Food and Drug Safety in America

We gain insight into food regulation with Joan Sylvain Baughan; her combination of international experience and degrees in microbiology and medical technology enhances her ability to assist clients with matters involving the safety and regulatory status of materials used in contact with food, drugs, and medical devices globally. She speaks on the American regulations regarding food and drugs and how this differs in other jurisdictions.


Have regulations into food health and safety tightened since you first began practicing law?

My practice focuses on the regulation of materials used in contact with food and drugs. This is a very specific area, which has evolved and changed dramatically since I first began practicing law. In the United States, the way in which the Food and Drug Administration (FDA) regulates food-contact materials has moved from a system of notice and comment rulemaking to a Food Contact Notification (FCN) system. The FCN System is far more efficient and effective, and it offers a faster path to regulatory clearances for food-contact materials; however, FCNclearances are proprietary, so that a FCN clearance is only valid for the manufacturer identified in the FCN (and that manufacturer’s customers). This system enables FDA to review information on each individual manufacturer’s process to ensure safety.


How does this compare to other countries surrounding the US? Do you think any regulations should be adopted in the US?

During this same time frame, the authorities in other jurisdictions throughout the world (the European Union (EU), China, Japan, Korea, South America, etc.) have been developing and/or updating their own systems for regulating food-contact materials. Many of these jurisdictions previously had no specific regulations in this area, and most are looking to the US FDA as a source of guidance in determining the criteria to use when evaluating the safety of materials for use in contact with food. For the most part, however, while applying similar safety criteria, other countries have not adopted the same type of proprietary system adopted under FDA’s FCN program. Rather, other countries still tend to implement a system of adopting generic clearances for food-contact materials by way of “positive lists” of permitted substances that apply to all manufacturers.


What issues do you commonly deal with in the food health and safety sectors?

A common issue in the food-contact area is the problem of public perception, or misunderstanding, of the safety of certain materials for food-contact use. Rather than relying on sound science to determine whether something is safe for its intended use, all too often we see reliance on unsupported assertions designed to frighten consumers. In the United States, FDA recently amended its regulation on the eligibility criteria for substances that may be considered ‘Generally Recognised as Safe’ (GRAS). The new rule updates and clarifies the types of scientific data and information that can properly be relied upon to support a GRAS determination for the use of a given material. While it’s unlikely that the general public will apply (or even be aware of) these criteria, those in the regulated industry have the benefit of understanding FDA’s thinking in this regard, which focuses on correctly applying scientific principles.


What can companies do to reduce the chances of them being involved in cases involving the said issues above?

Evaluating the safety of and establishing a suitable regulatory status for the intended use of a food-contact material early in the product development stage, maintaining excellent records, and properly communicating regulatory compliance information along the supply chain are the best ways to avoid problems.


How different are the EU regulations in comparison to the FDA’s? Are there any regulations you think the FDA should adopt from the EU?

Both the EU and the US FDA have adopted systems that are based on safety, but the way in which this is achieved is vastly different in the two jurisdictions. At the risk of over-simplifying, both jurisdictions look at the amount of a particular substance that may migrate from a food-contact material into food, but the data needed to assess the potential for migration, and the corresponding toxicology data needed to support the safety of the substance for the intended use, differ. The “form” of the ultimate decision to permit the use of a particular material differs, as well (as mentioned above, the EU has a generic ‘positive list’ system while the US FDA now regulates new food-contact materials by way of a proprietary food-contact notification system). I can’t say that either jurisdiction should adopt regulations from the other, but I would certainly support a joint effort to harmonise the requirements worldwide.


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