Regulatory Law

Experience

Brownson PLLC attorneys have considerable experience helping businesses navigate the dynamic field of regulatory and administrative law.  We provide our clients with timely and unambiguous answers to difficult questions.  We track changes in the law and work directly with companies to facilitate compliance.  We represent companies in federal and state administrative forums when disputes arise.

We work hard to help create value and competitive advantage for our business clients by anticipating, tracking, coordinating and resolving compliance issues in many areas including:

  • Consumer Products
  • Occupational Safety and Health
  • Professional Licensure
  • Dietary Supplements
  • Liquid Tobacco Products and CBD Oil

Lawyers at the firm have substantial experience for clients in Minnesota, North Dakota, Wisconsin, and Colorado, among other locations, in areas of Regulatory Law across the nation involving:

  • Regulatory compliance and subpoenas in Indiana, New York and California,
  • Regulatory Comments to the Federal Drug Administration (FDA) concerning International Drug Scheduling, Tobacco Products Regulatory and Information Collection Requests, Nicotine Warnings and Packaging for Nicotine-containing E-liquids,
  • Counseling start-up businesses concerning regulatory requirements for CBD oil,
  • Litigation involving dietary supplements, Occupational Safety & Health Administration (OSHA) violations and compliance, and smokeless tobacco.

We take pride in maintaining up-to-date knowledge about the regulatory and administrative issues that matter most to our clients.  Our goal is to help businesses stay informed and compliant within standard industry requirements and practice.  We regularly update both our blog and our Twitter account as important changes happen.

Business clients expect prompt and clear answers to legal questions.  Brownson PLLC brings the skill and depth to provide answers ranging from the origin and evolution of historical factors and public policies weighing on the regulatory state to the very latest iteration of what must be done and when.  These skills and experience allow us to advise, negotiate and advocate for clients in many niche areas that fall under the regulatory and administrative law umbrella.

Winning is important – winning within a budget is imperative.  Clients trust Brownson PLLC to provide early and realistic evaluations of disputed matters, to plan and stick to a reasonable budget, and then to execute while keeping the client well advised of important milestones.  We have successfully advocated company and industry positions in state and federal rulemaking procedures, administrative disputes, attorney general investigations and agency appeals.  We have engaged with administrators and counsel representing OSHA, FDA, EPA, DOJ and DEA, as well as state-level regulatory authorities overseeing:

  • Product Compliance (Manufacturing and Retail)
  • Detentions and Seizures
  • Citations and Appeals
  • Environmental Claims and Abatement

We expect to earn your trust and reliance by understanding your business, by staying well-informed, and by responding to your calls and messages with clear answers and recommendations.

Representative Matters

Representative Cases

  • V.Z. USA Nutrition, Inc. v. United Naturals, Inc., Zag Global, Inc. and Steven Curtis Holfeld a/k/a Steve Curtis (N.D. Ill.)  3:15-cv-50263 (2017).
  • In the Matter of: Four Star Ag, LLP (OSHA 2017).
  • Secretary of Labor v. Larson Grain Company (OSHA 2016).
  • In the Matter of FDA Detention Order 1130 (2015).
  • In Re: Asbestos Products Liability Litigation (MDL 875) (E.D. Pa).
  • In re Ephedra Product Liability Litigation 314 F.Supp.2d 1373 (J. P. N. L. 2004).
  • NVE Inc. v. Dept. of Health & Human Servs., 436 F.3d 182, 186 (3d Cir. 2006).
  • Tuttle v. Lorillard Tobacco Co., 377 F.3d 917 (8th Cir. 2004).

Regulatory Compliance and Subpoenas

  • Indiana E-Liquid Statute and Regulations – (compliance).
  • California Proposition 65 – (product warnings).
  • California Attorney General – (age verification).
  • New York Attorney General – (child safety packaging).

Regulatory Comments

  • Docket No. FDA-2018-N-1072 for “International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Cannabis Plant and Resin; Extracts and Tinctures of Cannabis; Delta-9-Tetrahydrocannabinol (THC); Stereoisomers of THC; Cannabidiol.”
  • Docket No. FDA-2017-N-5095 for “Existing Center for Tobacco Products Regulatory & Information Collection Requirements.”
  • Docket No. FDA-2015-N-1514, RIN 0910-AH24 for “Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products.”
  • Docket No. FDA-2014-N-0189, RIN 091 O-AG38 for “Deeming Products to be Subject to the Federal Food, Drug, and Cosmetic Act as Amended by the Family Smoking Prevention and Tobacco Control Act.”
  • Docket No. FDA-2015-N-1514, RIN 0910-AH24 for “Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products.”

Recognition

Memberships

  • Defense Research Institute (DRI)
  • MSBA’s Food, Drug & Device Law Section