Regulatory & Compliance Advisory
Guidance on US labeling, marketing claims, and advertising compliance for health and wellness products, including review against applicable FDA and FTC frameworks and assessment of market-entry regulatory risk.
US market advisory for consumer health & wellness brands.
Regulatory, go-to-market, and product sourcing guidance for companies bringing health and wellness products to the United States.
Overview
Lumway Wellness Inc. advises consumer health and wellness companies on what it takes to operate in the US market: from regulatory positioning through to go-to-market execution and supply chain decisions.
That perspective comes from direct, operational experience: reviewing product labeling and marketing claims against FDA and FTC frameworks, assessing advertising and endorsement compliance, and evaluating manufacturing and ingredient sourcing partners for a US direct-to-consumer health and wellness brand.
Services
Market Entry & Business Strategy
Support for companies planning or executing entry into the US market: positioning, competitive assessment, and channel and pricing strategy.
Product Development & Sourcing
Evaluation of manufacturers and suppliers, product specification review, and supply chain and quality risk assessment.
Approach
A defined engagement, before work begins.
Align the decision.
We start with the business question, the market context, and the outcome that matters. The scope is built around a decision to make, not a generic workstream.
Make the work tangible.
Before launch, we map the working sessions, deliverables, review points, and timing. You can see exactly what will be produced and how it supports the decision.
Put the right people in the room.
Your statement of work names the Lumway team and client owners, with a clear cadence for decisions and feedback throughout the engagement.
Who We Work With
We work with early- and growth-stage consumer health and wellness brands operating in the US market, including companies managing dietary supplement labeling and advertising compliance, entering new product categories, or evaluating manufacturing and sourcing partners.
- Dietary supplement labeling & advertising compliance
- Entering new product categories
- Evaluating manufacturing & sourcing partners
Team
Regulatory & Compliance Practice
Reviews product labeling, marketing claims, and advertising against FDA and FTC frameworks, and assesses regulatory risk for new products and markets. The work is grounded in hands-on compliance experience for a US direct-to-consumer health and wellness brand, including labeling review under 21 CFR Parts 101/111 and endorsement disclosure assessment under the FTC Endorsement Guides.
Market Entry & Strategy Practice
Evaluates competitive landscape, positioning, and channel and pricing strategy for companies entering or scaling in the US consumer health and wellness market.
Product & Sourcing Practice
Evaluates manufacturers and suppliers, reviews product specifications, and assesses supply chain and quality risk for consumer health and wellness products.
Tell us about your project.
Share a few details about your company and what you are working on, and we will come back to you with how we can help.
Or reach us directly at info@lumwaywellness.com