Foods, Beverages and Dietary Supplements, Regulatory
Service Areas
Our work in this area includes:
– Assisting companies in determining regulatory classification, pathways, and product compliance requirements
– Reviewing product labeling, websites, and other promotional material for FDA compliance
– Assisting with product safety compliance issues, such as product recalls, safety assessments of food and beverage additives and ingredients, and California Proposition 65
– Counseling on Food Safety Modernization Act (FSMA) requirements, including Foreign Supplier Verification Program (FSVP) plans and the Voluntary Qualified Importer Program (VQIP)
– Advising on compliance with current good manufacturing practices, FDA inspection practices, and recordkeeping and traceability requirements
– Management of third-party laboratory testing
– Management of FDA inspections and responses to Warning Letters, untitled compliance letters, and Forms FDA-483
– Management of import detentions, import refusals, and requests for reconditioning
– Providing counsel on Import Alerts, including petitioning companies from removal from Import Alert, and other import/export issues
– Assisting with petitions for mitigation of liquidated damages assessed by U.S. Customs
– Assisting with foreign and domestic food facility registrations and U.S. agent representation
Regulatory Experience
Our experience includes representing domestic and international businesses, and import and export matters regulated by FDA, CBP, USDA, and EPA.
Representative Food Regulatory Experience:
- Successfully removed food company from Import Alert after decades-long placement, permitting US market access
- Negotiated the release of various FDA-regulated food products following FDA detention
- Mitigated liquidated damages claim for confectionary business by 1%
- Successfully limited recall scope for food ingredient manufacturers and provided strategic guidance during recall
- Advised on FDA’s enforcement discretion policy for infant formula during a public health crisis
- Advised on product labeling and packaging requirements
- Advised on Proposition 65 compliance for ceramicware and food contact materials
- Advised on EPA pesticide tolerances for food products
- Provided counsel on FDA FSMA compliance requirements
- Advised on FDA Menu and Vending Machine labeling rules
- Guided cheese producer on Reportable Food Registry requirements and whether an incident constituted a reportable food event
- Obtained USDA VS permits for animal-origin containing materials in food products
- Counseled on USDA treatment protocols for identified pest in FDA-regulated grain products
Why Work With Us?
- Experienced and committed: While it helps that many of the products we advise on are ones we would use or recommend to friends and family, we are invested and care about you and the issues you are facing. We dedicate our resources to resolve your questions, and to help you reach the next peak.
- Responsive: We recognize that business happens quickly. We pride ourselves on being responsive to clients, and available when you need us, whether this means accommodating international time zones or strategizing for an unannounced FDA inspection.
- Client-focused: We focus on identifying the best legal and business solutions with your products and risk tolerance in mind.
- Partnership: We like to view our partnership as a long-term relationship, growing with you as an extension of your regulatory team.
- Specialized: Our practice is niche and our expertise is specialized. Chances are we have experience and the resources to address the regulatory questions keeping you up at night.
Food, dietary supplement, and beverage clients include:
· Importers · Exporters · Manufacturers · Contract manufacturers · Distributors · Trade organizations
