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Regulatory Issues

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FDA Approves 3 Natural Color Additive Petitions

The U.S. Food and Drug Administration has granted three color additive petitions that will expand the palette of available colors from natural sources for manufacturers to safely use in food.

The FDA is in line with U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr.’s priority to phase out petroleum-based dyes in the nation’s food supply as part of the administration’s broader initiative to Make America Healthy Again.

Since the HHS and FDA announcement last month during a press conference at HHS on petroleum-based food dyes, more U.S. food manufacturers have committed to removing them within the FDA’s set time frame of the end of next year.

“On April 22, I said the FDA would soon approve several new color additives and would accelerate our review of others. I’m pleased to report that promises made, have been promises kept,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “FDA staff have been moving quickly to expedite the publication of these decisions, underscoring our serious intent to transition away from petroleum-based dyes in the food supply and provide new colors from natural sources.”

The color additive petitions approved today are for:

  • Galdieria extract blue, a blue color derived from the unicellular red algae Galdieria sulphuraria. The FDA has approved the color additive for use in nonalcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, and whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives). The petition was submitted by the French company Fermentalg.
  • Butterfly pea flower extract, a blue color that can be used to achieve a range of shades including bright blues, intense purple, and natural greens. Produced through the water extraction of the dried flower petals of the butterfly pea plant, this color additive is already approved for use in sport drinks, fruit drinks, fruit and vegetable juices, alcoholic beverages, dairy drinks, ready to drink teas, nutritional beverages, gums, candy, coated nuts, ice creams, and yogurt. Today’s approval of a petition by St. Louis-based Sensient Colors LLC expands the approved use for coloring ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), plain corn chips, tortilla chips, and multigrain chips.
  • Calcium phosphate, a white color approved for use in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies. The petition was filed by Innophos Inc. of Cranbury, New Jersey.

Under the Federal Food, Drug, and Cosmetic Act (Chapter VII, section 721), color additives are subject to FDA approval to determine whether they are safe before they may be used in food. The FDA determines whether an additive is safe to use by considering the projected human dietary exposure to the color additive, the additive’s toxicological data, and other relevant information, such as published literature. Once the FDA approves a color additive petition, any manufacturer can use the coloring for the approved uses.

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ReposiTrak Adds 50 Suppliers to Its Traceability Network

ReposiTrak, the world’s largest food traceability and regulatory compliance network, leveraging its established inventory management and out-of-stock reduction SaaS platform, is preparing to welcome 50 new dairy and dairy-alternative suppliers into the queue for the ReposiTrak Traceability Network. These new members will efficiently exchange intricate, FDA-required Key Data Elements for each Critical Tracking Event in their supply chains, ensuring proactive compliance well before the January 2026 deadline.

Among the 50 new suppliers are 3 standout members with a rich history. One is a Wisconsin-based, family-owned cheesemaker founded more than a century ago, now recognized as one of the nation’s top premium cheese and whey products makers. Another is a U.S.-based cooperative founded in 1938, consisting of 600 farm families and 7,000 associates. With award-winning milk, cheese, and other dairy products, it serves 30% of the U.S. market while emphasizing sustainable dairy practices. The third is a Swedish pioneer in plant-based alternatives, with its oat-based products available internationally.

“ReposiTrak’s network, the largest operational traceability network, is helping dairy and plant-based suppliers achieve seamless compliance with FDA regulations and retailer traceability requirements,” said Randy Fields, chairman and CEO of ReposiTrak. “By joining the network, these suppliers can efficiently share traceability data with an unlimited number of in-network customers, all without the need for additional hardware or software.”

The ReposiTrak Traceability Network requires no additional hardware or software and the ReposiTrak team assists in making the connections needed under the new regulation. Suppliers can connect to an unlimited number of trading partners and share data for a low, flat fee.

ReposiTrak provides retailers, suppliers, food manufacturers and wholesalers with a robust solution suite to help reduce risk and remain in compliance with regulatory requirements, enhance operational controls and increase sales with unrivaled brand protection. Consisting of three product families – food traceability, compliance and risk management and supply chain solutions – ReposiTrak’s integrated, cloud-based applications are supported by an unparalleled team of experts. For more information, please visit https://repositrak.com

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FSIS Issues Alert for Beef Tallow Products From Mexico

The U.S. Department of Agriculture’s Food Safety and Inspection Service is issuing a public health alert for beef tallow products that were illegally imported from Mexico and are ineligible for entry into the United States. The products were not certified for export to the U.S. by the government of Mexico as being produced under equivalent inspection, they do not identify a certified establishment number on their packaging, and they were not presented to FSIS for import reinspection as required. These factors make the products ineligible to import into the U.S. and unfit for human consumption. FSIS is continuing to investigate how these products entered the country.

The following products are subject to the public health alert, regardless of the product date.

  • 1-kg or 500-g bag packages containing “INCA GRASA COMESTIBLE DE SEBO BOVINO” (edible fat from beef tallow).

The products subject to the public health alert do not bear an establishment number nor a USDA mark of inspection. These items were shipped to distribution and retail locations in Arizona.

The problem was discovered when FSIS was performing surveillance activities at a retailer and found beef tallow products from an unverified supplier in Mexico and, therefore, ineligible for import into the United States.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an illness should contact a healthcare provider.

FSIS is concerned that some product may be in consumers’ pantries or on retailers’ shelves. Retailers who have purchased the products are urged not to sell them. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

Consumers and members of the media with questions about the public health alert can contact Jose Gallardo, Owner, MEXDIS, LLC, at 520-455-7239 or mexdisllc20@gmail.com.

Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or send a question via email to MPHotline@usda.gov. For consumers that need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.

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