FDA Regulatory
Foley’s highly experienced FDA Regulatory attorneys provide counsel and advise you on food and beverage, drug, biologic, dietary supplements, cosmetic, and medical device development, as well as other regulatory matters that are subject to the jurisdiction of the U.S. Food and Drug Administration (FDA).
Our FDA Regulatory attorneys have the in-depth experience you need to manage your FDA regulatory and compliance matters. We provide comprehensive counseling to companies that are subject to the FDA and its counterpart authorities abroad in all phases of the product development cycle, including strategic business planning, product development and testing, submissions, product marketing, regulatory compliance and enforcement, advertisement and promotion, and legislative branch lobbying at both the federal and state levels. Whether you operate in the food and beverage, drug, dietary supplements, cosmetic, or medical device industry, we have the skills and specialized services needed to serve your FDA-regulated business.
When it comes to reviewing your FDA marketing applications for compliance with FDA regulations, we have the experience you need — especially if you are short on manpower, time, or specific knowledge. During the review process, we work directly with the FDA reviewing divisions to ensure your filings are reviewed in as timely a manner as possible, and that any substantive issues raised by the reviewers are resolved promptly. We also routinely work with and have access to a wide network of consultants (e.g., medical experts, pharmacologists/toxicologists, regulatory chemists, engineers, software experts, and investigators) when the need arises.
We will prepare you for guidance meetings and meetings with FDA advisory committees that are reviewing your applications. In the event the FDA seeks to impose conditions on a marketing approval, the team has experience crafting post-market surveillance studies, labeling revisions, and completing other projects to ensure those conditions are met. We also have significant experience in securing user-fee reductions or waivers.
We regularly represent businesses in FDA compliance and enforcement matters, and are equipped to deal with FDA headquarters’ compliance offices and the regional, district, and resident field offices. Our FDA Regulatory attorneys will guide you through the FDA inspection process. When inspection observations and/or warning letters are issued, we help craft responses and corrective action programs. We can determine the scope of any necessary recall actions, implement requisite recalls, and advise you on field corrections, product modifications, and supplemental labeling, as needed.
If your FDA regulatory compliance and enforcement matters are more complex, we can assist in injunction actions and seizures, and litigate or negotiate consent degrees so you can continue or resume product distribution. In addition to FDA compliance emergencies, we can help you avoid enforcement problems by conducting regulatory and data-integrity audits focused on general circumstances or discrete situations in which you may have potential exposure concerns.
Additionally, we monitor compliance with FDA regulations promulgated pursuant to the Bioterrorism Act, including facility registration, prior notice of imported food and beverage shipments, and records maintenance and inspection; with FDA Hazard Analysis and Critical Control Points programs; and with import/export procedures.
We have extensive experience in U.S. and international policy relating to the regulation and trade of agricultural commodities, food and beverage, textiles, and plant-based pharmaceutical products derived from biotechnology, as well as of other emerging technologies, most notably nanotechnology.
Tracking these controversial issues from their inception, we have an understanding of the regulatory regimes of many major U.S. trading partners worldwide. We also have amassed a vast network of U.S. and international contacts, and have compiled an extensive database of international regulations governing agricultural commodities, food and beverage, and plant-based pharmaceutical products derived from biotechnology, cosmetics, food and beverage packaging, and other products derived from nanotechnology. We can address your issues ranging from advising whether a product containing transgenic materials must be labeled in Peru to recommending how to arrange a transfer of sophisticated transgenic materials to China.
New policy initiatives continue to be proposed regulating food and beverage, agricultural commodities, and pharmaceutical products derived from biotechnology, as well as the fast-growing range of products derived from nanotechnology processes. We will continue to use our knowledge and experience and determine how it directly affects you.
We bring experience in every phase of the regulation of small molecule and biologic/biotech drugs — both prescription and OTC — for your business, including pathway advice (e.g., clinical trials), regulatory and compliance issues relating to bulk and finished prescription and OTC drugs, approvals, advertising, marketing, and distribution. In addition to providing advice relative to FDA and Federal Trade Commission (FTC) implications of these products, we also have substantial experience in counterpart regulatory systems in the EU, Japan, Korea, China, and other markets.
Our product-development and testing capabilities for your business include preparing pre-IND meeting requests, preparing for and leading pre-IND meetings between sponsors and FDA, and resolving issues that may arise in the IND process. FDA team members have specific experience in evaluating drug product formulations for conventional human and animal drugs, and the cell technology in biotechnology-produced drugs. We can assist with your clinical research issues, informed consent matters, and review and approval with IRBs.
With strategies designed to maximize your protection of a product or process idea, we have the experience and the skills to help you make your product a commercial success, including the licensing or sale of IP assets. We also have extensive experience addressing issues that affect generic drugs, including FDA's "Orange Book," patent extension and marketing exclusivity, bioequivalence determinations and related competitive disputes, state formulary matters, and those that can arise with pharmacy and therapeutic committees.
Whether it is human and animal foods, functional foods, beverages, nutraceuticals, or dietary supplements, we have the extensive experience you need for dealing with the FDA, the United States Department of Agriculture (USDA), FTC, and other relevant agencies. Our attorneys can assist you with:
- Reviewing health claims, nutrient content claims, structure-function claims, and dietary guidance statements
- Reviewing nutrition and organic labeling
- Monitoring compliance with USDA and CBP country of origin labeling requirements
- Representing you in FTC proceedings (e.g., advertising claims under the Lanham Act, as well as in proceedings before the National Advertising Division of the Council of Better Business Bureaus)
- Handling food and beverages safety compliance issues, including product recalls, cGMPs, FDA inspection procedures and warning letters, and conducting safety assessments of food and beverage additives and ingredients
- Monitoring compliance with the FDA’s Hazard Analysis and Critical Control Points programs
- Monitoring compliance with the 1994 Dietary Supplement Health and Education Act (DSHEA), including advising you on general labeling and advertising issues, nutrition labeling, and evaluation of permissible claims (e.g., health claims, nutrient content claims, and structure-function claims)
- Monitoring compliance with cGMP guidelines
- Preparing and submitting notifications of new dietary ingredients
We can advise you on pathway issues related to the approval and marketing of direct and indirect food and beverage additives, as well as dietary ingredients for dietary supplements in the United States and a number of major international markets, including the EU, Latin American, and the Asian/Pacific regions. With your end goal as a guideline, our attorneys and scientific staff will collaborate on projects concept to commercialization. In addition, we provide strategic advice on the content and business implications of such relevant initiatives as the EU’s REACH control policy. Other services that may be of interest to your business include:
- Counseling on approval pathways for food and beverage additives
- Obtaining FDA approval for the use of new food and beverage additives
- Preparing and submitting food and beverage additive petitions and notifications establishing that an additive is Generally Recognized as Safe (GRAS)
- Analyzing GRAS status for food and beverage additives
- Counseling on the regulatory compliance of substances used in food and beverage packaging and processing equipment
- Preparing and submitting food and beverage contact notifications
- Analyzing GRAS status for food and beverage packaging materials and components of packaging materials
- Evaluating proposed ingredients for compliance with DSHEA
- Determining whether a proposed dietary ingredient is subject to DSHEA’s new dietary ingredient notification requirements
- Preparing pre-market notifications for new dietary ingredients
- Counseling on dual pathway strategies for dietary ingredient/supplement approval in combination with food and beverage additive or drug approval
If you are appearing before the FDA and its counterpart authorities abroad, we can provide you with counsel on all phases of the product development cycle, including pre-clinical activities, clinical trials, the application process, and the post-market environment. We have experience with the design process and the failure analysis, verification, or validation protocols, as well as the necessary reports needed to produce medical devices. We also have been intricately involved in representing sponsors, public and private institutions, IRBs, clinical research organizations (CROs), site management organizations (SMOs), and principal investigators on a variety of complex matters involving clinical research.
Our attorneys can advise you on device clearance and approval strategies, including 510(k) strategies, product classification, and reclassification. We also offer counseling on IDE requirements, clinical trial issues, and humanitarian device requirements. To help you reach patients as quickly as possible, we can develop regulatory strategies such as fast track, accelerated approval, and treatment IDEs to bring your new products to market. We can provide counsel throughout the application process, including leading FDA meetings and appeals.