Kleinfeld, Kaplan & Becker works with a wide variety of clients to develop creative solutions for issues relating to foods and beverages, ensuring compliance with requirements for –
- Preventive controls and Good Manufacturing Practice (GMP)
- Food safety, recalls and reporting
- Ingredient clearance
- Labeling and advertising
- Organic products.
Our work covers FDA-regulated foods, USDA-regulated products (meat, poultry and certain egg products), TTB-regulated alcoholic beverages, and related areas, including FTC-regulated advertising (such as environmental claims), EPA-regulated pesticides, CBP-regulated imports, and CPSC-regulated consumer products, as well as state law issues (such as hemp regulation and California’s Proposition 65).
We represent clients in enforcement actions brought by FDA, USDA and other regulatory agencies. We also handle contracts and due diligence reviews relating to food law.
The following provides more detail on each of these points.
Preventive Controls & GMP
Our firm helps clients comply with FDA’s regulations under the Food Safety Modernization Act governing preventive controls and GMP, FDA manufacturing requirements for specific foods (such as low-acid and acidified foods), and USDA HACCP regulations. We have assisted clients in understanding the requirements and exemptions that apply to their business, drafted SOPs to help meet those requirements, worked with quality teams and technical experts to implement Food Safety Plans, and advised on handling governmental inspections and responding to inspectional observations.
Food Safety, Recalls and Reporting
Our firm helps clients assess the risks posed by safety-related manufacturing deviations and contamination, and determine whether a recall is needed and what its scope should be. We advise on voluntary and mandatory reporting requirements, 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 other products subject to CPSC jurisdiction.
Our firm provides direction to clients on the legal status of food ingredients, including food additives, Generally Recognized as Safe (GRAS) substances and color additives. We have collaborated with scientific experts to prepare successful GRAS notifications and food additive petitions, and we advise on procedures for reaching “self-GRAS” determinations. Our firm also assists with ingredient clearance for USDA-regulated products, including the use of new manufacturing technologies.
Labeling and Advertising
Our firm assists clients in reviewing labels for regulatory compliance, including advice on naming of foods and standards of identity, federal and state requirements for the net quantity of contents, the Nutrition Facts panel, ingredients lists, identification of the manufacturer/distributor, CBP country of origin labeling requirements, and USDA bioengineered food labeling requirements. We frequently interface with FDA on food labeling issues and assist clients in submitting petitions and comments for nutrient content claims, health claims, and other labeling matters. We also assist clients with label approval for USDA-regulated products and deal with 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 firms assists clients in compliance with USDA organic regulations, including assistance in interpreting and revising the National List, and responding to compliance actions by certifying bodies and the USDA National Organic Program.
Our firms works with alcoholic beverage manufacturers, as well as manufacturers of products containing alcohol (for example, as part of flavors or fragrances), to assist with compliance with regulations of the Department of the Treasury, Alcohol and Tobacco Tax and Trade Bureau (TTB), as well as compliance with applicable FDA regulations and advertising law.
Our firm represents clients in enforcement actions, including responses to FDA and USDA 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, TTB 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 food companies and products that are being considered for acquisition or investment.