Claims do matter, but this isn’t the whole picture. The formulation and how the product works are also important. A key consideration is how the product is represented to consumers…it’s overall representation. An ingredient commonly used in cosmetics does not automatically mean that a finished product will be classified as a cosmetic. There can be an important regulatory distinction between claims such as ‘brightens skin’ and ‘helps skin look brighter’. Classification is not simply a matter of changing a few words on a label. Health Canada can consider the overall representation of the product, including its name, packaging design, images and symbols used on the label, directions of use, implied claims, information on websites and social media posts.

The best strategy is to address classification early on during product development, rather than after the formula, packaging and marketing materials have been finalized.

Companies should consider:

• Reviewing the formulation
• Assessing the product’s intended mode of action
• Evaluating implied claims across all marketing channels
• Documenting the scientific and regulatory rationale for the proposed classification
• Engaging with Health Canada where the classification remains uncertain

Our team can help assess your product and develop the right regulatory strategy for you. Reach out to us to learn more.

The post Cosmetic or Therapeutic? – The regulatory grey zone appeared first on Focal Point.

This publication represents a key component of FDA’s continuous efforts to enforce the provisions established by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Specifically, the document provides comprehensive clarity on the FDA’s new authority to demand mandatory recalls for cosmetic products, a regulatory power formally granted under section 611 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

After evaluating public feedback submitted on the initial draft released on December 18, 2025, the FDA opted to finalize the guidance without making any substantive modifications. The finalized guidance serves as a critical operational framework for the beauty and personal care industry by detailing three primary areas of focus:

• The specific criteria and conditions under which the FDA possesses the authority to issue a mandatory recall order. 
• The exact procedural steps the agency will execute when enforcing a mandatory recall action. 
• The strict expectations placed upon the industry to ensure full compliance with these mandatory regulatory directives. 

Despite the crystallization of these mandatory enforcement powers, the FDA explicitly notes that it still strongly urges companies to proactively execute voluntary recalls whenever violative or unsafe cosmetic merchandise is identified in the supply chain. Follow us on LinkedIn for more such regulatory insights.

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Companies marketing these affected formulations within California are subject to a mandatory two-step compliance framework. The immediate requirement mandates that responsible entities file a Priority Product Notification with the CA DTSC no later than November 30, 2026. 

Following this initial disclosure, organizations must commit to a secondary compliance action by March 30, 2027. By this deadline, businesses must submit one of the following official documents to the state: 

• A notification indicating the intent or confirmation to remove the chemical from the product. 
• A notification indicating the intent or confirmation to remove the specific product from the California market. 
• A notification indicating the intent or confirmation of a product-chemical replacement. 
• A Preliminary Alternatives Analysis Report, or utilizing other approved alternate reporting options. 

Please contact our team if you would like us to review your nail product formulations and assist you with timely submissions and prevent potential market disruptions.

The post Upcoming California DTSC Deadlines for Nail Products Containing TPhP appeared first on Focal Point.

The newly posted data offers comprehensive insights into 37 distinct categories of consumer goods for the 2023 calendar year. Industry professionals can now access detailed metrics detailing sales volumes, emission profiles, and volatile organic compound (VOC) concentrations. Furthermore, the release encompasses in-depth information regarding chemical speciation and reactivity. 

For manufacturers, formulators, and distributors, this release is a critical indicator of future compliance requirements. CARB has indicated that this finalized survey data will serve as the technical baseline for drafting upcoming regulatory amendments. These future rule changes will be specifically designed to drive further emission reductions across the consumer products sector.

Stakeholders are advised to review these metrics closely to anticipate potential regulatory shifts and evaluate how future VOC limits may impact product formulations in the California market. 

The post CARB Finalizes 2023 Consumer Products Survey Data appeared first on Focal Point.

This proposed regulatory update is being initiated through the state’s “Labor Code” listing pathway. For businesses manufacturing or distributing products that may result in exposure to atrazine, this represents a significant compliance development that could trigger new warning label obligations. 

Industry stakeholders and interested parties have an opportunity to participate in the regulatory process. The OEHHA has opened a public feedback period, and all comments regarding this intent to list must be submitted no later than November 9, 2026. 

Companies are encouraged to proactively review their material formulations and supply chains to assess potential impacts. For further details on the proposed listing and the submission process, contact us today.

The post Atrazine Targeted for Prop 65 Carcinogen Listing appeared first on Focal Point.

If you need assistance assessing affected products in your portfolio and potential website disclosure obligations, please contact us.

The post Oregon Toxic-Free Cosmetics Act approaches implementation appeared first on Focal Point.

To stay updated, please contact us.

The post US Federal Bill Proposes New standards for recycled-content claims appeared first on Focal Point.

Distributed manufacturing is a decentralized manufacturing approach in which equivalent manufacturing units operate at different locations under the oversight of a single quality system. Under the proposed “hub-and-spoke” model, a central hub provides quality oversight, while multiple equivalent manufacturing units or “spokes” manufacture the same drug at different locations.

Currently, each manufacturing unit located at a different physical location generally requires a separate establishment registration. The proposal would allow qualifying distributed manufacturing networks to register as a single establishment, with a streamlined process for adding, relocating, or removing manufacturing units. Advance notification to FDA would be required for relocation or closure of a unit.

The proposal would also clarify that certain foreign establishments manufacturing drugs or APIs that ultimately enter the US market through another foreign establishment must register with FDA and submit applicable drug listing information. This is intended to improve FDA visibility into upstream drug supply chains.

If finalized, the changes could reduce duplicative registration requirements for qualifying distributed manufacturers while increasing supply-chain visibility and registration obligations for certain foreign establishments. The proposal is not currently effective. Follow us for more such updates.

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Previously, a formal notice of intent was issued in the Canada Gazette, Part I, on February 14, 2026, which proposed adding a “P” identifier to 220 polymers categorized under reduced regulatory requirements (RRR). With the public consultation phase now officially closed, the formal order to amend the DSL was enacted and subsequently published in the Canada Gazette, Part II, Volume 160, Number 19, dated September 8, 2026. 

Through this finalized regulatory action, the “P” marker has been officially attached to 204 RRR polymers on the DSL. 

Understanding the “P” Designation: This specific designation serves as a crucial compliance signal for manufacturers and importers. The “P” indicates that the listed polymer was exclusively notified and evaluated under the specific parameters of an RRR polymer.

Consequently, if a company is formulating with or importing an alternative form or version of that polymer that does not meet the strict RRR criteria, that specific version is not considered to be listed on the DSL. As a result, such non-RRR versions remain entirely subject to the standard reporting and assessment obligations under Canada’s New Substance Notification regulations. 

If you would like assistance with your product portfolios or have specific compliance questions regarding this DSL amendment, contact us.

The post Minister of the Environment Amends DSL to Apply “P” Designation to Over 200 Polymers appeared first on Focal Point.

Key Procedural Updates:

The bulletin outlines several critical changes to the submission and screening process for regulated entities:

• Combined Screening Timelines: Health Canada is streamlining its notification process. For applications involving foreign buildings that utilize full Good Manufacturing Practice (GMP) evidence, including requests for extending a New Evidence Required By (NERBY) date, applicants will now receive a single, combined screening completion notice within 95 days. This consolidates the previously separate DEL screening completion notice and the GMP screening acceptance notice, and Health Canada will no longer issue a standalone DEL screening completion notice at the 65-day mark.

• Modified Milestone Targets: For applications assigned to Stream 3 (foreign building applications requiring full GMP evidence review), Health Canada will now issue either a GMP compliance notification or a GMP compliance notification of a NERBY extension grant within 170 days, adjusting the previous target of 140 days.

• GMP Evidence Submission Methods: While Health Canada continues to recommend that importers submit GMP evidence concurrently with their DEL application, they are introducing greater flexibility. GMP evidence can now be submitted directly from the foreign building or by a third party acting on its behalf.

• LiquidFiles Implementation: To facilitate the secure transfer of large data packages, the bulletin introduces the use of LiquidFiles for submitting GMP evidence. For files exceeding 1 GB, applicants must submit them in batches using this system. 

While these changes alter submission mechanisms and specific milestone notifications, Health Canada has explicitly stated that the overall DEL application service standards established in guidance document GUI-0127 remain unchanged.

Companies importing or manufacturing within Canada should review these updated timelines and coordinate with their foreign sites and third-party auditors to ensure GMP evidence submissions align with the new LiquidFiles procedures and combined screening targets.

Our team is here to assist you with DEL applications, reach out today.

The post Health Canada Updates DEL Screening Process to Improve Efficiency appeared first on Focal Point.