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- FDA Finalizes “Healthy” Rule
- ICYMI: New CDRH Device Recall Communication Pilot Program
- Caution: “Non-Toxic” Claims Are Not Always What They Seem
- New Year, New Litigation Trends (?)
- California Corner
- Hemp Happenings®
- U.S. Patent & Trademark Office News: New Late Term Continuation/Divisional Fee
New Year, New Resource!
Welcome to the inaugural edition of Amin Wasserman Gurnani’s Regulatory Roundup newsletter, where we’ll provide you with brief updates on the latest regulatory news and litigation trends impacting the health, wellness, and beauty sectors! We’ll also include our “California Corner,” featuring updates from the always-busy Golden State, as well as occasional patent and trademark updates and Hemp Happenings® as they arise. Note that Hemp Happenings® will no longer be distributed as a separate newsletter and, moving forward, will be incorporated in the AWG Regulatory Roundup.
Please drop us a line with any feedback, suggestions, or questions about our coverage. Thank you for reading, and we look forward to keeping you informed in 2025 and beyond!
FDA Finalizes “Healthy” Rule
After 10 years in the making, FDA closed out 2025 with a big announcement. On December 19, 2024, the agency issued its final rule to update the “healthy” nutrient content claim. Under the updated criteria, to bear a “healthy” claim a food product must:
- Contain a certain amount of (food group equivalent) from at least one of the food groups or subgroups (such as fruits, vegetables, fat-free and low-fat dairy, etc.) recommended by the Dietary Guidelines for Americans with no other added ingredients other than water.
- Meet specified limits for saturated fat, sodium, and added sugars.
Nuts and seeds, higher fat fish (e.g., salmon), certain oils, and water are examples of foods that now qualify but did not previously. FDA’s announcement also notes that the agency is continuing to explore the development of a front-of-pack symbol that manufacturers could use on food labels to indicate a product meets the “healthy” claim criteria. The new rule is effective on February 25, 2025, but companies have until February 25, 2028, to stop using “healthy” under the current rules.
Importantly, the 2024 Consolidated Appropriations Act (signed into law in March 2024) includes language that appears to preempt lawsuits targeting labeling that allegedly contains non-compliant “healthy” claims. Specifically, Section 745 states that “[a]ny food product manufactured and labeled as ‘healthy’ during the compliance period FDA provides in that final rule shall not be directly or indirectly subject to any state-law requirements that are not identical” to the current or updated FDA requirements.
FDA Authorization for FCNs Related to PFAS No Longer Effective
On January 3, 2025, FDA announced its determination that 35 food contact notifications (FCNs) related to PFAS are no longer effective because the manufacturers or suppliers ceased production, supply, or use of these substances. The 35 FCNs had previously authorized food contact substances used for grease-proofing coatings applied to paper and paperboard packaging to prevent leaking of oil and water. This follows a similar announcement from FDA in February 2024.
FDA Updates Food Allergen Labeling Guidance, Coconut No Longer a Major Allergen
On January 7, FDA released “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry.” Most notably, the guidance removes certain tree nuts from its list of major allergens that must be declared on product labels, and coconut is no longer on the list. The guidance also updates the interpretation of “milk” to include milk from goats, sheep, or other ruminants and “eggs” to include eggs from ducks, geese, quail, and other fowl.
FDA Issues Draft Guidance for Labeling of Plant-Based Alternatives to Animal-Derived Foods
Last week, FDA also issued “Draft Guidance for Industry: Labeling of Plant-Based Alternatives to Animal-Derived Foods,” which includes the agency’s recommendations on best practices for naming and labeling of certain plant-based foods that are marketed and sold as alternatives for animal-derived foods (plant-based alternative foods). According to FDA, its recommendations are intended to help consumers understand the nature or source of individual plant-based alternative foods and to assist manufacturers in ensuring the labeling for products (and product names) are truthful, non-misleading, and accurately describe the food. FDA will accept comments on the Draft Guidance through May 7, 2025.
FDA Issues Draft Guidance on Actions for Lead
As part of its Closer to Zero initiative to reduce dietary exposure to contaminants, on January 6, FDA issued a final guidance for industry on the action levels for lead in processed food intended for babies and young children. The guidance, titled “Action Levels for Lead in Processed Food Intended for Babies and Young Children: Guidance for Industry,” provides the levels of lead at which FDA may regard the food as adulterated under the FD&C Act. The guidance includes the following action levels:
- 10 ppb for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain- and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats;
- 20 ppb for single-ingredient root vegetables; and
- 20 ppb for dry infant cereals.
ICYMI: New CDRH Device Recall Communication Pilot Program
On November 21, 2024, FDA’s Center for Devices and Radiological Health (CDRH) announced a new pilot program intended to increase the timeliness of its communications to the public about medical device recalls (removals or corrections) initiated by regulated companies where the agency believes the recalls are to address a potentially high-risk problem or issue.
At this time, the new pilot program only covers cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology medical devices. For other types of devices, there will be no change to existing agency recall procedures or recall communication timelines.
Caution: “Non-Toxic” Claims Are Not Always What They Seem
The company Lumineux is discontinuing claims that its mouthwashes are “Certified Non-Toxic” after the National Advertising Division (NAD) found it did not possess adequate substantiation.
Lumineux’s in vitro cytotoxicity evidence was found to be irrelevant because it did not reflect real-world conditions and thus was not dispositive of any health effect (or lack thereof), only assessed a single type of toxicity, and was on a slightly different formula. The mouthwashes were also “Made Safe” certified, which was purportedly a “non-toxic” certification. However, NAD concluded that it also did not reflect real-world application. Although only limited information was available on the certification process, NAD still highlighted numerous potential gaps, such as animal toxicity, reasonable misuses, and consideration of the product format. Also problematic was that the certification had expired, rendering the “certified” statement false.
This decision reinforces that NAD, like FTC in its Green Guides, holds “non-toxic” claims to a heightened standard given that they are not readily verifiable by consumers, and the consequences of a false claim can be severe. NAD previously held, and did so again here, that consumers’ view of “non-toxic” is likely broader than the scientific understanding of the term.
New Year, New Litigation Trends (?)
It’s too early to tell what 2025 will have in store regarding class action trends. Still, in 2024, there was no shortage of complaints and demand letters targeting on-label claims like “natural flavors,” “no artificial flavors/preservatives,” and “no artificial ingredients” for products containing malic acid, ascorbic acid, and/or citric acid. Plaintiffs allege these ingredients are synthetic and, even if not used for a preservative or flavor function, cause the claims to be deceptive.
Another trend from last year involved “microcontamination,” with plaintiffs attacking trace levels of heavy metals and PFAS in products ranging from cosmetics to beverages, especially where the products were promoted as “tested” and “safe” or the brand promoted as “trusted.”
Last year we also saw a rise in Proposition 65 Notices of Violation and lawsuits in California targeting lead, mercury, cadmium, and PFAS in food, beverages, supplements, cosmetics, and other products. We’ll continue to monitor in 2025, but for now, sourcing ingredients from trusted suppliers and conducting regular heavy metal and PFAS testing of finished products is key to reducing risk.
California Corner
Reminder: three new laws will go into effect in 2025.
The first, AB 2762, prohibits the manufacture, sale, delivery, holding, or offer for sale of a cosmetic containing certain intentionally added ingredients, including Dibutyl phthalate, Diethylhexyl phthalate, Formaldehyde, Methylene glycol, Quaternium-15, Mercury, and Isobutylparaben, among other substances.
Second, AB 2771 prohibits the manufacture, sale, delivery, holding, or offer for sale of cosmetics containing intentionally added PFAS. Both laws went into effect January 1, 2025.
Finally, AB 2863 amends California’s automatic renewal and continuous service offer law, with changes effective July 1, 2025. Similar to FTC’s recently adopted “Click-to-Cancel” Rule, the law requires sellers to obtain express affirmative consent from consumers to the automatic renewal or continuous service offer terms and prohibits the misrepresentation of material facts or terms related to the transaction. Unique additions include a requirement to disclose information prior to obtaining certain billing information, as well as mandatory click-to-cancel button placed around save offers (attempts/offers to entice the subscriber to keep the subscription and not cancel). The rule also covers free trials that transfer to a subscription, and requires that consumers must be able to cancel in the “same medium” used to sign up for the subscription. While FTC’s rule and California’s law are similar, now is the time to carefully review both to determine if your subscription and automatic renewal programs comply. Reach out if we can help!
In other California news, on January 3, Governor Newsom issued Executive Order N-10-25 directing various state agencies to provide recommendations related to limiting the harms associated with “ultra-processed foods” and chemicals used as food and chemical additives, including but not limited to label warnings, continued investigation of adverse health impacts of food dyes, and conducting state-level evaluations of GRAS food additives.
CARB Product Surveys Return! Did You Meet the First January Deadline?
The California Air Resources Board (CARB) is conducting a mandatory survey of consumer products for all companies (foreign and domestic) selling products falling within 37 covered product categories into California, including certain personal care products and household cleaners. The survey opened on December 3, 2024, and is due on April 8, 2025. The survey requires the disclosure of full product formulas, and for any products the company does not own, it must connect the manufacturer/formulator with CARB via email. Although the deadline to do so was January 14, 2025, there’s still time to act if you haven’t already. Additional information on the survey can be accessed here, and please reach out if we can assist.
Hemp Happenings®
As previously reported, we expect bills restricting THC in hemp products to be a high priority in several key states, including Illinois, Missouri, Ohio, and Texas. We’ll also be monitoring challenges to hemp laws across the country. While courts rejected a challenge to emergency regulations in California prohibiting detectable THC in hemp food/beverages and dietary supplements, injunctions are in place in other states, including Arkansas, Louisiana, and New Jersey.
At the federal level, Congress authorized yet another extension of the Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill). Although this means the definition of “hemp” remains unchanged, we expect the 119th Congress to take up this issue and potentially modify the definition to address intoxicating hemp products – and possibly propose a new framework to regulate hemp-derived cannabinoid products under federal law. How this might affect the existing patchwork of state laws regulating hemp products remains to be seen.
U.S. Patent & Trademark Office News: New Late Term Continuation/Divisional Fee
The USPTO has introduced new fees for continuation and divisional (together, “continuing”) applications filed late in the patent term. Specifically, the USPTO will charge a $2,700 fee for large entities (small entities about half that) when filing a continuing application more than six years after the earliest priority benefit date. For filing a continuing application more than nine years after the earliest benefit date, the USPTO will charge a $4,000 fee for large entities (small entities about half that). These fees will be in addition to the filing, search, and examination fees. The filing fee for large entities is increasing by $30 to $350; the search fee is increasing by $70 to $770, and the examination fee is increasing by $80 to $880. Any continuation applications should be filed before January 19, 2025 to avoid these fee increases.
Thanks for reading!
Rend Al-Mondhiry, Editor