Greetings from “Table Talk” Juris Law Group’s Monthly Food Digest, where we delve into noteworthy developments in the realm of food regulation over the past month. In this issue, we explore significant updates in food regulation, including FDA guidance changes, third-party safety audits, and state-level legislation that could impact your business. As always, we welcome your feedback and invite you to reach out to our team with any questions or comments. For queries or further discussion, you’re welcome to reach out via email at [email protected].
FDA Releases Refreshed Roster of Key Guidance Topics for the Food Sector
In July, the FDA updated its Key Guidance Topics list for its Food Program, adding six crucial guidance documents set for release. This includes four new draft topics and two finalized versions of previously drafted documents. The FDA plans to issue these by December 2023.
While the Key List aims to enhance transparency and provide insight into FDA priorities, it’s not legally binding. Initiated in June 2021, the list is updated semi-annually, with the next revision expected in early 2024.
Spotlight on New Draft Guidance Topics
- Dietary Supplement Master Files Draft: This draft will outline required documentation and best practices for dietary supplements.
- Low-Moisture Foods Draft: Focuses on quality and safety protocols for low-moisture foods, including infant formula.
- Arsenic in Baby Food Draft: Aims to set acceptable arsenic levels in food for babies and young children.
- Cadmium in Baby Food Draft: Will establish permissible cadmium levels in food for the youngest consumers.
Finalized Versions of Previously Drafted Guidance
- Amendment to the Menu Labeling Supplemental Guidance: This finalized guidance comes with amendments to enhance clarity and applicability in the realm of menu labeling.
- Guidance on Protein Efficiency Ratio (PER) Rat Bioassay Studies: This final guidance focuses on demonstrating that a new infant formula supports the Quality Factor of Sufficient Biological Quality of Protein through rat bioassay studies.
Why These Updates Are Crucial:
As we near year-end before an election, regulatory activity typically spikes. This year’s Priority List includes notable topics that could significantly affect the industry. Drafts on arsenic and cadmium levels in baby foods could offer important insights into the FDA’s current position. If released by December 2023, these would precede the FDA’s “Closer to Zero” 2024 timeline. Additionally, the draft on low-moisture foods has implications for a range of products, including infant formula and cereals.
FDA Unveils Findings from Third-Party Food Safety Audit Pilot
The FDA recently announced that three third-party food safety audit standards—BRC Global, FSSC 22000, and SQF Edition 9—are in line with its Preventive Controls for Human Food regulations. Additionally, GLOBALG.A.P. Version 5.4 aligns with specific Produce Safety rules. Compliance requires adhering to both the primary standard and an FDA addendum. For a complete review, see our HL Update.
The Significance of the Audit Findings:
Audits adhering to these FDA-endorsed standards should meet PCHF and FSVP requirements. Due to resource constraints, FDA won’t conduct further assessments, making these four standards the only officially recognized ones. Facilities using other standards lack FDA assurance and may warrant extra scrutiny. How the FDA uses these findings for future risk categorization and inspections remains to be seen.
Schumer Calls on FDA to Probe PRIME Energy Drinks Over Caffeine Content
Senate Majority Leader Chuck Schumer has written to FDA Commissioner Dr. Robert Califf, raising concerns about the 200 mg of caffeine in 12-ounce PRIME energy drinks and their appeal to young consumers. Schumer calls for an FDA investigation into PRIME’s marketing, including health claims and caffeine disclosure. The FDA has acknowledged the letter but hasn’t initiated any formal action against PRIME yet.
Why you should care:
The letter may reignite public scrutiny of caffeinated drink marketing, particularly its effects on minors. Despite PRIME’s caffeine disclosure and warnings, this renewed focus could lead to state regulations or class-action lawsuits against such beverages.
Illinois Advocates for Uniform Date Code Labeling on Food Packages
Illinois has passed legislation aimed at standardizing date code labeling on food packaging. The law encourages food manufacturers and retailers to voluntarily adopt uniform terminology to signify quality and safety dates. This law will be effective as of January 1, 2024.
Why you should care:
While date code labeling remains largely voluntary at both federal and state levels, the new Illinois law suggests growing momentum among states to establish a standardized system for open-date labeling on food products. This is in line with FDA’s 2019 recommendations on the use of specific terminology for quality dates.
FDA Addresses CSPI’s Petition Concerning Allergen Risk Management
In response to a petition from the Center for Science in the Public Interest (CSPI), the FDA will update its allergen risk management guidelines. While it declined to ban intentional addition of major allergens like sesame when cross-contact risks exist, it approved CSPI’s second request, clarifying that allergen labels should only list actual ingredients, not potential cross-contact allergens.
Why you should care:
The FDA’s response to CSPI has broader implications for food allergen management. Commissioner Califf advises against intentionally adding sesame to new products but acknowledges industry challenges in managing allergen cross-contact and labeling. He commits to further stakeholder consultations for practical solutions.
FDA Rejects Earthjustice’s Request for a Complete Ban on Phthalates in Food Packaging
In a July 21, 2023, letter, the FDA rejected Earthjustice’s appeal to revisit its May 2022 decision. The original petition aimed to ban certain phthalates in food contact materials. The FDA refuted Earthjustice’s claim of neglecting safety data, stating that current federal standards don’t require considering phthalates from non-food sources or their “cumulative effects.”
Why you should care:
Phthalate safety remains a focus for NGOs, leading to federal and state restrictions. The FDA currently allows only nine phthalates in food contact. Earthjustice and allied NGOs criticize the FDA’s latest decision, accusing it of delaying tactics amid growing evidence of health risks.
IARC and JECFA Issue Conflicting Reports on Aspartame Safety
On July 14, the International Agency for Research on Cancer (IARC) and the Joint Expert Committee on Food Additives (JECFA) issued differing assessments of aspartame safety. JECFA reaffirmed its safety, while IARC labeled it “possibly carcinogenic” due to limited evidence. The FDA maintained that aspartame is safe and disputed IARC’s findings.
Why you should care:
An IARC classification could significantly influence U.S. legal and regulatory outcomes, including potential listing under California’s Proposition 65. However, the “limited” evidence from IARC may not trigger automatic listing, and strong endorsements of aspartame’s safety from JECFA and the FDA could discourage class-action lawsuits and efforts to overturn FDA approvals.
FDA Unveils New Tools for Monitoring Food Chemical Safety
The U.S. Food and Drug Administration (FDA) recently enhanced its website with two new sections focusing on food chemical safety oversight. The first section is an inventory of unauthorized substances deemed unsafe due to failing Generally Recognized as Safe (GRAS) standards, featuring items like Cannabidiol (CBD) and caffeinated alcoholic beverages, along with details on enforcement activities. The second section lists additives and substances under current review, including Per- and Polyfluoroalkyl Substances (PFAS) and lead. The FDA emphasizes that these lists will be updated periodically and are not comprehensive.
Why you should care:
Amid growing criticism over its food chemical safety approach, the FDA has added new features to its website to bolster transparency and credibility. These tools aim to help industry stakeholders comply with regulations and offer valuable insight for state legislators and NGOs into the FDA’s ongoing commitment to food chemical safety.
FDA Unveils User Fee Schedule for Fiscal Year 2024 Pertaining to FSMA Programs
The FDA has released its fiscal year 2024 fee structure for various programs under the authority of the Food Safety Modernization Act (FSMA). This annual announcement typically occurs in the late summer, focusing this year on reinspection fees and the costs associated with the Voluntary Qualified Importer Program (VQIP).
Reinspection Fees Explained
Under FSMA rules, the FDA can charge fees for follow-up inspections at domestic and foreign facilities. These reinspection fees aim to cover the costs of verifying compliance with Federal Food, Drug, and Cosmetic Act food safety standards. Reinspections occur when initial checks reveal significant non-compliance and assess the effectiveness of corrective actions.
For FY 2024, the FDA has outlined an hourly rate structure for these reinspections:
- Hourly Rate for Domestic Travel: $291
- Hourly Rate for Foreign Travel: $312
Voluntary Qualified Importer Program (VQIP) Fees
VQIP is a fee-based program to fast-track food import reviews. The 2024 user fee is $14,975, effective from Aug. 1, 2023, to Sept. 30, 2024. Additional inspection charges are $272/hour without travel, $291 with domestic travel, and $312 for foreign travel.
Why This Matters
The FDA has suspended reinspection and recall fees until it issues guidelines for small business fee reductions. There’s no timeline for when the agency will start enforcing these fees.
Furthermore, Adoption of VQIP has been slow, with just six approved importers last fiscal year. Stakeholders should closely monitor these fees and upcoming guidance due to their impact on operational costs.
Updates on State legislations
Legislation aimed at limiting PFAS usage has been enacted in three states: Oregon, Minnesota, and Nevada:
- Starting on January 1, 2025, Oregon will implement SB 543, a law that prohibits the use of PFAS as a deliberate additive in food service containers like dishes, cups, bowl lids, and takeout clamshells.
- In Minnesota, a comprehensive environmental finance and policy bill, HF 2310, will forbid the use of PFAS as a deliberate ingredient in select consumer products beginning January 1, 2025. This prohibition will extend to all products by January 1, 2032. Additionally, the law requires manufacturers to disclose information about products containing PFAS. A pre-existing Minnesota regulation, effective as of January 1, 2024, already bars PFAS from being intentionally added to all food packaging.
- Nevada’s SB 76, which takes effect on October 1, 2024, limits manufacturers from offering plant-based food containers that are in direct contact with food and contain deliberately added PFAS. However, any uses approved at the federal level are exempt from this rule.
In a related development, the Northeast Waste Management Officials Association (NEWMOA), representing environmental protection agencies from eight northeastern states, has unveiled a draft legislation. This model proposal aims to significantly curtail or eliminate the deliberate inclusion of PFAS in all kinds of consumer goods.
- Starting January 1, 2023, California will ban the sale of food packaging containing specific PFAS chemicals. The ban extends to containers, disposable dishes, and utensils. Manufacturers must disclose PFAS content on websites by 2023 and on packaging by 2024.
By July 1, 2023, the state will also limit the sale of juvenile products, like cribs and car seats, containing specified PFAS chemicals, requiring safer substitutes.
Two more PFAS laws, effective January 1, 2025, were signed in September 2022. AB-1817 bans textile goods with certain PFAS chemicals and requires certification of PFAS-free products. AB-2771 limits the production and sale of cosmetics with intentionally added PFAS.
This is part of a four-phase PFAS regulation plan rolling out over two years.
This uptick in state-level regulations reflects the escalating concern over the use of PFAS, signaling an ever-changing regulatory environment that companies are advised to keep a close eye on.
We value your perspective, so if you have any comments or feedback, don’t hesitate to contact any member of our team. We are keen to hear your thoughts.
