Regulatory Law

Brownson Norby 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
  • Tobacco Products

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 Norby 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 budget is imperative.  Clients trust Brownson Norby 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.

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Regulatory Law Summary

Brownson • Norby, PLLC’s annual Regulatory Law summary is useful to businesses seeking legal assistance in compliance and dispute resolution with federal, state, and local agencies –Updated for 2018

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FDA and CBD

Earlier this month, on April 9, 2018, FDA published a notice requesting comments from the public on the scheduling of cannabis-related substances ("Cannabis Plant and Resin; Extracts and Tinctures of Cannabis; Delta-9-Tetrahydrocannabinol; Stereoisomers of Tetrahydrocannabinol; Cannabidiol"). See here: FDA Request for Comments. As of today, April 20, 2018--a renowned cannabis holiday--nearly 6,ooo comments have been posted. The deadline to submit comments Continue Reading

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FDA Revises Ingredient Listing Guidance Ahead of Looming Deadline

FDA has released another revision to Ingredient Listing Guidance (found here), which clarifies some longstanding issues surrounding the listing requirements (previously created for traditional tobacco products) as applied to ENDS products. The first major point addressed in the new guidance is clarifying those items for which an ingredient listing entry is required. Under the previous guidances, manufacturers were required to Continue Reading

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Indiana and CBD – A Legislative Story for the Ages

On Wednesday, March 21, 2018, Indiana Governor Eric Holcomb signed into law Senate Bill 52, which legalized CBD oil (having .3 or less THC content) for all. This comes after a turbulent set of months, which kicked off in November 2017 after the State Attorney General issued an opinion that under the applicable law (HEA 1148) CBD oil was only legal Continue Reading

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FDA Brings Nutrition Labels into the (Health-Focused) 21st Century

Today, March 1, 2018, FDA issued a statement regarding the revamped nutrition label requirements. In this modern age, where fitness and nutrition have become a larger focus in many peoples lives (see the cult-like phenomena: CrossFit, Soul Cycle, Whole 30, Clean Eating, Paleo, Keto, etc.), there has been push for more information about what exactly we are eating. Well, all Continue Reading

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Brownson • Norby Submits Comments to FDA Regarding Deeming Rule

This month, Brownson • Norby, PLLC’s Regulatory Practice Group submitted two comments relative to FDA’s regulation Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 21 CFR Parts Continue Reading

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FDA Publishes Goals for 2018 – See What is in Store for the Tobacco Industry

Today, December 14, 2017, FDA published a summary of its "major policy goals for 2018." Since the administration change, and since the addition Scott Gottlieb as FDA commissioner, in 2017, regulated agencies have seen a change in the direction of regulatory reform. This is due in part to the reinvigoration of the Congressional Review Act, but also can be attributed Continue Reading

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FDA Postpones Upcoming Deadlines for those in “Natural Disaster Areas”

Today, October 18, 2017, FDA updated its compliance deadlines to reflect a new extension for those manufacturers and importers "affected by recent natural disasters"--a list of such areas is provided on here.  The deadline for those in the designated areas has been moved out six months: The deadline for submission of the ingredient listing for those in the designated areas has Continue Reading

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New Rules for Retailers Accepting SNAP Benefits

At the end of 2016, the USDA published a final rule entitled “Enhancing Retailer Standards in the Supplemental Nutrition Assistance Program (SNAP).” See Federal Register This rule is aimed at “support[ing] healthy lifestyles for SNAP recipients”. Those retailers currently accepting SNAP benefits must adhere to the new requirements—the first of which goes into effect Monday, October 16, 2017—in order to continue accepting Continue Reading

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More Updates to the Deeming Rule Guidance – Free Samples

Today, October 11, 2017, FDA published an updated version of its "Prohibition of Distributing Free Samples of Tobacco Products" guidance, which, sets its restrictions on free samples apart from many of its other rules and requirements by extending the prohibition to components and parts. (note, in many of its recent guidances, FDA has stated an intention not to extend enforcement of Continue Reading

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FDA Deeming Rule Update

The past few weeks have seen some activity at FDA relating to the Deeming Rule, which is of particular interest given the looming deadlines for submitting the Establishment Registration and Product Listing (9/30/2017) and the Ingredient Listing (11/8/2017). Of note is that FDA is seeking industry insights and participation, presumably in an effort to better inform FDA on the ENDS Continue Reading

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FDA Publishes Revised Compliance Deadline Guidance Following Recent Pushback of PMTA Deadline

The current Deeming Rule deadlines for ENDS products that were on the market August 8, 2016 or prior are as follows: November 8, 2017 - Deadline to submit ingredient listing Deadline to remove modified risk statements from packages (e.g. "low", "light", "mild", etc.)   August 10, 2018 - Packaging requirements: Manufacturers and retailers must ensure their product packages and ads Continue Reading

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Minneapolis Bans Menthol

On August 2, 2017, the Public Health Advisory Committee—a subcommittee of the Minneapolis City Council—approved an amendment to the 2015 Minneapolis ordinance that would restrict sales of all flavored tobacco products—notably, to now include menthol, mint and wintergreen tobacco products—to “tobacco product shops”. According to the committee, the amendment is necessary to “help dissuade young people from smoking and to Continue Reading

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FDA Publishes New Compliance Deadline Chart

FDA has published its new compliance deadline chart, which sets forth the various new deadlines and to which entities such deadlines apply. The chart can be found here: FDA New Compliance Deadline Chart It further notes a clarification that: Retailers that mix and prepare e-liquids or create or modify vaporizers will be regulated as both retailers and manufacturers. Importers of tobacco Continue Reading

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It’s Official, FDA Has Postponed Deeming Rule Deadlines

Last week FDA released a statement regarding its intent to postpone the forthcoming Deeming Rule deadlines for the ENDS community. Today, FDA updated its website to reflect these new deadlines: You can find the FDA statement here: FDA Web Statement

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US Representative Hunter Introduces Bill That Could Mean Big Changes for the ENDS Industry

Today, US Representative Duncan Hunter (R-CA) introduced the "Cigarette Smoking Reduction and Electronic Vapor Alternatives Act". The Act provides various standards for vaping devices and e-liquid products, but most significantly, the Act would remove these devices from the current FDA deeming regulation designed for traditional tobacco products.  If bill becomes law as it currently reads, then some or all of the Continue Reading

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The Dormant Commerce Clause — Not Just for Civil Procedure Final Exams

On Monday, January 30, 2017, the Seventh Circuit held unconstitutional certain parts of an Indiana law which regulated the manufacture of e-liquids sold in the State. Of the law, the court noted "[w]hat is remarkable, however, is the Act’s extensive regulation beyond the manufacture and sale of e-liquid solutions in Indiana." Consequently, because the reach of the law went so Continue Reading

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FDA Final Rule: Is it a Drug/Device or a Tobacco Product?

FDA published its final rule clarifying what it considers to be the distinction between tobacco products, and products derived from tobacco that constitute a drug or device. This distinction is important because FDA has separate requirements and standards to which entities must adhere depending on whether they manufacture or sell tobacco products or they manufacture and sell drugs or devices. That said, Continue Reading

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February Deadline to Submit Health Documents Still Looms for Newly Deemed Products

While FDA has postponed the deadline to submit Ingredient Listings from February 8, 2017 to June 2017, it has yet to act with regard to the Health Document Submissions requirement. That said, February 8, 2017 remains a critical date for manufacturers and importers of newly deemed tobacco products. The guidance provided by FDA provides that for this submission, FDA seeks Continue Reading

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FDA Postpones Deadline for ENDS Ingredient Listing Submission

In a recent revision to the guidance on Ingredient Listings, FDA has postponed the deadline for the Ingredient Listing--which was previously due on February 8, 2017. However, FDA recognizes that some manufacturers of newly deemed products are not familiar with the forms for listing ingredients and, therefore, may need additional time to complete them accurately. In addition, we are aware Continue Reading

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FDA Pushes Back First Major Deadline for E-Cigarette Industry

Today, December 9, 2016, FDA sent out a notification that the deadline for domestic manufacturers to submit Establishment Registration and Product Listing has been pushed back from December 31, 2016 and are now due June 30, 2017. This change has been formally noted in Revised Guidance published in November. See here for Revised Guidance "The guidance has been revised again to Continue Reading

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Attorney Lindsey Streicher to Attend Conference in D.C. on the New FDA Deeming Rule

On October 26, 2016, attorney Lindsey Streicher will attend the Food and Drug Law Institute's Introduction to Tobacco Law and Regulation: How FDA Regulates the Tobacco Industry conference in Washington D.C. Topics covered will include the new FDA deeming rule concerning ENDS products (e.g. e-cigarettes, vapor pens, etc.). For more information, please email Lindsey (LStreicher@brownsonnorby.com)

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