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Regulatory Strategy & Compliance

headshot of amber duncan, williams mullen partner
aduncan@williamsmullen.com
EMAIL

Regulation influences every stage of a company’s operations—product development, market entry, marketing, distribution, pricing, and long‑term growth. Our team partners with clients to anticipate regulatory demands, manage multi‑agency oversight, and translate regulatory complexity into predictable, commercially practical strategies. We deliver integrated counsel grounded in deep industry experience and the resources of a full‑service firm.

Deep Agency Insight

Many of our attorneys have served within federal and state agencies, giving clients rare visibility into how regulators prioritize issues, interpret guidance, and approach enforcement. That perspective helps us position submissions, shape advocacy, and limit risk before issues escalate. We regularly advise on matters involving:

  • Federal Trade Commission (FTC)
  • Food and Drug Administration (FDA)
  • Alcohol and Tobacco Tax and Trade Bureau (TTB)
  • Bureau of Alcohol, Tobacco, Firearms & Explosives (ATF)
  • Drug Enforcement Administration (DEA)
  • Consumer Financial Protection Bureau (CFPB)
  • Consumer Product Safety Commission (CPSC)
  • State Attorneys General
  • State Alcohol Beverage Control (ABC) agencies
  • State Departments of Revenue & Taxation
  • Local health, zoning, and permit authorities

Industries We Serve

Our work spans highly regulated and consumer‑facing industries, and we counsel clients across the full supply chain — manufacturers, importers, wholesalers/distributors, and retailers, including e‑commerce and direct-to-consumer (DTC) platforms. Key sectors include:

  • Tobacco, nicotine, vapor & modern oral products
  • Alcoholic beverages
  • Consumer products
  • Firearms & outdoor products
  • Retail, e‑commerce & direct‑to‑consumer businesses
  • Hospitality, venues & experiential marketing environments
  • Health, wellness & lifestyle product companies
  • Marketing, media & digital‑platform driven brands

Full Lifecycle Regulatory Support

We support clients from initial market entry through compliance, audits, investigations, and enforcement.

Permitting, Licensing & Approvals

We secure and maintain federal and state permits, licenses, certifications, registrations, facility approvals, and location‑specific approvals. For multi‑state footprints, we build repeatable filing playbooks and calendars that prevent delays and keep operations compliant.

Compliance Programs & Risk Management

We design or enhance compliance structures—SOPs, training, internal controls, audit frameworks, documentation, and testing protocols tailored to withstand regulatory scrutiny.

Agency Engagement & Submissions

Our team prepares rulemaking comments, advisory‑opinion requests, voluntary disclosures, petitions, data submissions, labeling reviews, and facility‑level materials presented to federal and state regulators.

Investigations, Enforcement & Administrative Litigation

We represent clients in civil investigative demands, AG inquiries, agency enforcement actions, and administrative appeals before commissions, boards, and regulators. Our focus is early issue‑spotting, strategic positioning, and minimizing operational and reputational disruption.

Specialized Regulatory Capabilities

Advertising & Marketing Compliance

We help brands develop and launch compliant campaigns across every channel—digital, social, mobile, retail, experiential, and creator‑driven. Our work includes:

  • Claim review, substantiation, and disclosure compliance
  • FTC, FDA, TTB, and state consumer‑protection alignment
  • Social‑media, influencer, and UGC compliance
  • Advertising clearance and comparative claims
  • Brand safety, content‑moderation protocols, and online review management

Our work integrates seamlessly with the firm’s Advertising, Marketing & Media practice, which Amber Duncan co‑chairs, offering clients a full suite of brand‑protection and digital‑media capabilities.

Promotions, Sweepstakes & Pricing

We handle the full lifecycle of promotions—from concept to prize fulfillment—across all 50 states:

  • Drafting official rules and promotional materials
  • Structuring sweepstakes, contests, giveaways, loyalty programs, and on‑site activations
  • Managing state bonding and registration
  • Ensuring compliant, channel-appropriate disclosures
  • Advising on pricing accuracy, reference pricing, coupons, gift cards, and loyalty programs

Product Labeling, Claims & Substantiation

We review labels, packaging, and claims for consumer products, ensuring alignment with:

  • FDA labeling and claims
  • TTB formula and label review
  • FTC claim‑substantiation standards
  • State‑specific warnings, disclosures, and placement rules
  • Responsible marketing standards for age restricted products

We build claim matrices, testing protocols, and internal playbooks that help in‑house teams maintain consistency and defensibility.

Influencer, Social & Creator Programs

We design and operationalize influencer and creator programs that comply with:

  • FTC Endorsement Guides
  • Platform‑specific rules (Meta, TikTok, YouTube, etc.)
  • State consumer‑protection requirements
  • AI‑generated content restrictions and disclosure requirements

We prepare influencer agreement templates, brand‑use guidelines, approval workflows, content‑rights structures, and monitoring processes—making large‑scale programs manageable.

E‑Commerce & Direct‑to‑Consumer Compliance

We advise DTC businesses and marketplace operators on:

  • Licensing, tax, shipping, reporting, and delivery‑sales requirements
  • Website policies, terms, disclosures, and ADA accessibility considerations
  • Price accuracy and error‑pricing remediation, returns, and customer‑service compliance
  • Age gating and identify-verification requirements
  • State‑specific remote‑sales restrictions

We create compliance matrices and step‑by‑step operational guides that unlock new markets while minimizing risk.

Multi‑State Monitoring & Regulatory Tracking

For companies with national footprints, we build and maintain state‑by‑state surveys and charts covering:

  • Licensing and registration requirements
  • Reporting and tax filings
  • Pricing and promotional restrictions
  • Delivery‑sales rules
  • Advertising and labeling requirements
  • AG priorities and enforcement trends

Our living charts allow clients to rapidly identify risk, operational impacts, and required updates.

Rulemaking, Policy Engagement & Advisory Opinions

Where regulatory text is unclear—or where industry participation can influence outcomes—we prepare:

  • Rulemaking comments
  • Agency petitions
  • Advisory‑opinion requests
  • Voluntary disclosures
  • Industry engagement strategies
  • Legislative monitoring where regulatory language intersects with policy priorities

When legal and political strategy overlap, we coordinate with our Government Relations team to ensure client perspectives reach the right decision‑makers.

Post‑Enforcement & Governance Improvement

After resolving a regulatory matter, we help clients strengthen internal processes by:

  • Updating SOPs, training modules, and compliance documentation
  • Building internal review workflows
  • Creating escalation paths for future risk identification
  • Institutionalizing corrective action to prevent recurrence
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