AWG Regulatory Roundup — July 28, 2026
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- Push to Phase Out Petroleum-Based Food Dyes Continues
- FDA Issues Final Rule to Amend the Standard of Identity for Orange Juice
- FDA Warns Against Unnecessary Food Facility Registration
- FDA Outlines Public Health Priorities Under Four Strategic Pillars
- New Registration Pathway for Multi-Site Drug Manufacturers
- FDA Issues Letter to Infant Formula Industry
- Agencies Collaborate to Tackle Contamination in Meat, Poultry, and Eggs
- USDA Bioengineered Food Disclosure Rule Faces Overhaul
- Court Places California’s Recycling Law on Hold
- New Hampshire Bans Artificial Dyes in School Meals
- Illinois to Require Intentionally Added Ingredient Listing for Diapers
Push to Phase Out Petroleum-Based Food Dyes Continues
As part of the administration’s broader effort to phase out petroleum-based food dyes, on July 22, 2026, FDA published a final order revoking the authorized use of Orange B for coloring the casings or surfaces of frankfurters and sausages, concluding that its use has been abandoned by industry. The agency also proposed to revoke the authorized use of Citrus Red No. 2 for coloring the skins of mature oranges on the same grounds. Public comments on the Citrus Red No. 2 proposal are due August 24, 2026, and should be submitted to Docket No. FDA-2026-N-6304 via regulations.gov.
FDA Issues Final Rule to Amend the Standard of Identity for Orange Juice
On July 20, 2026, FDA issued a Final Rule amending the Standard of Identity for pasteurized orange juice for the first time since 1963, lowering the minimum Brix level (a measure of dissolved sugar content) from 10.5 to 10 degrees and permitting up to 15% mandarin or tangerine juice by volume. According to a press release issued by HHS Secretary Kennedy, the change is intended to reduce U.S. orange juice producers’ reliance on imported high-sugar oranges, which had been necessary to meet the prior standard due to Florida’s citrus crops having faced sustained pressure from greening disease, hurricanes, and freezes. The action is part of a broader FDA initiative to review more than 250 Standards of Identity across various food categories.
FDA Warns Against Unnecessary Food Facility Registration
FDA published a constituent update on July 20, 2026, reminding businesses to only register food facilities when required. FDA noted an increase in registered food facilities that do not need to be registered and, consequently, strain FDA resources (by subjecting the facility to unnecessary inspections, for example) or create confusion about a facility’s compliance obligations. The update also reminds businesses to safeguard their food facility registration information (e.g., registration number, PIN, login) as they can be misused by third parties who use this information to access, change, or cancel the facility’s registration.
FDA Outlines Public Health Priorities Under Four Strategic Pillars
On July 15, 2026, Acting FDA Commissioner Kyle Diamantas published an FDA Voices post outlining the agency’s strategic priorities under four “Public Health Pillars”: (1) keeping America the premier destination for innovation by modernizing regulatory pathways and embracing AI; (2) strengthening health security through resilient domestic supply chains and enhanced inspections; (3) expanding patient access to safe, effective, and affordable medical products by accelerating reviews and fostering generic and biosimilar competition; and (4) building a healthier America through improved food safety, nutrition policy, and post-market oversight. The post, written to coincide with FDA’s 120-year history and the nation’s 250th anniversary, signals the administration’s intent to prioritize regulatory speed and domestic manufacturing while maintaining scientific rigor and patient safety.
New Registration Pathway for Multi-Site Drug Manufacturers
On July 13, 2026, FDA published a Proposed Rule that would provide a pathway for a “distributed manufacturing establishment” (DME, as defined in the Proposed Rule) that manufactures drugs at multiple different physical locations (referred to as “distributed manufacturing units” or DMUs) to register as a single drug manufacturing establishment. The proposal would establish separate drug registration requirements for DMEs and each DMU, as well as provide a way to make expedited updates when, for example, a new DMU is added to a previously registered DME. In addition, the Proposed Rule would clarify that drug establishment registration and drug listing requirements apply to each foreign establishment that manufactures, repacks, relabels, or salvages a drug that is imported/offered for import into the U.S. regardless of whether it undergoes further manufacture, preparation, propagation, compounding, or processing at a separate foreign establishment prior to being imported/offered for import into the U.S. The proposed changes are intended to help FDA gain more insight into the drug supply chain. Comments on the Proposed Rule must be submitted by September 11, 2026 via regulations.gov.
FDA Issues Letter to Infant Formula Industry
On July 13, 2026, FDA issued a letter to the infant formula industry in response to recent botulism outbreaks and cereulide contamination incidents. The letter reminds industry of manufacturer responsibilities under 21 CFR Parts 106 and 117 to maintain production and in-process controls, conduct supplier audits, develop a food safety plan, and conduct verification activities. The letter also urges industry to monitor recall notifications, outbreak investigations, and FDA import alerts.
Agencies Collaborate to Tackle Contamination in Meat, Poultry, and Eggs
On July 9, 2026, USDA, HHS and EPA announced an updated Memorandum of Understanding (MOU) on Drug Residues, Pesticide Residues and Chemical Contaminants in Meat, Poultry, and Egg Products. The MOU establishes a framework for interagency coordination among FSIS, FDA, and EPA across three core areas: collaborating on sampling and testing programs for chemical residues and contaminants; coordinating the development of tolerances, action levels, and screening levels; and sharing information and expertise to support regulatory actions when chemical residues are detected in meat, poultry, egg products, or food-producing animals.
USDA Bioengineered Food Disclosure Rule Faces Overhaul
USDA’s recently published 2026 Unified Agenda indicates the agency is moving to revise its National Bioengineered Food Disclosure Standard, with a Proposed Rule targeted for this August. As previously reported, in October 2025 the Ninth Circuit Court of Appeals struck down key provisions of the current rule concerning the digital link and text-message disclosure options and the detectability exemption, which had allowed highly refined and processed foods to avoid disclosure requirements on the grounds that modified genetic material was no longer detectable in the finished product.
Court Places California’s Recycling Law on Hold
Adding to a growing list of setbacks for the California Attorney General, on July 14, 2026, a federal court in California issued a preliminary injunction blocking enforcement of the state’s “Truth in Recycling” law (SB 343), which had been scheduled to take effect on October 4, 2026 and would have significantly restricted recyclability claims, including use of the chasing arrows symbol generally and around resin code markings. The court found that the plaintiffs were likely to succeed on both constitutional vagueness and First Amendment commercial speech grounds, and concluded that California had not adequately shown the restrictions would directly advance the state’s recycling and consumer confusion goals. Notably, the injunction applies to the State of California but does not extend to local government or private enforcement; however, the pending constitutional challenge may deter enforcement by these parties. The court’s decision also introduces uncertainty for California’s broader extended producer responsibility program under SB 54, which relies on SB 343’s recyclability framework to determine whether covered materials qualify as recyclable.
New Hampshire Bans Artificial Dyes in School Meals
New Hampshire Senate Bill 577, signed into law and effective July 1, 2028, will prohibit public schools from offering food in school meals that contain FD&C Red No. 3, Citrus Red No. 2, and Orange B. The bill also encourages public schools to avoid offering food in school meals that contain FD&C Blue No. 1, Blue No. 2, Green No. 3, Red No. 40, Yellow No. 5, and Yellow No. 6 and to work with vendors to transition away from foods that contain these dyes.
Illinois to Require Intentionally Added Ingredient Listing for Diapers
Illinois House Bill 4702 was signed into law and, 18 months after the effective date of January 1, 2027, will require diaper packaging to display a complete list of all intentionally added ingredients, with the goal of protecting “adults, parents, and small children who may be allergic to ingredients that may be present in diapers.” The labeling requirements will not apply to products manufactured prior to the effective date.
