORGANIC ENFORCEMENT
USDA’s Agricultural Marketing Service (AMS) is responsible for regulating the organic food industry. Recently, AMS published a final rule that strengthens oversight and enforcement of organic regulations. The rule is codified in 7 CFR Part 205 and will be implemented in March 2024. Once implemented, the rule will require additional businesses within the organic supply chain to be certified, improve and strengthen documentation requirements for organic products, and increase authority for inspections of certified operations. AMS developed this rule to respond to the possibility of organic fraud, where a product is sold and labeled as organic but was not, in fact, certified organic.
With a continual increase in claims made on food labels and an increased focus on consumer protection, regulatory agencies have committed to revisiting label claims that may require additional regulation or changes to existing regulations to improve compliance.
Stay tuned as these new approaches to labeling are refined and implemented by USDA and FDA.
By Shawn K. Stevens, Esq., and Elizabeth Presnell, MS, Esq.
