FDA Regulatory

Dykema’s FDA team combines regulatory and legislative experience and understanding our clients’ business needs. Whether it is counseling or bet the company crises, we know our clients' business priorities and products. 

The Dykema team has extensive experience in pharmaceutical, biologic, medical device, food, cosmetics and dietary supplement regulation. We represent our clients in all phases of the product life cycle, from discovery through clinical investigation, premarket review and post-market regulation, including clinical trial compliance, licensing agreements, product clearance, approval and registration, product and ingredient notifications and recalls, inspections, audits, Warning Letters and Citizen Petitions, civil and criminal investigations and litigation, as well as congressional oversight. 

We provide strategic management of complex regulatory and legislative issues, both to establish and maintain compliance with existing laws and regulations, as well as to help our clients build strong reputations and lasting relationships with key decision-makers. We work closely with clients to enhance their understanding of agency decisions and policies while helping them to anticipate and benefit from regulatory and public policy changes. Our practice has built coalitions to advocate on behalf of collective interests and works closely with trade associations and specialty groups to enact legislation and/or reform regulations. 

Our clients include food and dietary supplement companies, ingredient manufacturers, global foodservice operators, financial institutions, medical device manufacturers, pharmaceutical and biotechnology companies, and cosmetic and personal care companies. 

Our team members bring significant experience in Congress and private industry. Our lawyers have worked on Capitol Hill, in regulatory agencies and in industry trade associations. Our practice is fully integrated with our other Firm practice areas, such as corporate, IP advertising, product liability, litigation, government relations and other disciplines. Our objective is to bring the right solutions for the issues and challenges that confront our clients. 

Areas of Focus 

Pharmaceuticals and Biologics 

Dykema represents pharmaceutical and biologics clients in approvals, compliance with post-market requirements. Our team includes attorneys and other professionals who have decades of experience in government service and the private sector, as well as concentrated backgrounds in science, regulation, and public policy. We have experience managing international inspections undertaken by the FDA of pharmaceuticals as well as active pharmaceutical ingredients. 

We assist clients in managing compliance with diverse post-market surveillance, establishment registration, labeling and product listing requirements. Our experience includes litigation in industry vs. industry lawsuits as well as in cases brought under the Administrative Procedures Act (APA). 

Our cross-disciplinary focus enables us to help our clients maintain consistent positions and to identify and implement the most beneficial overall legal and regulatory strategies. 

Pharmaceutical Representative Matters 

  • Assisted a client in managing FDA inspections of facilities in China 
  • Assisted client in resolving a stalled drug approval 
  • Responded to numerous Warning Letters and Form 483 inspections 
  • Work with clients to resolve Good Manufacturing Practices (GMP) issues 
  • Assisted clients with marketing and advertising issues 
  • Prepared clients for FDA inspections of their facilities as well as Active Pharmaceutical Ingredient (API) facilities 

Medical Devices  

The Firm's regulatory practitioners represent clients in a broad range of matters involving the development and marketing of medical devices. Our deep understanding both of the industry and the regulatory environment allows us to work with clients toward the conception and implementation of the most appropriate regulatory pathway.  

We are involved with providing a broad range guidance for medical devices, including clearances of and approvals for 510(k)s, de novo submissions and PMAs, as well as Humanitarian Device Exemptions (HOE). Our lawyers have worked closely with leading diagnostic companies and investors to assure appropriate and flexible regulation for breakthrough genetic and molecular diagnostic tests. We also assist with the broad spectrum of post-market compliance, including supplementation, post-market surveillance, establishment registration, product listing, inspections, medical device reporting and recalls. 

We work with our litigation, government strategies and Federal Trade Commission (FTC) colleagues in legislative advocacy as well as advertising disputes, and work with our clients to devise legislative solutions to challenges that are beyond regulatory resolution. 

Medical Devices and Diagnostics Representative Experience 

  • Secured clearances for more than 40 medical devices 
  • Managed more than 30 recalls/market withdrawals and matters that involved significant reputational issues, including one instituted in the wake of a death 
  • Assisted clients in managing post-market enforcement matters 
  • Worked with clients to address advertising issues 
  • Assisted clients in responding to issues involving Good Manufacturing Practices (GMP) 
  • Assisted clients with responses to Warning Letters and Form 483 responses 
  • Assisted clients with Emergency Use Authorization (EUA) applications for COVID-19 uses 
  • Worked with clients on Quality System Regulation (QSR) audits 
  • Prepared clients for FDA inspections 

Food and Dietary Supplements 

Our FDA team represents clients in the food and dietary supplement industries, as well as medical food, food additives, food ingredients and pet food industries. Among the areas with which we assist in compliance are the Dietary Supplement Health Education Act (OSHEA), Food Safety Modernization Act (FSMA), Fair Packaging and Labeling Act (FPLA) and the Bioterrorism Act.  

Our attorneys have extensive experience in government, as well as in-house, in all facets of food and dietary supplement regulation. From product development, product safety, labeling, Generally Regarded as Safe (GRAS) standards, product and facility inspections, promotion and advertising, enforcement, recalls and citizen petitions, we have the experience to help our clients navigate the complexities of the FDA's food provisions. Our lawyers have represented the food industry in most of the major recall events of the past two decades, and have significant experience assisting clients in the development of global regulatory operations and policies.  

We develop strategies to advocate our clients' positions regarding rulemaking and legislation that affects the food and dietary supplement industries. In addition, we represent clients in advertising matters before the FTC, the National Advertising Division of the Council of Better Business Bureaus (NAO) and the State and Federal courts. 

Food and Dietary Supplements Representative Experience 

  • Worked with the FDA, USDA, U.S. Pharmacopeia (USP) concerning ingredient labeling and other compliance issues related to several pharmaceutical products
  • Provide counseling concerning a variety of issues related to product defects, including working with government and business partners to determine whether and how to conduct market withdrawals or recalls or how to safely repurpose product, if possible
  • Advise on FDA regulations for pesticides for imported produce, including resolving the seizure of a large quantity of commodities from North Africa
  • Regularly advise on responses to cGMP violations for vitamins and nutraceuticals
  • Advise on cGMP compliance for food manufacturing and processing plants
  • Managed many of the major national food recalls for one or more affected clients for the past two decades, including melamine in human and pet food, peanut butter, food allergens, lettuce, peppers, tomatoes, meat, poultry and numerous other pathogens, adulterants and other major contamination events 
  • Developed and implemented crisis management, client and media strategies for numerous clients facing food and supplement safety concerns and other crises, including one involving fatalities
  • Successfully removed over 40 companies from Import Alert and successfully released goods detained by the FDA on more than 60 occasions
  • Developed global regulatory programs for 8 different food and dietary supplement companies
  • Drafted/redrafted portions of food and dietary supplement regulations for numerous international governments
  • Managed more than 10 inspections of food facilities in the United States and internationally
  • Assisted clients in preparing responses to nearly 500 inspection reports, Warning Letters and Import Holds
  • Regularly advise financial institutions on developments in the food industry
  • Managed the preparation of more than 40 Citizen Petitions, 75 Generally Regarded as Safe (GRAS) affirmations and 20 Food Additive Petitions
  • Participated in the development and implementation of a strategy that led to securing a health claim from the FDA
  • Counseled on numerous key international food and food ingredient standards, including those for chocolate, juice, pesticide residues, nutrition labeling, and labeling of transgenically produced foods and dietary supplements, among many others 
  • Negotiated with the FDA and Congress regarding major food legislation and rulemaking (e.g., strategy development, negotiation and drafting of comments), such as biotech derived food labeling, partially hydrogenated vegetable oils, bioterrorism legislation and the Food Safety Modernization Act (FSMA) 
  • Developed label and advertising review strategies and worked with teams from several clients for approval of advertising and social media 
  • Negotiated resolutions to FDA and FTC challenges, as well as several consent decrees and other enforcement actions Involving the FDA, FTC and the Department of Justice 
  • Revamped a company’s advertising and social media policies in the wake of an FTC consent decree 
  • Drafted and submitted more than 70 petitions and comment letters to FDA and USDA concerning interim rules, draft guidance and petitions submitted by competitors 

Cosmetics and Over the Counter Drugs 

Dykema is well-versed in advising clients in the cosmetics industry and in the OTC drug industry for monographed OTC drugs on FDA compliance, including product packaging, labeling, and advertising, and identifying and addressing possible safety issues. We provide counseling and representation in all areas of cosmetics and OTC drug regulation, including the distinctions between claims permitted for cosmetics and for OTC drugs, Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and various procedures and policies companies are required to adopt for marketing monographed OTC drugs, and to obtain approval of color additives. 

Our team also counsels on enforcement actions, including customs detentions, responses to Warning Letters, factory inspections responding to 483 and market withdrawals, when necessary. Our team has also assisted in addressing public relations issues arising from negative social media and consumer product reviews as well as counterfeiting issues for both cosmetics and OTC drug products, which we coordinate with our IP Practice Group. We also assist in obtaining registration and listings for OTC manufacturing facilities and OTC products. 

Our team regularly counsels clients on all areas of advertising, marketing and promotion, claim substantiation, compliance with the Federal Trade Commission Act (FTC) and state false advertising statutes. We represent clients in advertising challenges before the FTC and the National Advertising Division of the Better Business Bureaus (NAD) and in consumer class actions. We also represent clients in Lanham Act Section 43(a) litigation involving false and deceptive advertising and unfair competition matters, as well as litigation arising under state unfair competition and false adverting laws. 

Our team has experience in both government and industry, serving as senior in-house attorneys in pharmaceutical, medical device and cosmetic companies in several major international corporations. We have successfully defended clients in regulatory proceedings before the FDA and FTC, as well as in advertising challenges before the NAO, ERSP and the FTC, in addition to Federal Lanham Act litigation. We have assisted in structuring business transactions involving regulated products and industries, including corporate acquisitions and divestitures, public offerings, joint ventures and distribution agreements. 

Cosmetic and Personal Care Representative Matters 

  • Assisted clients in identifying potentially violative ingredients 
  • Assisted clients in responding to Warning Letters 
  • Worked with clients on advertising matters before the Consumer Protection Bureau of the Federal Trade Commission 
  • Represented clients on advertising issues before the National Advertising Division of the Better Business Bureaus (NAD) 
  • Assisted litigators in defending consumer class actions 

USDA  

Dykema has experience before the USDA and its many departments, including the Animal Plan Health Inspection Service (APHIS), Food and Nutrition Service (FNS), Food Safety and Inspection Service (FSIS) and the National Organic Program (NOP). 

Specifically, we advise clients on nutrition and labeling, meat and poultry safety and labeling perishable products, animal feed, organic agriculture, transgenic crops, plant pests, animal welfare, various permitting questions, product development and recalls.  

Our practice involves day-to-day compliance issues, administrative proceedings and litigation, as well as advertising issues involving FTC and NAO. 

USDA Representative Matters 

  • Assisted numerous companies in securing label approvals 
  • Represented industry before key international standard setting organizations 
  • Assisted more than 30 companies in managing recalls 
  • Advised clients on compliance with the Food Safety Modernization Act 
  • Advised clients on compliance with Hazard Analysis Critic al Control Points (HACCP) regulations 
  • Assisted clients with responses to USDA Warning Letters 
  • Worked with clients to address food safety issues 
  • Assisted clients on compliance with organic regulations 

Cannabis  

We advise clients throughout the process on various regulatory agencies, such as the FDA, DEA and FTC for the advertising, distribution and sale of cannabis and cannabis-containing products. This includes FDA regulatory Issues presented by manufacturing, using and selling product solely made of cannabis or Its derivatives, as well as product that contains cannabis or its derivatives, such as CBD, which may be a derivative of the industrial hemp cultivar of cannabis, which is now no longer covered by the Controlled Substances Act under the Farm Bill of 2018. 

Cannabis Representative Matters 

  • Developed 50 state survey of cannabis laws and regulations 
  • Advised three major cannabis product sellers on advertising regulations governing their products 
  • Assisted in developing position papers addressing prospective legislative and regulatory changes to state cannabis laws 
  • Advised clients on progress of legislative and regulatory developments concerning cannabis 

Events & Speaking Engagements