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FSVP & FSMA

 

The FDA Food Safety Modernization (FSMA) Act of 2011 is a food safety system that focuses on preventing contamination rather than primarily reacting to problems after they occur. 

The FSMA rule for Importers of Food for Humans and Animals, called Foreign Supplier Verification Programs ...

Detention & Refusal

 

Your product may be detained because it appears to be adulterated, meaning the product is contaminated, is not safe, or does not otherwise meet applicable standards; misbranded, meaning the labels contain false or misleading information; an unapproved new drug ...

HACCP

 

Hazard Analysis Critical Control Point is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished ...

Registration & Listings

 

Companies in pursuit of selling products in the U.S. should be registered with the FDA. In addition, certain products are required to be listed with FDA prior to being sold in the U.S. The FDA currently only accepts registration and product listing on their electronic system ...
 

Label Review & Design

 

The FDA has strict regulations on the content and the form of labeling, including labels on foods, cosmetics, dietary supplements and drugs. The Federal Trade Commission (FTC) regulates all types of advertisement and given that labels are a unique form of advertisement ...

Red & Green Lists, Import Alerts

Import alerts inform FDA field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of FDA laws and regulations.  These violations could be related to the product, manufacturer, shipper ...

VQIP                                               

The FDA Food Safety Modernization Act (FSMA) enables the Food and Drug Administration (FDA or the Agency) to better protect public health by helping to ensure the safety and security of the food supply. FSMA also requires FDA to establish a voluntary, fee-based program for the expedited review ...

New Product Development

 

Compliance with federal and state regulations should be taken into consideration starting from the beginning of the product evaluation and development process.  At FDAeasy.com, we initially discuss with our clients how they want their product to be regulated and then our ...
 

Proposition 65             

 

California established Proposition 65, also known as “Prop 65” or the Safe Drinking Water and Toxic Enforcement Act of 1986. Prop 65 requires businesses to publish clear and reasonable warning on any significant amount of chemicals in their products known to cause cancer ...