Dietary Supplements
Kleinfeld, Kaplan & Becker offers legal and regulatory guidance related to the manufacture, distribution, and marketing of dietary supplements, including:
- Good Manufacturing Practice (GMP) regulations
- Safety, recalls and reporting
- Ingredient clearance
- Labeling, advertising and notifications for structure-function claims
- Enforcement and product challenges.
Our focus is on strategic planning to minimize regulatory issues and maximize product competitiveness in the dietary supplement marketplace. We work with a number of dietary supplement trade associations to assist the industry in keeping abreast of, and influencing, regulatory policy.
GMP Regulations
Our firm helps clients comply with FDA’s dietary supplement GMP regulations, as well as Foreign Supplier Verification Program (FSVP) and related 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 the regulations, and advised on handling governmental inspections and responding to inspectional observations.
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 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.
Ingredient Clearance
Our firm provides direction to clients on the legal status of dietary ingredients and other ingredients used in dietary supplements, including food additives, Generally Recognized as Safe (GRAS) substances and color additives. We assist clients in evaluating whether dietary ingredients are “new” dietary ingredients (NDIs), determining whether an NDI notification is needed, and developing strategies for successful ingredient clearance.
Labeling, Advertising and Notifications for Structure-Function Claims
Our firm advises on all aspects of dietary supplement labeling, including statements of identity, the Supplement Facts panel, ingredient lists, identification of the manufacturer/distributor, CPB 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 advise clients on providing notifications to FDA for structure-function claims.
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.
Enforcement
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 food companies and products that are being considered for acquisition or investment.