Kleinfeld, Kaplan & Becker advises manufacturers and marketers of cosmetics on formulation, labeling, advertising and claims substantiation.
Formulation and Manufacturing
Our firm helps clients review ingredients, identify potential regulatory issues (such as color additive approvals or Proposition 65 chemicals), and assure that ingredients are adequately substantiated for safety. We assist with FDA guidance on cosmetic good manufacturing practice and advise on handling governmental inspections and responding to inspectional observations.
Cosmetic Safety, Recalls and Reporting
Our firm helps clients assess the risks posed by safety-related manufacturing deviations and contamination, determine whether a recall is needed, and what the scope of any recall should be. We advise on reporting, recall implementation and effectiveness checks, and documentation of corrective and preventive actions. We assist with governmental inspections relating to product deviations and recalls. We also handle CPSC-related recall issues for containers or related products subject to CPSC jurisdiction.
Labeling and Advertising
Our firm assists clients in reviewing labels for regulatory compliance, including advice on label declarations, federal and state requirements for the net quantity of contents, ingredients lists, identification of the manufacturer/distributor, and CBP country of origin labeling requirements. We also assist clients with organic claims and state law labeling issues (for example, for hemp products).
Our firm assists clients in developing advertising claims, to ensure that claims are consistent with regulatory requirements and are adequately substantiated. We assist clients in dealing with challenges relating to labeling and advertising claims, including challenges by competitors, consumers and regulatory agencies.
Our firm represents clients in enforcement actions, including responses to FDA inspectional observations, warning letters, recall requests and import detentions, as well as more significant actions such as seizures and injunctions. We also represent clients before the FTC and other federal regulatory agencies, as well as state agencies.
Contracts and Due Diligence
Our firm supports clients in negotiating and drafting regulatory-related agreements such as guarantees, labeling agreements, supply agreements, quality agreements, etc. We also carry out due diligence analyses of cosmetics companies and products that are being considered for acquisition or investment.