• On July 1, 2025, FTC Chairman Andrew Ferguson designated July as “‘Made in the USA’ Month,” and reiterated the Commission’s commitment to cracking down on deceptive MUSA claims.
  • The FTC quickly followed this announcement on July 8 by sending warning letters to four companies, reminding them to comply with FTC’s 2021 Made in USA Labeling Rule (MUSA Labeling Rule).
  • Significantly, the FTC also sent letters to Amazon and Walmart regarding allegedly deceptive MUSA claims made by third-party sellers on the two companies’ e-commerce websites. The FTC targeted various consumer products, such as work boots, baseball hats, whiskey glasses, pasta serving utensils, and American flags. Food products are subject to the same MUSA standard.
  • The FTC notices could signal a potential expansion of the compliance requirements imposed on online marketplaces for MUSA claims made by third-party sellers, with implications for all types of advertising claims appearing in listings developed by third-party sellers online and possibly at brick-and-mortar retailers. Read more here.
  • On May 28, 2025, the U.S. Food and Drug Administration (FDA) issued a “no questions” letter to Wildtype, Inc. in response to the California-based company’s pre-market evaluation filings for their cultured salmon cell material.
  • FDA’s letter marks the first instance FDA has issued a “no questions” letter for cultured salmon material, indicating the agency has no further questions regarding the product’s safety under its intended conditions of use. Wildtype’s cultured salmon joins cultured chicken cell material from GOOD Meat Inc. and Upside Foods and cultured pork fat cells from Mission Barns as one of four cell-cultured products to receive a “no questions” letter from FDA.
  • Although Wildtype’s salmon is already being sold at a restaurant in Portland, Oregon (see here), Wildtype may face challenges bringing their products to other markets.  As we have previously reported, many states have imposed cultivated product bans.
  • Keller and Heckman will continue to monitor developments involving cell cultivated food products.
  • Senior FDA officials recently signaled that the agency does not anticipate major disruptions to the issuance of guidance documents, even as federal agencies brace for the impact of Executive Order 14192, “Unleashing Prosperity Through Deregulation” which, as previously reported, mandates that federal agencies eliminate 10 regulations for every new regulation issued (the “10-1 Executive Order”).
  • Quoted in an article by Inside Health Policy, Grace Graham, Deputy Commissioner for Policy, Legislation and International Affairs at FDA, stated at the Drug Information Association’s annual conference last month that “I think if you look at the executive order, it’s very broad, a number of things can qualify as deregulatory and so we are still working on it and looking at it, but you will continue to see guidance come out of the agency, as you would have in the past.”
  • Further, citing the 10-1 Executive Order, among others, the Department of Health and Human Services (HHS) published a Request for Information (RFI) in the Federal Register on May 14, 2025 inviting public comment on regulations and guidance that should be revised, withdrawn, or repealed. The comment deadline on the RFI is next Monday July 14, 2025.
  • Keller and Heckman will continue to track developments surrounding the 10-1 Executive Order and its potential implications for FDA.
  • On June 20, 2025, Louisiana Governor Jeff Landry signed SB 14, now known as Act 463, into law to require on-pack QR codes linking consumers to an ingredient disclosure statement on a web page controlled by the manufacturer. The law requires that a statement must be adjacent to the QR code informing consumers that additional ingredient information can be found by scanning the code. The web page is required to contain the following disclaimer in a prominent location: “NOTICE: This product contains [insert ingredient here]. For more information about this ingredient, including FDA approvals, click HERE.” The disclaimer will link to FDA’s web page regarding food chemical safety.
    • Notably, Act 463 does not contain a federal preemption provision like the recently passed Texas law (SB 25) requiring on-pack warning labels for food products that contain specific ingredients. We briefly discussed the impact of this provision in a previous blog post.
  • The ingredients subject to disclosure requirements are largely the same as those covered by Texas SB 25. However, unlike the Texas law, ficin, titanium dioxide, and diacetyl tartaric and fatty acid esters of mono- and diglycerides (DATEM) are not included in Act 463. The Louisiana law instead includes acesulfame potassium, aspartame, and sucralose in their list of ingredients subject to disclosure.
  • Additionally, Section 662 of the law requires foodservice establishments that cook or prepare food using seed oils to display a disclaimer on either the menu or another “clearly visible” location at the establishment. The disclaimer must read: “Some menu items may contain or be prepared using seed oils.” For purposes of this section, “seed oil” includes canola or rapeseed oil, corn oil, cottonseed oil, grapeseed oil, rice bran oil, safflower oil, soybean oil, and sunflower oil.
  • Beginning with the 2028-29 school year, Act 463 also prohibits Louisiana public and nonpublic schools that receive state funds from serving meals that contain any of the fifteen ingredients listed under Section 197.2(B), including sucralose and a majority of the FDA approved colors. This section of the law does not apply to any food or beverages sold in concession stands or vending machines.
  • The law’s disclosure requirements for retail and restaurants will take effect on January 1, 2028. Keller and Heckman will continue to monitor updates on the passage of state laws requiring ingredient disclosure statements.
  • On July 2, 2025, the European Commission published a new Communication entitled “a strategy to position the EU as the world’s most attractive place for life sciences by 2030.” Recognizing that “the European life science sector is at a critical juncture” with fierce competition from the U.S. and China and innovative companies are struggling to scale up in Europe, the Communication anticipates numerous initiatives intended to accelerate and facilitate market access to life sciences innovation and build public trust in new technologies. A key element of this strategy is the awaited European Biotech Act, which aims to make relevant regulations “more conducive” to innovation in the life sciences space.
  • Notably, the strategy highlights the Commission’s intention to render current food regulatory approval procedures “more agile and proportionate, without compromising safety.” The Commission recognizes that innovators must currently navigate complex (and potentially multiple) regulatory frameworks, both under EU and national legislation, which reduces the competitiveness of the EU compared to other regions. For example, in order to be placed on the EU market, a novel food must go through several regulatory approval steps, including risk assessment by the European Food Safety Authority (EFSA), which can take a significant amount of time. The new strategy aims to make these procedures more efficient and significantly reduce their length.
  • To boost regulatory efficiency and innovative thinking, the Commission also aims to integrate into future EU legislation experimentation clauses and use of test environments such as “regulatory sandboxes” permitting the development of new ideas without being subjected to regulatory restrictions. The Commission further plans to adopt a new artificial technology (AI) tool to help researchers navigate the complex EU regulatory landscape.
  • Citing consumer uncertainty resulting from a lack of clear information on the risks and benefits of so-called “ultra-processed foods” (UPFs), the Commission intends to seek advice on UPFs from the Scientific Advice Mechanism and the European Group on Ethics in Science and New Technologies.
  • Keller and Heckman will continue to monitor and post relevant updates on the European Commission’s new life sciences strategy.
  • On Monday, June 30, 2025, FDA’s Human Food Program published its proposed 2025 guidance agenda (FDA’s news release shown here). The agenda contains possible new topics for guidance documents or revisions to existing guidance documents.
  • The entire list of new guidance topics under the 2025 agenda can be found here. The potential new topics include:
    • New Dietary Ingredient (NDI) Notifications and Related Issues: Identity and Safety Information About the NDI: Guidance for Industry
    • Food Colors Derived from Natural Sources: Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry
    • Action Levels for Cadmium in Food Intended for Babies and Young Children; Draft Guidance for Industry
  • Importantly, guidance documents do not establish legally enforceable rights or responsibilities (see here). Rather, guidance documents represent FDA’s “current thinking” on a particular topic and serve merely as a resource for businesses and organizations. FDA’s good guidance practices outlined in 21 CFR 10.115 provide, among other things, that the agency will seek public comment on any guidance documents that address more than minor changes in interpretation or policy (Level 1 guidance).
  • Keller and Heckman will continue to monitor developments related to FDA’s forthcoming guidance documents.
  • On June 20, 2025, Texas Governor Greg Abbott signed SB 261 into law banning the “manufacture, processing, possession, distribution, offer for sale, and sale of cell-cultured protein” starting on September 1, 2025. The law will be in force until September 1, 2027, where the state legislature will then assess whether to cease or continue the ban. The law defines cell-cultured protein as “a food product derived from harvesting animal cells and artificially replicating those cells in a growth medium to produce tissue.” Violations of the ban are punishable by up to one year in jail, a fine of up to $4,000, or both. Tex. Penal Code Ann. § 12.21.
  • In support of SB 261, the Texas House of Representatives cited concerns over cell-cultured protein posing “safety risks for consumers, as its creation process involves direct interaction with microplastics that can cause disruptions in the human cell membrane.”
  • Opponents of the law argue that it conflicts with federal oversight. As we reported previously, lab-grown meat was first approved for sale in the United States in 2023. Both FDA and USDA share regulatory jurisdiction over the industry as detailed in a 2019 memorandum of understanding between the agencies. The FDA oversees the cell collection and growth process, while USDA is responsible for the labeling and inspection of the final product.
  • Texas now joins Indiana, Mississippi, Montana, and Nebraska in enacting lab-grown meat laws this year, while Alabama and Florida did so last year. In March 2025, the Oklahoma House approved a similar bill, but it did not pass through the Senate.
  • Keller and Heckman will continue to monitor developments related to cell-cultured meat.
  • FDA announced on Tuesday, June 24, 2025, that it has updated Compliance Program 7321.005, now titled General Food Labeling Requirements and Labeling-Related Sample-Analysis – Domestic and Import. This updated Compliance Program (CP) includes guidelines and procedures that the FDA uses for both domestic and overseas inspections of food facilities.
  • The major changes were summarized by FDA as “incorporation of sesame as the ninth major food allergen” and “guidance on gluten-free labeling requirements.” The CP also includes nutrient declaration changes to make the document align with the updated Nutrient Facts Label. A more extensive list of updates can be found on page 4 of the Compliance Program.
  • The updated CP has been heavily edited throughout, both in terms of its text and formatting. The document was originally 33 pages long in total; the updated version is now almost twice as long at 61 pages.
  • Keller and Heckman will continue to monitor FDA regulatory changes related to food labeling.
  • Sources have reported to Reuters that the U.S. government intends to remove its recommendation within the Dietary Guidelines for Americans (DGA) that adults limit alcohol consumption to one or two drinks per day. Instead, the DGA, 2025-2030 are expected to include a generalized 1-2 sentence statement that encourages Americans to drink in moderation or limit alcohol intake.
  • The DGA are updated every five years by the US Department of Agriculture (USDA) and the US Department of Health and Human Services (HHS). The Guidelines have advised drinking no more than one to two drinks per day since 1990. The guidelines are still under development and subject to change, so it is unclear what effect the finalized recommendations will have on the alcoholic beverage industry.
  • Science Over Bias, a coalition of beer, wine, and spirits interests, released a statement to Reuters and other media members saying the Dietary Guidelines for Americans has not yet been published and should be based on “sound scientific evidence” and “free from bias.”
  • Keller and Heckman will continue to monitor updates related to the Dietary Guidelines for Americans.
  • On June 17, 2025, General Mills announced its plans to remove certified color additives from all of its U.S. cereals and what the company referred to as its K-12 school portfolio by summer 2026.  Certified color additives authorized for use in food in the United States are found in FDA’s color additive regulations, specifically 21 CFR part 74, subpart A.
  • The same day, Kraft Heinz similarly pledged to remove the certified color additives  from its U.S. portfolio before the end of 2027. Jeff Harmening, chairman and CEO of General Mills, calls the company’s scheduled change an example of meeting “evolving consumer needs.”
  • These moves come a few months after the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) encouraged the food industry to phase out the use of  certified color additives (see previous blog here). FDA has not initiated any formal regulatory process to revoke the authorizations for synthetic color additives, but instead will likely continue to encourage voluntary phase outs and possibly state bans (see here).
  • Keller and Heckman will continue to monitor developments related to synthetic color additives.