Agriculture

At OFW Law, we have daily contact with agencies throughout the U.S. Department of Agriculture. Our attorneys and Senior Policy Advisors have worked with officials in, and have themselves served at, the highest levels of the Department. Moreover, they… Read More

Forestry & Natural Resources

OFW Law Attorneys and Senior Policy Advisors (SPA’s) have extensive background and experience in forest management, particularly public lands management and Forest Service issues. Members of the OFW team have been involved in Forest Service issues… Read More
Professionals: Peter B. Matz

Risk Management & Crop Insurance

Protecting crops, livestock, and business with appropriate risk management tools is crucial today for farmers and agribusiness alike, and OFW attorneys are active in all aspects of the Federal crop insurance program under the USDA Federal Crop Insura… Read More

Trade Association & Coalition Counsel

For many years, OFW Law’s attorneys have served as counsel to trade associations and coalitions whose members are regulated by the U.S. Department of Agriculture (USDA) and other agencies. We provide a full range of services to our trade associatio… Read More

USDA Agricultural Marketing

Professionals: Peter B. Matz

USDA Animal and Plant Health

USDA Counsel & Due Diligence

OFW Law’s agriculture attorneys are an important resource for other law firms, investment bankers, venture capitalists, accountants, and other professionals engaged in matters requiring expertise in U.S. Department of Agriculture law and regulatio… Read More

USDA Food Assistance Programs

The domestic and international food assistance programs operated by the Food and Nutrition Service (FNS), the Foreign Agricultural Service (FAS), and the US Agency for International Development (USAID) offer a wide range of business opportunities for… Read More

USDA Food Safety & Labeling

OFW Law attorneys and Senior Policy Advisors are uniquely positioned to assist meat, poultry and egg product establishments in food safety and labeling matters before the USDA’s Food Safety and Inspection Service (FSIS). Our experience and expertis… Read More

USDA Packers & Stockyards

The USDA’s Grain Inspection, Packers and Stockyards Administration (GIPSA) regulates the marketing of livestock, poultry and meat to protect producers and consumers from unfair, unjustly discriminatory and anti-competitive trade practices in violat… Read More

Food & Cosmetics

At OFW Law, our lawyers form attorney-client relationships with members of the conventional food and cosmetic industries to further the client's legal, regulatory, competitive, and other business objectives by employing a variety of available means… Read More

Compliance Matters

OFW Law’s attorneys and advisors counsel food and cosmetic industry clients regarding compliance with a variety of statutory and regulatory requirements, guidance documents, and informal policies, including those governing: Labeling and advertisin… Read More

Due Diligence

OFW Law’s food and cosmetic industry attorneys are an important resource for other law firms, investment bankers, venture capitalists, accountants, and other professionals engaged in matters requiring expertise in laws and regulations governing foo… Read More

Enforcement Matters

While anticipating regulatory challenges will minimize the risk of most potential problems, enforcement matters nevertheless can arise. OFW Law’s attorneys and advisors regularly assist members of the food and cosmetics industries in undertaking or… Read More

Trade Association Counsel

For many years, OFW Law’s attorneys have served as counsel to food and cosmetic industry trade associations, whose members are regulated by FDA and other agencies. We provide a full range of services to our trade association clients and their membe… Read More

Consumer Product Safety

Nothing is more important to a company than the safety of the products it sells. OFW Law's consumer product safety practice understands that, and works with manufacturers, importers, distributers and retailers of all sizes to help ensure that their… Read More

Consumer Product Safety Commission Compliance

OFW Law's consumer product safety practice draws on decades of experience working with the Consumer Product Safety Commission (CPSC) to tackle our clients' most challenging issues. We work with our clients in evaluating product complaints and other… Read More

Food & Consumer Product Safety

OFW Law's extensive experience in the food industry puts our attorneys in a unique position to assist clients with compliance and liability issues related to products regulated by both the Consumer Product Safety Commission (CPSC) and the Food and D… Read More

Product Development, Compliance & Due Diligence

OFW Law works with clients to develop comprehensive programs that help them manage and reduce product liability and regulatory compliance risks. We evaluate products and product designs, warnings, warranties, use and care instructions and advertising… Read More

Safety Standards Development

Product safety standards are often at issue in determining the safety and product liability risks of a product. OFW Law's attorneys are experienced in working with clients before standards organizations such as the American Society of Testing and Ma… Read More

Dietary Supplements

OFW Law represents members of the dietary supplement industry and, by employing both conventional and creative means, helps to protect and advance their legal, regulatory, competitive, and other business interests. Our attorneys and Senior Policy… Read More
Professionals: Bruce A. Silverglade

Compliance Matters

OFW Law professionals counsel clients regarding compliance with a variety of statutory and regulatory requirements, guidance documents, and informal policies of the Food and Drug Administration (FDA), Federal Trade Commission (FTC), and numerous othe… Read More

Enforcement Matters

OFW Law attorneys and advisors regularly assist clients in undertaking or resolving enforcement actions taken with regard to members of the dietary supplement industry by the Food and Drug Administration (FDA), Federal Trade Commission (FTC) and othe… Read More

FDA Counsel & Due Dilligence

OFW Law attorneys and advisors are frequently retained to assist with due diligence evaluations of companies regulated by the Food and Drug Administration (FDA), and to provide advice on contractual language and representations and warranties. We rev… Read More

Legislation & Regulations

At OFW Law, our dietary supplement attorneys and policy experts encourage and facilitate positive interactions between our clients, lawmakers, and regulatory officials on a broad array of policy, compliance, and enforcement matters. Historically, we… Read More
Professionals: Nancy A. Nord, Peter B. Matz

Promotion & Advertising

In addition to assisting with Food and Drug Administration (FDA) compliance and enforcement matters, OFW Law’s attorneys and advisors counsel dietary ingredient and dietary supplement clients on promotion and advertising matters, in both tradit… Read More

Drugs, Biologics & Controlled Substances

OFW Law advises our clients on every aspect of the regulatory process related to bringing a product to market, including: strategic planning and submission of dossiers for approval of New Drug Applications (NDAs), Investigational New Drug submissions… Read More

Controlled Substances

OFW Law’s attorneys have comprehensive experience serving clients involved with the manufacture and distribution of drugs that also are designated controlled substances or listed chemicals. The approval of these drugs falls under a parallel regulat… Read More

Drug Distribution

OFW Law’s representation of clients in the pharmaceutical industry does not stop once a product is on the market. After drugs leave their place of manufacture, they enter a complex distribution chain. Our attorneys are especially knowledgeable abou… Read More

Enforcement & Compliance

Counsel and Representation Before the FDA, Other Agencies, and Federal Courts OFW Law’s attorneys represent pharmaceutical industry clients on the entire range of issues related to marketed products, including labeling, advertising, recordkeeping,… Read More

Generic Drugs/ANDAs and 505(b)(2) NDAs

Advice and Representation for Approval and Market Entry For over 20 years, OFW Law’s attorneys have advised clients on how to bring generic drugs to market under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. We aid client… Read More

Human Cell & Tissue Products

OFW Law’s attorneys have extensive knowledge of FDA's regulatory program for human cell and tissue products (HCT/P). We advise clients on the establishment registration, product listing, donor screening and testing, and current good tissue practic… Read More

IND/NDA/BLA Process

OFW Law’s attorneys assist clients with development, submission, and approval requirements related to the conduct of human clinical research for drugs and biologic products including new chemical entities, well-characterized proteins, and antibodie… Read More

Investment & Due Diligence Support

OFW Law’s attorneys are an important resource for other law firms, investment bankers, venture capitalists, accountants, and companies seeking licensing investment, private placement or public offerings in matters requiring expertise in FDA drug, b… Read More

Marketing & Promotion

OFW Law advises clients on issues involving the marketing and promotion of drug products, including review of promotional materials, sales representative conduct and practices, patient registries, institutional promotion, promotion directed to consum… Read More

Privacy of Personal Health Information

We advise clients regarding the requirements for maintaining the privacy of protected health information, including the applicability of federal and state privacy requirements on pharmaceutical manufacturer-sponsored communications programs that are… Read More

Trade Association Counsel

For many years, OFW Law’s attorneys have served as counsel to trade associations whose members are regulated by FDA, DEA and other federal agencies. We provide a full range of services to our trade association clients and their member companies in… Read More

Employment Law

OFW’s Employment Law Practice Group provides advice and representation to companies, non-profits, trade associations, and employees in all facets of labor and employment law, including before the U.S. Equal Employment Opportunity Commission (“EEO… Read More
Professionals: Elliot Belilos, Stewart D. Fried

Environmental Law

OFW Law’s environmental law practice is one of the most dynamic in the country as it deals with the interplay between modern agriculture and environmental statutes and common law areas such as nuisance and trespass. Our farming, manufacturing and m… Read More

Government Relations

OFW Law has developed a bipartisan practice to address legislative and Government Relations issues for our clients. Composed of a team with senior level experience in the U.S. House and Senate, in the federal executive branch, and in state government… Read More

Health Care Policy

OFW Law’s Health Care & Medical Privacy law practice addresses the myriad legal and regulatory requirements that apply to providers of health care products and services. These range from individual health care practitioners and non-physician health… Read More

Compliance with the Federal Anti-kickback and Beneficiary Inducement Statutes

The federal Anti-Kickback and Beneficiary Inducement Statutes significantly restrict the marketing of pharmaceutical products. We assist our clients in Anti-Kickback- and Beneficiary Inducement-related compliance by evaluating marketing and other bus… Read More

Legislative Advocacy for Health Care & Medical Privacy Clients

OFW Law attorneys often represent Health Care & Medical Privacy clients before Congress, federal agencies, and state legislatures. Read More

Privacy of Protected Health Information

We advise clients regarding the requirements for maintaining the privacy of protected health information, including the applicability of federal and state privacy requirements on pharmaceutical manufacturer-sponsored communications programs that are… Read More

Indian Law

Holding the government to its word requires not only a strong will, but thorough research, a knowledge of treaties, detailed preparation, and an understanding of Indian cultures. At OFW Law, we intervene on behalf of Native American tribes in their i… Read More

International Trade

OFW Law provides advice on all aspects of international trade regulation, including the application of antidumping and countervailing duty laws; the negotiation, implementation and enforcement of trade agreements and treaties; and customs and global… Read More

Canadian Regulatory Affairs

OFW Law maintains a close watch on developments in Canadian regulatory affairs that may impact U.S. based companies, and has been actively engaged in the work of the Canada United States Regulatory Cooperation Council (RCC) in the RCC's efforts to a… Read More

Codex Alimentarius Commission

OFW Law also has detailed knowledge of the workings of the Codex Alimentarius Commission and its specialized committees, including the Codex Committee on Food Import/Export Certification and Inspection; the Codex Committee on Food Labeling; the Codex… Read More

Customs & Border Protection

OFW Law has in-depth experience in the whole range of matters that arise under the jurisdiction of U.S. Customs and Border Protection, including tariff classification and valuation; country-of-origin determinations and marking matters; compliance ass… Read More

Trade Agreements & Treaties

OFW Law closely tracks global events that may affect our clients' interests, including World Trade Organization (WTO) trade negotiations, plurilateral agreements such as those currently being negotiated under TTP and TTIP (Trans Pacific Partnership… Read More

Trade Remedies & ITC Practice

OFW Law actively participates in proceedings brought under U.S. trade remedy laws, including the antidumping and countervailing duty statutes, Sections 201 (safeguards provisions) and 301 (retaliation authority) of the Tariff Act of 1930. We have rep… Read More

Litigation

Individuals and companies under FDA, USDA, and DEA jurisdiction are subject to stringent public health statutes. Violation of these statutes carries the risk of civil liability, as well as criminal liability. At OFW Law, our attorneys represent busin… Read More

Medical Devices

The development, manufacturing, and marketing of a medical device require an in-depth understanding of the Food and Drug Administration (FDA) regulatory process, as well as the ability to interact effectively with FDA personnel. At OFW Law, our attor… Read More

FDA Due Diligence, Transaction & SEC-Related Assistance

OFW Law’s attorneys are an important resource for other law firms, investment bankers, venture capitalists, accountants, and other professionals engaged in matters requiring expertise in FDA medical device law and regulation. Our lawyers are freque… Read More

Medical Device Seminars

Free Attorney Seminars on Medical Device Law and FDA Regulatory Compliance “Interacting and Avoiding Problems with FDA: Common Device Company Pitfalls — How to Avoid Them” | pdf “Interacting and Avoiding Problems with FDA: Common Device Compa… Read More

SNAP/WIC

The U.S. Food and Nutrition Service (“FNS”) is the federal agency with primarily responsibility for administrating the Supplemental Nutrition Assistance Program (SNAP) and the Special Supplemental Nutrition Program for Women, Infants, and Childre… Read More
Professionals: Stewart D. Fried

OSHA

Professionals: Elliot Belilos