From the beginning of representation, our FDA attorneys work diligently to identify potential issues – such as the mislabeling, misbranding, or adulteration of a product — and throughout our representation remain dedicated to developing proactive and prudent solutions to all your regulatory and business problems. A unique advantage of working with Gaitan Law Group is the enhanced emphasis our FDA professionals place on keeping our clients informed throughout every step of the process, providing practical instruction to protect against future violations and delivering easy-to-implement solutions that will maximize compliance. Our attorneys work closely with clients to establish sustainable solutions to their FDA regulatory issues in order to ensure the ongoing success of their business.
The FDA attorneys at Gaitan Law Group walk manufacturers, importers, processors and distributors through the intricate labyrinth of government oversight that shapes the international marketplace of food, drugs, cosmetics, and medical devices. Our experienced team of attorneys and consultants guide businesses through the rules and regulations of other government agencies that also have jurisdiction over FDA regulated products, such as the U.S. Customs and Border Protection (CBP), U.S. Department of Agriculture (USDA), Environmental Protection Agency (EPA), and the Consumer Product Safety Commission (CPSC), among others. With a client base that spans the globe, our attorneys are accustomed to working within the FDAs multi-agency and cross-national system.
Our FDA attorneys possess knowledge and experience in other disciplines including business and corporate law, health care regulation, administrative law and litigation allowing us to develop interdisciplinary legal strategies for a wide range of clients across numerous industries. As part of this comprehensive approach, we have established a reliable network of industry consultants, with which we work closely to address our clients’ discrete needs.
Businesses rely on the FDA compliance attorneys at Gaitan Law Group to resolve a wide-range of compliance and enforcement issues, including, but not limited to:
- Label Reviews for foods and dietary supplements, drugs, cosmetics, and medical devices
- OTC Drug Facility Registration & Product Listing
- Medical Device Facility Registration & Product Listing
- Dietary Supplement Statement of Nutritional Support (structure/function claim) Notifications – 30 day notice
- Voluntary Cosmetic Registration & Listing
- BioTerrorism Act Compliance
- Food Facility Registration & U.S. Agent Services
- Removal from Import Alert
- USDA, EPA, FTC, CDC, CMS and CBP Compliance
- EPA Organic Labeling
- FTC Advertising review
- Imported Food Notices and Filings, including: Prior Notice; Acidified and Low-Acid Canned Food Filings (FCE-SID); VS Permits; “Pasteurized” notifications; USDA-APHIS Import Permits, FDA-CBP Import for Export Statements; and more
- Responding to Warning Letters, Inspectional findings (FDA 483s), Notices of FDA Action, Notices of Detention and Hearing for imported products, Refusals, Administrative Detentions, Import Alerts and other FDA enforcement actions
- Filing of Citizen Petitions and Requests for Advisory Opinions
- Freedom of Information Act Requests
The FDA’s ability to monitor the importation and distribution of foods and dietary supplements, drugs, cosmetics, and/or medical devices within the United States, is strengthened by an elaborate system of specialized “Centers” such as CFSAN, CDER, CBER, and CDRH. FDA further extends its scope of consumer protection through cooperative efforts with federal, state and local agencies, as well as international collaborations. Among the federal agencies that work in partnership with the FDA to regulate foods and dietary supplements, drugs, cosmetics, and/or medical devices, are the United States Department of Agriculture (USDA), Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Center for Disease Control (CDC), Center for Medicare and Medicaid Services (CMS), and Customs and Border Protection (CBP). FDA’s collaborative efforts consist of:
- FDA Intercenter Collaborative Review Process. FDA has established intercenter reviews of combination products, medical devices, drugs and biologics between CBER, CDER and CDRH
- Interagency Agreements and Memoranda of Understanding (MOU). Interagency MOUs provide for more efficient use of agency manpower / resources and to prevent duplication of efforts by FDA and agencies such as the USDA, FTC, EPA, CMS. PTO, and DOD when regulating the promotion, distribution, and importation of food and dietary supplement, drug, cosmetics, and medical device.
- International Agreements and Memoranda of Understanding (MOU). International MOUs with countries having the same or similar systems as FDA. Through MOU’s FDA establish quality and safety reviews and import/export certification criteria for food and dietary supplement, drug, cosmetics, and medical device products.
- State Operational Authority. Working through States authorities FDA expands its jurisdiction over food, drug and medical device facilities to collect samples, exercise embargo or detention powers, as well as to conduct joint inspections.
For more information please contact the practice group chair, Ann Marie Gaitan, Esq. at [email protected] or via telephone at 786.440.8115. We offer flexible fee arrangements.
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