Amazon Seller Compliance

Month: August 2024

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FDA Considerations Selling Foods in USA

 
Regulatory Considerations when Selling Foods and Beverages in the United States 

Selling food products in the United States requires compliance with various regulations to ensure consumer safety and public health. The regulatory framework is complex, involving multiple federal agencies, state laws, and industry standards. Here’s an overview of the key regulatory requirements: 

Federal Agencies: 
  1. Food and Drug Administration (FDA): Responsible for ensuring the safety and labeling of most food products, including dietary supplements.
  2. United States Department of Agriculture (USDA): Oversees meat, poultry, and egg products, as well as organic and bioengineered foods. 
  3. Federal Trade Commission (FTC): Regulates advertising and marketing claims. 
Three Regulatory Requirements: 
  1. FDA Compliant label – A Canadian Nutrition Facts table (NFT) differs from a Nutrition Facts Panel (NFP). Some noticeable differences include “calories from fat” required on an NFP. Rounding rules differ which could result in different numbers and impact nutrient claim qualifier statements. There are many other differences.  Bottom line is that you must prepare a new nutrition facts panel and have a FDA compliant label when launching in the United States.
  2. FSVP Agent – Under the Food Safety Modernization Act (FSMA) that came into effect in 2016, similar to the Safe Foods for Canadians Regulations (SFCR), this preventive plan was to protect US consumers from foodborne illness and ensure food safety measures and practices are adhered to by all food businesses. A FSVP Agent is a designated representative responsible for ensuring that foreign food suppliers meet the US food safety standards under the Foreign Supplier Verification Program (FSVP). The FSVP Agent verifies that foreign suppliers have adequate procedures in place to prevent or significantly minimize hazards in the food they produce 
  3. Food Facility Registration and US Agent (if applicable): Manufacturers, processors, packers, and holders of food products must register with the FDA. In addition, for foreign sites (ie. outside the United States) a US Agent must be linked to the registered food facility. Site renewal occurs every 2 years on the even numbered year.  
Penalties for Non-Compliance: 

Failure to comply with regulatory requirements can result in: 

  1. Warning letters and fines 
  2. Product recalls and seizures 
  3. Detainment at US border entry point
  4. Legal action and criminal penalties 
  5. Damage to reputation and consumer trust 
Conclusion: 

Selling food products in the United States requires a thorough understanding of the regulatory landscape. Compliance with federal agencies, industry standards, and, in some cases, state laws is crucial to ensure consumer safety and avoid legal consequences. Food businesses must stay up-to-date on changing regulations and industry developments to maintain a competitive edge and build trust with consumers. 

How Quality Smart Solutions Can Help with FDA Compliance
We offer solutions to meet the 3 requirements to sell your food in the United States. We will review your food label, register your manufacturing site and act as your US Agent, if applicable, and act as your FSVP agent.  With a former FDA inspector acting as your FSVP agent you have the assurance, trust and reliability to enter the US market. 

 

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Blog

Health Canada 2024 Changes for Nicotine Replacement Therapies (NRT)

Health Canada 2024 Changes for Nicotine Replacement Therapies (NRT) 

On August 22, 2024, the Honourable Mark Holland, Minister of Health, announced new measures aimed at preventing youth from being harmed by nicotine replacement therapies (NRTs). The following outlines the recent updates from Health Canada concerning NRTs. 

There is increasing concern that NRTs, particularly newer formats like nicotine pouches, are being used recreationally by youth under 18. To address these concerns, Health Canada has introduced new regulatory measures. Businesses involved with NRTs must comply with these updated requirements. 

What Are the New Measures? 

The Ministerial Order introduces the following changes: 

  • Prohibition on Advertising: Any advertising or promotion that could appeal to youth is now prohibited. 
  • Pharmacist Supervision: New and emerging NRTs can only be sold by pharmacists or under their supervision. 
  • Flavor Restrictions: Flavors other than mint or menthol are prohibited for new and emerging NRTs. 
  • Mandatory Warnings: Clear nicotine addiction warnings and indications of intended use as a smoking cessation aid are required. 
  • Label and Packaging Review: Manufacturers must submit label and package mock-ups for Health Canada’s review.  
Implications for Your Business 

Adults trying to quit smoking will continue to have access to smoking cessation aids like nicotine gums, lozenges, sprays, and inhalers at various retail locations in approved flavors. However, if you are a manufacturer or retailer of NRTs, it is essential to comply with these new measures to avoid appealing to youth and ensure adherence to Health Canada’s regulations. Non-compliance can result in your product/s becoming illegal to sell in Canada. 

Legal Sale of NRTs in Canada 

To legally sell NRTs in Canada, a natural health product (NHP) must have a Natural Product Number (NPN) license and bilingual labeling. If the NHP is manufactured outside of Canada, it requires a Health Canada licensed importer of record. The licensing timeline for NRTs, classified as Class 3 NHPs, typically takes approximately 210 days, although this is non-binding. 

How We Can Help 

At Quality Smart Solutions, we have prepared over 9,000 NPNs and possess the expertise needed to ensure compliance with Health Canada’s regulations. Navigating the complexities of NRT product licensing and preparing a comprehensive safety and efficacy report can be challenging. Our experienced and highly qualified team is here to help you achieve the best outcome for your product registration and market access strategy. Contact us today to discuss how we can support your business! 

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Blog

How to Create Health Canada Compliant Food Labels

How to Create Health Canada Compliant Food Labels 

When entering the Canadian market, designing your food labels correctly is not just important—it’s critical. The Canadian food labelling landscape is complex and unforgiving, with stringent requirements that can make or break your product’s success. Quality Smart Solutions (QSS) can get your labels compliant so you can successfully start selling in Canada effortlessly. 

4 Things You Need To Know  

Before you start designing your packaging, there are four key Canadian food labelling requirements that you need to understand: bilingual labelling, nutrition and health claims, location and legibility requirements, and the new front-of-pack nutrition symbol. Ignoring or misunderstanding these can lead to costly redesigns and delays in bringing your product to market.

1. Canadian Bilingual Requirements

In Canada, all mandatory information on a food label must be presented in both official languages—French and English. This is not a mere formality; it’s a legal requirement that applies across the country. If you plan to sell your product in Quebec or through Canada’s national retailers, every piece of information on your packaging must be in French, with French given equal prominence to English. 

For many U.S. brands, this requirement can come as a shock, often necessitating a significant increase in label text. Without careful planning and design, this can clutter your packaging and disrupt your brand’s communication hierarchy, potentially harming your product’s appeal. 

2. Nutrition and Health Claims

Canada’s health and nutrition claims are subject to meticulous and aggressive standards set by Health Canada and the Canadian Food Inspection Agency (CFIA). Claims about your product’s origin, content, quality, and the absence of allergens must be carefully vetted against Canadian regulations. 

Common claims like “Source of Protein” or “No Sugar Added” that are widely used in the U.S. may not be permitted on Canadian food labels. Failing to comply with these standards can lead to your product being pulled from shelves or, worse, legal action.

3. Location and Legibility

Canadian regulations prescribe exactly where information must appear on your packaging and how legible it must be. This includes specific minimum type sizes for mandatory information such as net weight, ingredients, common name, dealer name and address, and any claims. 

These requirements are not merely suggestions—they are enforced rigorously. Getting this wrong could lead to costly reprints or delays in your product launch.

4. New Canadian Front-of-Pack (FOP) Nutrition Labelling

Starting January 1, 2026, Canada will require a new front-of-pack nutrition symbol on products containing 15% DV or more of saturated fat, sugar, or sodium. This is a significant new requirement that could impact your product’s shelf appeal and consumer perception. 

Understanding and correctly applying this new symbol will be crucial for any brand looking to enter or expand in the Canadian market. 

QSS is Your Essential Partner in Canadian Food Labelling Compliance 

Canadian food labelling laws can feel like a non-tariff barrier for many U.S. companies, particularly small and medium-sized businesses. However, when executed correctly, these regulations can become a competitive advantage, showcasing your brand’s commitment to transparency and consumer trust. 

QSS brings decades of experience in helping brands navigate these complexities. We ensure that your packaging not only meets Canadian regulatory requirements but also resonates with Canadian consumers. Our expertise in both compliance and design means that your product will stand out for all the right reasons. 

If you have questions about Canadian food labelling, package design, or navigating the Canadian market, QSS is here to help. 

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News

New Update on FDA Sodium Reduction Efforts

The FDA has taken a significant step forward in its ongoing sodium reduction initiative by issuing new, voluntary sodium reduction targets in a draft guidance, marking the launch of Phase II in their efforts. This follows Phase I, aimed at decreasing diet-related diseases associated with high sodium intake, where final voluntary sodium reduction goals were established in 2021. 

The Journey Towards a Healthier Food Environment  

Excessive sodium consumption is a major public health concern in Canada and worldwide. The average Canadian consumes over 3,400 milligrams of sodium per day, exceeding the recommended daily limit of 2,300 milligrams. High sodium intake can lead to high blood pressure, heart disease, stroke, and kidney disease, resulting in significant healthcare costs and early mortality. 

FDA’s Sodium Reduction Initiative 

In 2021, the FDA set voluntary sodium reduction targets for food manufacturers, aiming to reduce sodium levels in processed and restaurant foods. The agency established two-year and four-year targets, encouraging industry-wide sodium reduction. The next phase of this initiative involves: 

  1. Revised targets: The FDA has revised its sodium reduction targets, setting more stringent goals for certain food categories. 
  2. Expanded scope: The initiative now includes additional food products, such as canned vegetables, soups, and sauces. 
  3. Monitoring progress: The FDA will track industry progress towards meeting the targets, providing guidance and support where needed. 

The industry has been working towards meeting the Phase I targets by April 2024. The newly proposed Phase II targets set the next milestone for industry to achieve within three years after the finalization of this guidance. These targets are designed to address the excessive sodium intake in the U.S., which currently averages nearly 50% above the recommended limits. 

Impact on Public Health and Benefits of Sodium Reduction  

Reducing sodium in food products can have numerous benefits, including: 

  • Improved public health: Lower sodium intake can lead to reduced blood pressure, cardiovascular disease risk, and stroke incidence. 
  • Increased consumer choice: As manufacturers reformulate products, consumers will have access to a wider range of lower-sodium options. 
  • Economic benefits: Reducing sodium can help alleviate healthcare costs associated with diet-related diseases. 

Excess sodium intake is a major contributor to high blood pressure, which is a leading risk factor for heart disease and stroke—conditions that disproportionately affect racial and ethnic minority groups in the United States. The FDA’s efforts are grounded in strong scientific evidence that reducing sodium intake can significantly lower the risk of these health issues, potentially preventing hundreds of thousands of premature deaths and illnesses in the coming years. 

Impact on Businesses 

The new sodium reduction targets set by the FDA could have significant implications for various businesses, particularly those involved in the food manufacturing and food service industries. Companies may need to reformulate their products to meet the new sodium reduction goals, which could involve altering recipes, sourcing new ingredients, or adjusting production processes. This may lead to increased costs and require changes in marketing strategies to communicate these adjustments to consumers. 

Small and medium-sized enterprises (SMEs) might face additional challenges due to limited resources for research and development. However, staying compliant with the FDA’s voluntary targets is crucial not only to avoid potential scrutiny but also to align with consumer demand for healthier food options. 

Challenges and Opportunities 

While the FDA’s initiative is a crucial step towards reducing sodium in food products, challenges remain: 

  • Industry compliance: Encouraging industry-wide adoption of sodium reduction targets may require ongoing support and monitoring. 
  • Consumer education: Raising consumer awareness about the importance of sodium reduction and providing guidance on healthier choices is essential. 
  • Innovation and reformulation: Manufacturers must innovate and reformulate products to meet sodium reduction targets while maintaining taste and quality. 

Andrew Parshad, CEO of Quality Smart Solutions, commented on the FDA’s new draft guidance: 

“The FDA’s continued efforts to reduce sodium levels in the U.S. food supply reflect an important public health initiative that we fully support. However, we recognize that these new targets present significant challenges for businesses, especially smaller companies with limited resources. At Quality Smart Solutions, we are committed to helping our clients navigate these changes efficiently and effectively, ensuring that their products remain compliant while also meeting consumer expectations for healthier options.” 

Progress and Future Assessments 

Preliminary data from 2022 indicates that about 40% of food categories have already reached or are close to the Phase I targets. The FDA plans to continue assessing progress on sodium reduction every three years, with more comprehensive data expected in the future to evaluate the full impact of Phase I. 

How to Get Involved 

The FDA is welcoming comments on the draft guidance through November 14, 2024. Stakeholders can submit their feedback electronically via regulations.gov.  

If you have any feedback or concerns regarding the new sodium reduction targets, connect with us today to ensure your voice is heard in this important regulatory process. Quality Smart Solutions is here to assist you in this process. We can help consolidate your responses and submit a comprehensive, industry-relevant submission to the FDA on your behalf. 

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Blog

Health Canada plans to share document about health products containing CBD this fall

This fall, Health Canada is anticipating sharing a policy consultation document about health products containing (CBD). This proposal has been in the works since 2019.

In 2022, Health Canada  released  a report on health products containing cannabis.

Released earlier this year, The Forward Regulatory Plan for 2024 to 2026 details regulatory initiatives that Health Canada will be proposing or finalizing in the next 2 years.

New regulatory initiatives underway

According to the Food and Drugs Act of this plan, Health Canada plans to amend the Food and Drug Regulations, Natural Health Products Regulations and Pest Control Products Regulations ensuring a consistent and flexible approach to the regulation of biocides (surface disinfectants and surface sanitizers).

Are biocides affected?

At present, biocides are regulated under separate regimes. This causes heavy difficulties for many industry regulators as they continue to work with biocides. This became clear throughout the COVID-19 pandemic.

The proposed amendments will:

  • form 1 comprehensive framework for regulating biocides
  • allow regulatory oversight based on risk and evolving evidence
  • present a use of foreign decisions pathway

Note: The Biocides Regulations were formerly termed Regulations Amending the Food and Drug Regulations, Part C (Biocides, use of foreign decisions for disinfectants and surface sanitizers).

All of these initiatives form part of a larger spectrum of work on contemporary regulations all related to Health and Biosciences Sector Regulatory Review Roadmap.

What is Health Canada’s goal?

The intention of Health Canada is to fashion regulatory pathway for health products containing cannabidiol that would not require practitioner oversight.

How do you proceed? Get assisted by Quality Smart Solutions 

For detailed insights into these regulatory changes and ongoing consultations, reach out to our team of former Health Canada experts at Quality Smart Solutions. We help ensure compliance with modernized regulations governing natural health products (NHPs) and non-prescription drugs, enhancing safety and quality standards across Canada while facilitating business growth and innovation.  Fill in the form below and let’s get started!

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