FSMA Gives FDA Recall Authority Over Adulterated Food and Broadens Standards for Food Detention

Why Should You Attend:

One of the fundamental changes by FSMA in FDA’s authority is the agency’s ability to require recall of a food product which FDA considers to be adulterated or misbranded in a way that there is a reasonable probability that the product will cause serious adverse health consequences or death to humans or animals.

Historically, FDA has not been able to require recall of food products, unlike drugs and medical devices. For the first time, FSMA gives FDA authority to require recall of a food product which the agency considers to present a reasonable probability of adverse effect on public health. FSMA also has expanded the category of food which is subject to administrative detention.

This webinar will help attendees stay informed concerning the procedures applicable to FDA with respect to mandatory food recalls. Attendees will also learn industry options for responding to a proposed FDA recall.

Areas Covered in the Webinar:

• FSMA change from historic practice on food recalls
• FSMA recall procedure
• Industry options
• Change of FDA Administrative Detention Standards under FSMA

Who Will Benefit:

• Quality and Compliance Personnel
• Regulatory Personnel
• Grocery Manufacturers Association (GMA)
• Small and Mid-Sized Business Owners

Instructor Profile:

Ralph A. Simmons has over 35 years of experience in FDA regulation of food, and related products such as direct food additives, and food-contact substances. This experience has included the representation of companies with FDA-regulated products and experience as a senior policy advisor within FDA. The experience in FDA included work on regulations to implement FSMA.

Mr. Simmons has extensive experience in working with FDA on FSMA regulations and regulations in related areas, such as direct food additives and food-contact substances. This experience has included representing industry in negotiations with FDA, which avoided having food-contact material suppliers being registered under FDA’s program of registration of food facilities, located domestically and internationally.

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