AWG Regulatory Roundup — June 16, 2026
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- FDA Adds Bemotrizinol to OTC Sunscreen Monograph, A First in Over 20 Years
- FDA Issues Consumer Warnings About Skin Products Containing Mercury and/or Hydroquinone
- FDA Updates Pesticide Monitoring Program
- FTC Sues Supplement MLM Over Children’s Health Claims
- EPR Enforcement is on the Way
- Vermont Enacts Law Targeting Heavy Metals in Baby Foods
- New York’s Shelf-Life Legislation Pending Governor’s Signature
- Alaska Legislation to Prohibit Dyes from School Meals Pending Governor’s Signature
- Texas AG Targets Glyphosate Residues in Major Food Brands
- Illinois Ban on EU-Restricted Cosmetic Ingredients Awaits Governor’s Signature
- A Win for Generics: Supreme Court backs generic drugmaker in ‘skinny label’ patent case
FDA Adds Bemotrizinol to OTC Sunscreen Monograph, A First in Over 20 Years
On June 10, 2026, FDA issued a Final Order approving the addition of bemotrizinol (sold by the company DSM Nutritional Products LLC (DSM) under the name PARSOL® Shield) at concentrations up to 6% as a permitted sunscreen active ingredient under the Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use. The Final Order is set to take effect on August 9, 2026. As we previously reported, this Final Order follows a Proposed Rule issued by the agency in December 2025 and is the first new sunscreen active ingredient authorized by FDA in over 20 years. It is also the first approved Tier 1 OTC Monograph Order Request (OMOR) since the CARES Act reformed and modernized the OTC drug review process in March 2020. As a result of its successful Tier 1 OMOR, DSM will have exclusivity for 18 months following the effective date of the Final Order.
FDA Issues Consumer Warnings About Skin Products Containing Mercury and/or Hydroquinone
On June 1, 2026, FDA issued a Medication Health Fraud Update advising consumers not to use over-the-counter (OTC) skin lightening products due to high levels of mercury and/or hydroquinone. The advisory also notes that there are no FDA-approved or legally marketed OTC skin lightening products and warns of the health risks of repeated exposure to mercury and serious skin problems associated with hydroquinone.
FDA Updates Pesticide Monitoring Program
On May 28, 2026, FDA’s Human Foods Program announced updates to its pesticide residue monitoring compliance program, focusing on risk-based sampling that prioritizes foods commonly consumed by infants and children across more than 150 raw agricultural commodities. The updated program – the first update in 15 years – also modernizes laboratory testing methods and strengthens coordination with federal and state regulatory partners. The agency also released a Pesticide Report Data Dashboard and will provide annual summary reports on its Pesticides webpage.
FTC Sues Supplement MLM Over Children’s Health Claims
The FTC sued multilevel marketer Amare Global Holdings and three of its principals for allegedly making false and unsubstantiated claims that Amare’s dietary supplements could treat depression, anxiety, and ADHD in children and adults. The complaint, filed in the Central District of California, also alleges Amare misled recruits about potential earnings as “brand partners.”
EPR Enforcement is on the Way
States with Extended Producer Responsibility (EPR) requirements are beginning to shift from program design and implementation to active compliance monitoring, raising the stakes for noncompliant producers. Several of these states are already signaling or initiating enforcement against non‑registered producers and late filers, with some issuing fee invoices and warning that unregistered producers “may be subject to enforcement.”
This early wave of enforcement focuses on three main categories of noncompliance: 1) failure to register with the state program or a PRO by statutory deadlines; 2) failure to submit required packaging data reports; and 3) failure to pay assessed fees. Several statutes authorize escalating per‑day penalties for repeat violations up to, and in some cases exceeding, $50,000 per violation per day, as well as suspension of a producer’s ability to sell covered products in the state until compliance is demonstrated. For producers who have not yet engaged, the practical takeaway is that the window for “grace period” compliance is closing as agencies move away from education to active case development. Non‑participation increasingly carries both financial risk and the risk of losing market access in key states.
Vermont Enacts Law Targeting Heavy Metals in Baby Foods
On May 26, 2026, Vermont’s Governor signed House Bill 536 into law, which prohibits the sale or distribution in Vermont of any baby food product that contains arsenic, cadmium, lead, or mercury exceeding FDA regulatory limits. “Baby food product” is defined as any food manufactured, packaged, and labeled in a jar, pouch, tub, or box sold specifically for babies and children younger than two years of age, excluding infant formula.
Under the new law, which becomes effective on January 1, 2027, manufacturers will be required to test a representative sample of each production aggregate at least once a month using an ISO/IEC 17025-accredited laboratory that meets specified analytical sensitivity standards and must provide results to the attorney general upon request. Manufacturers must also post heavy metal test results on their website for the product’s shelf life plus one month, along with identifying product information and a link to FDA guidance on heavy metal health effects in children. In addition, products sold online must include a clearly labeled link to this information on the product page. For products subject to an FDA action level, regulatory limit, or tolerance under 21 CFR 109, the product label must also carry a QR code linking to test results and the relevant FDA guidance page. Violations are enforceable by the state’s attorney general under the Consumer Protection Act or by private parties. A separate provision extending these requirements to infant formula takes effect only upon the attorney general’s confirmation that California or two other states have enacted substantially comparable infant formula requirements.
New York’s Shelf-Life Legislation Pending Governor’s Signature
New York State Senate Bill S7618B has passed both legislative chambers and will be transmitted to Governor Kathy Hochul for signature. The bill would require food manufacturers, processors, and retailers that choose (or are required by law) to display a date label on foods to use either “BEST if Used by” or “Best if Used or Frozen by” for quality dates, or “USE by” or “USE by or Freeze by” for safety dates. Abbreviated versions (“UB” and “BB”) may be used if the products are too small to accommodate the full terms. The use of “SELL BY” on products manufactured on or after July 1, 2028 would be prohibited. In addition, the person or entity responsible for placing a safety or quality date on a product must estimate shelf life using a scientifically valid method deemed acceptable by the Department of Agriculture and Markets in consultation with the Department of Health, which takes into account the product’s quality, characteristics, formulation, processing impact, packaging and protective wrapping or coating, and typical transportation, storage, and display conditions, including retail store and consumer conditions.
The bill does not have an exemption clause for dietary supplements. If signed into law, it takes effect 180 days after signature.
Alaska Legislation to Prohibit Dyes from School Meals Pending Governor’s Signature
Alaska Senate Bill 187 passed the Senate and House and was transmitted to Governor Mike Dunleavy on June 4, 2026. The bill would ban the use of Red Dye 3, Red Dye 40, Yellow Dye 5, Yellow Dye 6, Blue Dye 1 and Blue Dye 2 in school-provided meals, effective January 1, 2028.
Texas AG Targets Glyphosate Residues in Major Food Brands
A few days after FDA’s announcement regarding its enhanced pesticide monitoring program, Texas Attorney General Ken Paxton announced an investigation into glyphosate residue in food products from major companies including Bayer and PepsiCo, alleging some are sourcing oats and other crops from foreign countries where glyphosate use as a pre-harvest desiccant is permitted, which EPA has banned for domestic oat production. The AG’s office issued civil investigative demands to the companies, citing research linking glyphosate to cancer risk and endocrine disruption. His office is also investigating compliance with Texas consumer protection laws, and whether parents have been misled by health claims made for these food products.
Illinois Ban on EU-Restricted Cosmetic Ingredients Awaits Governor’s Signature
Illinois House Bill 3409, the Chemicals in Cosmetic Products Act, has passed both legislative chambers and will be sent to Governor J.B. Pritzker for signature. The bill would prohibit cosmetic products that contain certain intentionally added chemicals, including PFAS, mercury, and certain phthalates and parabens, consistent with European Union restrictions. Technically unavoidable trace quantities of the prohibited ingredients due to impurity, the manufacturing process, storage, or packaging would be exempted. If signed into law, the bill takes effect on July 1, 2028.
A Win for Generics: Supreme Court backs generic drugmaker in ‘skinny label’ patent case
The U.S. Supreme Court unanimously ruled in favor of Hikma Pharmaceuticals, ending a major “skinny label” patent dispute. The Court held that generic drug makers do not induce patent infringement simply by making commonplace market statements about their generic drugs when their official FDA labels explicitly exclude patented uses.
Amarin’s drug Vascepa is approved for both severe hypertriglyceridemia and cardiovascular (CV) risk reduction. Hikma launched a generic version with a “skinny label” that carved out the patented cardiovascular use. Amarin argued that Hikma’s press releases and marketing materials—which referred to its pill as a “generic version” or cited overall Vascepa sales—encouraged doctors to prescribe the generic for the patented CV use.
The Supreme Court disagreed, stating that Amarin failed to plausibly allege that Hikma actively encouraged doctors to infringe on the patent. The Court clarified that the central question is whether a generic actively encourages infringing use, not merely whether a doctor could plausibly read a generic company’s marketing statements as instructions to infringe.
