Foods & Beverages

Food and beverage companies play a crucial role in developing, producing, and safely introducing products to the market. In an industry where consumer safety and trust are paramount, ensuring compliance with a complex and dynamic regulatory landscape is essential. This demands adherence to an intricate mosaic of federal and state-specific regulatory frameworks.

At Asebey Life Science Law, we provide expert legal guidance to help clients meet federal and state requirements. This includes advising on broad federal regulations, such as the Food Safety Modernization Act (FSMA), Current Good Manufacturing Practices (CGMPs), labeling and advertising, and food import compliance.

We also offer substantive guidance to companies developing New Dietary Ingredients or seeking “generally regarded as safe” (GRAS) designation for their food additives. Whether introducing innovative products to the marketplace or managing ongoing compliance, we provide the legal support needed to protect your brand and confidently navigate the food and beverage sector.

Services Provided

Label, website, and advertising reviews for FDA compliance
Regulatory opinions regarding novel foods and beverages
GRAS notification dossier preparation
FDA Warning Letters and 483 responses to FDA
FDA and state food facility inspection management
California Prop 65 defense
FDA Import Alert removal
IP License negotiation & drafting
General compliance with the Food Safety Modernization Act (FSMA), Foreign Supplier Verification Program (FSVP), Hazard Analysis and Risk-based Preventive Controls (HARP-C)
Food import detentions and refusals representations before CBP and FDA
Petitions for mitigation of liquidated damages
CBP Import Compliance

Representative Matters

Advised a US Fortune 500 company on FSMA compliance matters associated with the acquisition of an Australian food company
Removed a major Chilean salmon company from FDA Import Alert
Successfully represented seven Indian food companies in removal from FDA Import Alert related to pesticide tolerance levels
Negotiated and drafted licensing, purchase, and distribution agreements for various client food companies in the US, Japan, and Latin America
Managed a food recall for a US pet food company
Successfully removed a pet food company from FDA Import Alert
Managed third-party laboratory testing to successfully support a petition for release of detained food entries
Represented a US company in a Prop 65 action related to the company’s beverages
Provided in-person FSMA training to food exporters in Tokyo, Osaka, and Nagoya at the invitation of the Japan Export Trade Organization (JETRO)
Negotiated a food brand licensing agreement for a Chilean food distributor
Provided Spanish-language training on FSMA implementation and compliance to Colombian food export companies in Bogotá, Medellin, Cali, and Barranquilla
Advised Colombian government regulators on FSMA implementation and compliance requirements
Successfully defended a Colombian company in a Prop 65 action
Advised various US companies on FSMA compliance
Successfully petitioned CBP for mitigated liquidated damages on behalf of a US food business

Tell us more about your regulatory needs so we can help you succeed.

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