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:
- Food and Drug Administration (FDA): Responsible for ensuring the safety and labeling of most food products, including dietary supplements.
- United States Department of Agriculture (USDA): Oversees meat, poultry, and egg products, as well as organic and bioengineered foods.
- Federal Trade Commission (FTC): Regulates advertising and marketing claims.
Three Regulatory Requirements:
- 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.
- 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
- 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:
- Warning letters and fines
- Product recalls and seizures
- Detainment at US border entry point
- Legal action and criminal penalties
- 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
