The proposal would also clarify that cosmetics sold directly to consumers are not subject to Louisiana’s facility permitting and inspection requirements. Businesses would still need to comply with applicable federal requirements under the FD&C Act and MoCRA, as well as state and local tax requirements.

If enacted, the changes could reduce regulatory and administrative requirements for small, home-based cosmetic businesses in Louisiana, while maintaining federal compliance obligations. Companies should monitor the legislation, particularly the $100,000 sakes threshold and product exclusions, when assessing eligibility for the proposed exemption.

For more such updates, contact us.

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Medical devices are subject to exemptions where PFAS are essential to the device and their use do not pose serious harm to users. Manufacturers should assess whether their products meet the applicable exemption criteria.

A new PFAS labeling requirement will also take effect January 1, 2027. Products containing intentionally added PFAS sold or distributed in New Mexico will be required to display a standardized PFAS symbol. The Environmental Improvement Board finalized the implementing rules in March 2026, with the Final Rule published in the New Mexico Register on May 5, 2026.

To ensure your compliance with this new requirement, please contact us.

The post New Mexico PFAS Protection Act: Cosmetics Restrictions Begin in 2028 appeared first on Focal Point.

The FY 2027 MDF and CMO facility fees represent an increase of approximately 149% from FY 2026. FDA attributes the increase largely to a one-time downward operating reserve adjustment that reduced FY 2026 facility fees.

A key change under OMUFA II is the consolidation of the previously separate facility and OMOR fee announcements into a single annual Federal Register notice beginning with FY 2027. This is intended to provide a more predictable and streamlined fee-setting process for FDA and industry.

The FY 2027 facility fee will be paid in two equal installments: 50% on October 1, 2026 and the remaining 50% on February 1, 2027, subject to the statutory appropriations conditions. From FY 2028 onward, the full facility fee will generally be due October 1. OMOR fees remain payable upon submission of the OMOR.

Companies that own qualifying OTC monograph drug facilities, including eligible CMOs, should assess their FY 2027 fee obligations and budget for the substantially higher facility fees. Companies planning to submit OMORs should also account for the increased OMOR fees. FDA’s OMUFA requirements apply independently of other FDA user fee programs such as PDUFA, GDUFA or MDUFA.

For more such updates, contact us.

The post FDA Announces FY 2027 OMUFA User Fee Rates and Streamlines Fee process appeared first on Focal Point.

The legislation is not currently expected to advance in Congress, but its introduction reflects continued federal scrutiny of PFAS in cosmetics. Companies should continue monitoring federal and state PFAS developments and review formulations, raw materials and packaging for intentionally added PFAS.

For further updates, do reach out to us.

The post US Federal: No PFAS in Cosmetics Act Introduced appeared first on Focal Point.

Beginning July 1, 2028, cosmetic products containing specified intentionally added substances will be prohibited from being manufactured, sold, delivered, held, or offered for sale in Illinois. The substances include Dibutyl phthalate (DBP), Diethylhexyl phthalate (DEHP), formaldehyde, paraformaldehyde, methylene glycol, quaternium-15, mercury, isobutylparaben, m-phenylenediamine and its salts, o-phenylenediamine and its salts, and specified PFAS and their salts, including PFOS, PFOA and PFNA.

The Act is intended to align Illinois restrictions with corresponding prohibitions under the European Union Cosmetics Regulations (EC) No. 1223/2009, as amended. Importantly, the law provides an exemption where a prohibited ingredient is present only as a technically unavoidable trace resulting from impurities in raw materials, the manufacturing process, storage, or packaging, provided the product was manufactured through a process intended to comply with the Act.

Cosmetic manufacturers and suppliers should begin reviewing formulations, raw material specifications, and supply chains against the substances listed under HB 3409 and assess reformulation needs well ahead of the July 1,2028 compliance date. To ensure your compliance with this new requirement, please contact us.

The post Illinois enacts restrictions on certain chemicals in cosmetics appeared first on Focal Point.

The R-ICL is an administrative list of substances found in products regulated under the Food and Drugs Act that were in Canadian commerce between January 1, 1987, and September 13, 2001. Under CEPA, substances on the R-ICL may be added to the DSL once specific eligibility criteria have been met.

With their addition to the DSL, these 656 substances have been removed from the R-ICL and are no longer subject to the New Substances Notification Regulations. This change may reduce regulatory requirements for companies using these substances in products regulated in Canada. For more such updates, contact us.

The post 656 substances added to Canada’s Domestic Substances List appeared first on Focal Point.

• Claims must remain cosmetic – In Canada, cosmetic claims are regulated under the Food and Drugs Act and the Cosmetic Regulations. While products may claim to moisturize, improve the appearance of skin or enhance radiance, claims suggesting tissue regeneration, stimulation of collagen production or cellular repair may imply a therapeutic purpose and could shift a product into the drug and natural heath product category, depending on the overall presentation.

• Scientific evidence matters – Many marketing materials reference in-vitro studies or clinical research involving injectable PDRN. Companies should ensure that any efficacy claims made for topical cosmetic products are supported by evidence relevant to the finished formulation and intended route of application. Extrapolating results from injectable products to cosmetics may not be considered appropriate substantiation.

• Ingredient sourcing and transparency – Since PDRN is commonly derived from salmon DNA, manufacturers should maintain appropriate documentation regarding ingredient identity, purity, manufacturing controls and supplier quality.

• Cross-border compliance – PDRN products originating from international markets may require claim adjustments before entering the Canadian market. Marketing language that is acceptable in one jurisdiction may trigger different regulatory classifications elsewhere, particularly when references are made to regeneration or DNA repair.

PDRN represents both an exciting innovation and a reminder that emerging ingredients require careful regulatory review. Companies introducing these products should evaluate ingredient documentation, product classification, claim substantiation, and advertising language early in the development process to support compliance while minimizing regulatory risk. If you wish to have your cosmetic ingredients or claims reviewed prior to market entry, please contact us.

The post PDRN – The New Popular Cosmetic Ingredient appeared first on Focal Point.

Inspectors reviewed 96 cosmetic products, including 41 imported products, through both online and in-person inspections. The findings underscore the importance of regulatory compliance:

• 35 products were found to be compliant
• 31 products required companies to commit to corrective actions
• 30 products were subject to stop distribution measures due to non-compliance

The most common deficiencies involved labeling non-compliance, while several products also failed to meet Cosmetic Notification requirements. These findings reinforce that Health Canada continues to prioritize accurate product labeling and ingredient disclosure, particularly for ingredients with specific conditions of use such as eucalyptus oil.

For cosmetic manufacturers, importers, and brand owners, this report serves as an important reminder that compliance extends beyond formulation. Companies should ensure that products meet the requirements of the Food and Drugs Act, the Cosmetic Regulations, and the Cosmetic Ingredient Hotlist, including:

• Accurate bilingual labeling and mandatory label information
• Timely submission of Cosmetic Notifications
• Compliance with ingredient-specific restrictions and cautionary statements
• Regular reviews of imported products to ensure Canadian regulatory requirements are met before market entry

Although HC notes that Compliance Verification Projects target products considered more likely to be non-compliant and therefore do not represent the overall Canadian marketplace, the results demonstrate that deficiencies can result in significant business impact, including stop-sale and stop-distribution actions. For companies operating in Canada’s cosmetics market, proactive label reviews and regulatory audits remain one of the most effective ways to reduce compliance risk.

Give us a call to ensure your product’s compliance.

The post Key Takeaways from Health Canada’s Cosmetic Compliance Verification Project appeared first on Focal Point.

Key updates include:

Reporting Requirements: Following confirmatory testing, Market Authorization Holders (MAHs) must assess whether nitrosamine impurities exceed the established Acceptable Intake (AI) limit and determine whether market action is required. MAHs are no longer required to notify Health Canada each time an elevated nitrosamine impurity level is detected. Notification is only required when a recall decision has been made, in accordance with the Drug, Natural Health Product and Biocide Recall guide (GUI-0039).

Risk Mitigation Expectations: While the guidance maintains a 3-year CAPA implementation timeline, Health Canada expects MAHs to implement risk mitigation measures and reduce nitrosamine levels below AI limits as soon as possible.

Safety: New contact information has been added for enquiries regarding applicable Acceptable Intake (AI) limits, including proposal for new AI limits.

Appendix 2: The decision tree has been updated to reflect the revised expectations for filing nitrosamine risk mitigation-related changes. 

If you wish to understand how these changes might affect your business, please reach out to us.

The post Health Canada updates guidance on nitrosamine impurities in medications appeared first on Focal Point.

Phase 1 reporting remains mandatory. Producers of packaging, electronics and electrical equipment, and single-use plastics destined for the residential waste stream must continue to submit required data.

Additionally, ECCC has announced plans to introduce a new reporting notice for 2027-2029 and is seeking stakeholder input.

For more information, contact us.

The post Federal Plastics Registry: Reporting Deadlines Updated appeared first on Focal Point.