Industry Challenges to Implementation of Rules Resulting from FSMA

Multiple rules have been proposed as a result of the Food Safety Modernization Act (FSMA), which have been published by FDA to ensure the quality of the foods and food ingredients used to manufacture dietary supplements. FDA has conducted open industry meetings in strategic locations across the United States to explain these upcoming rule changes to the affected industries and consumers at large. The dietary supplement industry must be aware of how these new food rules will impact the industry as the potential effects are profound.

The first major impact is the proposed rule entitled, Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, commonly referred to as “Preventive Controls." It is believed this rule will incorporate, expand upon and replace 21 CFR Part 110, Food Current Good Manufacturing Practices (cGMPs), and be known as 21 CFR Part 117. In this new rule, FSMA mandates comprehensive preventive controls across the food chain. Each covered facility would be required to implement a written food safety plan that focuses on preventing hazards in food. It also updates the CFR 110 regulations to include more prescriptive requirements for sanitation practices and includes hazard analysis and critical control points (HACCP)-like principles.

The food safety plan would include hazard analyses, preventive controls, monitoring procedures, corrective action plans, verification procedures and a written recall plan. The requirement for qualified individuals to write the safety plan and to implement these practices is key to the satisfactory implementation of this new rule. The proposed rule itself calls for the personnel to be qualified according to training approved by FDA.

In general, dietary supplement manufacturers are exempt from the rules of Part 117, provided they are compliant with 21 CFR Part 111, Dietary Supplement cGMPs. On the contrary, the ingredient manufacturers that supply the dietary supplement manufacturers would fall under Part 117, since it is intended to replace Part 110. In this respect, dietary supplement manufacturers would have a responsibility to oversee their suppliers to ensure they are compliant with the food safety regulations that apply to their operations. Otherwise, the dietary supplements manufactured from non-compliant ingredients would be adulterated within the meaning of the act.

The second FSMA regulation that would significantly impact the food and dietary supplement sectors will be the Foreign Supplier Verification Program (FSVP). Compliance would be required of the importers of food for humans and animals.

Under this proposed rule, importers would be required to perform certain risk-based activities to verify that food and ingredients imported into the United States have been produced utilizing methods that would ensure their safety. The minimum requirement would be that foods meet the same level of assurance expected from domestically produced food or ingredients. Even though FSMA provided increased inspections of foreign food facilities, FDA was also given authority to develop regulations that would require foreign suppliers to share the responsibility and be accountable for food safety.

Importers would be required to establish and follow a FSVP. The importer could be the U.S. owner or consignee of the food or ingredient at the time of entry. The importer could also be a U.S. agent, or representative of the foreign product owner or consignee. Under this proposed rule, an importer would be required to develop, maintain and follow an FSVP for each food it imports. The FSVP requires the importer to review the status of compliance of the food and the potential foreign supplier before importing the food. The FSVP would also include a hazard analysis that identifies the likelihood of potential hazards for each food imported. The importer must evaluate the severity of the illness or injury if such hazard occurs. The FSVP would include written verification activities, such as auditing, lot-by-lot sampling and testing and periodic review of safety records.

Importers would be required to have a written corrective action plan. The corrective action plan would include review of complaints, investigation of root causes, and plans to review and revise the FSVPs as necessary. Importers would be required to obtain a Dun and Bradstreet number. The number must be electronically provided for each offering when filing for entry with U.S. Customs and Border Protection. Importers would be required to keep certain records including those that document compliance status reviews, hazard analyses, foreign supplier verification activities, investigations, corrective actions and FSVP reassessments.

The proposed rule for foreign supplier verification contains modified requirements for dietary supplement products and ingredients. Foreign suppliers of dietary supplement ingredients and dietary supplements may not have to comply with hazard analyses and supplier verification activities providing they are compliant with dietary supplement cGMPs Part 111. Importers would be required to provide written assurance that they are in compliance with these regulations. Importers of finished dietary supplements (packaged and labeled for retail sale) are required to comply with all parts of the FSVP.

Finally, the U.S. dietary supplement manufacturer or distributor of finished products would have a responsibility to oversee the importer or foreign manufacturer to ensure the requirements of the FSVP have been followed. Otherwise, the food or dietary supplement would be held in customs or deemed adulterated should the product find its way into the United States.

As with the “Preventive Controls" proposed rule, the FSVP proposal also has an expected finalization date of October 2015. It is imperative that the food and dietary supplement industries both become intimately familiar with the requirements of these proposed rules. Compliance on both sides will be necessary in order to bring safe, unadulterated products to the U.S. marketplace.

Join Joy Joseph, president of Joys Quality Management Systems, at SupplySide West, Mandalay Bay, Las Vegas, as she outlines the impact of FSMA proposed rules upon 21 CFR Part 110. The session, “Ensuring Food Safety: Industry Challenges to Implementation of New Rules Resulting from FSMA," will take place on Tuesday, Oct. 7, from 3 to 3:50 p.m.

Joy Joseph is the president of Joys Quality Management Systems, which specializes in GMP implementation through training programs and facility auditing.