Regulatory Insight. Scientific Depth. Business-Driven Solutions.
Operating within the highly regulated sectors of healthcare and life sciences requires deep regulatory expertise and strategic business insight.
Frier Levitt’s FDA regulatory attorneys counsel clients across all aspects of FDA compliance, life sciences transactions, and regulatory advisory services. Drawing on decades of combined experience in FDA, DEA, FTC, USDA, and state regulatory matters, our scientifically trained attorneys deliver strategic counsel that enables clients to innovate and grow with confidence.
We advise domestic and international clients in industries including food and beverage, dietary supplements, pharmaceuticals, biologics, medical devices, cosmetics, cannabis, hemp, and psychedelics.
In an environment where innovation often outpaces regulation, Frier Levitt helps clients anticipate challenges and seize market opportunities while remaining compliant. Whether launching a new product, expanding operations, or responding to an enforcement action, Frier Levitt provides clear, practical solutions that align regulatory compliance with business growth.
Food and Beverage
The food and beverage sector faces stringent and evolving regulatory oversight. From the Food Safety Modernization Act (FSMA) to Current Good Manufacturing Practices (CGMPs), companies must ensure products are safe, accurately labeled, and compliant with both federal and state laws.
Our attorneys guide clients through labeling, marketing, import/export compliance, and defense against FDA or FTC enforcement.
- FDA labeling, website, and advertising compliance reviews
- FSMA, FSVP, and HARPC compliance planning
- GRAS (Generally Recognized as Safe) notification preparation and submission
- FDA Warning Letter and Form 483 response strategies
- Prop 65 compliance and defense
- Import detention and refusal representation before CBP and FDA
- Licensing, distribution, and co-packing agreement negotiation
- Advised a U.S. 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
- Successfully petitioned CBP for mitigated liquidated damages on behalf of a US food business
Dietary Supplements
Operating under DSHEA and related regulations, dietary supplement companies face heightened scrutiny over safety, labeling, and claims. Frier Levitt helps manufacturers, distributors, and investors anticipate and mitigate regulatory risks.
- FDA structure/function claim notifications
- NDI (New Dietary Ingredient) notifications
- Labeling, website, and advertising compliance reviews
- FSMA, FSVP, and HARPC compliance support
- Recall and FDA enforcement response planning
- Prop 65 litigation defense
- Import/export compliance for dietary supplements
- Assisted a Danish company in creating a dossier in support of a New Dietary Ingredient Notification (NDIN) for submission to FDA
- Provided regulatory opinion regarding use of hemp-derived cannabinoids in dietary supplements
- Guided a U.S. company in the development of dietary supplement beverages containing novel botanicals
- Provided guidance to a dietary supplement company seeking to generate data for claim substantiation under §403(r) of the Food, Drug and Cosmetics Act (FD&CA)
- Performed label, advertising, and social media review for Kava and Kratom-containing beverages
- Filed 30-day notice with FDA for client’s structure / function claims
- Managed national recall of dietary supplements and interfaced with FDA
Drugs & Biologics
Pharmaceutical and biotech companies face exacting FDA regulatory requirements across product development, approval, and post-market compliance. Our firm integrates scientific expertise and deep regulatory knowledge to navigate INDs, NDAs, ANDAs, BLAs, and biosimilar pathways efficiently and with confidence.
We advise on advertising and promotion compliance, facility inspection readiness, CGMP compliance, OTC labeling and listing, recall management, Import Alert removals, and resolution of FDA Warning Letters and enforcement actions.
- IND preparation and pre-IND meeting strategy
- NDA, ANDA, 505(b)(2), and BLA submissions
- CGMP compliance guidance
- Post-market labeling and surveillance
- FDA Warning Letter responses and Form 483 defense
- Licensing and M&A due diligence
- Orphan Drug and Priority Review Voucher strategy
- Response to Seizure Notices and mitigation of liquidated damages
- Advised Abbott Laboratories on FDA compliance matters in its capitalization and option to purchase Cephea Technologies
- Conducted regulatory due diligence on French pharmaceutical company HRA Pharma in connection to the company’s sale to Goldman Sachs and Astorg Partners
- Advised a U.S. biopharmaceutical company on the potential sale of option rights to a pediatric priority review voucher (PRV)
- Provided regulatory compliance services to a $2.4 billion hospital group on FDA and state health care laws governing the commercialization of de-identified human solid and liquid tissue
- Advised and negotiated on behalf of a European API manufacturer on a $94 million IP licensing and supply agreement with a prominent U.S. medical foods company
- Negotiated IP licensing agreement and sponsored research agreement between a biotech client company and Brigham and Women’s Hospital/Harvard University
- Assisted the U.S. subsidiary of a European biotech company in creating a Scientific Advisory Board
- Performed regulatory and IP due diligence on various psychedelic biotech ventures on behalf of Iter Investments, a venture capital fund
- Provided clinical trial and FDA regulatory advisory services to a U.S. biopharmaceutical venture developing psilocybin-derived therapeutics for various mental health indications
- Represented a U.S. stem cell company in responding to an FDA Warning Letter
- Advised several companies on marketing compounded semaglutide and tirzepatide drug products
- Retained by the United Nations Industrial Development Program (UNIDO) to assist Latin American cosmetics & OTC product manufacturers with FDA regulatory compliance
- Advised a U.S. generic drug company on FDA compliance when importing API from India
- Advised a Brazilian biologics company on the §351(k) pathway for licensing a biosimilar
- Assisted a Latin American pharmaceutical company with OTC listings and advertising compliance matters
- Represented an OTC drug company in responding to an FDA Warning Letter
- Prepared a Spanish API manufacturer for its first FDA inspection
Medical Devices
Frier Levitt advises medical device and IVD companies through classification, clearance, and approval processes, including 510(k), De Novo, and PMA submissions, and post-market compliance.
Our team counsels on FDA quality system regulations (QSR), labeling and advertising review, and enforcement defense. We also provide transactional support for manufacturing, licensing, and distribution agreements, as well as capital-raise and M&A events.
- FDA classification and 510(k)/PMA submissions, and regulatory opinions
- Labeling, packaging, website and advertising compliance
- QSR/CAPA remediation and inspection response
- FDA Warning Letter and inspection response strategies
- Import and Customs compliance for devices and IVDs
- MDR reporting, recall and crisis management
- Licensing and distribution agreement negotiation
- Led regulatory due diligence and advised Cardinal Health, Inc. on FDA regulatory requirements in connection with a $240M acquisition of a clinical decision support (CDS) software company
- Provided crisis management services, supervised implementation of corrective and preventive action (CAPA) plan, and interfaced with FDA in a self-disclosure of quality system deficiencies of a U.S. company’s Class III medical device
- Provided guidance to a U.S. medical device company on advertising compliance matters and potential unfair competition claims against a competitor with regard to a product utilizing 3-D printing for custom fabrication of medical orthotics
- Advised an Italian manufacturer of medical devices on removal from FDA Import Alert and response to FDA Warning Letter
- Provided FDA regulatory guidance to various Health IT and medical mobile app companies regarding product registration and clearance, as well as FTC advertising compliance
- Advised a Japanese Global 500 company on the clearance of a Class II IVD device in the U.S.
- Provided counsel to a global medical device company on the U.S. portion of a global Class II recall, creation and implementation of a CAPA, and mitigation of possible consumer and class action litigation
- Provided counsel to a U.S. medical device company on response to FDA Warning Letter and assisted in the creation of a CAPA related to GMP quality issues
- Initiated Lanham Act unfair competition litigation on behalf of a medical device client against a series of U.S. distributors and a foreign manufacturer of a non-cleared Class II medical device
Cannabis, Hemp & Psychedelics
Emerging regulated markets require experienced counsel to balance innovation with compliance.
We represent medical and adult-use cannabis businesses in licensing, packaging, advertising, and enforcement defense.
Our attorneys counsel hemp and CBD product companies on FDA, FTC, DEA, USDA, and state compliance, as well as import/export and Prop 65 defense.
For companies developing psychedelic-based therapies, we provide DEA licensing, IND preparation, clinical trial design support, and investment due diligence.
FDA Labeling, Advertising & Promotion
The promotion of FDA-regulated products continues to evolve across traditional and digital platforms. Frier Levitt’s attorneys have extensive experience counseling on FDA, FTC, and Lanham Act requirements for truthful, balanced, and substantiated product communications.
We assist with claim substantiation, social media and influencer campaigns, adherence and disease-state programs, corrective advertising, and training for marketing and medical affairs teams.
- Labeling and advertising review for drugs, biologics, devices, supplements, and foods
- Support for claims and comparative advertising
- Review of disease-state, adherence, and co-pay programs
- Corrective advertising and testimonial review
- FTC and Lanham Act false advertising disputes
- Development of internal SOPs and training programs
International Trade & Business Transactions
Expanding your business into the U.S. market presents both regulatory challenges and strategic opportunities. Frier Levitt provides comprehensive legal support tailored to the needs of international clients.
With a focus on life sciences and healthcare, we have assisted companies from the Netherlands, France, Spain, Japan, Canada, the United Kingdom, Italy, Chile, Colombia, Brazil, and India in entering the U.S. market. With extensive experience with Latin America and fluency in Spanish and Portuguese, our team helps global clients establish compliant and successful operations in the United States.
Our services encompass every stage of market entry, from customs and FDA regulatory compliance to connecting our clients with manufacturers, distributors, insurers, payment providers and venture partners. We also manage import and export requirements to ensure full compliance with FDA and U.S. Customs and Border Protection (CPB) requirements.
Whether you are pursuing U.S. market entry for a drug, medical device, or a highly regulated product, importing a food or dietary supplement, establishing a joint venture, registering a U.S. business entity, or seeking CBP and FDA import guidance, we deliver experienced strategic guidance and expertise needed for conducting your business with confidence in the United States.
- CBP Import Compliance
- Removal from FDA Import Alert
- Customs Detentions / Entry Denial
- Liquidated Damages Petitions
- Audit Preparation
- U.S. Business Registration
- Cross-border supply, distribution and sales agreement
- FDA compliance guidance
- Third-Party / White label manufacturing support for non-U.S. companies
- Warehousing / distribution / logistics support
- Joint Venture partnering support
Why Frier Levitt
From established FDA-regulated sectors to cutting-edge industries like cannabis, hemp, and psychedelics, our attorneys combine regulatory depth with practical business perspective. We help clients bring products to market, mitigate enforcement risk, and position themselves for sustainable growth.
Frier Levitt provides strategic, industry-focused legal counsel tailored to your needs. Contact our team today to learn how we can help you.
