AWG Regulatory Roundup — October 7, 2025
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- NMN No Longer Precluded from Use in Dietary Supplements<
- Comment Period for Ultra-Processed Foods Extended
- FDA Proposes to Revoke Authorization for Orange B
- FDA to Host a Food Allergen Thresholds Meeting
- IN-DEPTH: Extended Producer Responsibility — A View from the States
NMN No Longer Precluded from Use in Dietary Supplements
Last week, FDA answered two Citizen Petitions (see here and here) requesting clarity on the regulatory status of beta-nicotinamide mononucleotide (NMN) in dietary supplements, as well as the agency’s interpretation of the drug exclusionary clause in the FD&C Act. Notably, in its responses, FDA reversed its stance on NMN, having previously concluded that the ingredient was precluded from use in dietary supplements under the clause because NMN was studied as an investigational new drug prior to being marketed as a dietary supplement. Specifically, the agency initially had taken the position that while NMN may have been on the market as a dietary supplement prior to the date it was authorized for clinical investigations, such marketing did not constitute “lawful” marketing. However, FDA now takes the position that an ingredient, such as NMN, need not be “lawfully” marketed as a food or dietary supplement to satisfy the statutory requirement that it be marketed prior to the authorization date of any clinical investigation of the ingredient as a new drug, referred to as the “race to market” provision of the exclusionary clause. The agency declined to address or resolve concerns regarding other aspects of the exclusionary clause that were noted in the trade associations’ petitions, such as what constitutes a “substantial” clinical investigation and the use of evidence of marketing outside of the U.S.
Comment Period for Ultra-Processed Foods Extended
On September 18, 2025, FDA and USDA extended the comment period for the Request for Information on ultra-processed foods by 30 days. Comments, which are now due by October 23, 2025, should provide information to guide FDA and USDA in establishing a uniform definition for the term. Comments can be submitted via the Federal eRulemaking Portal to docket FDA-2025-N-1793.
FDA Proposes to Revoke Authorization for Orange B
On September 17, 2025, FDA announced a proposed rule to revoke Orange B as an approved food additive. The FDA states that the industry has abandoned this colorant; therefore, the regulation is outdated and unnecessary. The comment period for the proposed rule is open until October 17, 2025, and comments can be submitted to docket FDA-2025-C-3543.
FDA to Host a Food Allergen Thresholds Meeting
FDA will host a virtual public meeting and listening session from November 18-20, 2025, on food allergen thresholds and their potential application in the U.S. The agency is also requesting feedback on the following topics:
- Risk-based food allergen thresholds concepts,
- Risk communications and labeling,
- Potential applications of food allergen thresholds, and
- Challenges with food allergen thresholds in the U.S.
Those who wish to participate in the listening sessions must register by November 3, 2025.
IN-DEPTH: Extended Producer Responsibility — A View from the States
In the first of our new In-Depth features, we explore Extended Producer Responsibility (EPR) laws, a regulatory tool several states have implemented, and many others are considering. Taking necessary steps to comply now is critical, as one program is already underway, and several reporting deadlines are upcoming or have passed.
The goal behind EPR laws is to reduce the amount of single-use packaging materials, such as plastic and paper, sold in the state by shifting the cost burden of waste management of certain materials away from local governments and taxpayers to industry. Through these laws, industry must keep track of and report to the states the packaging materials shipped into each state and pay fees proportional to the types and quantities of their materials. State legislatures theorize that industry will reduce the use of single-use plastics and paper, shifting to smaller or more sustainable packaging options, thereby reducing their economic burden under EPR laws.
EPR laws are currently on the books in California, Colorado, Maine, Maryland, Oregon, Minnesota, and Washington. This year, Hawaii and Rhode Island passed legislation to evaluate potential EPR programs, with decisions likely to be made in 2026. Of the seven states with laws in place, each requires the “producer” of products sold in covered material to join a Producer Responsibility Organization (PRO)—or Stewardship Organization (SO) in Maine’s case. The PRO implements the EPR, meaning it collects information from producers, charges and collects associated fees, and reports the information to the states. Currently, the Circular Action Alliance is the only PRO approved by the states that require a PRO.
Although each state follows a similar structure, companies must individually analyze questions such as “who is the producer” and “what are the covered materials.” For example, for a cosmetic product sold nationally and packaged in covered material, the “producer” may differ from one state to another depending on where the brand owner is located, where the products are manufactured, or how the products enter the state. Additionally, what constitutes “product packaging” varies from state to state, with some states considering supply chain packaging to be covered in addition to the physical item and direct-to-consumer shipping materials.
Exemptions and exclusions also vary from state to state. For example, under Maryland law, a “small business” with less than $5,000,000 in gross global revenue, or which sold or distributed into the state less than one metric ton of covered packaging, is not a “producer.” Under California law, however, a producer with less than $1,000,000 in gross sales in the state in the prior year, is exempt from the reporting and fee obligations, but must still ensure (by January 1, 2032) that all covered material its offers for sale, distributes, or imports in or into the state is recyclable in the state or eligible to be being labeled as “compostable.” There are also varying exemptions for categories of materials used in certain transactions, such as business-to-business sales, or the packaging of various products, including infant formula, drugs, dietary supplements, and medical devices, as well as packaging items already covered by other state laws, such as bottles (among others).
Understanding the EPR puzzle is not an easy task, particularly as more states jump on the EPR bandwagon, and many existing laws are only just beginning to be implemented and enforced.
#TeamAWG has been tracking the EPR laws from their inception and helping clients meet their reporting deadlines and obligations. Given the varying scope of EPR laws, exemptions, and deadlines, it is crucial for companies to perform product-by-product reviews and assess compliance. If the team at AWG can assist, please don’t hesitate to reach out.
