Recent & Upcoming Regulatory Changes

North America

FDA Revokes Brominated Vegetable Oil (BVO) Authorization

In July, and as expected, the FDA revoked its authorization for the use of brominated vegetable oil (BVO). BVO has been subject to regulatory scrutiny for decades and was removed from the Generally Recognized as Safe (GRAS) list in 1970 due to toxicity concerns.

Still, it continued to be allowed in limited quantities under interim food additive regulations - but many manufacturers have already reformulated their products to exclude BVO due to consumer pressure and regulatory changes.

The bulk of health concerns surrounding this additive stems from the presence of bromine. Studies conducted by the FDA in collaboration with the National Institute of Environmental Health Sciences have demonstrated that BVO can

bioaccumulate in the body and cause toxic effects, particularly on the thyroid gland, which plays a crucial role in regulating metabolism and other bodily functions.

As FoodChain ID reported, only a few sodas and sports drinks contain BVO in the United States, as many beverage manufacturers have long worked to phase out the additive and reformulate their products.

The FDA ban went into effect on August 2, 2024. Manufacturers will be allowed a year to deplete their inventory of products containing BVO and reformulate prior to enforcement.

The substance is already banned in Japan, India, and the European Union.

Industry Comment

“One of the key responsibilities of the FDA is to review the safety of food ingredients and additives as additional science is available regarding potential safety concerns. If the FDA were to identify specific risks based on the totality of the scientific evidence, which warranted the discontinuation of their approval, stakeholders should be supportive of any revocation provided the decision is science-based.”

— Carla Saunders, Executive Director, International Food Additives Council (IFAC)

U.S. State Food Additive and Color Additive Bans

The latest updates on food and color additive bans in the U.S. show a significant trend towards stricter regulations at the state level, inspired by California's pioneering legislation.

It means that products containing banned ingredients will not be allowed to be marketed in specific states. Furthermore, failure to comply could result in penalties of up to $10,000 per violation.

Unilateral, or state ‘interference’ in trying to control food and beverage ingredients can be traced back to Vermont's 2014 enactment of a bioengineered law¹ that would require retailers to label food offered for sale if it is produced entirely or in part from bioengineering.

This effectively pushed the federal government, and more specifically, the USDA, to take action

resulting in the National Bioengineered Food Disclosure Law (NBFDL), signed by President Obama in 2016. This bill established an obligation for food manufacturers to disclose to consumers whether their food products are bioengineered or contain bioengineered ingredients.

California's own law², which was set to take effect on January 1, 2027, bans using brominated vegetable oil (BVO), potassium bromate, propylparaben, and Red Dye 3 in food products. This legislation has spurred similar actions in other states.

These state-level initiatives are, in part, a response to perceived gaps in FDA regulations. These regulations rely heavily on the GRAS system, allowing companies significant leeway in determining the safety of food additives without rigorous premarket FDA review.

Industry Comment

“Creating a patchwork of regulations sets a troublesome precedent for ingredients that have previously been approved at the federal level by the FDA.”

— Bill Dumais, Manager of State Affairs, American Bakers Assocation (ABA)

U.S. State Food Additive and Color Additive Bans

Example³: New York has proposed bills to prohibit the use of several additives, including azodicarbonamide, butylated hydroxyanisole (BHA), and titanium dioxide, among others. These bills also require companies to disclose when they use chemicals that are self-determined to be GRAS without FDA notification. Illinois and Pennsylvania have introduced comparable legislation⁴ banning numerous food dyes and other chemicals, which could force manufacturers to create different formulations for different states.

Speaking for the American Bakers Association, Dumais said the ABA continues to oppose state attempts to ban ingredients that the FDA recognizes as GRAS. “Manufacturers operating in states like California, Illinois, and New York should pay close attention when their respective state legislatures kick off new sessions in 2025, as these bills are expected to be reintroduced."

This video clip provides an overview and impact of the U.S. state food additive and color additive bans. View the full webinar on demand to learn more!

View Webinar

Industry Comments

“Manufacturers operating in states like California, Illinois, and New York should pay close attention when their respective state legislatures kick off new sessions in 2025, as these bills are expected to be reintroduced."

— Bill Dumais, Manager of State Affairs, ABA

“IFAC supports the FDA as the federal authoritative body for determining food ingredient and additive safety. The FDA is vital in reviewing the scientific evidence and setting science-based food safety standards. Other international regulatory and scientific bodies have also reaffirmed the safety of food ingredients and additives which are being targeted in some of these state bills.”

— Carla Saunders, Executive Director, IIFAC

FDA’s Uniform Compliance Date for Final Food Labeling Regulations

The FDA has announced that January 1, 2026, will be the uniform compliance date for final food labeling regulations issued in 2023 and 2024.

This standardization aims to minimize the economic impact on the food industry by allowing companies sufficient time to adjust to new labeling requirements. This approach helps the industry plan for using existing label inventories and developing new labeling materials efficiently.

Note: For some food labeling regulations, the FDA will set a compliance date that differs from the uniform compliance date if exceptional circumstances justify doing so. The specific compliance date is published when a final regulation is issued.

Industry Comment

Saunders said that while IFAC supports uniform compliance dates for food regulations to permit sufficient time for manufacturers to reach compliance, “it encourages the FDA to be responsive to stakeholders, including industry, in those instances where additional time for compliance may be necessary due to the complexity of regulations.”

— Carla Saunders, Executive Director, IFAC

FDA’s Proposed Front-of-Package Nutrition Labeling Rule

With public and legislative support for mandatory front-of-package (FOP) labeling growing⁵, we understand that the FDA is actively working on implementing an FOP nutrition labeling system as part of its broader nutrition initiatives. This initiative aims to provide consumers with easy-to-understand nutritional information directly on the front of food packages, complementing the existing Nutrition Facts label typically found on the back or side of packages.

The goal is to help consumers, particularly those with lower nutrition knowledge, quickly identify healthier food choices and build better eating patterns, which advocates have argued for after successful implementations in other countries, including Chile and Canada. The FDA needs to research to evaluate different FOP labeling

schemes⁶ and their effectiveness in helping consumers make healthier food choices. We understand that the experimental study, which includes focus groups and quantitative analyses, is now undergoing peer review.

The ABA said any potential FOP nutrition labeling scheme should not conflict with national labeling regulations or dietary guidance (e.g., Dietary Guidelines for Americans), and any FOP nutrition labeling scheme would need to be updated in tandem as national dietary guidance or labeling and trade regulations change.

The ABA also points out that recent regulatory changes that have required changes in almost all food labels, including revisions to the Nutrition Facts Label, the National Bioengineered Food

Industry Comment

“A FOP nutrition labeling scheme should support portion balance and variety, consistent with evidence-based national or regional nutritional guidance. Additionally, a FOP nutrition labeling scheme should consider trade obligations and global best industry practices to ensure no unintended negative impacts on trade. The U.S. should engage with trade partners to ensure ‘mutual recognition’ of any FOP nutrition labeling scheme without the need for additional labeling (e.g., stickers, unique packaging).”

— Bill Dumais, Manager of State Affairs, ABA

FDA’s Proposed Front-of-Package Nutrition Labeling Rule

Disclosure Standard, and sesame allergen labeling, have imposed billions of dollars of costs on the food supply, ultimately increasing consumer food costs. The purported benefits of those requirements were speculative and based on limited evidence.

The ABA recommends that the FDA undertake a retrospective analysis of the projected costs and benefits of the 2016 rule requiring revisions to the Nutrition Facts Label. Such an analysis would inform the projection of the costs and benefits of a requirement for an FOP nutrition labeling scheme.

The ABA has also asked the FDA to consider whether the Agency has the authority to require FOP nutrition labeling, given that the Food, Drug, and Cosmetic Act (FDCA) does not expressly authorize such a requirement.

IFAC and its members are awaiting the FDA's proposed rule on front-of-package (FOP) nutrition labeling and intend to engage with our industry partners once it is issued. “We encourage the FDA to ensure that any labeling is accurate, based on scientific evidence, and would reduce potential consumer confusion.”

Industry Comment

“We encourage the FDA to ensure that any labeling is accurate, based on scientific evidence and would reduce potential consumer confusion.”

— Carla Saunders, Executive Director, IFAC

The Food Safety Modernization Act (FSMA),

Rule 204

The FSMA Rule 204 is nearing its compliance date of January 2026. The primary goal of FSMA Rule 204 is to accelerate the identification and removal of contaminated food from the supply chain.

This is a component of the FDA’s ‘New Era of Smarter Food Safety’ blueprint, designed to encourage more investment in digital technology and traceability⁷.

By creating a ‘digital twin’ of their supply chain, combining traceability and digitalization, companies can play a crucial role in increasing the effectiveness of recalls through the swift identification and removal of contaminated foods from the market.

The final rule aligns with current industry best practices. It covers domestic, as well as foreign firms producing food for U.S. consumption along the entire food supply chain in the farm-to-table continuum⁸.

Canada Front-of-Package Nutrition Labeling Amendments

We are currently in a transition period since Health Canada published amendments to the Food and Drug Regulations (FDR) in 2022. This creates a new requirement for nutrition labeling on Front-of-Package (FOP) packaged foods.

The new regulation will require that foods high in saturated fat, sugars, and/or sodium must include a symbol on the front of the package. The aim is to help consumers make healthier food choices by quickly identifying products with high levels of these nutrients.

The transition period for Health Canada’s new regulations extends until December 31, 2025, allowing manufacturers time to comply. By January 1, 2026, all prepackaged foods sold in Canada must adhere to the new labeling requirements.

The Canadian Food Inspection Agency (CFIA) and Health Canada have developed tools and guides to assist industry stakeholders in understanding and implementing the new requirements, including the Front-of-Package Nutrition Symbol Labelling Guide for Industry.