United States Food Regulation

Sabal Food Safety Consulting is an institution dedicated to provide support to the food and beverage processing and manufacturing industry. We have “hands-on experience” that allows us to understand the hazards and their risks associated with your processes and, identify, develop and implement procedures to control them effectively. More than 25 years consulting, training and auditing processing and manufacturing facilities around the world. We know and understand your responsibilities and liabilities! The following paragraph is a brief summary of the consequences you might be subject if not in compliance with the requirements of the law.

The food and beverage industry is heavily regulated and enforcement is increasing exponentially mainly due to the development of the federal Food Safety Modernization Act (FSMA) signed by President on January 4th, 2011. Are you aware that the FDA has now the power to order you to recall your products? Are you aware that, under the new FSMA, the FDA will charge hourly fees during the investigation and follow up of a recall or withdrawal and the time is calculated by them? Are you aware that, Under Section 333(a) of the Food, Drug and Cosmetic Act (FDCA), “any person who violates the prohibition on introducing adulterated food into interstate commerce may be found guilty of a misdemeanor” by a court and can be imprisoned? This is the essence of the “Park Doctrine”, a legal principle that takes its name from a 1975 Supreme Court case, United States v. Park. The Supreme Court held that a corporate official may be found guilty of a criminal violation of the FDCA Section 333(a) if the official was in a position to prevent or correct the violation, even if the official did not know that the company was violating the Act! Have you assessed the cost involved in a recall of your products? Have you thought about the damage to your brand and the potential to lose your customers and go out of business due to a recall? The way to reduce to a minimum any of the previous mentioned risks relies on having an effective Food Safety Management System that was developed for your specific needs following current regulation. Developing and implementing Pre-Requisite Programs following current Good Manufacturing Practices (21 CFR 110) and the development, implementation and verification of an effective Hazards Analysis and Critical Control Points (HACCP) system will help you accomplish a safe, reliable and replicable process. Here is when selecting your consultant, auditor and trainer is of extreme importance and the reason why selecting Sabal Food Safety Consulting will make a difference among other companies providing these same services.