Boulder Food, Drug & Device LLC

FDA doesn't have to be complicated.

With almost twenty years of experience in food and drug law, let us help you.

Boulder Food, Drug & Device LLC
FDA, National

Areas of Food and Drug Assistance

Advertising and Promotion

We help you design and review your marketing, label, and labeling strategies to ensure compliance with FDA and FTC statutes and regulations.  Products covered include:

  • Foods (human and animal)
  • Drugs (human and animal)
  • Medical devices
  • Cosmetics
  • Dietary supplements.


With experience in food, dietary supplement, animal product, medical device, and drug recalls, we can help you determine whether your products must be removed from the market.  Almost all of our clients are familiar with the recall classification scheme (I, II, and III), but there may be other options such as:

  • Stock recovery
  • Market withdrawal

We can assist you with initiating, managing, and terminating market action and help you work with FDA.


Sometimes companies realize too late that they may be in violation of the Food, Drug, and Cosmetic Act and turn to us for advice and representation.  Actions taken by FDA include:

  • Warning letters
  • 483s
  • Seizures
  • Injunctions
  • Import holds
  • Debarment proceedings

Clinical trials

Our work includes advising sponsors, investigators, facilities, and CROs on compliance and contractual matters for clinical trials. We can also help our clients develop essential clinical trial documentation such as informed consent documents and investigator disclosures.  In rare cases, sponsors and investigators find their trials subject to clinical holds and need representation to help them get things moving again.

Product Development and Manufacturing

We help clients bring new medical device, food, dietary supplement, OTC drug, additive, new dietary ingredient, homeopathic, cosmetic, and animal products to market.  Often this can involve:

  • Determining whether and which pre-market submissions are required
  • Assessing compliance with good manufacturing practice requirements
  • Establishing and maintaining adequate documentation to address FSMA or QSR obligations
  • Deciding how best to structure manufacturing, supply, distrbution, and technical services agreements.

We are ready to help you.
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FDA Lawyer

About Boulder Food, Drug & Device LLC

Boulder Food, Drug and Device specializes in only one type of legal work:  Advising and representing companies working with FDA-regulated products and services.  Whether a client is a single-person startup, a foreign company looking to enter the US market for the first time, or an international corporation, our mission is to address clients' legal needs speedily and efficiently.  BoulderFDD provides professional, legal services as an alternative to unlicensed regulatory consultants or firms located in the high-cost east and west coast markets.

FDA Legal Team

Meet the team

Jason moved to Colorado almost 15 years ago, leaving FDA to work in the private sector.  He graduated from Michigan Law School (1994) and also holds an MPH from Johns Hopkins (2003).  Over his 30 year career he has worked for rural farmers, startups, small businesses, state and federal agencies, and domestic and foreign corporations.  While he has been in large, multi-national law firms, he is happiest working cost effectively with his clients on targeted engagements in a more personal setting.  He lives outside of Denver, Colorado.

Jason Sapsin


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