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Introduction
As the nicotine and tobacco industry evolves, novel products like e-liquids, nicotine pouches, and heated tobacco products are gaining widespread popularity. These innovations blur Regulatory boundaries—especially when they contain food-grade flavorings and botanical ingredients, or are ingested orally. In some cases, these include food-grade ingredients in tobacco alternatives, further complicating classification. This raises a critical question: Is it food, a supplement, a tobacco product, or a therapeutic good? Freyr Solutions offers strategic support to navigate these intersections.
Tobacco & Nicotine Products Categories We Support
Freyr provides Regulatory support across a broad spectrum of products , including:
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Combustible Products
Cigarettes, cigars, traditional tobacco
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Reduced Risk Products (RRPs)
Heat-not-burn devices, e-cigarettes, vapes
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Nicotine Replacement Therapies (NRTs)
Patches, gums, lozenges, nasal sprays, inhalers, oral nicotine pouches, botanical alternatives
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Smokeless Tobacco
Chewing tobacco, snuff, moist snuff, snus
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Beyond Nicotine
Botanical and functional inhalable products
Global Tobacco Regulation Landscape:
Key Regulations Across Top Regions
Ingredient and Compliance Support
Botanicals and Alternatives to Nicotine
Support for botanical ingredients and nicotine substitutes, including scientific literature research and competitor analysis.
Safety and Toxicology
QSAR, in-silico, and literature-based safety assessments for human and environmental health.
Regulatory Monitoring
Ongoing global monitoring and guidance on applicable standards like GMP, testing, and certification. This includes GMP compliance for nicotine products as mandated in regulated markets.
Raw Material and Device Compliance
Compliance checks for ingredients, devices, and materials—including restricted substances and food-contact safety.
Claims and Documentation
Review and support for label claims, technical documentation, and Regulatory submissions.
How Freyr Can Help
- Global Regulatory strategy and market access reports
- Product classification and registration support
- Label, packaging, and claims compliance
- Safety assessments and toxicological evaluations
- Raw material and formulation compliance
- Regulatory submissions and dossier preparation
- Compliance with GMP, testing, and certification standards
- Device + ingredient Regulatory services (e.g., e-liquids, vapes)
- Claim substantiation and Regulatory review
- Local representation and eco-labeling support
Why Choose Freyr
- End-to-end Regulatory support for all tobacco and nicotine categories
- Global market access expertise, including vapes, NRTs, and novel formats
- Strong Regulatory intelligence and real-time compliance monitoring
- Specialized support for device + ingredient products
- Safety, labeling, and claims compliance across regulated markets
- Strategic partner with deep HA relationships and global presence
Unsure how to classify your tobacco-derived product?
Connect with Freyr’s Regulatory specialists.
Frequently Asked Questions (FAQs)
Explore key questions and answers on nicotine and tobacco product compliance.
01. Is nicotine gum considered a food supplement or a drug?
In most regions, nicotine gum is regulated as a drug. For example, in the EU, it is typically a medicinal product, while the FDA in the US regulates it under OTC or prescription drug categories.
02. Can nicotine pouches be sold as food supplements?
Some countries may evaluate them if they are tobacco-free under Novel Food laws, depending on the ingredients. However, classification varies and requires Regulatory review.
03. Are e-liquids and vapes regulated as food products?
No. In the US, e-liquids and vaping devices require a PMTA (Premarket Tobacco Product Application) under the FDA. In the EU, they must comply with the TPD (Tobacco Products Directive).
04. Is nicotine allowed in food products in India?
No. Under FSSAI regulations, nicotine is prohibited in any food or dietary supplement product in India.
05. Are herbal or plant-based nicotine alternatives allowed in the EU?
Yes, but only if they have a documented history of safe use. Otherwise, they may require approval under EU Novel Food regulations.
06. What are the age restrictions for tobacco and nicotine product sales globally?
• US: 21+ (Tobacco 21 law)
• EU/UK: 18+
• India: 18+
Most countries also require child-resistant packaging and warning labels.
07. Are online sales of nicotine products allowed?
• US & EU: Allowed with age verification
• India: Prohibited
• Other regions: Varies by country
08. What documentation is needed for nicotine product registration?
Typically includes:
• Product classification rationale
• Safety and toxicology data (e.g., QSAR, in-silico)
• Label and claim review
• Country-specific submission dossiers
09. How does Freyr support nicotine and tobacco product compliance?
Freyr offers end-to-end support, including:
• Regulatory strategy and market entry
• Classification, submission, registration, and labeling
• Toxicological evaluations and documentation
• Device + ingredient compliance and local representation
• Custom clearance
10. Which countries does Freyr support for tobacco and nicotine compliance?
Freyr provides Regulatory support in key regions, including the US, Canada, EU, UK, India, UAE, South Africa, Vietnam, Philippines, and Australia.
