AWG Regulatory Roundup — June 17, 2025
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- FDA Releases NDI Notification Educational Materials
- Texas Legislation Restricting Use of Food and Color Additives Signed Into Law; Warning and SNAP Bill Sent to Governor
- Montana and Indiana Take a Stand Against Cell-Cultured Meat
- Hawaii Takes First Steps Toward EPR Program
- When is Sugar Not Sugar? When FDA Says So!
- Intellectual Property-Relevant Provisions in the ‘Big Beautiful Bill’
- Hemp Happenings® – California Proposes Permanent Regulations Prohibiting THC in Hemp Products
FDA Releases NDI Notification Educational Materials
On June 11, 2025, FDA released two educational videos and a fact sheet intended to help dietary supplement companies prepare organized, scientifically supported NDI Notifications and facilitate an efficient, timely review by FDA. The first video and fact sheet address common issues in the submission process that may lead to delays or a negative response from FDA, while the second video focuses on the post-submission process and what notifiers can expect regarding correspondence with the agency.
Texas Legislation Restricting Use of Food and Color Additives Signed Into Law; Warning and SNAP Bill Sent to Governor
Senate Bill 314, signed into law on May 27, 2025, prohibits certain food and color additives, including potassium bromate, synthetic food dyes, titanium dioxide, and “any additive that is substantially similar” to the ingredients listed in the legislation, from being included in free and reduced-priced school meals.
Senate Bill 25 was delivered to the Governor on June 1, 2025. In addition to amending physical and nutrition education requirements in the Texas school system and Texas medical schools, it requires manufacturers of food that contains certain ingredients including synthetic food dyes, potassium bromate, titanium dioxide, interesterified soybean oil, and numerous other ingredients to include a warning label that reads “WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom.” The bill expressly excludes dietary supplements from the warning label requirement.
On June 3, 2025, Senate Bill 379, which prohibits Supplemental Nutrition Assistance Program (SNAP) recipients from using their benefits to purchase sweetened drinks and candy, was also sent to the Governor. The bill defines sweetened drinks as those that are made with water and contain five grams or more of added sugar, or any amount of artificial sweeteners. The definition excludes milk or milk products, soy, rice, or similar milk substitutes, and beverages containing more than 50% vegetable or fruit juice by volume.
Montana and Indiana Take a Stand Against Cell-Cultured Meat
On May 1, 2025, Montana’s Governor signed into law House Bill 401, which criminalizes the sale of cell-cultured meat. A person who knowingly violates the law may face a fine of up to $250 and three months in prison, while retail establishments, restaurants, and other businesses may be subject to disciplinary action or license suspension. On May 6, 2025, Indiana’s Governor signed into law House Bill 1425, which places a two-year moratorium on the manufacture or sale of “cultivated meat products.” Violations during the two year-moratorium are subject to a fine of up to $10,000. Following the moratorium, such products will be considered misbranded if the product does not clearly indicate it is a cultivated meat product, and the label must include the phrase “THIS IS AN IMITATION MEAT PRODUCT.” Notably, at the international level, the Swiss Supreme Court has recently ruled that plant-based products cannot use animal product designations, even with qualifications.
Hawaii Takes First Steps Toward EPR Program
On May 27, 2025, Hawaii’s Governor signed into law what is now Act 103. The law directs the Hawaii Department of Health to conduct a needs assessment so the state can determine how, among other things, to best expand local material processing through an extended producer responsibility (EPR) program for packaging materials and paper products.
When is Sugar Not Sugar? When FDA Says So!
In litigation news, a yogurt company obtained dismissal with prejudice over claims about the sugar content of its products. The plaintiffs alleged that products labeled as “zero sugar” were deceptive because they contain four grams of allulose, a monosaccharide derived from fruit. However, as the court recognized, FDA guidance states that allulose does not contain the same caloric content as a typical monosaccharide, does not spike glucose levels, and does not promote cavities. For those reasons, FDA exercises enforcement discretion and allows companies to omit allulose from the sugar content declared on their products – in other words, allulose is not considered a sugar under the guidance. Thus, the court found that the plaintiffs’ claims were expressly preempted by federal law and dismissed the case.
Intellectual Property-Relevant Provisions in the ‘Big Beautiful Bill’
The “One Big Beautiful Bill Act” (OBBBA) passed the U.S. House of Representatives on May 22, 2025 and includes several intellectual property-related provisions that raise concerns about weakened IP valuation, audit integrity, and creator protections. First, the OBBBA merges the Public Company Accounting Oversight Board (PCAOB) into the Securities and Exchange Commission (SEC), which could impact intellectual property audits and valuation processes for public companies – a key component of many public companies’ market capitalization. Second, a new excise tax on income generated by colleges and universities from their investments would apply to royalty income generated by research and development, patents, copyrights, or other intellectual or intangible property that was subsidized by the federal government. Finally, when a nonprofit, such as a university, sells or licenses any name or logo, including copyrights or trademarks, that revenue would be treated as unrelated business income and included in gross income, taxed at ordinary rates. The OBBBA is currently under consideration in the Senate as part of the reconciliation process. The Senate has a target date of July 4, 2025, for voting on passage of the bill.
Hemp Happenings® – California Proposes Permanent Regulations Prohibiting THC in Hemp Products
On June 13, 2025, the California Department of Public Health (CDPHE) issued a rulemaking to make permanent its emergency regulations for Serving Size, Age, and Intoxicating Cannabinoids for Industrial Hemp, which were adopted in September 2024. The proposed permanent regulations require that final form hemp food products (including dietary supplements) intended for human consumption must have no detectable amount of total THC per serving and cannot exceed five servings per package. In addition, such products may not be sold to those under 21 years of age.
The comment period for the regulatory proposal closes on July 28, 2025, and a public hearing on the proposal will also be held on this date (the online hearing can be accessed here).
