About Us

Kilpatrick Townsend’s Food, Drug, Medical Device, and Cosmetics Practice

Increasing governmental regulation and enforcement by the U.S. Food and Drug Administration (FDA) has created new challenges, as well as opportunities for innovation for companies in the food, drug, cosmetics, and medical device industries. We understand the complexities of these challenges and offer clients strategic solutions to help them navigate the regulatory landscape throughout the life cycle of their products – from development to marketing. Providing effective and efficient legal services to FDA-regulated companies requires a multidisciplinary integrated approach, including assisting the firm’s clients with Federal Trade Commission (FTC), Consumer Product Safety Commission (CPSC), and National Advertising Division (NAD) related matters.

Our clients include companies dealing with food, medical devices, pharmaceuticals, over-the-counter (OTC) drugs (including homeopathic medicines), dietary supplements and cosmetic products. We counsel them in developing effective market entry regulatory strategies and navigating the numerous FDA requirements for their products. We also assist clients with compliance, enforcement and congressional matters, as well as corporate due diligence in acquisitions, sales, or mergers of FDA-regulated entities or products.

Areas of specific expertise include:

Drugs & Biologics

  • Pharmaceutical and Biologic Investigational New Drugs (IND), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Biologics License Applications (BLAs) submissions, Biosimilar submissions.
  • Prescription drug promotion and advertising, patent and exclusivity matters, including Orange Book listings.
  • OTC and homeopathic drug labeling and advertising, including review of monograph ingredients and claims, as well as assessment of FDA and FTC enforcement risk for these products.
  • Registration, listing, and adverse event reporting.
  • Cellular, Tissue, and Tissue Products (human and veterinary) regulatory requirements.

Medical Devices

  • Medical device classifications, 510(k) notifications, IDEs, and premarket approvals (PMAs).
  • Medical mobile applications (MMAs), Telemedicine, and medical device software.
  • Registration, listing, and adverse event reporting.
  • Management of Cybersecurity in Medical Device.

Foods & Dietary Supplements

  • Labeling of Foods, beverages, and medical foods, including claims and ingredients.
  • Dietary supplements ingredients, labeling, and packaging, as well as advertising and claim substantiation.
  • New Dietary Ingredients (NDIs).
  • Compliance with dietary supplement Good Manufacturing Practices (GMPs).
  • GRAS Notifications, food additive and food contact materials submissions.
  • Natural, organic and gluten-free claims.

Cosmetics & Personal Care Products

  • State regulation of product ingredients, advertising and other claims (e.g., Proposition 65).
  • FDA Ingredient and claims review, labeling and advertising.

Enforcement, Imports and Inspections

  • FDA Form 483 and Warning letters responses.
  • Product recalls and market withdrawals.
  • Import and export of FDA-regulated products.