Practice Area Overview

Food, Dietary Supplements, and Cosmetics

At Olsson Frank Weeda, our lawyers form attorney-client relationships with members of the food, dietary supplement, and cosmetic industries to further the client's legal, regulatory, competitive, and other business objectives by employing a variety of available means - both conventional and creative. Our attorneys lobby Congress and administrative agencies; write comments and muster coalitions of related interests in rulemakings; counsel on regulatory compliance, enforcement risk, and corrective action; draft notifications, petitions, and other voluntary or mandatory submissions; file complaints against competitors; and otherwise advance and defend client interests before courts, before federal and state enforcement officials, and in the marketplace. The experience and knowledge our lawyers offer are unique. We render timely, effective, and cost-efficient legal advice and services.

Anticipating Potential Legal and Regulatory Challenges

At Olsson Frank Weeda, we help shape the laws that govern the marketing of FDA-regulated products, including:

Conventional foods
Dietary supplements
Medical foods
Infant formula
Cosmetics

Our attorneys were instrumental in the enactment of the Nutrition Labeling and Education Act (NLEA), the Dietary Supplement Health and Education Act (DSHEA), the FDA Modernization Act (FDAMA), the Public Health Security and Bioterrorism Preparedness and Response Act (Bioterrorism Act), the Food Allergen Labeling and Consumer Protection Act (FALCPA), and the FDA Amendments Act. We also have been actively involved in rulemakings to establish regulations implementing these statutes. As a result, we are intimately familiar with the explicit requirements of these laws, as well as the policy nuances underlying them.

Our attorneys believe that, when feasible, anticipating and circumnavigating issues before they become real problems (e.g., enforcement action, business disruption, adverse publicity) is the most prudent approach to addressing regulatory challenges. At Olsson Frank, our attorneys encourage and facilitate positive interactions between clients, lawmakers, and regulatory officials on a broad array of compliance matters. We also prepare clients for handling FDA inspections and conduct due diligence reviews relative to the sale of food, dietary supplement, and cosmetic businesses.

Compliance Matters

Our attorneys counsel clients regarding compliance with a variety of statutory and regulatory requirements, guidance documents, and informal policies, including those governing:

Labeling and advertising claims, including triggered disclaimers
- Nutrient content claims
- Structure/function claims
- Health claims and qualified health claims
- Statements of nutritional support
- Third-party literature
- Cosmetics claims
- Miscellaneous descriptive claims (e.g., "organic," "natural," "fresh," "pasteurized")
Labeling representations
- Statements of identity, including names specified by a statute, standard of identity, or established common or usual name
- Net contents declarations
- Nutrition information (e.g., Nutrition Facts, Supplement Facts), including format, display, and exemptions
- Ingredients listings, including incidental additives
- Major food allergen labeling
- Names and places of business of manufacturers, packers or distributors (a/k/a "signature line")
- Country of origin markings and "Made in USA" representations
- Spices, natural and artificial flavors, colorings, and chemical preservatives
- Percent-juice declarations
- Warning, notice, and safe handling statements
- Irradiation disclosures
- Voluntary nutrition labeling at retail of raw fruit, vegetables, and fish
Product formulation, manufacturing, and packaging
- GRAS (generally recognized as safe) ingredients, including GRAS self-affirmation
- Color additives and food additives, both direct and indirect
- Dietary ingredients, including new dietary ingredients
- Cosmetics ingredients
- Fortification policy
- Current good manufacturing practices (CGMPs)
- Hazard analysis and critical control point (HACCP) systems
- Tamper-resistant packaging
Mandatory and voluntary submissions
- Nutrient content claim, health claim, and qualified health claim petitions
- FDAMA notifications for nutrient content claims and health claims
- Statement of nutritional support (structure/function claim) notifications and new dietary ingredient notifications for dietary supplements
- "Pasteurized" notifications
- Citizen petitions
- Temporary marketing permit applications
- New infant formula notifications and infant formula recall notifications
- Establishment registrations and process filings for acidified food and low-acid food in hermetically sealed containers
- GRAS notifications
- Food additive and color additive petitions
- Food contact substance notifications
- Notices for biotechnology products and bioengineered foods
Bioterrorism Act
- Food facility registration, including acting as U.S. agent for foreign facilities
- Prior notice of food imports
- Recordkeeping and records access
- Administrative detention

Our counseling addresses strict compliance, but we also advise clients regarding enforcement risk and options for mitigating risk in areas where compliance requirements are unclear. Our primary objective is to help clients accomplish their goals while complying with the law.

Enforcement Matters

While anticipating regulatory challenges will minimize the risk of most potential problems, enforcement matters nevertheless can arise. Our attorneys regularly assist clients in undertaking or resolving:

FDA inspections, including responding to Form FDA 483 inspectional observations
Recalls and market withdrawals
Response to warning letters
Corrective actions
Import detentions
Seizures, injunctions, and criminal prosecutions
Complaints by or about competitors

Our attorneys endeavor to minimize the impact of enforcement activity on client businesses, and to maintain a level playing field among industry competitors.

We Are Ready at a Moment’s Notice

Our lawyers represent clients across the country and throughout the world. We understand what it is like when clients face deadlines or unforeseen difficulties. Consequently, we are positioned and ready to immediately act on behalf of a client -- no matter the distance that separates us -- whether by phone, fax, e-mail, or onsite travel -- when compliance or enforcement issues arise.

Focus on Due Diligence Support

Our 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 food, dietary supplements, and cosmetics. Our attorneys are frequently retained to assist with due diligence evaluations of FDA-regulated companies and to provide advice on contractual language and representations and warranties.

Focus on Associations

For many years, we have served as counsel to 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 member companies, including:

Advice to the association's executive committee, board of directors, and staff
Antitrust monitoring of association meetings
Assistance in drafting and filing government documents
Counsel during periods of association transition, changes in leadership, and mergers
Regulatory advice to association staff on applicable federal and state requirements
Legal support to the association's government affairs and legislative initiatives

Publications

Olsson Frank Weeda attorneys have authored a number of publications for The Food Institute on compliance and enforcement matters. We also collaborate on seminars addressing regulatory matters.

What's New

Olsson Frank attorneys have drafted memoranda on the following recent developments. Please contact us if you are interested in obtaining a memorandum.