Increased federal and state restrictions and regulations on industries that produce, distribute, import or export dietary supplements, foods, drugs, medical devices and cosmetics are a matter of concern to everyone doing business within those industries. Future Food and Drug Administration (FDA) and California Department of Health Services (DHS) regulation and enforcement will only create more difficulty for affected companies.

Our firm is dedicated to helping drug, supplement, food, cosmetic and medical device companies navigate the complex regulatory landscape. W. Patrick Noonan P.C. represents companies who need assistance not only with the FDA and DHS, but also with the Drug Enforcement Administration, Federal Trade Commission, and Consumer Products Safety Commission. Visit our State Regulation section to learn more about our expertise in interfacing with California administrative and enforcement agencies. In addition, the firm is experienced in assisting clients in civil litigation in federal and state courts.

Click on the Practice Area of your choice to learn more about our specific expertise:

Pharmaceuticals
Dietary Supplements & Foods
Medical Devices
Cosmetics

W. Patrick Noonan P.C. provides counsel and assistance to companies and individuals involved in all areas of both the California Food and Drug Branch and FDA regulation of prescription and over-the-counter (OTC) drugs.

The firm assists clients with NDA/ANDA product approvals and investigational new drug ("IND") applications.

We have broad experience in legal issues concerning FDA and state regulation of manufactured drug products including: inspections, adverse drug reports, recalls, warning letters, labeling requirements, compliance with drug good manufacturing, Prescription Drug Marketing Act, drug master files, import and export issues including import detentions and submission of FDA 766 relabeling applications, OTC monograph requirements and prescription and OTC drug listing requirements. We can further assist clients with the promotion and marketing of drug products.

W. Patrick Noonan P.C. has also assisted companies in complying with the requirements of the Drug Enforcement Administration (DEA) concerning the manufacturing, distribution, importing and exporting of controlled substances and listed chemicals and certain machines subject to the Chemical Diversion and Trafficking Act of 1988.

The W. Patrick Noonan P.C. practice includes advising and assisting individuals and companies manufacturing and marketing conventional foods and beverages, medical foods, dietary supplements, functional foods, food and color additives, new dietary ingredients in meeting both FDA and state regulatory requirements for these products and components.

LABELING, INGREDIENTS AND ENFORCEMENT

W. Patrick Noonan P.C. provides assistance and counsel to clients in meeting the legal requirements for:

• Health claims for foods and dietary supplements
• Nutritional labeling requirements for foods and dietary supplements
• Nutrient Content claims for foods and dietary supplements
• Third Party Literature provisions for dietary supplements
• Website content and claims review
• Statements of nutritional support and other label and labeling requirements for dietary supplements
• Import and export requirements for foods and dietary supplements
• 75 day Notification for new dietary ingredients used for dietary supplements
• Self Affirmation of GRAS status for ingredients and GRAS notifications
• Low Acid Can Food regulatory filings

The firm can assist clients in preparing for food good manufacturing practice ("GMP") inspections, responding to warning letters, dietary supplement courtesy letters and assisting in the defense of FDA enforcement actions.

PROMOTION AND ADVERTISING.

We assist clients in meeting the advertising substantiation requirements of the Federal Trade Commission for foods and dietary supplements, and we also represent companies in proceeding before the National Advertising Division of the Better Business Bureau.

The firm provides counsel to medical device companies in understanding the obtaining compliance with FDA's regulation of medical device product approval, manufacturing and marketing.

W. Patrick Noonan P.C. assists clients in product approval issues including investigational device exemption (IDE) requirements, clinical studies and Section 510K premarket notification.

We also provide counsel on FDA regulation of marketed products including: inspections, FDA 483's, warning letters, recalls, quality system regulations (QSR) medical device reporting (MDR's) and other FDA regulatory actions.

In the area of cosmetics, our firm provides counsel and advice to many companies involved in the importing, manufacturing, distribution and sale of cosmetic products. This counsel includes advice on the colors and ingredients in product formulations, labeling claims, advertising and marketing programs.

The firm also provides assistance to California companies requiring export certificates for sale of product in the international market.

W. Patrick Noonan P.C. has been extensively involved in the formation and continued success of the Beauty Industry West organization.