The FDA implements laws that are provided by Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws. Dietary supplements have their own unique regulation, yet are processed by the FDA.
FDA Food Compliance Services to Food and Dietary Supplement Exporters
When entering regulated market such as the United States, it is not just sufficient to produce safe food or supplements but there should be a rigorous adherence to the U.S. FDA regulations. We offer all-inclusive regulatory and compliance consulting services to the exporters of food and dietary supplements at Compliance Networks. As a manufacturer, a contract packer, a labeler, or a distributor, our team of experts is going to make sure that your products will make it through the border without any hesitations or any regulatory concerns.
The importance of FDA Compliance in case of exporters
Regulatory Gatekeeper: The FDA implements laws that are provided by Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws. Dietary supplements have their own unique regulation, yet are processed by the FDA.
Customs Holds, Detentions & Rejections: Non-compliance may result in shipment holds, U.S. port refusals or even destruction.
Brand and Reputation Risk: Noncompliance with regulations may also harm the reputation of the brand, the cost of a recall, or a lawsuit.
International acceptance: The FDA standards are accepted or used as reference by many foreign regulators and thus being able to gain U.S. alignment provides you with leverage in more than one market.
Compliance Networks is a solution that assists you in managing such risks by simplifying regulatory complexity into a streamlined compliance process with multiple steps.
Our service offer to the exporters of foods and dietary supplements
We have broken down our services below. Every client might also require an individualized mix according to the type of product, market location and supply chain configuration.
1. Facility Registration and U.S. Appointment of Agent
Food Safety Modernization Act (FSMA) and other related regulations requires all foreign facilities producing, processing, packing, or holding food or dietary supplements that are to be imported to the United States to be registered by FDA.
In the case of dietary supplements, a facility has to be registered, and the foreign organization should have a U.S. Agent (physical resident of the U.S. or organization) to receive the regulation communications and inspection notice. US Imports+2Iaccse+2
We take you through registration, renewal, UFI (Unique Facility Identifier) and agent obligation.
2. Gap Assessment/ Regulatory Audit
We will do a complete inspection of your procedures, raw materials, production, quality control, labeling, documentation and find out the gaps with U.S. food and dietary supplement regulations.
Viewed as pertinent regulations, our audit is FDA food GMP (21 CFR Part 117 in case of foods) and Dietary Supplement Current Good Manufacturing Practices (DS CGMP, 21 CFR Part 111).
Upon the establishment of deficiencies, we provide a plan to overcome noncompliances.
3. cGMP Documentation Support and Compliance
In the case of dietary supplements, it is mandatory to comply with DS CGMP. This involves, setting up written procedures, specifications, testing, recordkeeping, quality control among others.
We help you develop or review:
• Know how to master manufacturing records and batch production records.
• Cleaning, calibration, QC Standard operating procedures (SOPs).
• Supplier qualification and component control process.
• and plans of laboratory protocol, statistical sampling plan, and reserve sampling.
• Managing complaints, returns, investigations.
4. Labeling & Claims Compliance
We review your product labels, ingredient listing, claims (structure/function, health claims), disclaimers, and make sure that they are compliant with FDA labeling requirements of dietary supplements and foods.
To mitigate regulatory risk, we assist you with necessary notifications (e.g. structure/function claims) or reviewing supporting evidence.
We can also help in the translation of regulatory language to label verbiage that will satisfy the U.S. standards and have a reduced risk of misbranding.
5. New Dietary Ingredient (NDI) Notification/ Ingredient Review
When your supplement contains an ingredient that is not sold in the U.S. prior to October 15, 1994, it is a rule that you need to file a New Dietary ingredients (NDI) notification with the FDA.
You have your ingredient dossier, toxicology, exposure data and we prepare your NDI submission which is approved by our scientific regulatory experts.
GRAS vs NDI applicability, risk assessment and safety substantiation are also reviewed by us.
6. Export Certification/ U.S. Export Documents
A large number of foreign purchasers or governments require FDA-type export certificates (Certificates of Free Sale, U.S. Export Certificates). The FDA grants certain kinds of certificates according to the eligibility.
We help in preparing the documents needed, apply to FDA seeking the required certificates, and make sure they are eligible and in compliance of exportation.
We also provide adherence to importing country conditions, certificate translation, legalization or word customization.
7. Support on Regulatory Liaison and Inspection
We are the gateway to FDA when we are inspected or audited.
Should any FDA Warning Letters or Observations occur, we facilitate in the root-cause analysis, CAPA (corrective action / preventive action), plans, and drafting responses.
We follow regulatory changes and keep your system up to date in FDA guidelines or legislation.
8. Continued Compliance/ Renewal Support
Compliance to regulations is not a single exercise. We give nonstop monitoring, in-house audit, refresher training, labeling, and regulatory surveillance.
We facilitate the organization of renewals, i.e., registration of the facility, renewals of agents, renewal of certificates, etc. in a manner that does not interrupt.
Why Choose Compliance Networks
Specialised Knowledge: Our regulatory department is experienced in U.S.FDA regulations on food and dietary supplements.
End-to-End Support: Since gap assessment up to the export certification and post-market monitoring, we have the complete lifecycle.
Tailored Solutions: We tailor services to your type of product, supply chain, target markets and risk profile of regulatory requirement.
Risk Mitigation: We assist you to mitigate unproductive forms of noncompliance, that is costly customs holds, recalls, or fines.
Client Education: We do not just tell you what to do, but we train and develop your team, develop your capabilities and transfer regulatory knowledge.
Typical Workflow & Timeline
Onboarding & Data Collection – First consumption of your product, plant facilities and process documentation.
Gap Audit Report and Report Audit – You are provided with an audit report and compliance roadmap within a couple of weeks.
Remediation & Documentation – This stage will require a few weeks or months depending on the level.
Regulatory Submissions – Registration of facilities, NDI notices, requests of export certificates, label notifications.
Regulatory Inspection Readiness – Pre-audit review, mock inspections, training.
Continued Support and Supervision – Quarterly audits, updates, regulatory watch.
Who Are The Beneficiaries of Our Services
• Food and beverage exporters.
• Suppliers of supplements: contract manufacturers/packers.
• The proprietors of dietary supplements in the United States.
• Distributors or re-labelers used in the importation into the U.S.
• Firms that introduce new products or are increasing ingredient range.
Your Path to FDA-Ready Export
Adherence to the rules of the U.S. FDA is not that simple and at the same time, does not need to be so daunting. By having Compliance Networks as your regulatory partner:
• You get a comprehensive, coherent road map of where you are to where you have to be.
• You reduce shipment delays, refusals or other regulatory inconvenience.
You protect your brand, safety of the consumer and access to the market.
Call us in advance to arrange a preliminary consultation or audit. We will assist you in making FDA compliance one of your competitive business benefits in exporting.