United States FDA compliance services

US Market Entry – 3-step FDA / USDA Food & Beverage Compliance Planner

Launching a new food, beverage or dietary supplement product in the US?

Considering different US distribution channels and e-commerce? 

Need a hand understanding US FDA and/or USDA compliance?

Advance compliance planning addresses key decisions in your marketing strategy.   We can help you confidently refine your product marketing and manufacture, in your chosen category.   Learn how to avoid common mistakes leading to costly and frustrating import delays, increased inspections, and other enforcement actions.

While learning about US processes and regulations can seem a little overwhelming, our US Market Entry 3-step FDA / USDA Compliance Planner does the work for you in providing the clarity, confidence and information you need to prepare for your US launch. 

Under new FDA food safety laws recently implemented in the US, food importers must work with their foreign suppliers to confirm that each line of food under FDA jurisdiction imported into the US complies with applicable food safety requirements, including electronic import documentation.   The new FDA laws are described as a 'multi-layered safety net'.   Multiple US federal and state authorities are involved in all aspects of food regulation. 

Why 3 Steps? 

A bit like dipping your toe into the sea, before committing to your US export project, it is quite understandable that you may feel like you need more information about what’s involved, and in fact diligence on your part early in the process will pay off – helping you make the big decisions with confidence.

With New Zealand’s long history as a trusted supplier of high quality safe food, you can be confident that food produced in New Zealand has the regulatory ingredients to make it on the worlds most demanding stages.  

Kathy Lloyd has been guiding food exporters through one-to-one consulting since 2017, tapping into her wealth of professional training and expertise from 20 years of working in food production, regulation, compliance, and market access across New Zealand’s food export sectors.   We have developed this introductory US compliance planner package through working with many SME exporters, and finding that the most efficient and effective approach to addressing US compliance is to focus down on the key requirements that will impact your US market launch.     

Waka Kuaka helps you to tap into this resource of expertise and experience so that so that unwelcome compliance hiccups, failed inspections and delayed border entry do not detract from your success and your reputation. 

How does the US Market Entry 3-step FDA / USDA F&B Compliance Planner work?

·        YOU decide whether to continue at each step, giving you complete control over the process.  

We understand the preparation necessary to commit to launch in the US, and if your circumstances or priorities change, you can simply cancel or postpone the next step until you are ready and focused.

·        NO hidden fees. 

Step 1 has a fixed fee; Steps 2 and 3 are tailored to your needs - fees are advised at the time of booking.

Step 1:   Explore your US export proposal over a 30 minute phone consultation - you’ll come away understanding the broad types of regulatory requirements you'll need to address.

Step 2:  A more in-depth, structured, product-focused regulatory overview carried out one-on-one via a Zoom consultation.   You may like to bring in a technical person, and it is likely you will have prepared questions.   A PowerPoint presentation is included. 

Step 3:  We prepare your more detailed regulatory navigation road-map summarised in a written report that you may use to help pitch your project to stake-holders and inform your production team.    Tailored to your product, marketing strategy and distribution channel, your road-map breaks down compliance activities with recommended timeframes and detailed cost proposals.  All applicable food safety and export documentation requirements are captured, to help you plan and keep track of compliance during product development.   

Following the 3 compliance planning steps you will be in a position to make informed decisions for addressing FDA compliance to support your US product launch.    Waka Kuaka offers a full range of US compliance services, which may be booked after completion of the 3 steps.

The US Market Entry 3-step FDA / USDA Compliance Planner package is designed for exporters wishing to gain a thorough overview of the applicable compliance aspects of their proposed product launch.    Through the consultations you will have the opportunity to share proposals and marketing strategies, and obtain recommendations and guidance as to how to ensure product compliance and a smooth export process.   US Agent and IOR services are also available through partner service providers.   You may choose to only book the Step 1 consultation at the start, and you can decide at any time whether to proceed with Steps 2 and 3.    All consultations must be booked in advance.   Once Steps 2 and 3 are booked, cancellation fees may apply - you will be advised at the time of booking if this applies to you.  Waka Kuaka standard terms of trade apply.  

 

 

FOOD FACILITY REGISTRATION

Food manufacturing, packing and holding facilities must be registered with U.S. FDA for foods under FDA jurisdiction destined for export to the U.S. We can register your facility and ensure you can retrieve current information about your facility registration status any time you need it.  

A requirement for food facility registration is to have an agent, which can be either a person or a company, and which must be resident in or based in the United States. We can provide a United States agent for the purposes of registering your food facility. 

Facilities must renew their registrations every two years during the biennial renewal period – we provide our clients with reminders to ensure that the renewals are processed smoothly.

FOOD SAFETY IMPORT DOCUMENTATION

Protect your brand and avoid costly delays and rejections during import clearance. The same attention to detail that ensures the quality and safety of your food products must also be given to your export and import documentation. We provide training and assistance to guide you through the whole export-import process, and we can submit Prior Notices of Import on your behalf or train your people to submit these correctly. 

Documentation requirements for importing food into the United States includes Prior Notice of Import and Foreign Supplier Verification Program (FSVP). 

FOREIGN SUPPLIER VERIFICATION PROGRAM DOCUMENTATION ASSESSMENT

New Foreign Supplier Verification Program (FSVP) rules mean that United States food importers must now verify compliance of all imported food shipments. Whether you are a supplier of raw materials and ingredients to another food facility, or you are producing and exporting a retail-ready or consumer-ready food or beverage to the United States, these rules will in some way extend to your food business, here in New Zealand. 

Exporters and importers will need to provide key FSVP information to their shipping company or US Customs Broker at United States import entry including food facility registration number and FSVP Importer ID number.

United States food importers must now make records available to the FDA on the verification activities they have carried out on the compliance status of all imported food. This is generally done through the importer’s FSVP program, which may include onsite audits to check that foreign suppliers are producing food in compliance with FDA food safety standards.    

Fortunately for many New Zealand suppliers, FSVP verification is greatly simplified because New Zealand was the first country to develop a food safety systems recognition arrangement agreement (FSSRA) with the FDA. 

Find out how this applies to your food product and your processing facility, and be on the front foot when it comes to supplying the right documentation for FSVP verification. We provide FSVP assessments to guide you on FSVP compliance and documentation.

PRIOR NOTICE OF IMPORT

Prior Notice of Import is required for all commercial consignments of foods which fall under U.S. FDA jurisdiction. We can submit Prior Notices on your behalf, and also offer a training package which includes written guidance and one-to-one coaching, to upskill your export team

A little background: Bioterrorism laws introduced in 2003 are behind FDA’s electronic prior notification system for all food commercially imported into the United States (only food, food ingredients, beverages and dietary supplements regulated exclusively by FDA are covered).     

Receiving Prior Notice allows FDA and Customs & Border Protection (CBP) to target import inspections. CBP requires that Prior Notices have been submitted correctly, BEFORE the import entry can be submitted – that means before the food arrives at the United States seaport or airport, so that the prior notice data is available in the import entry system (the FDA and CBP systems are electronically linked). Prior Notices must have been submitted at least four hours before arrival into the United States for airfreight and at least eight hours before arrival for seafreight. Prior Notices may not be submitted more than 15 days before the anticipated arrival of the food at the United States port of entry.

There are NO EXCEPTIONS for commercial consignments. Even food sold online direct to a consumer in the United States and sent via international mail, and shipments destined for display at trade shows require submission of Prior Notice.

COMPREHENSIVE LABEL GUIDANCE

We provide tailored guidance reports to assist you to design U.S. compliant labels for your food, beverages and dietary supplements. Our guidance includes regulatory references and covers all label requirements including format, mandatory and voluntary information, nutrition panels (Nutrition Facts and Supplement Facts), ingredient lists, allergen declarations, declaring colors, flavors and additives, and all types of claims and statements used on labels and advertising.

LABEL REVIEWS

We can review your labels and provide you with a tailored checklist to assist you to bring the labels into compliance. Included in this service are compliant nutrition panels for food and dietary supplements. Our label review service covers all applicable requirements including format, mandatory and voluntary information, nutrition panels, ingredient lists, allergen declarations, declaring colors, flavors and additives, and all types of claims and statements used on labels and advertising. If you have product information on your website, we can also include this in the review.

If you are short of time we can also work directly with your label designer to produce compliant labels.

INGREDIENTS AND ADDITIVES COMPLIANCE CHECK

Are your ingredients, additives, colors, dietary ingredients and botanical extracts permitted to be used in the United States? Does your dietary supplement contain new dietary ingredients? We provide you with advice and regulatory references to support product development. Find out about the notification process for new dietary ingredients.

CLAIMS AND STATEMENTS

Find out how to ensure the statements and claims made about your products comply with United States Federal Food Drug and Cosmetic Act and the Fair Packaging and Labeling Act. Some types of statements require notification or approval. Our comprehensive label guidance and label review services include Nutrition Facts panels (for food and beverage) or Supplement Facts panels (for dietary supplements), and advice on statements and claims about any of the following areas: 

• nutrient content
• general wellbeing
• physiological processes and impacts on the human body
• health benefits
• organic
• natural
• geographic origins

DIETARY SUPPLEMENT REQUIREMENTS

Dietary supplements fall under the same laws regulating food and beverage in the United States, and dietary supplements are included in the FDA’s definition of food. The requirements for dietary supplements are a combination of general food standards and specific standards for dietary supplements. 

Under the Dietary Supplement Health and Education Act (DSHEA) dietary supplements and dietary ingredients that are adulterated or misbranded are prohibited from being marketed. Manufacturers and exporters are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.

If your dietary supplement contains a dietary ingredient that was not marketed in the U.S. before 1 October 1994, it may need to be notified as a new dietary ingredient. 

New United States food safety rules (FSMA) are now transitioning into place over a five year period (2016 – 2021), and this also covers dietary supplements.  Some of the FSMA Rules give preferential treatment to imported foods produced under food safety regulatory systems that have been recognised by FDA as being comparable to those of the United States. For a number of reasons, dietary supplements and dietary ingredients manufactured in New Zealand may not be in a position to benefit from the exemptions granted to food and beverages. 

If you’re thinking of exporting dietary supplements to the United States, you’ll need to check that all of the ingredients and additives are approved and acceptable under FDA regulations, as well as meeting the requirements for structure/function statements and health claims. You’ll also need an FDA compliant Supplement Facts panel on your labels, as well as meeting applicable food labeling requirements. Our comprehensive label guidance and label reviews cover all applicable requirements for your product..

MANUFACTURING FOOD SAFETY STANDARDS

We can assist your food business to understand whether there are additional requirements for food, beverages and dietary supplements destined for the United States. 

We can assess your current food safety plan and check for compliance with applicable U.S. standards.