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Food and Beverage Consulting Food Regulations for FDA Approved Food Products

Leverage our expertise in food regulations, food Label compliance, nutrition facts panel creation, self-affirmed GRAS, and stay compliant with the applicable food regulations in the USA. We can be  your trusted regulatory compliance partner and can help you with product classification,  ingredient assessment, auditing, and safety & quality measures.  

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End-to-End Food & Beverage Compliance Solutions for the USA

We offer services related to the Food and Beverage Industry in the USA.

Food Label Compliance

We help you prepare a format that is ready to print as well as create a future-proof Nutrition Facts Panel and design print-ready full-compliant artfile ( brand images and logo).

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Food Facility Registration and Renewal

Get assistance to register your food facility with the FDA or review your current registration and avoid any late fee. Helpful for those who manufacture, process or pack foods.

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US Agent for Foreign Food Facility

We act as your liaison between FDA and your facility related to inspection or product issues. The US Agent is a US citizen with the qualifications and experience dealing with FDA matters.

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Foreign Supplier Verification Program (FSVP) Agent

As your FSVP import agent we review your manufacturer's food safety plan, conduct a hazard analysis and have a FSVP plan managed by a former FDA inspector.

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GRAS (Generally Regarded as Safe) Notification

Let us review your food ingredients and check whether GRAS is possible followed by preparing a detailed GRAS dossier and submitting it to FDA to ascertain your ingredient qualifies for sale in USA.

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Self-affirmed GRAS

Our FDA compliance professionals assist you in preparing a self-affirmed GRAS dossier and making sure your ingredients efficiently meet the safety qualifications for sale in USA.

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Food and Beverage Industry in the USA

The food and beverage industry is among the most significant parts of the US economy. Food and beverages include prepackaged and fresh foods (excluding baby food), meats and poultry, fruits & vegetables, and delicacies. Understanding the regulatory landscape is pivotal for your success as a business owner venturing into the U.S. food market.

Food and beverage consultant
Compliance to sell food products in the United States

FDA Food Safety, Facility & Importing Regulations

FDA Oversight: The Food and Drug Administration (FDA) is central in regulating food products. They enforce laws that govern food items' safety, labeling, and quality. Food Facility Registration: If your business manufactures, processes, packs, or stores food products, you must register your facility with the FDA. Please do so to avoid legal complications. Food Labeling: U.S. regulations mandate clear and accurate food labeling. This includes information on ingredients, nutritional facts, allergens, and more. Non-compliance can result in product recalls and fines. Food Additives: Understanding which additives are permissible and in what quantities is crucial. The FDA maintains a list of approved food additives. HACCP Plans: Certain businesses, like seafood and juice processors, must implement Hazard Analysis and Critical Control Points (HACCP) plans to ensure food safety. Food Safety Modernization Act (FSMA): The FSMA focuses on preventing foodborne illnesses. Compliance involves measures like risk assessment, preventive controls, and verification. Import Requirements: If you're importing food products into the U.S., you must adhere to specific regulations and may be subject to inspections.

Why should businesses utilize Regulatory Consultants?

Expertise: Regulatory consultants like us are well-versed in U.S. food regulations. They keep abreast of changes and nuances, ensuring your compliance. Customized Guidance: Every food business is unique. Our regulatory consultants tailor their guidance to your specific product and business model. Risk Mitigation: Our consultants will identify potential compliance risks and help you navigate them effectively, reducing the chances of costly fines or recalls. Time Efficiency: Navigating regulations can be time-consuming. Our consultants streamline the process, allowing you to focus on core business activities. Market Entry Strategy: If you're entering the U.S. market from abroad, our consultants can help you understand the nuances of international trade regulations. Labeling Expertise: Accurate labeling is crucial. Our regulatory consultants are experts at ensuring your product labels meet all FDA requirements. Safety Compliance: Food safety is paramount. Our consultants will assist you with implementing preventive controls and safety measures as mandated by the FSMA. Audit Preparedness: In case of FDA inspections or audits, our consultants help you prepare, minimizing disruptions to your business. Cost-Effective: While hiring consultants incurs costs, their expertise often results in cost savings by preventing compliance errors or recalls. Long-Term Success: Regulatory compliance is a process that takes time to complete. Our consultants provide ongoing support to ensure sustained adherence to regulations.
Compliance to sell food products in the United States

Hear from Some of Our Amazing Clients

Proven Expertise. Companies that have put their trust in us to become FDA-compliant.

5 Star Google Reviews
Shams W.Pawel Amazing Grass

“We’ve worked with Andrew and the QSS team for 5 years and they’ve always been very knowledgeable and professional. They’re a tremendous partner to have when dealing with Health Canada compliance regulations and will always work with you to come up with the best solutions.”

Michael MT Consulting

I have been working with Andrew and his team at QSS for a couple of years now. I have clients from many different parts of the world and each situation requires expertise and focus, which I’m getting from QSS. I highly recommend Andrew and QSS to any perspective client who wants to “get it right” regarding Canadian and cross border compliance.

Donal Gauvreau Sapro

I've used QSS services for many years now and they always deliver a very professional service. Everyone on the team is great to work with and the always come up with great solutions for your needs at a great price!

Why is FDA Food Compliance & knowledge of Food Regulations Important?

The US FDA  monitors foods and food ingredients for sale except for meat, poultry, and a few processed egg products. The regulatory agency imposes hefty penalties on businesses that fail to comply with the regulations. The FDA may also issue a stop sale or ban the sale of your product if any non-compliance is identified.

FDA Regulations

Every food manufacturer, packer, processor, distributor needs to submit certain records to the FDA to ensure all food products are safe and healthy for use.

Comply with FDA Regulations

Make foods with proper nutritional value. Give nutrient information in a standardized format followed by meeting label compliance.

Specific Regulations

There are specific regulatory requirements in place for food products, such as low-acid canned food, seafood, juice.

Food Facility Registration

Registering with the FDA is mandatory in the USA even if you have not started manufacturing, packing, processing or stocking food for human or animal consumption.

Frequently Asked Questions

The FDA monitors foods and food ingredients for sale and will impose penalties on any business that can’t comply with regulatory compliance.  This can include banning your product from sale in stores and online if there are non-compliances.  These regulations require that anyone in the food and beverage industry submit records to the FDA to make sure their products are safe & healthy for use, make foods with nutritional value displayed to meet label compliance and comply with facility registration.  There are also specific requirements in place for different food products like low-acid canned food, juice, and seafood.  These FDA regulations and guidelines are constantly changing and the paperwork can be quite complex, If you’d like us to help you, we’d be happy to.

There are no FDA fees for a food facility but foreign facilities will need to have an approved US FDA Agent in order to be compliant.  

According to the Nutrition Labelling and Education Act of 1990, almost all foods require 5 basic level requirements: quantity of content, nutritional information, ingredients, manufacturer or distributor, and product name.

The food & beverage compliance solutions for the USA we offer consists of:

  1. Food Label Compliance- We will prepare a format that is ready to print and create a future-proof Nutrition Facts Panel and design print-ready full-compliant (brand images and logo).
  2. Nutrition Facts Panel Creation- We can prepare your panel using raw material certificates and ingredient information.
  3. Food Facility Registration and Renewal – Get assistance to register your food facility with the FDA or review your current registration to avoid any non-compliances.
  4. GRAS (Generally Regarded as Safe Notification) – We’ll review your food ingredients to determine whether GRAS is possible and prepare a dossier to be submitted to the FDA to see if your ingredient qualifies for sale in the USA.
  5. Self-affirmed GRAS – Our FDA compliance professionals can assist you in preparing a self-affirmed GRAS dossier so your ingredients efficiently meet the U.S.A safety qualification requirements for sale.

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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

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