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Food safety in ingredient manufacturing, as well as in food and dietary supplement production, is essential for delivering goods that are both high-quality and safe for consumers. Maintaining high standards in ingredient safety is required to prevent contamination, guarantee nutritional integrity, and protect public health. For consumers to feel confident in the products they buy, it’s important that each ingredient and process complies with strict safety standards.

Regulations, including the Global Food Safety Initiative (GFSI), the Dietary Supplement Health and Education Act of 1994 (DSHEA), the Strengthening Organic Enforcement (SOE) rule of 2023, the Food Safety Modernization Act (FSMA), and the Foreign Supplier Verification Program and (FSVP) play a critical role in upholding safety standards for ingredients. These regulations set clear guidelines for ingredient safety, helping manufacturers and distributors navigate complex requirements and ensure consistency throughout the supply chain.

 
The Purpose of Each Regulation

Understanding the specific purpose of each regulation helps clarify how they collectively contribute to overall food safety. Not only does adhering to these regulations meet legal requirements, but it also builds consumer trust and ensures the reliability of your brand.
 
Global Food Safety Initiative (GFSI)
The Global Food Safety Initiative (GFSI) is a globally recognized benchmark for food safety management, widely accepted by industry leaders, retailers, manufacturers, and more. Established in 2000, GFSI aims to improve food safety across the supply chain by providing a framework for evaluating and certifying safety practices.

GFSI helps harmonize food safety standards worldwide, reduce food safety risks, and promote the consistent delivery of safe food products. This is accomplished through various benchmark schemes, such as:

• Safe Quality Food (SQF): SQF focuses on food safety and quality management, providing detailed requirements for ensuring the safety of food products at all stages of production, from farm to fork.
• International Featured Standards (IFS): IFS is a certification program designed to assess the safety and quality of processes and products for food manufacturers, especially those that supply large retailers.

• FSSC 22000: By combining ISO 22000 standards with additional industry-specific requirements, this scheme offers comprehensive certification to control food safety risks from production to consumption.

• British Retail Consortium: Widely recognized by retailers and manufacturers worldwide, the BRC standard focuses on guaranteeing product safety, quality, and compliance with legal requirements.

Achieving GFSI certification through these programs and many others demonstrates a commitment to the highest food safety standards. By meeting GFSI’s rigorous safety criteria, companies signal to retailers, regulators, and consumers that they prioritize product safety and quality at every step of production.
 
Dietary Supplement Health and Education Act of 1994 (DSHEA) 
The Dietary Supplement Health and Education Act of 1994 set standards for the manufacturing of dietary supplements in the United States. The goal of the DSHEA is to ensure the safety, quality, and accurate labeling of dietary supplements while also providing clear definitions of what is considered a supplement.
The DSHEA categorizes dietary supplements as products meant to enhance the diet, such as vitamins, minerals, herbal extracts, amino acids, and plant-based ingredients (botanicals). It outlines the following provisions for all supplements:

• Product safety and labeling: Dietary supplements are presumed safe under DSHEA unless proven unsafe, but manufacturers must ensure their products are indeed safe. Labels must be clear, with prominently displayed ingredient lists, net content, and suggested usage.

• Types of labeling claims: The act permits three types of claims on dietary supplement labels: Nutrient content claims, structure/function claims, and FDA-authorized health claims (qualified health claims). Nutrient content claims disclose the amount of a specific nutrient in a product. Structure/function claims explain how the supplement affects the body’s normal structure or function. Supported by substantial scientific evidence, qualified health claims link an ingredient with a reduced risk of a disease or health condition.

• Good Manufacturing Practices (GMPs): The DSHEA enforces compliance with GMPs, which detail how supplements must be produced, handled, and packaged to prevent contamination and maintain consistent product quality.

Under the DSHEA, if a product is found to be unsafe, mislabeled, or not in compliance with standards, the Food and Drug Administration (FDA) has the authority to regulate and take action against companies. This may include issuing warnings, mandating recalls, or removing the product from the market.
 
Strengthening Organic Enforcement (SOE) Rule of 2023
Introduced by the USDA National Organic Program (NOP) in 2023, the Strengthening Organic Enforcement (SOE) rule adds another layer of protection to organic products by ensuring their integrity through tighter controls and improved transparency. SOE outlines stricter requirements for tracking and documenting the entire supply chain, addressing critical gaps in the organic certification process. 

To further prevent fraud and mislabeling of organic products, the SOE rule also increases the accountability of certifying agencies. It establishes clearer standards for their operations, including detailed record-keeping and reporting requirements. Provisions under SOE help guarantee that consumers can trust the authenticity of the organic labels they see in the market.
 
Food Safety Modernization Act (FSMA)
Enacted in 2011, the Food Modernization Act marks a significant shift in U.S. food safety law, focusing on proactive measures to prevent foodborne illnesses rather than responding to outbreaks after they occur. FSMA emphasizes the importance of prevention, ensuring that potential hazards are identified and controlled before they reach consumers.

FSMA requires food facilities to implement detailed preventive controls and conduct risk assessments to identify and manage safety risks. It also strengthens compliance protocols by increasing the frequency of inspections and improving traceability as well as recall processes for rapid response in case of contamination. By prioritizing prevention and setting high safety standards, FSMA works to reduce cases of foodborne illnesses and protect public health.
 
Foreign Supplier Verification Program (FSVP)
Established by the FDA as part of FSMA, the Foreign Supplier Verification Program is designed to guarantee that imported food and ingredients meet U.S. safety standards. FSVP mandates that U.S. importers verify that their foreign suppliers adhere to safety standards equivalent to regulations for domestic products. To meet FSVP requirements, importers must conduct a thorough risk-based evaluation of their foreign suppliers. This involves assessing the supplier’s food safety practices, ensuring they comply with U.S. regulations, and taking action to fix any problems that arise. Importers also need to perform regular audits and keep detailed records to prove ongoing compliance.
 

How Food Safety Regulations Work Together

Together, these regulations create a comprehensive framework for food safety. GFSI’s benchmarks support consistent global standards, DSHEA’s provisions ensure that dietary supplements meet U.S. safety and labeling requirements, and SOE’s rules boosts the integrity of organic product claims. Under FMSA’s preventive standards, FSVP bolsters the safety of imported products.

The combined efforts of these regulations strengthen food safety by covering different segments of the supply chain—global practices, domestic supplement guidelines, organic certification, and preventative safety measures. This integrated approach helps protect consumers while also upholding product quality and integrity.
 

Ways Manufacturers and Distributors Can Stay Compliant

Maintaining compliance with GFSI, DSHEA, SOE, FSMA, and FSVP standards calls for a proactive and organized approach from manufacturers and distributors. Implement the following practices to effectively manage adherence to standards and contribute to a safer, more reliable food supply:

• Documentation and record-keeping: Keeping accurate and detailed records is fundamental for meeting regulatory requirements. This includes documenting all aspects of safety practices, quality checks, and ingredient sourcing.
• Supplier and partner collaboration: Work closely with suppliers and partners to ensure they adhere to regulations by setting clear communication channels, conducting regular audits, and aligning on safety and quality goals.

As food manufacturing regulations continue to evolve, keeping up-to-date and prepared is essential. Whether you have questions about your regulatory compliance strategy or want to explore how recent and upcoming changes might affect your operations, Palmer Holland is here to help.  
 

Your Partner in Quality Ingredients and Compliance

If you need a dependable source for premium ingredients that align with safety regulations, reach out to our team. We offer a range of safe ingredients that support your commitment to quality.
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